Podcasts about Innovation Act

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Best podcasts about Innovation Act

Latest podcast episodes about Innovation Act

Prescription for Better Access
Biosimilar's Role in Improving Patient Access

Prescription for Better Access

Play Episode Listen Later Feb 27, 2024 42:34


Biosimilars are entering the market at their fastest pace ever. In this episode, we interview a renowned health economist and an expert consultant in biosimilar distribution and patient support to explore the complex landscape of biosimilars, including examining the hurdles and breakthroughs in achieving acceptance by payers and providers and how best to improve patient access and affordability in a market dominated by established brands. Dr. Jason Shafrin, Senior Managing Director, Center for Healthcare Economics and Policy at FTI Consulting Marina Allen, SVP, Fingerpaint Market Access, Patient Support & Access Strategy Leader in Pharma-Biotech Biosimilars The Biologics Price Competition and Innovation Act of 2009 PBMs (Pharmacy Benefit Managers) Medicare Advantage Humira (biosimilars) 340B program Inflation Reduction Act Medicare Part D "brown bagging and white bagging" Mark Cuban (CostPlusDrugs) GoodRx average sales price (ASP) electronic health record (EHR) system Questions or comments?Email us at comments@prescriptionforbetteraccess.com.Find us on social media! Follow us on X, LinkedIn, YouTube and Threads.

Steve Blank Podcast
The Department of Defense Is Getting Its Innovation Act Together – But More Can Be Done

Steve Blank Podcast

Play Episode Listen Later Jan 17, 2024 8:26


Despite the clear and present danger of threats from China and elsewhere, there's no agreement on what types of adversaries we'll face; how we'll fight, organize, and train; and what weapons or systems we'll need for future fights. Instead, developing a new doctrine to deal with these new issues is fraught with disagreements, differing objectives, and incumbents who defend the status quo. Yet change in military doctrine is coming. Deputy Defense Secretary Kathleen Hicks is navigating the tightrope of competing interests to make it happen – hopefully in time.

AiArthritis Voices 360 Podcast
#360it: Medicare Drug Price Negotiation: How Will it Affect Patient Access?

AiArthritis Voices 360 Podcast

Play Episode Listen Later Jan 5, 2024 62:52


This episode is a 360it revisiting the topics put on the table during Episode 88 : Biosimilars - Interchangeability & Switching 2023   Join us in this breakout 360it from Episode 88 Biosimilars : Interchangeability & Switching 2023 as we dissect the Inflation Reduction Act (IRA) and its potential fallout on patient access to diverse treatment plans. Tracing the historical trajectory of the IRA, we uncover its role in price negotiations and the concerning shift in investments away from critical drugs tailored for specific diseases. This reallocation poses a tangible threat to the availability and diversity of treatments, including for those living with AiArthritis diseases. As we dive into the landscape of healthcare policy, the discussion emphasizes the pressing need for IRA improvements to consider the long term well-being of patients. Without these crucial enhancements, we will have a future with not only fewer innovative treatments but potentially less treatment options available.    Join us in fighting for improvements to the IRA and patient involvement in treatment access.   Episode Highlights :  The history of Medicare Part D and its positive impact on healthcare What is the Inflation Reduction Act Why the IRA price negotiations are important to understand and how it will affect your treatment access  How healthcare R&D will be negatively impacted by the IRA price negotiations  Consequences to Patients of Drug Price-Setting Policies for patients How can patients get involved in the IRA price negotiations  How the IRA will disincentivize small molecule drugs and indications for treatment plans    Resources Mentioned In This Episode: AiArthritis Biosimilars Hotline: https://www.aiarthritis.org/biosimilars  EMA - What Is A Biosimilar : https://www.ema.europa.eu/en/human-regulatory/overview/biosimilar-medicines-overview ASBM Statement on CMS drugs list announcement - https://safebiologics.org/medicare-price-negotiations-will-jeopardize-patient-access-to-new-medicines-result-in-worse-health-outcomes/ ASBM webinar on IRA - https://safebiologics.org/july-26-webinar-on-ira-medicare-price-negotiations/ An educational microsite for patients to learn more and read news articles -  www.IRAPatientInfo.org    Meet Our Co-Hosts & Guests:  Tiffany is the CEO at International Foundation for AiArthritis and uses her professional expertise in mind-mapping and problem solving to help others, like her, who live with AiArthritis diseases work in unison to identify and solve unresolved community issues. Connect with Tiffany: Facebook: @tiffanyAiArthritis Twitter: @TiffWRobertson LinkedIn: @TiffanyWestrichRobertson   Andrew Spiegel has nearly two decades of experience in the patient advocacy arena. Spiegel co-founded the Colorectal Cancer Alliance and was longtime board member of the Alliance became CEO in January of 2008 and ran the CCA for nearly 5 years, before undertaking his next venture, the Global Colon Cancer Association (GCCA).In addition to his work in the colon cancer community, Spiegel is an active advocate for health care policies both in the US and now worldwide. He is a co-founder and currently serves on the steering committee of the Alliance for Safe Biologic Medicines (ASBM). He is on the Board of Directors, and in December 2014 was elected to Chair, of the Digestive Disease National Coalition (DDNC),a founding member of the Coalition to Increase Clinical Trial Participation and in May of 2016 he began a three year term as a member of the Board of Directors of the International Alliance of Patient Organizations (IAPO) where he chaired the fundraising committee. Spiegel has won multiple awards for his work in patient advocacy.   Michael Reilly, Executive Director of Alliance for Safe Biologic Medicines, has served as the executive director of ASBM since its inception in 2010. He has more than a decade of experience in the federal government developing and implementing healthcare policy. Mr. Reilly served as the associate deputy secretary at the U.S. Department of Health and Human Services (HHS) from 2005-2008 responsible for policy development and implementation, as well as regulatory oversight for issues involving CMS and the FDA. In addition to serving as the associate deputy secretary, Mr. Reilly served as a senior advisor to the assistant secretary for public affairs and the assistant secretary for planning and evaluation at HHS from 2002-2005. Mr. Reilly has been quoted in a series of FDA publications and co-authored many articles on biosimilars for the Generics and Biosimilars Initiative Journal. He has also presented to health regulators worldwide, including the Australian TGA, Health Canada and the World Health Organization (WHO).   Charles M Clapton. Mr Clapton has nearly two decades of Capitol Hill experience, Notably, he served as health policy director for the Senate Committee on Health, Education, Labor, and Pensions, aiding the passage of the FDA Safety and Innovation Act (2012). He also played a pivotal role as a lead Republican staffer during the Affordable Care Act's congressional deliberations. He also impacted the House Ways & Means and Energy & Commerce Committees by shaping Medicare Part D prescription drug benefits, revise drug payment methods for Medicare Part B, and Medicaid changes in the Deficit Reduction Act of 2005.   Thomas Barker represents healthcare providers and payers before the Centers for Medicare & Medicaid Services (CMS) and other components of the Department of Health and Human Services (HHS), Congress, and the Department of Labor. Tom is a former commissioner of the Medicaid and CHIP Payment and Access Commission (MACPAC), an advisory body that provides policy advice to Congress and the states on the Medicaid and CHIP programs. He is one of the authors of the firm's Medicaid & the Law blog, www.medicaidandthelaw.com, which highlights and explains current legal and policy issues in the Medicaid program. Donate to Support the Show: https://www.aiarthritis.org/donate  Sign up for our Monthly AiArthritis Voices 360 Talk Show newsletter! HERE AiArthritis Voices 360 is produced by the International Foundation for Autoimmune and Autoinflammatory Arthritis. Visit us on the web at www.aiarthritis.org/talkshow. Find us on Twitter, Instagram, TikTok, or Facebook (@IFAiArthritis) or email us (podcast@aiarthritis.org).  Be sure to check out our top-rated show on Feedspot!

Citizens' Climate Lobby
CCL Training: The Energy Innovation Act Is Back!

Citizens' Climate Lobby

Play Episode Listen Later Sep 29, 2023 36:39


BIG NEWS! Rep. Salud Carbajal (D-CA-24) just reintroduced the Energy Innovation and Carbon Dividend Act (H.R.5744) in the U.S. House of Representatives this week!  Join CCL Staff for an all-volunteer webinar to get the details around the legislation this session and how you can take action and build support for the policy in your community and in Congress.  The Energy Innovation Act is a carbon fee and dividend bill — and it's pretty much our favorite climate policy ever. Polluters shouldn't use the air as a trash can. A policy like this charges polluters a fee for the carbon pollution they put into our air. The money collected goes to Americans in the form of a monthly “carbon cashback” payment to keep things affordable. Skip ahead to the following section(s): (0:00) Intro & agenda (1:17) Legislative and policy overview (9:25) Data behind the main benefits  (15:57) Talking about Energy Innovation Act (19:03) Get active in your community (33:10) Closing & a reminder of who we are More Resources: Presentation Slides: https://cclusa.org/reintro23  Take Action Write Congress: https://cclusa.org/energy   Energy Innovation Act Training Topic Page: https://community.citizensclimate.org/topics/energy-innovation-act   Energy Innovation Act Resource Directory: https://community.citizensclimate.org/resources#energy-innovation-act   Data Sources: https://energyinnovationact.org/data-sources  Questions? https://cclusa.org/forums  Share on Social Media: https://cclusa.org/stw   

Medscape InDiscussion: Psoriatic Arthritis
S3 Episode 5: New on the Market: Why Use Psoriatic Arthritis Biosimilars?

Medscape InDiscussion: Psoriatic Arthritis

Play Episode Listen Later Jun 22, 2023 22:48


Join Drs Stanley Cohen and Jonathan Kay as they discuss biosimilars in PsA, which will hit the US market this summer. They cover everything from working with your pharmacy to counseling patients. Relevant disclosures can be found with the episode show notes on Medscape (https://www.medscape.com/viewarticle/984272). The topics and discussions are planned, produced, and reviewed independently of advertisers. This podcast is intended only for US healthcare professionals. Resources Psoriatic Arthritis https://emedicine.medscape.com/article/2196539-overview Biosimilars for the Treatment of Psoriatic Arthritis https://pubmed.ncbi.nlm.nih.gov/31625769/ Biosimilars and the Extrapolation of Indications for Inflammatory Conditions https://pubmed.ncbi.nlm.nih.gov/28255229/ Adalimumab (Rx) https://reference.medscape.com/drug/amjevita-humira-adalimumab-343187 Comparison of Skindex-29, Dermatology Life Quality Index, Psoriasis Disability Index and Medical Outcome Study Short Form 36 in Patients With Mild to Severe Psoriasis https://pubmed.ncbi.nlm.nih.gov/22229951/ Infliximab (Rx) https://reference.medscape.com/drug/remicade-inflectra-infliximab-343202 Rituximab (Rx) https://reference.medscape.com/drug/rituxan-truxima-rituximab-342243 Subcutaneous Injection of Drugs: Literature Review of Factors Influencing Pain Sensation at the Injection Site https://pubmed.ncbi.nlm.nih.gov/31587143/ Biosimilars to Bring a Bumper Crop of Adalimumab Options https://www.centerforbiosimilars.com/view/part-1-biosimilars-to-bring-a-bumper-crop-of-adalimumab-options The Difference Between an Interchangeable Biosimilar and One That Isn't https://www.centerforbiosimilars.com/view/the-difference-between-an-interchangeable-biosimilar-and-one-that-isn-t The Non-Medical Switching of Prescription Medications https://pubmed.ncbi.nlm.nih.gov/31081414/ Implementation of the Biologics Price Competition and Innovation Act of 2009 https://www.fda.gov/drugs/guidance-compliance-regulatory-information/implementation-biologics-price-competition-and-innovation-act-2009 Systematic Review on the Use of Biosimilars of Trastuzumab in HER2+ Breast Cancer https://pubmed.ncbi.nlm.nih.gov/36009592/ Certolizumab pegol (Rx) https://reference.medscape.com/drug/cimzia-certolizumab-pegol-343185

