Podcasts about keytruda

In this week's episode of MedNews Week's Oncology Unplugged, host Chandler Park, MD, a medical oncologist at Norton Cancer Institute in Louisville, Kentucky, sat down with Vadim Koshkin, MD, an associate professor of medicine in the Division of Hematology and Oncology in the Department of Medicine at the University of California, San Francisco (UCSF) School of Medicine, as well as a genitourinary medical oncologist at the UCSF Helen Diller Comprehensive Cancer Center. In part 2 of this 3-part episode series, Drs Park and Koshkin discussed considerations for sequencing and combining antibody-drug conjugates for patients with bladder cancer, the potential future role of sacituzimab govitecan-hziy (Trodelvy) in this disease following the withdrawal of this agent's United States indication for use in patients with metastatic bladder cancer, and the evolution of treatment options for patients who progress on enfortumab vedotin-ejfv (Padcev) plus pembrolizumab (Keytruda).

Pushback against the Trump administration's massive government cuts exploded this weekend across America—and biopharma is no exception. Taking a deep dive into the leadership cuts, we found that more than half of the senior FDA leaders from six months ago are no longer there, and that's just the leadership. Across the Department of Health and Human Services, some 20,000 people will be leaving—of their own accord or otherwise—amounting to a 25% reduction in headcount that would leave HHS with around 62,000 employees. With many of these people likely destined for biopharma, does this pose an ethical problem?   Meanwhile, the escalating tariff war is beginning to ring alarm bells for the economy, with Goldman Sachs now predicting a 45% chance of a recession happening in the next 12 months. While pharma has historically been considered resistant to the challenges of a recession—people always need medicines—this time around could be different, in part because of the consumer-led obesity market. Thanks to the Trump administration's decision to nix a Biden era proposal to cover GLP-1s under Medicare Part D—at least for now—these drugs will continue to cost consumers a pretty penny.   Even without a recession being declared, Eli Lilly's and Novo Nordisk's stocks are falling significantly with the rest of the market. Lilly has lost more than $95 billion in market value in one month. Novo's value has declined $72 billion.   The drugmakers are also still battling makers of knockoff versions of their drugs. Most recently, Lilly filed a lawsuit against a med spa in Indianapolis for allegedly taking vials of tirzepatide and splitting them up into single doses that are sold to patients without the packaging inserts.  Of course, Lilly and Novo aren't the only pharma drug rivalry out there. There's also Keytruda vs. Opdivo, Leqembi vs. Kisunla and more.   Finally, we take a look at seven late-stage MASH candidates that could hit the market in the next few years, following the FDA's 2024 approval of Madrigal's Rezdiffra, the first treatment for the metabolic disorder. 

In this week's episode of MedNews Week's Oncology Unplugged, host Chandler Park, MD, a medical oncologist at Norton Cancer Institute in Louisville, Kentucky, sat down with Vadim Koshkin, MD, an associate professor of medicine in the Division of Hematology and Oncology in the Department of Medicine at the University of California, San Francisco (UCSF) School of Medicine, as well as a genitourinary medical oncologist at the UCSF Helen Diller Comprehensive Cancer Center. Drs Park and Koshkin discussed recent developments in bladder cancer management, including the significant benefits of enfortumab vedotin-ejfv (Padcev) plus pembrolizumab (Keytruda) compared with platinum-based chemotherapy in the metastatic setting, key outcomes from the phase 3 NIAGARA trial (NCT03732677) of perioperative durvalumab (Imfinzi) plus chemotherapy in muscle-invasive bladder cancer, the potential for disitamab vedotin (RC48-ADC) to join the advanced urothelial cancer treatment paradigm, and what the future may look like for HER2-targeted therapies in this disease.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.The European Union has rejected Lilly's Alzheimer's drug Kisunla, citing potential risks of brain swelling and bleeding. This decision follows a similar rejection of a rival drug, Leqembi. Novo Nordisk is facing challenges in its weight loss business due to compounded versions of its drug Semaglutide making up a significant portion of the market. Milestone Pharmaceuticals experienced a setback when the FDA issued a complete response letter for its tachycardia drug Cardamyst. The company is now focusing on restructuring and streamlining operations.Merck's injectable Keytruda has shown promising results in a pivotal trial, and BioNTech's bispecific treatment has elicited positive responses in the majority of patients with small cell lung cancer. Novo Nordisk's stock dipped after disappointing weight loss results for Cagrisema, and Biogen and Eisai's drug Leqembi faced setbacks in the UK and Australia. In other news, United States Pharmacopeia is offering career opportunities in various fields including science, technology, regulatory affairs, and quality assurance. Stay tuned for more updates on the latest developments in the pharmaceutical and biotechnology industries.

In today's episode, supported by Summit Therapeutics, we had the pleasure of speaking with Xiuning Le, MD, PhD, about the use of ivonescimab (SMT112) in patients with PD-L1–positive non–small cell lung cancer (NSCLC). Dr Le is an associate professor in the Department of Thoracic/Head and Neck Medical Oncology in the Division of Internal Medicine at The University of Texas MD Anderson Cancer Center in Houston. The phase 3 HARMONi-2 trial (NCT05499390) investigated ivonescimab vs pembrolizumab (Keytruda) in patients with locally advanced or metastatic, PD-L1–positive NSCLC without sensitizing EGFR mutations or ALK translocations. At the preplanned interim analysis, at a median follow-up of 8.7 months (IQR, 7.1-10.3), the median progression-free survival was significantly longer in the ivonescimab arm (n = 198) vs the pembrolizumab arm (n = 200), at 11.1 months (95% CI, 7.3-not estimable) vs 5.8 months (95% CI, 5.0-8.2), respectively (stratified HR, 0.51; 95% CI, 0.38-0.69; 1-sided P < .0001). The objective response rates were 50% (95% CI, 43%-57%) and 39% (95% CI, 32%-46%) in these respective arms. In our exclusive interview, Dr Le discussed the rationale for the HARMONi-2 trial, key findings from the study, and where these findings position the potential role of ivonescimab in the PD-L1–positive NSCLC treatment paradigm.

Last year, Alice Valder Curran, a partner at Hogan Lovells and a healthcare policy expert in Washington, D.C. joined host Jonah Comstock on the pharmaphorum podcast to talk about the intended and unintended consequences of the drug pricing negotiation provisions in the Inflation Reduction Act. On today's episode, Curran joins us once again for an update on the IRA, looking at the second batch of drugs announced in January, recent messaging from the Centers for Medicare and Medicaid Services and what it might communicate about their thinking, and more analysis of IRA's consequences, including a recent study on the impact of the IRA on early stage investment. She also talks about the possibility that, because of perverse incentives for pharmacy benefit managers, patient access to medications negotiated under the IRA could actually get worse. And she looks ahead to the third round of negotiations, which will see Part D drugs, including Keytruda, become eligible. While the IRA was the main focus of discussion, Curran and Comstock discuss a lot more about the current chaotic environment in DC, including the potential impact of layoffs on the functioning of agencies like CMS and FDA, the outlook for the possibility of IRA reform under the Trump administration, and the recent dispatch from Secretary of Health and Human Services Robert F. Kennedy indicating a change in policy around notice and comment rulemaking.  Things are happening fast in the United States government and the ripples could have big effects for the pharma industry. Tune in for the low-down from an expert insider. 