The Crypto Overnighter
408:Financial Services Innovation Act::FTX Donations Clawed Back?::Waves Announces New Stablecoin::Uniswap Partners with Moonpay::Terra-related Funds Frozen::Blockfi Wallet Accounts

The Crypto Overnighter

Play Episode Listen Later Dec 21, 2022 14:27


Heya Cryptozens, Episode 408: Financial Services Innovation Act FTX Donations Clawed Back? Waves Announces New Stablecoin Uniswap Partners with Moonpay Blockfi Wallet Accounts It's 10 PM Pacific time and the date is December 20th, 2022. Welcome back to the Crypto Overnighter. My name is Nikodemus, I'll be your host as we take a nightly look at the crypto, nft and metaverse space and the industry that surrounds it. And keep in mind, nothing in this show should ever be considered financial advice.  Email: nick@cryptoovernighter.com Salem Friends of Felines: https://sfof.org/ Twitter: https://twitter.com/CryptoCorvus1

Congressional Dish
CD259: CHIPS: A State Subsidization of Industry

Congressional Dish

Play Episode Listen Later Sep 23, 2022 83:53 Very Popular


A new law, known as the CHIPS Act, provides over $50 billion to existing, profitable companies to fund new semiconductor production facilities in the United States. In this episode, we examine why Congress decided to gift these companies our tax money now and explore the geopolitical implications of this funding decision. Beyond semiconductors, the law provides further corporate welfare for the creation of things that many of us tax payers likely support. This law is complicated; let's get nuanced. Please Support Congressional Dish – Quick Links Contribute monthly or a lump sum via PayPal Support Congressional Dish via Patreon (donations per episode) Send Zelle payments to: Donation@congressionaldish.com Send Venmo payments to: @Jennifer-Briney Send Cash App payments to: $CongressionalDish or Donation@congressionaldish.com Use your bank's online bill pay function to mail contributions to: 5753 Hwy 85 North, Number 4576, Crestview, FL 32536. Please make checks payable to Congressional Dish Thank you for supporting truly independent media! View the show notes on our website at https://www.congressionaldish.com/cd259-chips-a-state-subsidization-of-industry Background Sources Recommended Congressional Dish Episodes CD230: Pacific Deterrence Initiative CD218: Minerals are the New Oil CD215: COVID-19 Testimony CD205: Nuclear Waste Storage CD187: Combating China CD186: National Endowment for Democracy CD128: Crisis in Puerto Rico Semiconductor Industry “Pass the CHIPS Act of 2022 Fact Sheet.” July 2022. Semiconductor Industry Association. “Global Semiconductor Incentives.” February 2022. Semiconductor Industry Association. “2021 State of the U.S. Semiconductor Industry.” September 2021. Semiconductor Industry Association. Taiwan Bansari Mayur Kamdar and Medha Singh. Aug 2, 2022. “Chip stocks slip as Taiwan tensions mount.” Reuters. Karen M. Sutter. Mar 7, 2022. “U.S.-Taiwan Trade Relations” [IF10256]. Congressional Research Service. Yimou Lee, Norihiko Shirouzu and David Lague. Dec 27, 2021. “T-DAY: The Battle for Taiwan.” Reuters. PRISM Program Derek B. Johnson. Aug 27, 2018. “Court case puts PRISM back in the spotlight.” FCW. Wealthy Shareholders Juliana Kaplan and Andy Kiersz. Oct 19, 2021. “The wealthiest Americans now own almost all of the stock market — 89% to be exact.” Insider. National Endowment for Democracy “Board of Directors.” National Endowment for Democracy. National Science Foundation Directorate Mitch Ambrose. Mar 17, 2022. “NSF Stands Up Directorate for Technology, Innovation, and Partnerships.” American Institute of Physics. “Chairwoman Johnson and Ranking Member Lucas Welcome NSF Director Panchanathan's Announcement of New Directorate Aligned with Bipartisan Committee Proposal.” Mar 17, 2022. House Committee on Science, Space, and Technology. Fusion Research “Nuclear Fission and Fusion.” Diffen. “Client Profile: Commonwealth Fusion Systems: Summary.” Open Secrets. “Client Profile: Commonwealth Fusion Systems: Lobbyists.” Open Secrets. “Barton Gordon: Partner. K&L Gates. American Exception Book Aaron Good. 2022. American Exception: Empire and the Deep State. Skyhorse Publishing. The Law H.R. 4346: CHIPS Act of 2022 / Research and Development, Competition, and Innovation Act / Supreme Court Security Funding Act of 2022 GovTrack Overview Congressional Budget Office: Estimated Budgetary Effects of H.R. 4346 Bills Later Added to the CHIPS Act S. 3740: Micro Act of 2022 The one hearing H.R. 4863: Partnerships for Energy Security and Innovation Act S. 1359: Partnerships for Energy Security and Innovation Act of 2021 Audio Sources President Biden on Taiwan Sept 18, 2022 60 Minutes Scott Pelley: What should Chinese President Xi know about your commitment to Taiwan? President Joe Biden: We agree with what we signed on to a long time ago, that there's a One China policy and Taiwan makes their own judgments about their independence. We are not moving, we're not encouraging their being independent. That's their decision. Scott Pelley: But would US forces defend the island? President Joe Biden: Yes, if in fact, there was an unprecedented attack. Scott Pelley: [overdub] After our interview, a White House official told us US policy has not changed. Officially, the US will not say whether American forces would defend Taiwan. But the Commander in Chief had a view of his own. [interview] So unlike Ukraine, to be clear, sir, US forces, US men and women would defend Taiwan in the event of a Chinese invasion? President Joe Biden: Yes. Senator Bernie Sanders' Senate Session Speech Jul 27, 2022 Jen's Highlighted PDF The Future of U.S. Policy on Taiwan Dec 8, 2021 Senate Committee on Foreign Affairs 30:45 Sen. James Risch (R-ID): A unilateral change in the status quo regarding Taiwan would not only threaten the security and liberty of 23 million Taiwanese, but also significantly damage vital US interests and alliances in the Indo Pacific. We would lose a model of democracy at a time of creeping authoritarianism. It would give China a platform in the first island chain to dominate the Western Pacific and threaten, indeed, US homeland. The consequences for Japan security, and therefore, the US-Japan alliance, are hard to overstate. Semiconductor supply chains would fall into China's hands, and it would emboldened China in other territorial disputes, including with India, and in the South China Sea. Fostering a New Era of Fusion Energy Research and Technology Development November 17, 2021 House Committee on Science, Space, and Technology, Subcommittee on Energy Witnesses: Dr. Troy Carter, Director, Plasma Science and Technology Institute, University of California, Los Angeles and Chair, Fusion Energy Sciences Advisory Committee Long Range Planning Subcommittee Dr. Tammy Ma, Program Element Leader for High Energy Density Science, Lawrence Livermore National Laboratory Dr. Robert Mumgaard, CEO, Commonwealth Fusion Systems Dr. Kathryn McCarthy, Director, U.S. ITER Project Office Dr. Steven Cowley, Director, Princeton Plasma Physics Laboratory Clips Robert Mumgaard: However, from where I sit, I see three reasons why I'm very optimistic the US can create a definitive lead in this new industry. First, the growth of the private sector. Over $2.4 billion in private capital has been invested in the fusion companies that now number nearly 30. This is a similar amount of capital as in all the nuclear fission small modular reactor companies. This is coming from a large range of investors across venture capitalists, to university endowments, to large energy companies. And they're putting capital at risk in fusion because they understand that the world needs a fundamentally new source of clean energy if we are going to meet our decarbonization goals. And these companies are highly ambitious, with a recent survey stating that 84% of them believe that fusion will be on the grid in the 2030s or earlier. Robert Mumgaard: We will proceed with the commercialization of our first fusion pilot plant called ARC. We hope to have that online in the early 2030s. Robert Mumgaard: The second reason I'm optimistic is that the public program has produced a consensus plan. Detailed in the National Academies and FESAC (Fusion Energy Sciences Advisory Committee) Recommendations is a transition of the public funded program towards the US developing commercial energy. We need to stop some activities and transition to others. But the researchers are enthusiastic and they are ready. We have a new generation of leaders at national laboratories and universities hungry to develop that technology. And that plan has been authorized but has not yet been implemented. Robert Mumgaard: And we're not alone. The other companies like TAE and General Fusion, Helion, Tokamak Energy, are looking at similar timeframes and experiencing similar growth. All these companies are looking to see which governments are going to be the best partners. And unfortunately, we are already seeing defections, with a major facility that could have been built in the US, instead being built in the UK. It'd be much better if the US public program leveraged the private sector, aligning with the technical goals and timelines to keep it happening here. Robert Mumgaard: The third reason I'm hopeful is the movement towards public private partnerships and we know that when the public and private sectors work together and recognize what each side is good at, we create vibrant ecosystems. We saw this in commercial space, with NASA and SpaceX. We saw it even more recently with the COVID-19 vaccine Supply Chain Integrity October 1, 2020 Senate Committee on Armed Services, Subcommittee on Readiness and Management Support Watch on CSPAN Witness: Ellen M. Lord, Under Secretary of Defense for Acquisition and Sustainment 1:22:10 Ellen Lord: I believe there may well be a lot of this, frankly: not continuing to engage with these Chinese companies on sensitive issues, but in turn, developing industrial bases here that makes us not reliant on that back and forth. There's quite a bit of discussion within the inner agency right now about constraining Chinese involvement from everything from investments to specific commodities. But again, I think one of the areas where we could have the most impact on China broadly, is reshoring microelectronics. And right now, my team is working very closely across DOD, as well as the inner agency to come up with a very specific recommendation for some public-private partnerships in order to develop the capability here domestically. We at DOD are only about 1% of the overall microelectronics market, however, we have some critical needs. Attorney General Barr's Remarks on China Policy at the Gerald R. Ford Presidential Museum July 16, 2020 15:20 Attorney General Bill Barr: “Made in China 2025” is the latest iteration of the PRC's state-led, mercantilist economic model. For American companies in the global marketplace, free and fair competition with China has long been a fantasy. To tilt the playing field to its advantage, China's communist government has perfected a wide array of predatory and often unlawful tactics: currency manipulation, tariffs, quotas, state-led strategic investment and acquisitions, theft and forced transfer of intellectual property, state subsidies, dumping, cyberattacks, and industrial espionage. Cover Art Design by Only Child Imaginations Music Presented in This Episode Intro & Exit: Tired of Being Lied To by David Ippolito (found on Music Alley by mevio)

OnCall
Biosimilar Series: Part 3

OnCall

Play Episode Play 37 sec Highlight Listen Later Aug 24, 2022 9:45


In this episode, the third of our biosimilar education series, Neil Udovich spoke with Kathy Oubre, CEO of Pontchartrain Cancer Center, about the FDA approval process for biosimilars, the Biologics Price Competition and Innovation Act and safety issues or adverse effects related to biosimilar use. If you have any questions for our guests or have a topic you would like to learn more about, email us at OnCallGPO@gmail.com. 

America's Work Force Union Podcast
Bill Samuel (AFL-CIO) / John Rizzo (IBEW Local 1220)

America's Work Force Union Podcast

Play Episode Listen Later Jun 28, 2022 54:40


Bill Samuel, Government Affairs Director for the AFL-CIO, joined the America's Work Force Union Podcast and discussed how the Innovation Act, if passed, could create a renaissance for U.S. manufacturing. He also talked about the PRO Act and proposed legislation to increase the National Labor Relations Board budget by $300 million.   IBEW Local 1220 Business Manager John Rizzo appeared on the AWF Union Podcast and spoke about an upcoming union election at Intelligentsia Coffee to join Local 1220 and the results of a strike at Chicago's Public Broadcasting Service, WTTW.

Business Forward
Briefing: National Institute of Standards and Technology (NIST) on the Bipartisan Innovation Act

Business Forward

Play Episode Listen Later Jun 23, 2022 33:16


In this episode, Business Forward hosted a briefing with Dr. Laurie Locascio, Under Secretary of Commerce for Standards and Technology and Director of the National Institute of Standards and Technology (NIST), for a discussion on the Bipartisan Innovation Act. In her conversation with Business Forward Executive Director Liz Fairchild, Dr. Locascio answered tough questions on topics ranging from supply chains to diversity and inclusion in our innovation environment, and how business leaders can support the BIA. 

Long Reads Live
Sens. Cynthia Lummis and Kirsten Gillibrand on the Responsible Financial Innovation Act

Long Reads Live

Play Episode Listen Later Jun 14, 2022 21:50


This episode is sponsored by Nexo.io, NEAR and FTX US.    Today on “The Breakdown,” Sens. Cynthia Lummis and Kirsten Gillibrand join NLW to discuss their recently released Responsible Financial Innovation Act. They discuss: How Senator Gillibrand came to be interested in the topic.  How “ancillary assets” came to be defined for digital assets. The bill's approach to investor protections.  Stablecoins vs CBDCs.  And much more.   Find our guests on Twitter: @SenLummis @SenGillibrand - Nexo is an all-in-one platform where you can buy crypto with a bank card and earn up to 16% interest on your assets. On the platform you can also swap 300+ market pairs and borrow against your crypto from 0% APR. Sign up at nexo.io by June 30 and receive up to $150 in BTC. - NEAR is a blockchain for a world reimagined. Through simple, secure, and scalable technology, NEAR empowers millions to invent and explore new experiences. Business, creativity, and community are being reimagined for a more sustainable and inclusive future. Find out more at NEAR.org. - FTX US is the safe, regulated way to buy Bitcoin, ETH, SOL and other digital assets. Trade crypto with up to 85% lower fees than top competitors and trade ETH and SOL NFTs with no gas fees and subsidized gas on withdrawals. Sign up at FTX.US today. - Enjoying this content?   SUBSCRIBE to the Podcast Apple:  https://podcasts.apple.com/podcast/id1438693620?at=1000lSDb Spotify: https://open.spotify.com/show/538vuul1PuorUDwgkC8JWF?si=ddSvD-HST2e_E7wgxcjtfQ Google: https://podcasts.google.com/feed/aHR0cHM6Ly9ubHdjcnlwdG8ubGlic3luLmNvbS9yc3M=   Join the discussion: https://discord.gg/VrKRrfKCz8   Follow on Twitter: NLW: https://twitter.com/nlw Breakdown: https://twitter.com/BreakdownNLW - “The Breakdown” is written, produced by and features Nathaniel Whittemore aka NLW, with editing by Rob Mitchell, research by Scott Hill and additional production support by Eleanor Pahl. Jared Schwartz is our executive producer and our theme music is “Countdown” by Neon Beach. The music you heard today behind our sponsors is “Catnip” by Famous Cats and “I Don't Know How To Explain It” by Aaron Sprinkle. Image credit: Rob Mitchell/CoinDesk. Join the discussion at discord.gg/VrKRrfKCz8.

Late Confirmation by CoinDesk
BREAKDOWN: Sens. Cynthia Lummis and Kirsten Gillibrand on the Responsible Financial Innovation Act

Late Confirmation by CoinDesk

Play Episode Listen Later Jun 13, 2022 21:49 Very Popular


The senators discuss how the bill came together, and why crypto remains bipartisan. This episode is sponsored by Nexo.io, NEAR and FTX US. Today on “The Breakdown,” Sens. Cynthia Lummis and Kirsten Gillibrand join NLW to discuss their recently released Responsible Financial Innovation Act. They discuss:How Senator Gillibrand came to be interested in the topic. How “ancillary assets” came to be defined for digital assets.The bill's approach to investor protections. Stablecoins vs CBDCs. And much more. Find our guests on Twitter:@SenLummis@SenGillibrand-Nexo is an all-in-one platform where you can buy crypto with a bank card and earn up to 16% interest on your assets. On the platform you can also swap 300+ market pairs and borrow against your crypto from 0% APR. Sign up at nexo.io by June 30 and receive up to $150 in BTC.-NEAR is a blockchain for a world reimagined. Through simple, secure, and scalable technology, NEAR empowers millions to invent and explore new experiences. Business, creativity, and community are being reimagined for a more sustainable and inclusive future. Find out more at NEAR.org.-FTX US is the safe, regulated way to buy Bitcoin, ETH, SOL and other digital assets. Trade crypto with up to 85% lower fees than top competitors and trade ETH and SOL NFTs with no gas fees and subsidized gas on withdrawals. Sign up at FTX.US today.-“The Breakdown” is written, produced by and features Nathaniel Whittemore aka NLW, with editing by Rob Mitchell, research by Scott Hill and additional production support by Eleanor Pahl. Jared Schwartz is our executive producer and our theme music is “Countdown” by Neon Beach. The music you heard today behind our sponsors is “Catnip” by Famous Cats and “I Don't Know How To Explain It” by Aaron Sprinkle. Image credit: Rob Mitchell/CoinDesk. Join the discussion at discord.gg/VrKRrfKCz8.See Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.

The CryptoCeej
New Crypto Bill " Responsible Financial Innovation Act" This is a major game changer for crypto

The CryptoCeej

Play Episode Listen Later Jun 7, 2022 43:59


Senators Lummis and Gillibrand introduce their bi-partisan crypto bill. Addressing all digital assets --- This episode is sponsored by · Anchor: The easiest way to make a podcast. https://anchor.fm/app Support this podcast: https://anchor.fm/cryptoceej/support

America's Work Force Union Podcast
Bill Samuel (AFL-CIO) / Terry Newsome Jr (UA Local 72)

America's Work Force Union Podcast

Play Episode Listen Later May 26, 2022 54:40


Bill Samuel, Government Affairs Director for the AFL-CIO, joined the America's Work Force Union Podcast and discussed President Joe Biden's efforts to increase funding for the Occupational Safety and Health Administration (OSHA), the Innovation Act and President Biden's efforts to amend certain tariffs.   UA Local Union 72 Business Manager Terry Newsome Jr. appeared on the AWF Union Podcast and spoke about the excellent work opportunities for union members in Georgia due to the state's construction boom, along with efforts to grow the Local's apprenticeship program and expand the Local through organizing.

Citizens' Climate Lobby
CCR 71 Pets, African Wildlife, and Climate Change

Citizens' Climate Lobby

Play Episode Listen Later Apr 28, 2022 30:00


In this episode you will hear a lively conversation between our host, Peterson Toscano, and four South African veterinarians. Like many climate advocates, Peterson couldn't help himself, and asked Kristine and Roy Page along with their friends and fellow veterinarians Adrian and Ashleigh Tordiffe about climate change in South Africa and how it is affecting household pets and wild animals.  The conversation is rich, informed, and at times hilarious. You will learn about pets in South Africa, and about the many ways animal lovers everywhere can protect their pets from extreme heat, extreme cold, and vector-born illness spread by fleas and ticks. You will hear about the North American ticks that strikes fear in the hearts of all meat-loving South Africans.   Adrian is an academic and researches wildlife populations, and tells us about the adorable and very loud bush baby (also known as galago.) It is one of the very few nocturnal primate, and has two completely diets. In the rainy season it eats fruits and insects, and in the dry month it consumes plant gums produced by certain trees. Twice a year it has to completely transform its digestion system to accommodate its diet.  In addition to demonstrating the signature shrieking sounds the bush baby makes from high up in the trees, Adrian also tells us about how extreme heat and extended drought is making life harder for these amazing creatures.  Join Peterson for a beautiful summer day braai, on the back stoop of Roy and Kristine's home, as their many dogs roam around and the children play nearby. Joining the four veterinarians is Glen Retief, Peterson's husband, who grew up among wildlife in South Africa's Kruger National Park.  The Art House Krista Hiser is back with another installment of The Ultimate Cli-Fi Book Club. Every few months Krista Hiser shares with us her thoughts about climate-themed literature. This episode Krista looks at the 2010 satirical novel Solar by Ian McEwan.  Michael Beard is a Nobel prize–winning physicist whose best work is behind him. Trading on his reputation, he speaks for enormous fees, lends his name to the letterheads of renowned scientific institutions, and half-heartedly heads a government-backed initiative tackling global warming. While he coasts along in his professional life, Michael's personal life is another matter entirely. His fifth marriage is crumbling under the weight of his infidelities. But this time the tables are turned: His wife is having an affair, and Michael realizes he is still in love with her. When Michael's personal and professional lives begin to intersect in unexpected ways, an opportunity presents itself in the guise of an invitation to travel to New Mexico. Here is a chance for him to extricate himself from his marital problems, reinvigorate his career, and very possibly save the world from environmental disaster. Can a man who has made a mess of his life clean up the messes of humanity?  (Goodreads) Krista is also responding to a hard-hitting research paper Through the Eye of a Needle: An Eco-Heterodox Perspective on the Renewable Energy Transition by Megan K. Seibert and William E. Rees.  Abstract: This analysis makes clear that the pat notion of “affordable clean energy” views the world through a narrow keyhole that is blind to innumerable economic, ecological, and social costs. These undesirable “externalities” can no longer be ignored. To achieve sustainability and salvage civilization, society must embark on a planned, cooperative descent from an extreme state of overshoot in just a decade or two. While it might be easier for the proverbial camel to pass through the eye of a needle than for global society to succeed in this endeavor, history is replete with stellar achievements that have arisen only from a dogged pursuit of the seemingly impossible This research reveals just how tricky it is to take on climate change. It is a wicked problem with many moving parts we often do not want to see or acknowledge, but Krista encourages us to see the problems in their fullness so we respond with significant and effective solutions.  Dr. Krista Hiser is Sustainability Curriculum Coordinator for the University of Hawaii Office of Sustainability, where she facilitates change management, interdisciplinary dialogue, and professional development opportunities for faculty to design, update and transform courses to integrate sustainability across the curriculum. She serves on the advisory board for the Sustainability Curriculum Consortium (SCC) and on the Steering Committee for the Association for the Advancement of Sustainability in Higher Education (AASHE). You can read a written version of Krista's essay at The Ultimate Cli-Fi Book Club for Sustainability in Higher Education. You can hear standalone versions of The Art House at Artists and Climate Change.  Good News Report Our good news report comes from State College, PA, the home of Penn State University.   CCL volunteer Dick Jones and the State College CCL chapter is pleased to report that State College Bureau Council unanimously passed a resolution calling on congress to pass Energy and Innovation Act. It is one of over 100 city councils to pass such a resolution including Allentown, Bethlehem, Harrisburg, Pittsburgh, and York, PA.    