A patient with Duchenne muscular dystrophy taking Sarepta's gene therapy Elevidys has died of acute liver failure, possibly related to a recent viral infection. Sarepta, which said it will update Elevidys' label to reflect the new safety signal, saw its shares drop 22% on the news but analysts still seem positive on the drug, as treatment options for Duchenne remain limited.Meanwhile, both AstraZeneca and Taiho Pharmaceuticals announced acquisitions worth up to $1 billion or more in two sizzling therapeutic spaces, cell therapy and antibody-drug conjugates, respectively.Despite canceling a vaccine advisory committee late last month, the FDA on Thursday selected flu strains to be targeted in the upcoming 2025-2026 flu season. And at another federal agency, the Centers for Disease Control and Prevention, employees will have to wait a bit longer to see who will take the helm under Donald Trump, as the president's nominee, Dave Weldon, was pulled hours before he was set to appear before a Senate committee on Thursday. Like HHS Secretary Robert F. Kennedy Jr., Weldon has expressed anti-vaccine views in the past, particularly his continued suggestion of the link between vaccines and autism. Guggenheim Partners called the move to revoke Weldon's nomination “a positive sign for reigning in vaccine criticism.”In the weight loss arena, BioSpace takes deep dives into the tendency for biopharma to develop fast-followers, or me-too drugs—following a pattern seen with PD-1 checkpoint inhibitors after the approvals of Merck's Keytruda and Bristol Myers Squibb's Opdivo. One key difference between these two markets, however, is that when it comes to GLP-1s for weight loss, patients are not staying on these medicines. Drug developers are trying several approaches to improve treatment persistence, including titration, combinations and even secondary drugs that address side effects. They're also making other moves to differentiate themselves, including focusing on overall health outcomes—in areas like cardiovascular, sleep apnea and kidney disease.Following on BioSpace's coverage of the major patent cliffs that many Big Pharma companies are facing in coming years, we also take a look back at some of the companies that have already weathered such loss of exclusivity. It's rarely a straightforward story of sales crashing off patent, as companies take various tacks to extend their blockbuster sales.Finally, the cardiovascular space is expecting some movement this week. First, Alnylam is anticipating a decision on its RNAi silencer Amvuttra in ATTR-CM. An approval—which is widely expected—would make three companies on the market in this rapidly expanding space after Pfizer's tafamidis was approved in May of 2019, and BridgeBio's Attruby got the greenlight in November last year. And second, Milestone Pharmaceutical has a PDUFA coming up for etripamil in paroxysmal supraventricular tachycardia.

In episode 86 of the Podcast for Social Research, live-recorded at BISR Central, BISR's Ajay Singh Chaudhary and Danya Glabau sat down with fellow faculty Nafis Hasan to celebrate the launch of his new book, Metastasis: The Rise of the Cancer-Industrial Complex and the Horizons of Care. Nafis kicks off the discussion with a briefing on the successful cultivation of cancer cures for mice, but not humans, fundamental failures at the clinical level, the rise of cancer as a household name, and the blockbuster drug moving for $500,000 a shot. The three then discuss the primacy placed, among researchers, on genetic mutations above environmental causes, the notion of “financial toxicity,” and what it means to critique medical research at a moment of widespread cuts to public health institutions. Key questions arise along the way: why—despite the allocation of so many resources—are we not winning the war on cancer? Why has an entire political economy developed around genetic mutations, at the expense of public health campaigns—a more proven mitigator of cancer-related deaths? Why is capitalism so embedded in efforts to defeat cancer, and is there any alternative? Note: The Novartis drug with a half-million dollar price tag mentioned at the top of the podcast is Kymriah, not Keytruda. The Podcast for Social Research is produced by Ryan Lentini. Learn more about upcoming courses on our website. Follow Brooklyn Institute for Social Research on Twitter / Facebook / Instagram / Bluesky

Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.Industry is anxiously awaiting the hearing for FDA commissioner nominee Marty Makary, following disruptions and layoffs at the FDA. Novo Nordisk and Eli Lilly are intervening in legal battles against drug compounders over shortages of glp-1 compounds. ARS Pharmaceuticals has received FDA approval for Neffy spray for children with anaphylaxis. A Pitchbook report found $4.3 billion in funding for women-led biotech companies amid sociopolitical headwinds affecting initiatives to support women and minorities.Tariff threats, Novo launching a DTC program for WeGovy, Merck's legal dispute over injectable Keytruda plans, and Jazz's acquisition of Chimerix are also making headlines. The job market outlook is still uncertain, with layoffs cooling off but rare disease biotechs struggling as Congress fails to renew priority review programs. Various job opportunities in the biotech industry are also listed.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Novo Nordisk has launched a direct-to-consumer program for their drug Wegovy, offering it at a reduced price of $499 per month for uninsured or underinsured patients, less than half of the drug's list price. Meanwhile, rare disease biotechs are facing challenges as Congress has failed to renew the rare pediatric disease priority review program, creating uncertainty and concerns within the biopharma industry. Congress failed to renew the rare pediatric disease priority review program at the end of 2024, leaving rare disease biotechs in a difficult position. Companies spent $513 million on priority review vouchers in 2024. Delphia, a biotech company, launched a new precision medicine approach called Activation Lethality in May 2024. The top 10 best-selling drugs of 2024 included Merck's Keytruda and Abbvie's Humira. Pfizer is prepared to reshore manufacturing if tariff threats are realized. Other news includes BridgeBio Oncology's plan to go public, Abbvie's deal with Gubra, and GSK CEO Emma Walmsley's pay increase. Industry leaders will be discussing the future of orphan drug development and rare disease care at the upcoming World Orphan Drug Congress in 2025. Annalee Armstrong, senior editor for Biospace, invites readers to suggest topics for future coverage and provide feedback to improve their Biospace experience.

Donald Trump's tariffs have headlined myriad news stories this week—including at BioSpace, where we reported Pfizer CEO Albert Bourla's claim that his company is prepared to reshore manufacturing if the president makes good on threats made last month. Eli Lilly also appears to be preparing, commiting $27 billion to boost its U.S. manufacturing capacity.   Meanwhile, another regulatory meeting has been canceled under new HHS Secretary Robert F. Kennedy Jr. Reuters revealed last week that an upcoming meeting of the FDA's external advisers for vaccine policy on March 13 has been canceled—just a week after the CDC Vaccine Advisory Board's first meeting of 2025 was postponed. Also on the policy front, BioSpace took a deep dive into priority review vouchers (PRVs) after Congress failed to reauthorize the rare pediatric disease PRV program at the end of 2024. Our reporting shows this will be painful for many biopharma companies who rely on funds from the sale of PRVs.   Speaking of money, AbbVie and Eli Lilly struck a pair of mid-size deals in hot spaces. AbbVie made a late obesity play this week, inking a licensing deal worth up to $2.2 billion with service provider Gubra to bring a long-acting amylin drug to the market, while Lilly hopped onto the hot molecular glue train, paying more than $1.2 billion in a licensing deal with Magnet Biomedicine.  Finally, we examined the somewhat lethargic immuno-oncology space, which has companies, including BMS, Roche, Summit Therapeutics and BeiGene, targeting TIGIT, VEGF, RAS and more in their quest to bring the next Keytruda—which led the way in 2024 as the world's best-selling drug—to the market.  