Citizens Climate Radio
Ep 71 Pets, African Wildlife, and Climate Change

Citizens Climate Radio

Play Episode Listen Later Apr 28, 2022 30:00


In this episode you will hear a lively conversation between our host, Peterson Toscano, and four South African veterinarians. Like many climate advocates, Peterson couldn't help himself, and asked Kristine and Roy Page along with their friends and fellow veterinarians Adrian and Ashleigh Tordiffe about climate change in South Africa and how it is affecting household pets and wild animals. The conversation is rich, informed, and at times hilarious. You will learn about pets in South Africa, and about the many ways animal lovers everywhere can protect their pets from extreme heat, extreme cold, and vector-born illness spread by fleas and ticks. You will hear about the North American ticks that strikes fear in the hearts of all meat-loving South Africans. Adrian is an academic and researches wildlife populations, and tells us about the adorable and very loud bush baby (also known as galago.) It is one of the very few nocturnal primate, and has two completely diets. In the rainy season it eats fruits and insects, and in the dry month it consumes plant gums produced by certain trees. Twice a year it has to completely transform its digestion system to accommodate its diet. The Art House Krista Hiser is back with another installment of The Ultimate Cli-Fi Book Club. Every few months Krista Hiser shares with us her thoughts about climate-themed literature. This episode Krista looks at the 2010 satirical novel Solar by Ian McEwan. Krista is also responding to a hard-hitting research paper Through the Eye of a Needle: An Eco-Heterodox Perspective on the Renewable Energy Transition by Megan K. Seibert and William E. Rees. https://www.mdpi.com/1996-1073/14/15/4508 This research reveals just how tricky it is to take on climate change. It is a wicked problem with many moving parts we often do not want to see or acknowledge, but Krista encourages us to see the problems in their fullness so we respond with significant and effective solutions. Dr. Krista Hiser is Sustainability Curriculum Coordinator for the University of Hawaii Office of Sustainability, where she facilitates change management, interdisciplinary dialogue, and professional development opportunities for faculty to design, update and transform courses to integrate sustainability across the curriculum. She serves on the advisory board for the Sustainability Curriculum Consortium (SCC) and on the Steering Committee for the Association for the Advancement of Sustainability in Higher Education (AASHE). You can read a written version of Krista's essay at The Ultimate Cli-Fi Book Club for Sustainability in Higher Education. medium.com/the-ultimate-cli-fi…-for-sustainability You can hear standalone versions of The Art House at Artists and Climate Change. Good News Report Our good news report comes from State College, PA, the home of Penn State University.   CCL volunteer Dick Jones and the State College CCL chapter is pleased to report that State College Bureau Council unanimously passed a resolution calling on congress to pass Energy and Innovation Act. It is one of over 100 city councils to pass such a resolution including Allentown, Bethlehem, Harrisburg, Pittsburgh, and York, PA. If you have good news you want to share on the show, or if you have an idea for the art house, email Peterson. Radio @ CitizensClimate.org. Or leave a message our NEW listener voicemail (619) 512-9646

Ingrained
Episode 32: Momentum Grows for Sites Reservoir

Ingrained

Play Episode Listen Later Mar 29, 2022 11:01


A third straight drought year poses major challenges for California's environment, cities and farms. While cooperation, collaboration and innovation are needed in the short term, many feel a major part of the long-term water solution is additional storage. A remote area on the west side of the Sacramento Valley could be a big part of the solution. Sites Reservoir has been debated for decades, and getting this critical addition to water infrastructure appears more likely than ever. One major development in getting this project completed is the U.S. Environmental Protection Agency earlier this month formally invited the Sites Project Authority to apply for a $2.2 billion low-interest loan through the Water Infrastructure Finance and Innovation Act, which would bring the project significantly closer to construction and completion.  Jerry Brown “This really is a game changer,” said Sites Project Authority General Manager Jerry Brown. “Additive to the other sources of funds that we have, a prior loan from USDA and Proposition 1 funds from the state and federal sources, really rounds out our financing picture to a great extent. This puts us on a to track where we are now in a position to fund construction of the project, which is really exciting!” Brown said there are several steps needed, including applying for a new water right to the State Water Resources Control Board. There are other permits needed from the state and federal government. If all goes as hoped, ground will be broken in 2024 and the new reservoir will be in place in 2030.  He said if Sites were in place prior to the wet years of 2017 and 2019, it would have been completely full at 1.5 million acre feet to start 2020, and would have been able to provide about 400,000 acre feet of water for the state's cities, farm and environment.  Brown said while Sites will provide significant benefits for urban and agricultural customers, it's commitment for environmental water will set it apart from all other projects. “I don't think there's ever been a project like Sites that will provide the kind of assets and benefits for environmental purposes.” As the drought will provide significant impacts to the Sacramento Valley and state in the months ahead, hopefully getting Sites Reservoir built will provide major help in the future; especially vital considering our volatile climate.  Episode Transcript Jim Morris: After a promising start to the rainy season, California has gone extremely dry. The lack of water provides serious widespread challenges. As our climate volatility grows, the need for a more reliable water supply is even more vital. For a growing number of people, that's where Sites Reservoir comes into play. Jim Morris: Welcome to Ingrained, the California Rice Podcast. I'm your host, Jim Morris, proud to have worked with California farmers and ranchers for more than 30 years to help tell their stories. A lack of rain and snow has extended the drought for a third year, creating the likelihood of widespread pain. One hopeful sign for the future would be carrying out a project that's been discussed and debated for decades, Sites Reservoir. Jerry Brown is general manager of the Sites Project Authority. Jerry, let's start with key updates on the project. First, can you relay the big news from the US Environmental Protection Agency, what happened, and how important is this news? Jerry Brown: This really is a game changer. What happened was the Environmental Protection Agency is making an invitation to the Sites Reservoir Project to apply for what's called a WIFIA loan, Water Infrastructure And Finance Investment Act. And what that is, is a mechanism by which the federal government makes a loan available to a project like Sites. In this case, it's in an amount of about 49 percent of the project cost, which for Sites is roughly $2.2 billion. So it's a $2.2 billion loan that has been offered to the Sites Reservoir Project, and, additive to the other sources of funds that we have, a prior loan from USDA, the Proposition One money from the state, and the federal sources really rounds out our financing picture to a great extent and puts us on a track to where we are now in a position to fund the construction of the project, so that's pretty exciting. Jim Morris: Let's talk about that construction. Realistically, and perhaps optimistically, what is your timeframe that you're looking at? Jerry Brown: The loan doesn't really necessarily accelerate the project. There's still several steps that we have to take to get to the point where we can start construction. Probably most notable is the upcoming application that we're making for our water right. We are going to be seeking a new water right for the Sites Project, and that will be submitted within the next month. And, with that, it will kick off about an 18 to 24 month period that the State Water Resources Control Board takes to evaluate our application and make a final determination as to the water right that will be established for the project. Beyond that, there are some very critical permits that we need to secure through the Fish and Wildlife Service of both the state and the federal government. Those are under way. We've made an application recently for one of those, and there's a couple more to do, and we expect those to occur within the next 18 to 24 months, as well. So those critical activities will lead up to the point in time when we will be able to have the assets in place to then secure the loan with the federal government through WIFIA. Once that occurs, we'll be able to initiate construction fairly shortly after that. So, hopefully, by mid to late 2024, we'll start construction. And it's about a six-year period, which would put us at operational completion in about 2030. Jim Morris: If Sites were in place now, how much of a difference would it make? Jerry Brown: Because largely of the 2017, 2019 wet years, if we would've had Sites in place then, Sites would've started the 2020 year completely full at a million and a half acre feet. We estimated last year, had we had Sites in place, we would've had about a million acre feet of water in the reservoir for the farms and cities and environment. With the use that was projected last year, we would probably have about 400,000 acre feet available this year, which is still a very substantial amount, especially considering the very low conditions at our upstream reservoirs, Shasta, Oroville, Folsom. Jim Morris: We have three distinct segments in California, and they sometimes intertwine, the environment, cities, and farms. How would each of these benefit if Sites is built? Jerry Brown: The one piece of this, while I believe the benefits for the cities and farms are very important and necessary to make the project work, is the environmental element. I don't think there's ever been a project like Sites that will provide the kind of assets and benefits for environmental purposes. We're still figuring the final participation by the federal government, but, on a high end, there could be up to around 40 percent of the project, the Sites Project, that would be dedicated for environmental purposes. And that is huge, because never before has the state or the federal government owned and operated an asset like Sites, that will have both storage and water supply for the environment in the driest of years. And with that, we recently entered into some collaboration with some environmental groups to evaluate how we can optimize the use of this environmental storage to provide the optimum benefit for all the different environmental objectives that are out there. So we're super excited about that. And the board is very committed to this as a component of the project. I think one other thing to note, one of the criticisms about the Proposition One investment in environmental purposes is that maybe it's going to be somewhat of a bait and switch where we say we're going to do something, and then, when times get tough, it's not going to happen. But I can tell you with a hundred percent confidence that this board and this project is going to seek to have an ironclad contract with the environment, with the State of California, to the point where, as long as there's a California, there will be an environmental component to the Sites Reservoir. Jim Morris: When you look at rice, we have shown that you can grow a crop that's very helpful for our cuisine and incredible for our economy, but then we also have the Pacific Flyway Benefits, and looks like salmon will be benefiting from rice farming as well. So does it need to be an or conversation, or can Sites be part of a greater and picture that help our water overall in California? Jerry Brown: I've been involved in California water for decades. And we are at a stage where it seems like we are at odds a lot in terms of what kind of strategy to take to improve our situation. There's the or camp, which seems to be of a mindset that we can extend and optimize what we have. That we don't need to do much of anything, but we just need to conserve and recycle, and that will take care of all of our issues. That is a strategy, but I believe that what we're seeing today and the stresses that are occurring in our natural and developed systems, which are significant, we're seeing the results of that just an or strategy. There is an element to extending our supplies that we have, but there's also the and part of this, which is we need to build new facilities and find smart ways to extend the resources that we have to provide for the changing climate, the growing population, and all the needs of California, including the environment. And we think Sites Reservoir is a great tool that will allow us to do the and. Jim Morris: I've lived in the Sacramento Valley my entire life. And, I have to say, it's a big concern when we look at what the drought is doing to our region. So let's talk about some optimism. If not now, when would this ever happen? What kind of momentum do you see for this project, and what kind of optimism do you have at this time that this is going to get done and help our state? Jerry Brown: We are at a critical juncture where the Sites Reservoir and other storage projects, whether it be groundwater, storage, or surface storage, recycled water, conservation, desalination, all of these things are necessary to secure our future. And with SGMA, with the stresses that our existing resources are under, we have to invest. And I think more and more people are recognizing that. Somebody asked me this the other day, "What is different today than maybe 10 or 20 years ago in terms of the possibilities for Sites Reservoir?" And I think a big part of it is the recognition of the changing climate and the effect that that's having on the availability of our water supplies. And, I think, people see the sensibilities of essentially providing additional storage of water, so that as we get more of our precipitation in the form of rain instead of snow, that we have someplace that is reserving this supply, diverting it during the wettest periods, when that can be done safely, and saving it for the dry periods when we really need it most, all of us. Jim Morris: I appreciate Jerry Brown taking time to visit on this key project. As the year progresses, we will keep you updated on developments with Sites Reservoir, as well as drought impacts in the Sacramento Valley. You can find out much more at podcast.calrice.org. We appreciate your comments, questions, and reviews. Thanks for listening.

Too Much Test Podcast
Too Much Test Podcast - Episode 8

Too Much Test Podcast

Play Episode Listen Later Oct 29, 2021 79:56


0:00 Intro0:57 FDA Bans Compounded HCG, FSH & HMG2:31 Biologics Price Competition and Innovation Act of 2009 & Insulin Pricing5:02 Different Types of Insulin10:26 Real Cost of High Priced Medicines11:50 Open Source Insulin13:51 How Medicine Patents Work - BS14:29 Why is Aromasin so Expensive in the US?16:38 Why isn't Sustanon 250 FDA Approved?17:09 Hucog HCG from India18:00 ADHD Meds tainted with Fentanyl21:28 Your being ripped off! - Medicine Middle Men24:50 PPI's - Proton Pump Inhibitors - Heart Burn Alternatives26:30 Leaky Gut, CBOW, Gut Issues31:15 Lectins - Hidden Inflammation in the body38:34 Another Bad Episode for TYL :(40:10 Pressurized Tubes of $h!T46:00 Do Needles Actually Cause Scar Tissue?49:05 Our Injection Preferences51:30 How to Measure your Member Correctly52:22 Can You Grow Your Member?55:12 Fitness Influencer Exercises and Programs61:32 Watch the Biggest Guy in Your Gym Workout63:00 Super Set Sam64:14 How WE Workout67:39 David Calls Out TYL's Check Workouts - Flat Bench71:25 Our Goals73:00 David going Pro?78:30 David Coaching Sam for His First Show?78:53 Outro#MensHealthPodcast #TestosteronePodcast #BodybuildingPodcastTest Your Levels Linkshttps://linktr.ee/testyourlevelsYoutubeInstagramTikTokSam Stolt's Linkshttp://bit.ly/sam-stolt-linksYoutubeInstagramTikTokTwitterDavid DeMesquita Linkshttps://taplink.cc/dynamite_dYoutubeInstagram

Listory Listen
US House Passes Bill to Require Financial Regulators to Set Up Digital Assets Working Group - CoinDesk

Listory Listen

Play Episode Listen Later Jun 29, 2021 1:42


❤️ Loved it!👎 Meh…Summary transcript: https://www.listory.com/ll/8ce5fd1611708263e3946734b0903202345b56b4Original story: https://www.coindesk.com/cftc-sec-us-house-representativesDescription: The Eliminate Barriers to Innovation Act of 2021 seeks to establish a digital asset working group with representatives from the SEC and CFTC.

DoctorApple NEWS
DoctorApple NEWS 102

DoctorApple NEWS

Play Episode Listen Later Jun 25, 2021 12:16


25/06/21 - Saída de Sculley, e-world, power mac 9500, unitron mac 512, tsmc a15 chip, iphone 13 mais bateria, bug nome de wifi ios, American Choice and Innovation Act, Apple Watch e plano de saúde, banco do brasil suspende apple pay, nubank deve aceitar apple pay, android rede de localização, atualização chrome, atualização airtag, youtube pip, rumores de iphone 14, https://www.doctorapple.com.br

Necessary B******t Podcast
Episode #75: 28 Trillion Problems and China Is One

Necessary B******t Podcast

Play Episode Play 42 sec Highlight Listen Later Jun 21, 2021 98:28


In this episode, Josh and Ian give an update on the latest political news from the G7 summit and the global pandemic. They talk about the COVID-19 vaccines and their side effects, the latest info-dumb on the Fauci emails, "trusting the science" and skepticism of authority, personal hygiene and rights vs. responsibility, the SARS-COV-2 "lab-leak theory" and hyper-politicization, tribalism and zealotry in American politics, W. Virginian Senator Joe Manchin and bipartisanship, the meaning behind political representation, how local and state politics can turn national, psychological problem solving, the US Competition and Innovation Act and Biden's national budget proposal, the recent G7 summit and the myriad problems of China, the US national debt and the "value" of currency, and the nature of human freedom. Follow them on Twitter at:Josh @Simpsonj423Ian @modernovermanand the podcast @NBSPodcast1Website: https://www.necessarybspod.com/Links:No, Dr. Fauci's emails were not leaked, they were obtained through FOIA requestsAnthony Fauci's Emails Reveal The Pressure That Fell On One ManScientist Opens Up About His Early Email to Fauci on Virus OriginsCOVID Data TrackerPresident Biden's budget proposal projects debt rising past WWII levelshttps://www.usdebtclock.org/47th G7 Summit: 11-13 June 2021John Cena Apology to ChinaInside Higher Ed Senate Passes Bill Funding Technology Research Through NSFt5 days agoSenate passes $250 billion tech bill aimed to boost US competition with ChinaJoe Manchin: the Democrat who holds the fate of Biden's agenda in his handsOpinion | The secret strategy that explains how Joe Manchin wields his powerManchin on his veto power over Biden agenda: 'It's not a good place to be'Recorded 16 June 2021Support the show (https://www.patreon.com/nbsproductions)

Let's Get After it with Chris Cuomo
Is piecemeal the way?

Let's Get After it with Chris Cuomo

Play Episode Listen Later Jun 10, 2021 23:16


A major concern  over the sheer volume of unemployment relief payments during COVID was always the potential for fraud.  Well, that fear may have become a reality.  And, as Chris surmises, if the amount the imposters stole is anywhere near what Axios has reported, then foreign crime syndicates have surely won this  battle.  Also on the Table: We'd all prefer something rather than nothing, right? This same logic may apply to how to get a stagnant Senate to move.  Case and point: the Senate passing the Innovation and Competition Act with a 68/32 vote.  Is it time to consider doing HR1/S1 in pieces to get more Senators on board?You've Been Warned: Never mess with another person's  Lip Smackers. But if you do, you better be as fast as Chris was in the hilarious childhood story he tells that didn't end well for his sister.Cuom'ote of the Day: "The Mo Man was fat, but quick and crafty."

SBE Council On ForbesBooks Radio
Growth Without Barriers - DIGITAL EDITION: US Innovation Act & INFORM Act; PRO Act; DC AG's misguided lawsuit against Amazon.

SBE Council On ForbesBooks Radio

Play Episode Listen Later Jun 2, 2021 13:16


Karen Kerrigan, SBE Council, on the status of U.S. Innovation Act and INFORM Act; increased workplace regulation via the PRO Act and the impact on automation; DC AG's misguided and curious lawsuit against Amazon.

Unchained
Unconfirmed: Rep. Tom Emmer, One of the Most Active Crypto Congress Members, on Taxes and DeFi - Ep.241

Unchained

Play Episode Listen Later May 28, 2021 38:08


House Representative Tom Emmer, of Minnesota, is one of the most active voice for crypto and blockchain in the US government. In this episode, he discusses: what book made Tom fall down the crypto rabbit hole  why Tom believes the Financial Accounting Standards Board needs to set clear accounting standards for cryptocurrencies why the current way of accounting for Bitcoin on balance sheets may be a detriment to companies in the future how he feels about the acting head of the OCC putting together a “sprint team” of federal regulators to establish overarching crypto standards why he is fighting to change tax rules for forked coins what problems the Eliminate Barriers to Innovation Act might solve why he is so passionate about the Securities Clarity Act, which would explicitly separate digital tokens from securities how DeFi should be regulated and why he is not a fan of FATF’s recently proposed guidance Tom’s prediction for when these bills may actually become law    Thank you to our sponsors! Crypto.com: https://crypto.onelink.me/J9Lg/unchainedcardearnfeb2021  Tezos: https://tezos.com/discover?utm_source=laura-shin&utm_medium=podcast-sponsorship-unconfirmed&utm_campaign=tezos-campaign&utm_content=hero   NEAR: https://near.org    Episode Links   Tom Emmer Twitter: https://twitter.com/RepTomEmmer  Website: https://emmer.house.gov/  Documents Mentioned FASB letter https://emmer.house.gov/2021/5/emmer-urges-fasb-to-issue-clear-accounting-standards-for-virtual-currencies Eliminate Barriers to Innovation Act https://www.forbes.com/sites/jasonbrett/2021/04/22/us-house-passes-bill-to-create-first-crypto-task-force-on-digital-assets/ Safe Harbor for Taxpayers with Forked Assets Act https://emmer.house.gov/2021/5/emmer-introduces-legislation-to-protect-taxpayers-with-digital-assets-pending-further-irs-guidance Securities Clarity Act https://emmer.house.gov/2020/9/emmer-introduces-legislation-to-provide-clarity-for-digital-assets-under-securities-law Proposed FATF Guidance (quick breakdown) https://www.coincenter.org/a-quick-analysis-of-fatfs-2021-draft-cryptocurrency-guidance/    Miscellaneous Congressional Blockchain Caucus https://congressionalblockchaincaucus-schweikert.house.gov/members US Regulatory “sprint” https://decrypt.co/71975/us-agencies-sprint-align-on-bitcoin-regulations  Michael Saylor episode https://unchainedpodcast.com/why-bitcoin-now-michael-saylor-on-the-best-way-for-companies-to-buy-bitcoin/ Age of Cryptocurrency https://www.amazon.com/The-Age-of-Cryptocurrency

Unchained
Unconfirmed: Rep. Tom Emmer, One of the Most Active Crypto Congress Members, on Taxes and DeFi - Ep.241

Unchained

Play Episode Listen Later May 28, 2021 38:08


House Representative Tom Emmer, of Minnesota, is one of the most active voice for crypto and blockchain in the US government. In this episode, he discusses: what book made Tom fall down the crypto rabbit hole  why Tom believes the Financial Accounting Standards Board needs to set clear accounting standards for cryptocurrencies why the current way of accounting for Bitcoin on balance sheets may be a detriment to companies in the future how he feels about the acting head of the OCC putting together a “sprint team” of federal regulators to establish overarching crypto standards why he is fighting to change tax rules for forked coins what problems the Eliminate Barriers to Innovation Act might solve why he is so passionate about the Securities Clarity Act, which would explicitly separate digital tokens from securities how DeFi should be regulated and why he is not a fan of FATF's recently proposed guidance Tom's prediction for when these bills may actually become law    Thank you to our sponsors! Crypto.com: https://crypto.onelink.me/J9Lg/unchainedcardearnfeb2021  Tezos: https://tezos.com/discover?utm_source=laura-shin&utm_medium=podcast-sponsorship-unconfirmed&utm_campaign=tezos-campaign&utm_content=hero   NEAR: https://near.org    Episode Links   Tom Emmer Twitter: https://twitter.com/RepTomEmmer  Website: https://emmer.house.gov/  Documents Mentioned FASB letter https://emmer.house.gov/2021/5/emmer-urges-fasb-to-issue-clear-accounting-standards-for-virtual-currencies Eliminate Barriers to Innovation Act https://www.forbes.com/sites/jasonbrett/2021/04/22/us-house-passes-bill-to-create-first-crypto-task-force-on-digital-assets/ Safe Harbor for Taxpayers with Forked Assets Act https://emmer.house.gov/2021/5/emmer-introduces-legislation-to-protect-taxpayers-with-digital-assets-pending-further-irs-guidance Securities Clarity Act https://emmer.house.gov/2020/9/emmer-introduces-legislation-to-provide-clarity-for-digital-assets-under-securities-law Proposed FATF Guidance (quick breakdown) https://www.coincenter.org/a-quick-analysis-of-fatfs-2021-draft-cryptocurrency-guidance/    Miscellaneous Congressional Blockchain Caucus https://congressionalblockchaincaucus-schweikert.house.gov/members US Regulatory “sprint” https://decrypt.co/71975/us-agencies-sprint-align-on-bitcoin-regulations  Michael Saylor episode https://unchainedpodcast.com/why-bitcoin-now-michael-saylor-on-the-best-way-for-companies-to-buy-bitcoin/ Age of Cryptocurrency https://www.amazon.com/The-Age-of-Cryptocurrency

Citizens' Climate Lobby
CCL Training: Messaging For The Energy Innovation Act

Citizens' Climate Lobby

Play Episode Listen Later May 21, 2021 38:53


Join CCL's Marketing Director Lesley Beatty for a training that will provide an overview of the important role of focus and resonance in communicating the four key points behind the Energy Innovation and Carbon Dividend Act, as well as additional messaging recommendations, depending on your audience, and where to find all of the supporting resources. Skip ahead to the following section(s): Four Key Leading Messages (2:49) Using The Expanded Messages (19:45) Supporting Graphics & Videos (29:30) CCL’s Support For Price On Carbon (35:30) Resources on CCL Community (37:00) Presentation Slides: http://cclusa.org/messaging CCL Training Page: https://community.citizensclimate.org/resources/item/19/378   Price On Carbon Page: https://citizensclimatelobby.org/price-on-carbon/ 

Thinking Crypto Interviews & News
US Digital Asset Group - US Bitcoin Mining Growth - SEC Ripple Harassment - Coinbase USDT

Thinking Crypto Interviews & News

Play Episode Listen Later Apr 23, 2021 17:28


The U.S. House of Representatives has passed several pieces of bipartisan legislation including a section on digital assets, according to a press release from the House Financial Services Committee on Tuesday. Known as the Eliminate Barriers to Innovation Act of 2021 (H.R. 1602), the bill was introduced by Reps. Patrick McHenry (R-N.C.) and Stephen Lynch (D-Mass.) in March. Foundry USA bitcoin mining pool from FoundryServices just became at top 5 pool in the world! Bitcoin hashrate is quickly shifting from China to North America. Bitcoin broker NYDIG acquires firm that finances Bitcoin mining farms, Arctos Capital. Coinbase PRO is adding Tether UDST. SEC accuses Ripple of harassment, asks the Judge to block access to some discovery records. BitGo has placed over $700 million in insurance coverage for large amounts of cryptocurrency held at arm’s length from the rough winds of the internet.