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. AbbVie has recently entered the obesity market through a deal with Gubra for Amylin, worth up to $2.2 billion. This move positions AbbVie among industry leaders like Novo Nordisk and Eli Lilly. The focus on redefining obesity as a chronic disease is gaining momentum, with recent FDA documents and The Lancet Diabetes & Endocrinology commission highlighting the importance of maintenance treatment. In immuno-oncology, experts are searching for the next breakthrough beyond Keytruda and Yervoy. Novel targets, combinations, and pre-emptive immunization are being explored as potential areas of growth. The upcoming World Orphan Drug Congress in 2025 will gather industry leaders to discuss the future of orphan drug development and rare disease care. Positive developments have been reported for Biogen and Eisai's Leqvio in Europe, AstraZeneca and Amgen's Phase III win for Tezspire, and advancements in non-opioid painkillers by Lexicon. The text also discusses the maturation of immuno-oncology, the potential of mRNA technology in rare diseases, recent FDA approvals for rare disease treatments, the evolving mindset towards treating obesity as a chronic disease, and updates on FDA-related news. Lastly, job opportunities in the biotech industry are available at AbbVie, Moderna, Arvinas Inc., and Sonothera. Share your input on topics to cover in the biopharma industry.

In this episode of Oncology Unplugged, a podcast series from OncLive and MedNews Week, podcast host Chandler Park, MD, a medical oncologist at Norton Cancer Institute in Louisville, Kentucky, was joined by Petros Grivas, MD, PhD; and Ruben Raychaudhuri, MD, to talk about a pilot trial investigating neoadjuvant accelerated methotrexate, vinblastine,doxorubicin, and cisplatin (aMVAC) plus pembrolizumab (Keytruda) in patients with non-urothelial muscle-invasive bladder cancer, findings from which were presented at the 2025 Genitourinary Cancers Symposium. Dr Grivas is clinical director of the Genitourinary Cancers Program and a professor in the Clinical Research Division at Fred Hutchinson Cancer Center, as well as a professor in the Division of Hematology and Oncology at the University of Washington School of Medicine in Seattle. Dr Raychaudhuri is an assistant professor in the Clinical Research Division at Fred Hutchinson Cancer Center, as well as an assistant professor in the Division of Hematology and Oncology at the University of Washington School of Medicine. In their exclusive conversation, Drs Park, Grivas, and Raychaudhuri discussed key efficacy and safety findings from this study; the need for conducting dedicated research in bladder cancer patient populations with variant histologies; and the potential of biomarkers, such as HER2 expression, to improve the bladder cancer treatment paradigm in the future.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world. A lawsuit against Merck related to the HPV vaccine Gardasil, led by Robert F. Kennedy Jr., has been suspended after confirmation. Biopharma bankruptcies are at a peak, with 14 companies filing for chapter 11 protection in 2023 and numbers remaining high in 2024. Gilead has passed on an option for a cancer drug from Arcus, and Merck has partnered with Epitopea to identify unknown tumor antigens. The American Biomanufacturing Summit is set to take place in April 2025 in San Francisco, bringing together industry leaders for exclusive sessions and networking opportunities. The pharmaceutical industry is facing challenges such as patent cliffs and regulatory changes, with companies like Exelixis looking to next-generation cancer drugs for growth. Novo is seeking $830 million in a fraud case against a Singaporean biotech company over a kidney drug. Additionally, there are insights on site survival for clinical research sites and how biotechs can avoid state and local tax surprises. Trump's administration is reportedly seeking to dismantle parts of the FDA workforce, leading to concerns about job security within the agency.Biopharma bankruptcies remained high in 2024, with 14 companies filing for chapter 11 protection, the most in over a decade. Cour Pharmaceuticals solidified its mission last year with a series a raise. Some biotechs are facing unexpected tax consequences when dealing with big pharma. Several top pharma companies are facing massive patent cliffs, including Merck's Keytruda. Novo seeks $830 million in a fraud case against a Singaporean biotech, while Exelixis looks to next-gen cancer drugs. Biogen and Stoke strike a co-development deal for Dravet syndrome. The FDA faces uncertainty as the Trump team seeks to dismantle the workforce. Aardvark Therapeutics raises $94 million for obesity treatments. Abbott, Life Edit Therapeutics, and Regeneron Pharmaceuticals are hiring for various positions.

In collaboration with KidneyCAN, CancerNetwork® spoke with Eric Jonasch, MD, a professor in the Department of Genitourinary Medical Oncology of the Division of Cancer Medicine, and the director of the von Hippel Lindau Center at the University of Texas MD Anderson Cancer Center in Houston, Texas, about the missions and goals of the Kidney Cancer Research Consortium. Jonasch is the principal investigator of an effort, supported by a Department of Defense (DoD)–funded grant, that aims to improve the treatment of patients with renal cell carcinoma (RCC) by developing a network of clinical trial centers that have expertise in both developing and executing new research efforts.  “We want to do the clinical trials that the industry wouldn't do otherwise and do the trials that are going to allow us to gain knowledge faster,” Jonasch said. “We do this by, number one, using novel agents; number 2, using more efficient and innovative clinical trial designs; and, number 3, incorporating correlative studies, including biopsies and various other circulating biomarkers analyses that allow us to get smarter faster.” Many of the ongoing and recently completed trials in the kidney cancer space focused heavily on immune therapy, utilizing checkpoint-blocking antibodies like nivolumab (Opdivo) and pembrolizumab (Keytruda) or CTLA-4–blocking agents like ipilimumab (Yervoy). Of the studies moving the space forward, Jonasch highlighted an ongoing phase 1b/2 trial (NCT05501054) evaluating ipilimumab, nivolumab, and ciforadenant (CPI-444), an A2A inhibitor, in RCC along with other trials. During the discussion, Jonasch mentioned the initiative to incorporate biopsies in treatment more frequently, particularly through giving a pre- and post-biopsy to see how the results change during therapy. This approach gives investigators an opportunity to see how cancer cells interact with immune cells.  Additionally, Jonasch stated that they wish to expand their efforts to the broader kidney cancer community, as currently, work in the consortium only takes place in 7 “ivory tower” institutions that may be difficult to access for some patients. One of the ways they're combatting this barrier is through working with the Veterans Affairs hospital system. Once that effort is complete, Jonasch hopes the consortium will be able to start helping more patient groups.  KidneyCAN is a nonprofit organization with a mission to accelerate cures for kidney cancer through education, advocacy, and research funding. You can learn more about KidneyCAN's work here: https://kidneycan.org/ Reference Beckermann K, Rini B, Haas N, George D, Jonasch E. Phase 1b/2 trial of ipilimumab, nivolumab, and ciforadenant (INC) (adenosine A2a receptor antagonist) in first-line advanced renal cell carcinoma. Oncologist. 2023;28(suppl 1):S13–4. doi:10.1093/oncolo/oyad216.022.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world. Sage has rejected Biogen's unsolicited buyout offer and will seek strategic alternatives. Biogen and Eisai have received approval for a monthly maintenance regimen for Alzheimer's drug Leqembi. Veru's drug has shown promise in sparing lean mass in overweight adults on Wegovy. The Duchenne muscular dystrophy space is on the verge of a pivotal era with several companies developing investigational therapies. Akero has rebounded in a mid-stage trial, Daiichi Sankyo is optimistic for 2025, and Allakos is cutting its workforce. The text discusses the advancements in the Duchenne Muscular Dystrophy (DMD) space as it enters a pivotal era, with companies such as Capricor Therapeutics, Wave Life Sciences, and RegenxBio working on investigational therapies to address unmet needs. It also mentions Daiichi Sankyo's recent success with the approval of Astrazeneca-partnered Dato-DXD. Additionally, new treatments are in development for Achondroplasia to challenge Biomarin's Voxzogo. Novo's obesity drug shows promising results, Merck's Keytruda combo fails in a Phase III trial for GI cancer, and Tris Pharma wins late-stage for a non-opioid painkiller. The text also invites feedback from readers on topics they would like to see covered in the future.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.Novo has developed a next-generation obesity drug that has shown promising results with up to 22% weight loss in patients. This news comes after a disappointing performance from Cagrisema, which missed Novo's projection of 25% weight reduction in its phase III trial. In other news, Merck's keytruda combination therapy has failed to extend survival in phase III gastrointestinal cancer trials, indicating that the drug may be reaching its limits after numerous approvals. Aardvark Therapeutics has filed for an IPO to advance its lead candidate for obesity treatment. President Donald Trump's actions in his first week in office have caused upheaval in the biopharma industry, including a freeze on communications at major public health agencies. Additionally, Purdue Pharma and the Sackler family have settled opioid lawsuits for $7.4 billion, and Biogen is planning to cut research employees. AbbVie has partnered with Neomorph for a collaboration worth up to $1.64 billion. The biopharma industry is facing uncertainty due to Trump's initial policies and decisions.

En este episodio, analizamos las principales noticias económicas y corporativas que están marcando el inicio del 2025: Mercados al alza: Los futuros del S&P 500, Nasdaq 100 y Dow Jones apuntan a una apertura positiva. Exploramos cómo los datos del índice de precios al productor (PPI) de diciembre podrían influir en las expectativas de recortes de tasas de la Reserva Federal. Regulaciones internacionales: Indonesia planea una regulación para establecer una edad mínima en redes sociales, siguiendo el ejemplo de Australia. Reflexionamos sobre el impacto global de estas medidas en plataformas como TikTok, Meta, y Snap. Adquisiciones estratégicas: United Rentals anuncia la compra de H&E Equipment Services por $4.8 mil millones. Discutimos cómo esta fusión fortalecerá su posición en el mercado de equipos de alquiler. Innovación farmacéutica: Merck adelanta el lanzamiento de la versión subcutánea de Keytruda, su medicamento estrella contra el cáncer. Analizamos su estrategia para extender la exclusividad de la patente y su impacto en el mercado farmacéutico. Inversiones en inteligencia artificial: Applied Digital se beneficia de una inversión masiva de Macquarie para construir infraestructura de inteligencia artificial. ¿Qué significa este movimiento para el sector tecnológico? Acompáñanos para explorar cómo estos eventos impactan los mercados y las estrategias corporativas globales. ¡Dale sabor financiero a tu día con estas actualizaciones!

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world. Johnson & Johnson has made a significant move in the neurology field by acquiring Intra-Cellular for $14.6 billion, gaining access to assets such as Caplyta for schizophrenia and bipolar depression. Biogen has submitted an offer to acquire Sage Therapeutics after facing regulatory and clinical challenges. Gilead is diversifying with a potential $1.7 billion inflammation pact with Leo, focusing on targeting stat6. The FDA's evolving biomarker focus was highlighted by a committee's decision to limit the use of Keytruda and Opdivo in certain cancers based on PD-L1 expression levels. AGC Biologics is offering representative scale-down data for gene of interest candidates before committing to a GMP contract, potentially accelerating timelines by up to 6 months. Other news includes GSK's acquisition of Idorsia targeting rare cancer, AbbVie absorbing the cost of a schizophrenia failure, and collaborations between Merus and Biohaven. Additionally, five novel FDA approvals have been achieved in 2024, while Passage Bio is cutting staff to extend cash runway.The FDA's evolving focus on biomarkers is reflected in the scrutiny of Keytruda and Opdivo for stomach and esophageal cancers based on PD-L1 expression levels. This trend leverages ever-maturing datasets to make more informed decisions about drug approvals. In addition, five novel FDA approvals in 2024 included new mechanisms of action in oncology and neurosciences. Gene therapies for cardiovascular diseases like congestive heart failure and cardiomyopathy are advancing in the clinic, benefiting from technological advancements and positive early data. The NextGen Class of 2025 startups are focusing on ADCs, radiopharmaceuticals, and cell and gene therapies. Pfizer's subcutaneous PD-1 blocker showed positive results in bladder cancer trials, while Denali and AbbVie/Calico faced setbacks in ALS trials. The FDA is proposing setting a bar for weight-loss therapies as the obesity space heats up, with Metsera touting powerful weight loss results.

Guest Name: Cuong Do Title: President & CEO Website: https://bioviepharma.com/ Ticker: BIVI Bio: Cuong Do President & Chief Executive Officer​ Cuong Do, MBA, is the President and Chief Executive Officer of BioVie Inc., a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease. Do is a highly experienced life sciences executive, who has served in various leadership roles at multiple global enterprises and publicly owned companies over the past 35 years. Prior to his appointment with BioVie, Do was President of Samsung Global Strategy Group where he helped to set the strategic direction for the company's diverse business portfolio, including the growth of its biologics businesses. He was previously the Chief Strategy Officer for Merck, a leading US pharmaceutical company on the Fortune 500 list, where he played a key role in defining the company's strategy, including its focus on oncology and creating its leading position with the anti-PD-1 therapy, pembrolizumab (KEYTRUDA®). Do also held leadership roles in the technology space at Lenovo and Tyco Electronics, and was a senior partner at McKinsey & Company, where he spent 17 years helping to build the company's healthcare, high tech and corporate finance practices. Do is an active entrepreneur who founded Callidus Biopharma (a biotech company working in rare diseases that was acquired by Amicus Therapeutics in 2013), Lysodel Therapeutics (a company developing an innovative pharmaceutical product for obesity), and M6P Therapeutics (a company developing gene and enzyme replacement therapies for rare lysosomal storage disorders). He is a founding member of Social Impact Partners, which is a purpose-driven alliance of global experts and young change-makers working to fight against Alzheimer's Disease. Do also serves as a member of multiple advisory boards to companies and academic institutions, including Seneca Therapeutics, Stanford Medicine, The Tuck School of Business at Dartmouth, Fulbright University Vietnam, Ideal Semiconductors, ILiAD Biotechnologies and others. Do is also a passionate philanthropist, particularly in autism and education. He founded Profectum Foundation, which specializes in providing training and education for professionals and parents of children with autism or special needs. He also founded Identifor, Inc. and the Identifor Foundation to help autistic teenagers identify abilities and strengths to make the transition to adulthood. He currently or formerly served on the boards of Celebrate the Children (a school for children with special needs in New Jersey), Autism Speaks and its Executive, Strategy, Science and Family Services committees and Caring for Cambodia (a non-profit working to educate 7,000+ K-12 students in Siem Reap, Cambodia). He holds a BA from Dartmouth College, and an MBA from the Tuck School of Business at Dartmouth. --- Support this podcast: https://podcasters.spotify.com/pod/show/smartmoneycircle/support

New research suggests that estrogen plays a role in allowing hormone receptor-negative breast cancer to grow. This is because estrogen limits the ability of the immune system to attack cancer cells; it also makes immunotherapy medicines, like Keytruda (chemical name: pembrolizumab), less effective. Dr. Donald McDonnell, senior author of the study, explains the results and how they might make a difference for people with breast cancer. Listen to the episode to hear Dr. McDonnell explain: what eosinophils are and how he started studying them in connection with breast cancer how estrogen in the body affects the immune system how a hormonal therapy medicine, like tamoxifen, can make an immunotherapy medicine, like Keytruda, more effective

Good morning from Pharma and Biotech Daily, the podcast that gives you only what's important to hear in Pharma and Biotech world.Biogen and UCB recently achieved unexpected success with their late-stage trial for dapirolizumab pegol in lupus. This has led to plans for a second trial by the end of the year. At the American College of Rheumatology meeting, investigational CAR T therapies for lupus were highlighted, showing potential effectiveness. SignalChem Biotech is offering kinase drug discovery solutions, providing a promising avenue for future developments in the field. Additionally, there are reports of potential competition between BridgeBio and Pfizer, as well as Neurogene dropping a gene therapy program. Updates on Merck's Keytruda and Lilly's cholesterol pill are also making waves in the industry.These advancements in biotech and pharma highlight the ongoing progress and innovation in the field. Stay tuned for more updates on job opportunities in the biotech industry and other important news.