Citizens' Climate Lobby
CCL's Reintroduction All Supporter Call: The 2021 Energy Innovation Act & Carbon Dividend Act

Citizens' Climate Lobby

Play Episode Listen Later Apr 2, 2021 30:49


The Energy Innovation and Carbon Dividend Act of 2021 has been reintroduced into the House by Rep. Ted Deutch (D-FL-22) and 28 original cosponsors. Join this training by Mark Reynolds, Citizens' Climate Lobby's Executive Director, Madeleine Para, CCL's President, Dr. Danny Richter, CCL's Vice President of Government Affairs, and Lesley Beatty CCL’s Director of Marketing for an overview of the new bill, it's legislative details, action steps, and messaging recommendations.  Skip ahead to the following section(s): (0:00) Overview (3:01) Legislative Details (14:29) Action Steps (19:26) Messaging Recommendations Helpful resources: Use our Action Tools to write to your members of Congress: http://cclusa.org/write   Send a postcard to President Biden about this policy: http://cclusa.org/postcard   Write a letter to the editor about this bill: http://cclusa.org/lte   Amplify the news on social media: http://cclusa.org/facebook   Check out the current cosponsors of the bill here: http://energyinnovationact.org   Learn more about how the bill works here: http://energyinnovationact.org/how-it-works/  The bill is a “carbon fee and dividend” approach to carbon pricing. You can learn more about that idea here: https://citizensclimatelobby.org/price-on-carbon/   Check out Columbia University’s assessment of this legislation: https://www.energypolicy.columbia.edu/research/report/assessment-energy-innovation-and-carbon-dividend-act   Noah Kaufman’s “Nature Climate Change” paper that Danny referenced: https://www.energypolicy.columbia.edu/research/article/near-term-net-zero-alternative-social-cost-carbon-setting-carbon-prices   You can sign up for our text alerts here: http://cclusa.org/text   You can join our Monthly Calling Campaign here: http://cclusa.org/mcc   You can contribute to CCL by visiting http://cclusa.org/donate  Tonight’s Reintroduction Presentation Slides: https://docs.google.com/presentation/d/1MpKiPwHlIg71PwfpQ-c53Z59Wf9RaquerGTMVVmXf8U   Community page on the bill: https://community.citizensclimate.org/topics/energy-innovation-act  Comparison between the new bill and the one from last Congress: https://community.citizensclimate.org/resources/item/19/486  Q&A on the Energy Innovation and Carbon Dividend Act: https://community.citizensclimate.org/resources/item/19/285 

Long Reads Live
Why the CEO of New York Life Just Joined the Board of One of Bitcoin's Fastest-Growing Companies

Long Reads Live

Play Episode Listen Later Mar 11, 2021 17:04


Today on The Breakdown, NLW catches up on the news from the past few days, looking at: NFTs heating up – and capturing some negative attention in the process Infrastructure acquisitions and M&A heat up Eliminate Barriers to Innovation Act 2021 Coinbase’s $100B valuation NYDIG’s $200M round and new board member -- Earn up to 12% APY on Bitcoin, Ethereum, USD, EUR, GBP, Stablecoins & more. Get started at nexo.io -- Enjoying this content?   SUBSCRIBE to the Podcast Apple:  https://podcasts.apple.com/podcast/id1438693620?at=1000lSDb Spotify: https://open.spotify.com/show/538vuul1PuorUDwgkC8JWF?si=ddSvD-HST2e_E7wgxcjtfQ Google: https://podcasts.google.com/feed/aHR0cHM6Ly9ubHdjcnlwdG8ubGlic3luLmNvbS9yc3M=   Follow on Twitter: NLW: https://twitter.com/nlw Breakdown: https://twitter.com/BreakdownNLW   The Breakdown is produced and distributed by CoinDesk.com

The Special Situation Cast
Maritime Technology Analyst Patrick Finn: Why We Can Forget About U.S. Offshore Windfarms

The Special Situation Cast

Play Episode Listen Later Dec 9, 2020 102:09


I interview Patrick Finn who is a Maritime Technology Analyst at Thetius. Thetius is focused on analysis and research into emerging maritime technologies. I'm interested in Scorpio Bulkers which is a maritime company that's selling all of its bulkers and moving into windfarm installation vessels. Patrick helps me understand the Jones Act and other applicable regulations better. Why is it in place? What is the effect of the jones act on the maritime industry? Could this hamper the development of U.S. offshore wind?  Is it possible to operate in U.S. waters while skirting the Jones Act?  We talk about the “Clean Economy Jobs and Innovation Act,” H.R. 4447. For example, congress asked for clarifications of the bill regarding wind vessels. Could this hurt or help the industry?Near the end, we also get into some of the technologies that could make shipping more efficient, more profitable, and more environmentally friendly. Relevant links to the discussion:https://maritime-executive.com/editor...Patrick Finnhttps://www.linkedin.com/in/pwfinn/Thetiushttps://thetius.com/

Crypto Nation
Blockchain Innovation Act Approved (Consumer Safety Technology Act)

Crypto Nation

Play Episode Listen Later Oct 12, 2020 8:07


Blockchain Innovation Act Approved (Consumer Safety Technology Act) --- Send in a voice message: https://anchor.fm/crypto-nation/message Support this podcast: https://anchor.fm/crypto-nation/support

Carbon Removal Newsroom
Carbon removal's biggest bill to date? The Clean Economy Jobs and Innovation Act passes the House

Carbon Removal Newsroom

Play Episode Listen Later Oct 2, 2020 10:59


The Clean Economy Jobs and Innovation Act involves billions of dollars being allocated across the carbon removal ecosystem. It just passed the US House of Representatives, and President Trump has stated his intent to veto it if it reaches his desk, but right now the focus is on its way through the Senate. Our panelist this week is Dr. Shuchi Talati, senior policy advisor at Carbon180. You can also read her recap of the bill here. --- Send in a voice message: https://anchor.fm/carbonremovalnewsroom/message Support this podcast: https://anchor.fm/carbonremovalnewsroom/support

Citizens' Climate Lobby
CCL Training: Handling Challenging Questions About The Energy Innovation Act

Citizens' Climate Lobby

Play Episode Listen Later May 1, 2020 26:58


Join CCL Strategy Director Tony Sirna and Government Affairs Coordinator Adeline DeYoung for a training that will highlight recommendations for communicating about the Energy Innovation Act and including how to approach talking with community members who may voice concerns about provisions within the legislation. Skip ahead to the following section(s): Importance of Listening (4:48) How To Find & Use This CCL Resource (8:03 ) Role-play scenarios (15:14) CCL Community: https://community.citizensclimate.org/handling-challenging-questions Presentation Slides: http://cclusa.org/handling-challenging-questions-slides Join CCL: https://cclusa.org/join

Ropes & Gray Podcasts
Non-binding Guidance: FDA Regulatory and Patent Implications of the Transition Provision of the Biologics Price Competition and Innovation Act

Ropes & Gray Podcasts

Play Episode Listen Later Mar 5, 2020 15:49


Non-binding Guidance
Non-binding Guidance: FDA Regulatory and Patent Implications of the Transition Provision of the Biologics Price Competition and Innovation Act

Non-binding Guidance

Play Episode Listen Later Mar 5, 2020 15:49


Plugged In
#45: Kenny Stein on the American Energy Innovation Act (3-4-20)

Plugged In

Play Episode Listen Later Mar 4, 2020 15:56


Kenny Stein, IER's Policy Director, joins the show to discuss the 555-page American Energy Innovation Act recently introduced in the senate. Kenny provides an overview of the bill's major features as it currently stands and explores the impacts of potential amendments. Links: • More analysis from Kenny Stein here: https://www.instituteforenergyresearch.org/about/kstein/articles/

Not So Different: a Podcast from The Center for Biosimilars
1: Goodwin Attorneys Give a Look at Biosimilar Litigation

Not So Different: a Podcast from The Center for Biosimilars

Play Episode Listen Later Jan 5, 2020 21:43


In the past decade of experience with the the Biologics Price Competition and Innovation Act, a number of questions about the biosimilar pathway have been resolved through litigation. This week on the podcast, we're speaking with attorneys Robert Cerwinski, JD, and Alexandra Valenti, JD, both of whom are partners at Goodwin, about experience with litigation, the road ahead for biosimilars, and Goodwin's recently published guide to biosimilar litigation. 

Citizens' Climate Lobby
CCL Training: Columbia University's Assessment of the Energy Innovation Act

Citizens' Climate Lobby

Play Episode Listen Later Nov 15, 2019 34:30


Join Dr. Noah Kaufman, Research Scholar at Columbia University, and Jerry Hinkle, CCL Research Coordinator, for a live webinar discussing the recently released Columbia University's "Assessment of the Energy Innovation Act." This study offers an up-to-date, independent assessment from a prestigious institution of the Energy Innovation Act’s impacts on emissions, air pollution, and Americans’ finances. It confirms that the Energy Innovation and Carbon Dividend Act is effective at reducing emissions and is good for people. Skip ahead to the following section(s): Emissions Impacts (8:13) Energy Production & Prices Impacts (15:04)Government Revenues (20:01)Impacts Beyond The Assessment's Scope (24:29) ​​​​​​​Comparison To Other Proposals (27:39) Columbia Website: energypolicy.columbia.edu/research/report/assessment-energy-innovation-and-carbon-dividend-actCCL Training Page: https://community.citizensclimate.org/resources/item/19/184Follow Citizens' Climate Lobby on Facebook: https://www.facebook.com/CitizensClimateLobbyTwitter: https://twitter.com/citizensclimate

Citizens' Climate Lobby
Introduction To The Energy Innovation Act

Citizens' Climate Lobby

Play Episode Listen Later Jun 28, 2019 7:26


Join Dr. Danny Richter, Vice President for Government Affairs with Citizens' Climate Lobby, in a training that walks through the components the bipartisan Energy Innovation and Carbon Dividend Act of 2019, H.R. 763, and helps new volunteers understand the details of this historic legislation. Skip Ahead To The Following Section(s):The Policy Benefits (1:37)How It Works (3:18)Support The Act (5:43) Take Action: http://cclusa.org/energy-innovation-actEndorse The Act: https://energyinnovationact.org/endorse/More Details: http://cclusa.org/ennergy-innovation-qaQuestions? http://cclusa.org/energy-innovation-act-forumFollow us on Facebook: http://facebook.com/CitizensClimateLobby/Twitter: http://www.twitter.com/citizensclimate