In today's episode, supported by PDS Biotech, we had the pleasure of speaking with Kevin Harrington, MD, PhD, FRCP, FRCR, FRSB, about the role of PDS0101 (Versamune HPV) in patients with human papillomavirus type 16 (HPV16)–positive head and neck squamous cell carcinoma (HNSCC). Dr Harrington is head of the Division of Radiotherapy and Imaging at The Institute of Cancer Research in London, United Kingdom, as well as a fellow of the Royal College of Physicians and the Royal College of Radiologists. In our exclusive interview, Dr Harrington discussed current unmet needs for patients with recurrent/metastatic HNSCC, the rationale for the continued investigation of PDS0101 plus pembrolizumab (Keytruda) in patients with HPV16-positive HNSCC, and how the ongoing phase 3 VERSATILE-003 trial may change the treatment paradigm for patients with this disease. 

Listen to a soundcast of the 9.17.2024 FDA approval of Keytruda (pembrolizumab) for unresectable advanced or metastatic malignant pleural mesothelioma.

This is Zack Fuss. Today we are breaking down Merck, one of the world's largest and oldest pharmaceutical companies. The company has been shaping medicine and fostering innovation for over 130 years. From its humble beginnings as a small family pharmacy in Germany, today's iteration of Merck has transformed into a nearly $300 billion market cap business with particular strength in oncology.  At the heart of Merck's recent success is Keytruda, arguably the world's most important cancer drug. This single medication now generates over $25 billion in annual revenue. But, Merck's story is not only about Keytruda, it's about a company that's consistently pursued innovative science, combined with a handful of bold decisions, which resulted in the development of some of the world's first vaccines and breakthroughs in diabetes treatment.  To break down Merck, I am joined by Ashwin Varma, who is currently a medical student at UT Health San Antonio. We unpack Merck's business model, explore its industry-leading oncology franchise, and examine its pipeline of future drugs, and understand how they have navigated the complex world of pharmaceutical patents and regulation. Please enjoy this Breakdown on Merck.  For the full show notes, transcript, and links to the best content to learn more, check out the episode page here. ----- This episode is brought to you by Alphasense. AlphaSense has completely transformed the research process with cutting-edge AI technology and a vast collection of top-tier, reliable business content. Imagine completing your research five to ten times faster with search that delivers the most relevant results, helping you make high-conviction decisions with confidence. AlphaSense provides access to over 300 million premium documents, including company filings, earnings reports, press releases, and more from public and private companies. Invest Like the Best listeners can get a free trial now at Alpha-Sense.com/Invest and experience firsthand how AlphaSense and Tegas help you make smarter decisions faster. — This episode is brought to you by EightSleep, the temperature-controlled mattress cover that heats or cools your mattress to transform your sleep. The Pod 4 Ultra is the new gold standard in intelligent sleep systems. It can be added to your current mattress like a fitted sheet and is been clinically proven to give you up to an hour more quality of sleep every night. The cooling capability can cool your side of the bed to 20 degrees below room temperature, all managed by the pod's autopilot feature, which adjusts the temperature throughout the night. Go to eightsleep.com/breakdowns and use the code glueguys for $350 off.  ----- Business Breakdowns is a property of Colossus, LLC. For more episodes of Business Breakdowns, visit joincolossus.com/episodes. Editing and post-production work for this episode was provided by The Podcast Consultant (https://thepodcastconsultant.com). Show Notes (00:00:00) Welcome to Business Breakdowns (00:05:50) History and Evolution of Merck (00:08:32) Merck's Blockbuster Era and Challenges (00:10:51) Understanding the Pharma Industry (00:15:32) Merck's Current Business and Financials (00:20:48) Patent Protection and R&D Strategies (00:35:00) Checkpoint Inhibitors: A Breakthrough in Cancer Treatment (00:35:54) The Rise of Keytruda: From Trials to Triumph (00:37:56) Keytruda's Expanding Indications and Market Impact (00:39:56) Understanding Cancer Therapy Lines (00:42:09) Keytruda's Competitive Landscape and Future Challenges (00:46:33) Merck's Strategy for Post-Patent Success (00:57:41) Leadership and Organizational Structure at Merck (01:04:01) Lessons from breaking down Merck

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.This week's commercialization news includes updates on Zepbound supply, Enjaymo's new home, and expanding access to HIV drugs. Medicare has tweaked rules for drug price talks, while GSK reports that its RSV vaccine protects against disease over three seasons. GSK's Viiv plans to expand the supply of HIV drugs in Africa, and Sanofi's rare disease drug finds a new home at Recordati. Other news includes a protein prediction winning the Chemistry Nobel and Alnylam submitting an important drug application. Trends suggest that biosimilars may make a mark in 2025, with incentives favoring them in the Medicare market. Protein prediction wins the Chemistry Nobel Prize, Alnylam submits a crucial drug application, Lilly partners with AI specialist Insitro to develop metabolic medicines, and Purespring raises $105 million for gene therapy for kidney disease. AI startup Basecamp allies with The Broad Institute to create 'programmable' genetic medicines. Additionally, Lilly appoints Mount Sinai scientist Thomas Fuchs as its first Chief AI Officer to lead AI initiatives in drug discovery and clinical trials. Other news includes J&J closing a cancer study, Alnylam seeking approval for a potential blockbuster drug, and Propharma receiving a regulatory and compliance award at CPhI.The Supreme Court declined to review a Texas abortion case related to emergency care, a blow to the Biden administration's efforts. A survey found that nearly 70% of healthcare organizations affected by cyberattacks experienced disruptions in patient care. Steward Health Care is auctioning off assets, including closing Norwood Hospital in Massachusetts. Baxter reported no structural damage at their North Carolina site affected by Hurricane Helene. The payer-provider relationship in healthcare is becoming more complex with consolidation and value-based care, leading to tensions over reimbursement and access.Kezar's lupus trial has been put on hold after four patient deaths, making it a potential buyout target. Investor Kevin Tang is interested in acquisition. Big pharma is also investing in cell and gene therapies, with companies like Lilly and Sanofi making moves in the industry. The Genscript Biotech Global Forum 2025 is coming up on January 15, offering a platform to discuss innovations and challenges in gene and cell therapy. Additionally, Lilly's obesity clinical program faces challenges, while Stealth's ultrarare disease candidate may not meet approval standards.Eli Lilly's obesity program is highlighted as a key factor in the company's dominance in the industry, with CEO David Ricks confident in their position. Wuxi Biologics faces uncertainty in the U.S. after setbacks, while big pharma companies show growing interest in cell and gene therapy. Five radiopharma biotechs are identified as potential buyout targets, and Trilink Biotechnologies introduces custom sets of mRNA for screening studies. Other news includes increased investment in cell and gene therapy, activist investor Starboard's stake in Pfizer, and Merck's success with Keytruda in head and neck cancer. AstraZeneca puts $2 billion towards heart disease drugs, Sanofi offloads a rare autoimmune drug, and AbbVie trims earnings guidance.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.Sage has decided to discontinue the development of its Alzheimer's drug candidate, dalzanemdor, after disappointing mid-stage readouts. This is the third setback in neurology for the company in six months. Meanwhile, cell and gene therapy investments have increased after a challenging period. The Alliance for Regenerative Medicine reported that investments reached $10.9 billion in the first half of the year, surpassing 2019 totals but still below peak levels during the pandemic.Keytruda has shown success in head and neck cancer trials, leading to a potential $1.9 billion collaboration deal for Merck. Additionally, Wuxi Biologics faces an uncertain future in the U.S. following regulatory challenges.Biotech mergers and acquisitions have leveled off, with private biotechs being acquired at a faster rate than public ones in 2024. Kailera Therapeutics has emerged with $400 million for obesity drugs, while Triveni has received $115 million to accelerate immune drug work. Judo Bio has launched with $100 million to develop RNA drugs for the kidney. Sanofi's rare disease drug has found a new home with Recordati.An Alzheimer's drugmaker, Cassava Sciences, is facing accusations of data manipulation but is continuing with two phase 3 studies. The top biopharma conferences to watch in 2025 are highlighted as important events for research progress and clinical trial results in the industry. Oncologists are comfortable referring patients for CAR T-cell therapy, but formal referral processes are lacking.The newsletter "Emerging Biotech Weekly" covers these developments and more in the biopharma industry.

NZ Herald Deputy Political Editor Thomas Coughlan speaks to Jack Tame about the recent week in politics, regarding Casey Costello and release of her independent advice, no more free Covid tests, Keytruda, Parking penalties increasing, and more... LISTEN ABOVESee omnystudio.com/listener for privacy information.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.Bristol Myers has received approval for a first-of-its-kind schizophrenia drug, Cobenfy, and plans to sell it despite potential insurance barriers for patients. Biogen and UCB are planning a large study for their lupus medicine, Biohaven is seeking approval for a neurological disorder drug, and Amgen claims success for immune drugs. Scientist.com discusses streamlining IND applications for cell and gene therapy innovations, while Arch raises $3 billion for a biotech fund. The article also covers strategies to keep clinical trials on schedule and provides insights into the market strategies of drugmakers. Additionally, upcoming events and trending news in the biopharma industry are highlighted. Biopharma Dive offers in-depth journalism and insights into the biotech and pharma industries, covering topics such as clinical readouts, FDA approvals, gene therapy, drug pricing, and research partnerships.Bristol Myers Squibb (BMS) has received FDA approval for KarXT, the first new schizophrenia therapy in 35 years. The drug targets muscarinic receptors and is considered ahead of competition from AbbVie and Neurocrine Biosciences. Pfizer's withdrawal of Oxbryta has left the sickle cell community scrambling, as the therapy was predicted to reach $750 million in sales. Sanofi and Regeneron's Dupixent has received approval for use in chronic obstructive pulmonary disease. The FDA's oncology drugs advisory committee has recommended limiting the use of Keytruda and Opdivo in stomach and esophageal cancer patients with low PD-L1 expression. Additionally, AbbVie's acquisition of Cerevel is showing promise with a phase III win in Parkinson's disease. Cassava has agreed to pay a $40 million fine to resolve an SEC probe, while Roche is looking to push Gazyva into lupus nephritis with positive late-stage data. Lilly is facing scrutiny over drug pricing compared to Novo Nordisk. The BACE credential is highlighted as a way to advance a career in the biotech industry.Senators have introduced a bill to establish cybersecurity standards for healthcare providers, health plans, and business associates. A study found that hospital acquisitions provide a one-time efficiency boost to margins but do not continue to improve operating metrics in the long term. Canopy CEO Shan Sinha discusses healthcare workplace violence and technology's role in protecting workers. The unexpected consequences of hospital quality scores are explored, suggesting a reexamination of the federal hospital-acquired condition reduction program. AI is being integrated into healthcare to give back time and prioritize people in day-to-day tasks. In other news, hospitals in Florida are preparing for Hurricane Helene, a major U.S. prison is criticized for substandard healthcare, and families in states banning health care for transgender teens may have to travel for care. Healthcare Dive provides in-depth journalism on topics such as health IT, policy, insurance, and more for decision-makers in the industry.The FDA recently approved Bristol Myers Squibb and Karuna Therapeutics' new drug, KarXT, now known as Cobenfy, for schizophrenia. This marks the first new mode of action approved for the condition in decades. The drug showed promising results in clinical trials, with patients on Cobenfy actually losing weight compared to gaining weight on other medications. However, there is still room for improvement as over 50% of patients discontinued treatment. The approval of Cobenfy highlights Bristol Myers Squibb's deal-making skills and sets the stage for a new generation of treatments for schizophrenia. Other upcoming drugs in the field may further shake up the market. Pharmaceutical companies are continuously working on market strategies to successfully launch new drugs post-FDA approval, as turning a new drug into a successful asset remains a challenge in the

Many Kiwis will be feeling relief today as new Pharmac funded drugs officially become available. Continuous Glucose Monitors are now being funded alongside widened access to insulin pumps and consumables. Cancer drug Keytruda is also now more accessible. Cancer Society Chief Executive Nicola Coom told Heather du Plessis Allan that Keytruda will make a massive difference for those who've re-mortgaged their homes and travelled overseas for treatment. She said that its absolutely life changing. LISTEN ABOVE See omnystudio.com/listener for privacy information.