Citizens' Climate Lobby
Policy Details and Messaging Practice For the Energy Innovation Act - #CCL2019 Conference

Citizens' Climate Lobby

Play Episode Listen Later Jun 21, 2019 152:33


Rick Knight, CCL Research Coordinator Lesley Beatty, CCL Director of Marketing Our research and marketing departments have teamed up to dive into the details of the bill, and how to communicate with different audiences about it. #CCL2019 Conference Presentations & Videos: http://cclusa.org/presentationsFollow us on Facebook: http://facebook.com/CitizensClimateLobbyTwitter: https://twitter.com/citizensclimate

Citizens' Climate Lobby
CCL Training: Understanding Economic Support For The Energy Innovation Act

Citizens' Climate Lobby

Play Episode Listen Later Jun 15, 2019 35:08


Join CCL Research Coordinator Jerry Hinkle for a training that evaluates the climate and health benefits of the Energy Innovation Act and compares them to the policy costs. Economists wholly support charging for carbon pollution, and many support returning all funds to households. Why such strong support? The recent peer-reviewed literature makes clear that the policy benefits of a revenue neutral carbon tax that refunds all money to households greatly exceeds the policy costs. From this, supporters will better understand why economists insist a revenue neutral carbon tax is good for the economy and society. Skip ahead to the following section(s):Economists Statement on Carbon Dividends (3:53)Health Co-Benefits (11:54)Climate Benefits (15:47)Policy Costs vs. Benefits (24:19)Webinar Q&A: https://youtu.be/4JPON1vqCcA Presentation Slides: http://cclusa.org/economic-impactsFollow us on Facebook: http://facebook.com/CitizensClimateLobbyTwitter: https://twitter.com/citizensclimate

Not So Different: a Podcast from The Center for Biosimilars
12: A Regulatory Attorney Shares His Take on Interchangeability

Not So Different: a Podcast from The Center for Biosimilars

Play Episode Listen Later Jun 9, 2019 15:18


Recently, the FDA released its long-anticipated final guidance on demonstrating interchangeability, and developers have been grappling with how the guidance will impact them. This week on the podcast, we're speaking with regulatory attorney James Shehan, JD, chair of regulatory practice at Lowenstein Sandler, LLP. In a prior role, Shehan had a hand in crafting the language that became the Biologics Price Competition and Innovation Act, which set forth the legal standard for interchangeability. Shehan discusses what the newly released guidance means for developers, what he thinks about the upcoming transition of insulins to regulation as biologics, and his view on the potential for interchangeable insulin biosimilars.

Frankly Speaking About Cancer with the Cancer Support Community

In 2010, the Biologics Price Competition and Innovation Act signed into law by President Barack Obama as part of the Affordable Care Act, aimed to promote the development of biological products and create competition, with the goals of increasing treatment options and reducing health care costs. On this episode, we are joined by Dr. Leah Christl who is the Associate Director for Therapeutic Biologics in the Office of New Drugs in the FDA's Center for Drug Evaluation and Research. Today, we are starting to see the fruits of that labor, there are several biosimilars on the market and more are under review for approval. In 2015, the U.S. Food and Drug Administration approved the first biosimilar product which happens to be a supportive treatment for cancer patients undergoing chemotherapy for acute myeloid leukemia.

SCOTUScast
Sandoz, Inc. v. Amgen, Inc. Post-Decision SCOTUScast

SCOTUScast

Play Episode Listen Later Aug 11, 2017 14:52


The Biologics Price Competition and Innovation Act of 2009 (BPCIA) provides an abbreviated pathway for obtaining Food and Drug Administration (FDA) approval of a drug that is biosimilar to an already licensed biological product. Among other things, BPCIA provisions require applicants for approval of a new biosimilar to provide the manufacturer of the already licensed product with a notice of commercial marketing and certain information about the biosimilar. Failure to comply permits the manufacturer to pursue infringement litigation against the applicant on an accelerated basis. -- Amgen claims to hold patents on methods of manufacturing and using filgrastim--a biologic used to stimulate the production of white blood cells--and markets one such product, Neupogen. Sandoz sought FDA approval to market a biosimilar called Zarxio. When the FDA accepted Sandoz’s application for review, Sandoz notified Amgen that Sandoz intended to market Zarxio upon receipt of FDA approval. Sandoz also indicated that it would not share with Amgen the relevant application and manufacturing information as required by the BPCIA and invited Amgen immediately to sue for infringement. Amgen did so, and further asserted claims for “unlawful” conduct in violation of California’s unfair competition law. The basis for the latter claims was Sandoz’s alleged failure to comply with the BPCIA requirements that Sandoz (a) share the application and manufacturing information pertaining to Zarxio, and (b) provide a notice of commercial marketing prior to obtaining FDA licensure. Amgen sought injunctive relief in federal district court to enforce both requirements against Sandoz, which counterclaimed for declaratory judgments that Amgen’s patent was invalid and not infringed, and that Sandoz had not violated the BPCIA. -- While the litigation was pending, the FDA licensed Zarxio, and Sandoz provided Amgen with further notice of commercial marketing. The district court thereafter granted partial judgment in favor of Sandoz on its BPCIA counterclaims and dismissed Amgen’s unfair competition claims with prejudice. A divided U.S. Court of Appeals for the Federal Circuit affirmed in part, vacated in part, and remanded the case. The Federal Circuit held that Sandoz had not violated the BPCIA disclosure requirements and that Amgen could not pursue state law remedies to enforce the BPCIA. The court also held that an applicant may provide effective notice of commercial market only after FDA licensure and therefore enjoined Sandoz from marketing Zarxio until 180 days passed after Sandoz’s second notice. -- By a vote of 9-0, the Supreme Court unanimously vacated in part and reversed in part the judgment of the Federal Circuit and remanded the case. In an opinion by Justice Thomas, the Court held that the BPCIA’s requirement on sharing application and marketing information is not enforceable by an injunction under federal law, but that the Federal Circuit should determine on remand whether a state-law injunction is available. The Supreme Court further held that an applicant may provide the requisite notice of commercial marketing before obtaining FDA licensure; therefore Sandoz fully complied with this requirement through its initial notice, the Federal Circuit erred in enjoining Sandoz from marketing Zarxio on this basis, and Amgen’s state law unfair competition claim predicated on the view that the BPCIA forbids pre-licensure notice must fail. Justice Breyer issued a concurring opinion. -- And now, to discuss the case, we have Erika Lietzan, who is Associate Professor of Law at the University of Missouri School of Law.

Teleforum
Courthouse Steps: Amgen, Inc. v. Sandoz, Inc.

Teleforum

Play Episode Listen Later Apr 28, 2017 26:33


The Biologics Price Competition and Innovation Act of 2010 (42 U.S.C. § 262) created an abbreviated pathway for FDA approval of biological products determined to be “biosimilar” to a reference product. The Act outlines a patent resolution and information exchange scheme, with litigation safe harbors during this “patent dance.” -- Subsection (l)(2)(A) provides that not later than 20 days after the application is accepted for review, “…the subsection (k) applicant – shall provide to the reference product sponsor a copy of the application…and other information that describes the processes used to manufacture the biological product…” Subsection (l)(8)(A) provides “[t]he subsection (k) applicant shall provide notice to the reference product sponsor not later than 180 days before the date of the first commercial marketing of the biological product licensed under subsection (k).” -- In 2015, Sandoz filed a subsection (k) application based on Amgen’s filgrastim (Neupogen®), but refused to provide its (l)(2)(A) disclosure and claimed that pre-FDA approval notice satisfied (l)(8)(A). Amgen sued in federal court on state law claims of unfair competition and conversion, and patent infringement, and requested a preliminary injunction. The district court granted Sandoz’ motion for partial summary judgment, holding that (l)(2)(A) disclosure was optional and that Sandoz did not have to wait for FDA approval before providing (l)(8)(A) notice. -- In a fractured opinion, the Federal Circuit affirmed on the (l)(2)(A) issue, holding that subsection (l)(9)(C) provided a remedy for the reference product sponsor to bring an immediate declaratory judgment action if the subsection (k) applicant failed to provide its (l)(2)(A) information, showing that disclosure was optional. The court reversed on the (l)(8)(A) issue, holding that notice before the FDA approved the subsection (k) application was ineffective under the statute. The Court granted certiorari on both issues. -- This case presents intriguing questions of statutory interpretation, as the boundaries of the BCPIA are explored. -- Featuring: Mr. Andrew A. Hufford, Intellectual Property Attorney, Brinks Gilson & Lione.

Pharma Intelligence Podcasts
Device Week Podcast - Episode 89

Pharma Intelligence Podcasts

Play Episode Listen Later Apr 14, 2017 11:24


On this week's Medtech Insight podcast: cybersecurity and US FDA warning letter headaches for St. Jude; a conversation with AdvaMed CEO Scott Whitaker; a profile of device-maker InVivo Therapeutics, which is looking to leverage 2tst Century Cures provisions; a verdict was reached in a Kimberly-Clark fraud suit; comments roll in on the Diagnostic Accuracy and Innovation Act in the US; and more.

Ice Station Housman
Episode #0021 - "Cuts"