At the recent World Conference on Lung Cancer and European Society for Medical Oncology annual meetings, two packages of lung cancer data from a partnership between Akeso and Summit Therapeutics and another collaboration between iTeos Therapeutics and GSK showed much promise of disrupting the current standard of care. But they also drew some questions and debate.  In this week's episode of “The Top Line,” Angus Liu from Fierce Pharma and Gabrielle Masson from Fierce Biotech discuss the key issues behind those two readouts.    To learn more about the topic in this episode:  iTeos-GSK's TIGIT combo shows 30% more tumor shrinkage than Jemperli, but safety signals scare investors Akeso, Summit's PD-1 bispecific crushes Merck's Keytruda in study, signaling potential new standard in lung cancer 'Cooking with gas': Regeneron sees its Opdualag rival as next big thing for treating solid tumors ESMO: Bristol Myers moves Opdualag into phase 3 trials in competitive first-line lung cancer field See omnystudio.com/listener for privacy information.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Various developments in the biopharma industry are discussed, including Novo's CEO being pressured to cut prices of obesity and diabetes drugs, the FTC suing major pharmacy benefit managers over insulin prices, Bluebird laying off another 25% of its workforce, and Apellis' eye drug being turned down in Europe. Large pharmaceutical companies face challenges as patent protections for their blockbuster drugs expire, forcing them to find new products and markets. Resources are provided on topics such as oncology research, AI in clinical research, overcoming clinical trial delays, and creating compelling biopharma data packages.Masimo CEO Joe Kiani resigned following a proxy battle with an activist investor, and Michelle Brennan was named as the acting CEO. Medtronic and Siemens Healthineers partnered on spine surgery, with Siemens integrating its robotic x-ray imaging system with Medtronic's spine surgery suite. Roche launched a test that can detect 12 respiratory viruses simultaneously, including influenza and COVID-19. The FDA appointed Ross Segan to lead the office responsible for premarket authorizations and recalls. A study found that only 30 out of 157 heart devices with class I recalls had undergone premarket clinical testing.The text discusses various healthcare-related news and insights for healthcare leaders on September 25, 2024. It highlights the need for more oversight in remote patient monitoring in Medicare to avoid fraud and misuse, as well as the increasing number of claims denials reported by providers. The Department of Health and Human Services is set to invest nearly $75 million in rural healthcare, focusing on expanding substance use disorder treatment and maternal healthcare services.Amgen's immune drugs for eczema and myasthenia gravis met their objectives in phase 3 trials, but results underwhelmed Wall Street. Novo's CEO was pressed by the Senate to cut prices of obesity and diabetes drugs. Struggling 2seventy scrapped a key cancer study to save money in the near term. Biogen and UCB received long-awaited lupus data. To improve cancer treatments, the nonprofit Cancer Research Institute aims to foster partnerships between scientists and the pharmaceutical industry.Merck's Keytruda combination therapy failed in a phase III colorectal cancer study, following a similar outcome for Bristol Myers Squibb in December 2023. Amgen saw late-stage wins in eczema and myasthenia gravis, with mixed results according to analysts. Novo Nordisk's CEO agreed to meet with PBMs on pricing for Ozempic and Wegovy, which are expected to dominate the next round of Medicare price negotiations in 2025. The BACE credential is recommended for those seeking to advance their biotech career.Sour Patch Kids has created a translator app to simplify corporate jargon for Gen Z entering the workforce. Mazda's new brand platform aims to enhance customer experiences and community activations. TikTok has updated its search ads with keyword targeting, while Firehouse Subs brings back its hot sauce bar with a new campaign. Coca-Cola is discontinuing its spiced flavor after just 7 months.Regeneron's Eylea empire is facing challenges as competitors launch biosimilars of the blockbuster eye drug. Sales of Eylea have decreased while Roche's drug Vabysmo has seen a significant increase in sales. Additionally, gene therapies are entering late-stage trials for wet AMD, potentially changing the treatment landscape dominated by Eylea.Novo Nordisk and Eli Lilly are investing billions in licensing and M&A deals to expand their obesity pipelines beyond GLP-1s, solidifying their dominance in the market. Regulators and policymakers are urged to create incentives to make MPoX a more attractive investment opportunity to effectively combat disease. Cancer and diabetes drugs are predicted to dominate the 2025 Medicare ne

The FDA clears capsule that creates sensation of fullness in the stomach; Complete Response Letter issued for gastroparesis treatment; Apple's sleep apnea notification feature gets clearance; Keytruda gains malignant pleural mesothelioma indication; Ebglyss approved for atopic dermatitis

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Amazon has partnered with Talkspace to expand its digital health benefits program, which also includes Omada Health. Community Health Systems (CHS) subsidiary is acquiring 10 urgent care centers, following in the footsteps of other for-profit health systems. Steward Health Care auctioned off Glenwood Regional Medical Center for $500,000, but there are concerns about the continued involvement of hospital landlord Medical Properties Trust in operations. The text also includes sponsored content on safeguarding healthcare against ransomware and cybercrime, as well as information on trends in telehealth and strategies for improving provider data accuracy for payers. Healthcare Dive provides news and insights for healthcare leaders and is a publication operated by Industry Dive.Roivant's subsidiary, Dermavant, is being acquired by Organon, giving Organon access to a psoriasis and eczema cream called Vtama. This acquisition will provide Roivant with additional cash to fund its research and development plans. Meanwhile, biotech M&A activity has plateaued, with private company acquisitions continuing while public company acquisitions have slowed down. One biotech, Ratio Therapeutics, backed by Bristol Myers Squibb, is optimistic about the boom in radiopharma and the pharmaceutical industry's shift towards targeted radiation drugs. In other news, Novartis' Kisqali has received expanded FDA approval which could double its market for breast cancer treatment. Additionally, Express Scripts is suing the FTC over a report critical of pharmacy benefit manager business practices. The industry is also exploring new ways to deliver genetic therapies and improve clinical trial execution through systems thinking. Overall, the biopharma industry is experiencing exciting times with various developments and advancements in drug development and healthcare technology.Zimmer has decided to pull its hip implant off the market due to fracture risk, with plans to phase out its use by December. Merit Medical has acquired Cook's lead management business for $210 million, adding devices used in heart rhythm device procedures to its portfolio. Synchron has connected brain-computer interface technology to Amazon Alexa, allowing patients to control various functions without using their hands or voice. Senseonics has received FDA clearance for a one-year continuous glucose monitoring system, and Boston Scientific has closed its acquisition of Silk Road Medical. The wearables market is expected to grow by 13% annually between 2024 and 2030, highlighting the importance of adhesives in wearable device development. AI is increasingly influencing the value chain of medical device companies, and manufacturers are exploring ways to utilize AI throughout the product lifecycle. These developments reflect the ongoing innovation and evolution within the medtech industry.Roivant has sold Dermavant to Organon in a deal worth up to $1.2 billion, allowing Roivant to focus on their autoimmune-focused Immunovant and upcoming trials. Summit Therapeutics' bispecific for non-small cell lung cancer has shown promise against Keytruda but still needs more data. Other news includes the FDA approving Keytruda for pleural mesothelioma, Bernie Sanders claiming generics companies can offer a cheaper alternative to Ozempic, Novartis expanding Kisqali's use in breast cancer, and HRSA threatening sanctions against J&J. In the world of enzyme development, SignalChem Biotech offers tailored services. Additionally, new gene therapies for sickle cell disease are reaching patients, and the race for an obesity pill is heating up among companies like Novo, Roche, and Terns.The FDA is facing challenges with conducting overseas drug manufacturing inspections, with 42% of registered plants overdue for inspections. Indian drugmaker Zydus Lifesciences received a warnin