Ice Station Housman

Play Episode Listen Later Apr 7, 2017 80:40


This week on the show we discuss proposed budget cuts by the Trump Administration to the weather related government programs.   Show Notes!   Weather Service Employees ‘Shocked’ by Reported Budget Cuts Quote from above article: “It’s not a well-thought-through idea, in my opinion,” said Daniel Sobien, president of the National Weather Service Employees Organization. Though he speaks only for the relatively large weather service staff, the cuts discussed in the White House-to-agency “pass-back” documents will affect all of NOAA—“the people who make sure employees get paid, do the hiring and the paperwork, plus the satellite program, which has a direct link to weather forecasting,” he said. NWS is highly dependent on the rest of NOAA, he said. NOAA overall is reportedly slated for a 17 percent cut, but NWS and the National Marine Fisheries Service would take a hit of just 5 percent. But that is still “hugely devastating,” Sobien said. That’s because the lack of say for managers in reshuffling discretionary spending means that “the only thing they can do is lay people off, so it’s just as bad as a 17 percent cut,” he said.”   Trump's Plan to Slash NOAA Budget Puts Lives, Climate Research at Risk, Scientists Say Quote from above article: “The National Environmental Satellite, Data and Information Service, which monitors weather and collects climate data, would see the largest budget cut – $513 million, or 22 percent of its funding. Former NOAA employees say the move would put the American public in danger. Jane Lubchenco, NOAA administrator under President Barack Obama, told weather.com the "draconian cuts" to the agency that oversees weather forecasting and funds weather and climate research would "be devastating to the economy, jobs and to the safety and livelihoods of Americans in every state." Many of the cuts are directly relevant to NOAA’s ability to provide timely and accurate weather forecasts and warnings, now and in the future, Lubchenco said. She called the cuts to the satellite program, NWS and research program particularly worrisome, noting 90 percent of weather forecasting data comes from satellites.”   Notes from Katie NOAA $990 mil cut from budget $83 mil for ship to do ocean surveys $400 mil cut from Polar Follow-On: satellites schedules to launch in 2024/26 for forecasting $100 mil cut from satellite services which could impact climate data collection 26% cut to recharting the coastlines From the Washington Post: The programs in the crosshairs include NOAA’s Coastal Zone Management grants and Regional Coastal Resilience grants, which come to $75 million combined, according to the document; its $10 million in Coastal Ecosystem Resiliency grants; the National Estuarine Research Reserve System, an annual investment of about $23 million; and its $73 million Sea Grant program. Regional Coastal Resilience grants, which deal more specifically with bracing communities for adverse climate and weather events. These programs “build resilience of coastal communities to the negative impacts from extreme weather events, climate hazards, and changing ocean conditions,” according to a recent NOAA presentation. the Coastal Ecosystem Resiliency Grants, which are more focused on restoring ecosystems so they can adjust to changing conditions in a way that also benefits humans. Wetlands, when healthy, can help keep pace with sea-level rise. Also proposed for the chopping block are several research and education initiatives that provide valuable information to help coastal communities plan for the future. The National Estuarine Research Reserve System is a group of 29 sites throughout the coastal United States — including spots along the East and West coasts, the Gulf Coast, the Great Lakes, Hawaii and Alaska — that have been set aside specifically for the study of estuarine systems, or the areas where rivers flow into the sea. The program produces scientific data on these unique ecosystems and provides training and education for local communities and policymakers on protecting and managing them. Of similar importance is the Sea Grant program, a partnership between NOAA and universities across the nation, which supports coastal research and education. The program relies on on-the-ground agents, who help establish a “real connection” between academics and coastal communities, said Jeff Carney, an architecture professor and director of the Coastal Sustainability Studio at Louisiana State University, which houses the Louisiana Sea Grant program. These programs can be vital sources of information on everything from fisheries management to storm preparation. EPA $330 mil cut from Superfund Cleanups. 30% reduction $129 mil cut from EPA enforcement to catch polluters.  33% reduction $233 mil cut from EPA research that establishes federal health and safety guidelines 50% reduction $482 mil cut from EPA assistance grants that go to state and tribal to clean up pesticides and toxic wastes.   40% reduction $347 mil cut from 50 EPA programs like Energy Star and diesel engine replacement meant to reduce emissions. From Washington Post: proposal by the White House would slash the EPA’s budget by 31 percent — nearly one third — from its current level of $8.1 billion to $5.7 billion. It would cut 3,200 positions, or more than 20 percent of the agency’s current workforce of about 15,000. would discontinue funding for the Clean Power Plan — the signature Obama administration effort to combat climate change by regulating carbon dioxide emissions from power plants. It would sharply reduce money for the Superfund program and cut the budget for the EPA’s prominent Office of Research and Development roughly in half, to $250 million. It also would eliminate “more than 50 EPA programs.” Among them: the Energy Star program, which aims to improve energy efficiency and save consumers money; infrastructure assistance to Alaska Native villages and the Mexico border; a grant program that helps cities and states combat air pollution; and an office that focuses on environmental justice issues. Article from Scientific American: https://www.scientificamerican.com/article/trump-budget-cuts-funds-for-epa-by-31-percent/ Some programs at EPA would see increases. The blueprint would shift $4 million above current spending levels to state revolving funds and $20 million to the Water Infrastructure Finance and Innovation Act program. EPA Administrator Scott Pruitt had said he wanted to protect those funds. The State Department, which saw perhaps the largest cut behind EPA, is shouldering much of Trump's emphasis on nationalism. The president is fulfilling his promises to depress U.S. activity abroad by eliminating the Global Climate Change Initiative. The budget also zeros out funding for the Green Climate Fund and the Climate Investment Funds. The White House would eliminate the Advanced Research Projects Agency-Energy (ARPA-E), as well as loan guarantee programs, greenhouse gas reducing technologies and advanced vehicle programs. The Office of Science would see a $900 million cut and is meant, according to the proposal, to focus on "basic science and energy research and development." The budget also would include $140 million to restart licensing activities for nuclear waste storage at Yucca Mountain, a thorny issue on Capitol Hill.   Chesapeake Bay $73 mil to $0 Chesapeake Bay Chesapeake Bay Program: Regional partnership that directs and conducts the restoration of the Chesapeake Bay in the United States. As a partnership, the Chesapeake Bay Program brings together members of various state, federal, academic and local watershed organizations to build and adopt policies that support Chesapeake Bay restoration. By combining the resources and unique strengths of each individual organization, the Chesapeake Bay Program is able to follow a unified plan for restoration. Became part of the EPA in 1983 50+ partnerships involved The Chesapeake Bay Foundation (CBF) is a non-profit organization devoted to the restoration and protection of the Chesapeake Bay in the United States. It was founded in 1967 and has headquarters offices in Annapolis, Maryland. Budget cut worries: Most of the Chesapeake Bay Program’s federal money goes to states, local governments and community groups through grants. The foundation focuses on coordinating and monitoring the efforts of the six bay watershed states and the District of Columbia. Besides Virginia, these states include Delaware, Maryland, New York, Pennsylvania and West Virginia. From Capital Gazette (Maryland Newspaper) a closer look at proposed cuts for other federal departments and agencies that collaborate in the bay restoration effort makes clear that the impact on the bay would go well beyond this single onerous and inexplicable decision. As The Capital has noted, the impact will trickle down to bay cleanup efforts at the state and county levels, too. Great Lakes $330 mil to $0 GLRI The Great Lakes Restoration Initiative was launched in 2010 to accelerate efforts to protect and restore the largest system of fresh surface water in the world — the Great Lakes The program, primarily administered through the EPA, has traditionally enjoyed strong bipartisan support and has standalone authorization at that funding level through 2021, meaning Congress can restore some or all funding.

Live to Grind
EP 31 Licensing Products and making Reality TV in the Process with Louis Foreman

Live to Grind

Play Episode Listen Later Jun 3, 2015 55:08


Louis Foreman talks about his success with starting and selling companies. In this show you will learn how to license a product,the negative impact the Innovation Act has on Inventors, and how Louis made his Reality TV Show "Everyday Edison's" wildly successful.

IP Fridays - your intellectual property podcast about trademarks, patents, designs and much more
3D Printing and Intellectual Property – Interview with Paul Banwatt – Reintroduction of the Innovation Act – IP Fridays Episode 24

IP Fridays - your intellectual property podcast about trademarks, patents, designs and much more

Play Episode Listen Later Mar 20, 2015 25:52


3D-printing has many implications in view of intellectual property – Paul Banwatt talks with Ken Suzan about this topic. Also we cover the reintroduction of the Innovation Act by Bob Goodlatte, pushing patent reform in the US. Lastly, we invite you to our IP Fridays Meetup in San Diego. We are also proud to be [...]

Kinsella On Liberty
KOL106 | Peter Schiff Show: Obamacare, Patent Reform

Kinsella On Liberty

Play Episode Listen Later Dec 11, 2013 20:32


Kinsella on Liberty Podcast, Episode 106. I was a guest today on the Peter Schiff Show (guest host Stefan Molyneux), discussing: ObamaCare's Next Legal Hurdle. Stephan Kinsella, patent attorney & director of the Center for the Study of Innovative Freedom, on how ObamaCare still fails any reasonable legal test, whether anything constructive may come from the Apple/Samsung battle, and why entrepreneurs needn't worry about their intellectual property. Links to issues discussed: Oklahoma lawsuit to derail Obamacare? House passes Innovation Act by vote of 325-91: a small solution to a big patent problem See also Another Problem with Legislation: James Carter v. the Field Codes: From an 1884 paperby James C. Carter, The Proposed Codification of Our Common Law: A Paper Prepared at the Request of The Committee of the Bar Association of the City of New York, Appointed to Oppose the Measure, defending New York's common law from David Dudley Field's attempt to (legislatively) codify it: At present, when any doubt arises in any particular case as to what the true rule of the unwritten [i.e., judge-found, common-law developed] law is, it is at once assumed that the rule most in accordance with justice and sound policy is the one which must be declared to be the law. The search is for that rule. The appeal is squarely made to the highest considerations of morality and justice. These are the rallying points of the struggle. The contention is ennobling and beneficial to the advocates, to the judges, to the parties, to the auditors, and so indirectly to the whole community. The decision then made records another step in the advance of human reason towards that perfection after which it forever aspires. But when the law is conceded to be written down in a statute, and the only question is what the statute means, a contention unspeakably inferior is substituted. The dispute is about words. The question of what is right or wrong, just or unjust, is irrelevant and out of place. The only question is what has been written. What a wretched exchange for the manly encounter upon the elevated plane of principle! For more on problems of legislation, and discussion of legal codes and codification efforts, see myLegislation and the Discovery of Law in a Free Society; and the articles collected here; also my posts Book Recommendations: Private, International, and Common Law; Legal Theory and The UN, International Law, and Nuclear Weapons. In particular, for further related commentary, see my Legislation and the Discovery of Law in a Free Society, e.g., note 78 and related text.

Kinsella On Liberty
KOL106 | Peter Schiff Show: Obamacare, Patent Reform

Kinsella On Liberty

Play Episode Listen Later Dec 11, 2013 20:32


Kinsella on Liberty Podcast, Episode 106. I was a guest today on the Peter Schiff Show (guest host Stefan Molyneux), discussing: ObamaCare's Next Legal Hurdle. Stephan Kinsella, patent attorney & director of the Center for the Study of Innovative Freedom, on how ObamaCare still fails any reasonable legal test, whether anything constructive may come from the Apple/Samsung battle, and why entrepreneurs needn't worry about their intellectual property. Links to issues discussed: Oklahoma lawsuit to derail Obamacare? House passes Innovation Act by vote of 325-91: a small solution to a big patent problem See also Another Problem with Legislation: James Carter v. the Field Codes: From an 1884 paperby James C. Carter, The Proposed Codification of Our Common Law: A Paper Prepared at the Request of The Committee of the Bar Association of the City of New York, Appointed to Oppose the Measure, defending New York's common law from David Dudley Field’s attempt to (legislatively) codify it: At present, when any doubt arises in any particular case as to what the true rule of the unwritten [i.e., judge-found, common-law developed] law is, it is at once assumed that the rule most in accordance with justice and sound policy is the one which must be declared to be the law. The search is for that rule. The appeal is squarely made to the highest considerations of morality and justice. These are the rallying points of the struggle. The contention is ennobling and beneficial to the advocates, to the judges, to the parties, to the auditors, and so indirectly to the whole community. The decision then made records another step in the advance of human reason towards that perfection after which it forever aspires. But when the law is conceded to be written down in a statute, and the only question is what the statute means, a contention unspeakably inferior is substituted. The dispute is about words. The question of what is right or wrong, just or unjust, is irrelevant and out of place. The only question is what has been written. What a wretched exchange for the manly encounter upon the elevated plane of principle! For more on problems of legislation, and discussion of legal codes and codification efforts, see myLegislation and the Discovery of Law in a Free Society; and the articles collected here; also my posts Book Recommendations: Private, International, and Common Law; Legal Theory and The UN, International Law, and Nuclear Weapons. In particular, for further related commentary, see my Legislation and the Discovery of Law in a Free Society, e.g., note 78 and related text.

At The Nexus
At The Nexus #104: You Name It, You Mame It

At The Nexus

Play Episode Listen Later Dec 7, 2013 73:30


With the legendary Sam Ebertz as guest, Ryan Rampersad and Matthew Petschl present new standards for Bluetooth and USB 3.1, the Innovation Act and the Supreme Court ruling on software patents, Android 4.4.1 and Microsoft's next OS, Threshold, and literally, so much more.

Finnegan IP Law Podcast Series
Bill Lewris Examines Follow-On Biologics: An Overview and Comparison of the 2010 Biologics Price Competition and Innovation Act and the Hatch-Waxman Act

Finnegan IP Law Podcast Series

Play Episode Listen Later May 22, 2011 14:34


comparison innovation act hatch waxman act biologics price competition