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.Target has launched a collection designed by 'fur-fluencers' to attract pet owners, along with reality TV-styled social content and national ads featuring mascot Bullseye. PayPal's new ad campaign stars Will Ferrell and emphasizes the use of PayPal for both in-store and online transactions. Old Navy is celebrating its 30th anniversary with a '90s-inspired collection and campaign. JC Penney's football-themed campaign includes weekly deals promoted by celebrities like Shaquille O'Neal. Walmart is using Fubo's takeover ad format to connect content and commerce in a CTV environment, highlighting the importance of digital accessibility, the impact of generative AI on marketing strategies, and the evolution of in-store retail media.Steward Health Care has been auctioning off assets, with 15 hospitals transitioning to interim managers and the sale of its Arkansas facility. A data breach at a CMS contractor could affect over 946,000 Medicare beneficiaries. PBM executives have declined to revise controversial testimony given to a House committee. The Biden administration has finalized a rule raising mental health coverage standards for private plans. Medicare Advantage bonuses are expected to drop for the first time since 2015. Payers are exploring ways to improve the quality of provider data through technology.J&J led a $50 million financing round for imaging company SpectraWave, which will support commercial expansion and product additions for their system used in treating coronary artery disease. Apple announced a new sleep apnea feature for its smartwatch, while Roche is set to launch a new continuous glucose monitoring system in Europe. The FDA has found that many AI devices lack validation data, with only 28% being tested prospectively. Singapore is seen as an ideal hub for medtech companies looking to expand in Southeast Asia.A new lung cancer drug developed by Summit has shown a "striking" benefit over Keytruda in a detailed study, confirming earlier claims by the company. The positive results led to a significant increase in shares. In other news, three biotechs raised $700 million in IPOs, the House backed a bill restricting China's role in US biotech, and Centessa's sleepiness drug showed promising results.The Senate is expected to hold Steward CEO Ralph de la Torre in contempt for failing to appear before a subcommittee. In other news, Elevance is acquiring Indiana University Health's insurance business, and Steward Health Care has sold some assets and transitioned hospitals to interim managers. Abortion laws are changing in the US, with North Dakota overturning a near-total ban. California's data exchange framework is proving successful in improving health equity and streamlining information.Three biotechs, Bicara Therapeutics, Zenas Biopharma, and MBX Biosciences, raised $700 million in IPOs, marking the busiest week for biotech stock sales since February. Biotech IPOs are considered the industry's lifeblood, providing insight into mature startups waiting to test public markets. Moderna admitted during an investor presentation that they were overly optimistic about their RSV vaccine's market share potential compared to rivals GSK and Pfizer. Roche's subcutaneous Tecentriq received FDA approval, beating competitors Merck and Bristol Myers to market. Additionally, Gilead's shot succeeded in its second HIV trial.Biopharma Dive provides in-depth journalism and insight into trends shaping biotech and pharma, covering topics from clinical readouts to FDA approvals, gene therapy, drug pricing, and research partnerships. Subscribe to Biopharma Dive for daily news and insights in the industry.

Cancelan festejos patrios los municipios de Galeana y General Zaragoza, en NL Colapsa Río Copala, incomunicadas la comunidad de San Juan Lagunas y Putla Oax.Mas detalles en nuestro Podcast

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.EPRO, or electronic patient-reported outcomes, is increasingly used in clinical trials to improve data accuracy, patient compliance, and reduce administrative burdens. Swing Therapeutics achieved 98% patient compliance in their pilot trial using EPRO, leading to an FDA de novo marketing authorization. EPRO boosts efficiency, saves costs, and improves trial outcomes.The BioSecure Act, which restricts contracts with certain Chinese companies in the US biotech industry, has advanced in the House but still needs Senate support. Bain Capital closed a $3 billion biotech fund and has been acquiring startup companies. Centessa's sleepiness drug showed promising results, lifting the company's shares. New data raise doubts about AstraZeneca and Daiichi's cancer treatment successor. Candid aims to prove the worth of bispecifics in autoimmune diseases.Roivant Sciences has acquired the rights to develop and commercialize Bayer's pulmonary hypertension drug, Mosliciguat, under an in-license agreement worth up to $294 million. Roivant has created a new "vant" called Vant to focus on this project. The Biosecure Act has passed through the U.S. House of Representatives and is set for a Senate vote. AstraZeneca and Daiichi Sankyo's Dato-Dxd failed to significantly improve overall survival in Phase III NSCLC trials, but there is still potential for FDA approval. Terns Pharmaceuticals announced a $125 million raise following positive Phase I data for their oral GLP-1 candidate for obesity.Old Navy is celebrating its 30th anniversary by throwing back to the '90s in a new collection and campaign to enhance its iconic brand. PayPal has launched its largest-ever US ad campaign featuring Will Ferrell, promoting the use of PayPal for both in-store and online transactions. Angela Zepeda, former Hyundai CMO, has been appointed as the global head of marketing for X. Pizza Hut is turning TikTok content into real-world currency for a promotion in the UAE, while Target is targeting pet owners with a collection designed by "fur-fluencers." Marketers are leveraging AI on mobile platforms and genAI is impacting marketing strategies.Merck's Keytruda, a leading immuno-oncology drug, has been highly successful in treating various cancers and has become the world's top-selling drug. However, determining the true value of a drug like Keytruda involves more than just sales numbers. U.S. drug pricing watchdog ICER tracks pricing decisions and their impact, but the industry is exploring new methods to factor in aspects like disability and income disparity. A new formula that considers "standard of living" is being explored to offer a different perspective on pricing in the pharmaceutical industry. As Keytruda celebrates its 10-year anniversary on the market, the impact of this cancer drug and other immunotherapies is being analyzed, along with the future direction of the field.

Summit Therapeutics made headlines this weekend at the 2024 World Conference on Lung Cancer, revealing that its bispecific antibody outperformed Keytruda in first-line non-small cell lung cancer. Meanwhile, bispecifics are one of several therapeutic classes on the agenda at the 2024 European Society for Medical Oncology (ESMO) Congress in Barcelona later this week. Last week, BioMarin held a public address intended to calm anxious investors after rounds of layoffs and pipeline changes—but many were left wanting. Also undergoing major upheaval is Lykos Therapeutics, which laid off 75% of its workforce after failing to secure approval for its MDMA-based post-traumatic stress disorder therapy and announced last week that CEO Amy Emerson is stepping down from her role. In Washington, D.C., Congress is back in session this week and wasted no time in reviewing the BIOSECURE Act, which passed a House vote on Monday.  And on the weight loss front, Terns Pharmaceuticals is moving ahead to Phase II after its investigational GLP-1 pill elicited positive results in Phase I, and Amgen is pushing MariTide into a broad late-stage development program that will test the obesity treatment in other weight-related conditions, such as heart, kidney and liver diseases.

Will bispecifics be the drugs to dethrone cancer's biggest blockbusters? Akeso is the latest company with a bispecific to impress in a head-to-head study, this one for non-small cell lung cancer. On the latest BioCentury This Week podcast, BioCentury's editors discuss the latest data from Akeso's ivonescimab, a VEGFxPD-1 bispecific antibody that went up against Keytruda pembrolizumab in one of its largest indications, first-line non-small cell lung cancer.The editors also discuss data from  Vaxcyte that the infectious disease company parlayed into the year's largest follow-on financing and a new initiative by FDA veteran Janet Woodcock to bolster quality in biopharmas' manufacturing. This episode of BioCentury This Week was sponsored by Parexel Biotech.View full story: https://www.biocentury.com/article/65350700:01 - Sponsor Message: Parexel Biotech01:39 - Akeso's Bispecific Challenge08:22 - Vaxcyte Pneumococcal Vaccine12:32 - Woodcock's Quality Initiative14:48 - Recap: The BioCentury Show on BiosimilarsHave a question? Send us a text!

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.Candid, a startup, is investing $370 million to prove the worth of bispecifics in autoimmune diseases. Summit's lung cancer drug has shown significant benefits over Keytruda, a popular immunotherapy drug. Relay's breast cancer drug also showed promise in early trials. Biotech IPOs are crucial in the industry, and their performance is being closely monitored. Early study data on Terns, a potential contender in the obesity drug market, is also discussed.Summit Therapeutics has declared victory over Keytruda in advanced non-small cell lung cancer, with their drug Ivonescimab showing a 49% higher effectiveness in reducing disease progression or death in a late-stage study. GSK is set to approach the FDA with positive Phase III data for a long-acting asthma medication. Terns Pharmaceuticals' investigational GLP-1 pill has shown promising weight loss results. Sino Biological has launched a new center for bioprocessing, and various pharmaceutical companies are making advancements in their pipelines. The FDA tracker highlights Travere's full approval for an IgAN drug.The challenges faced in the cell and gene therapy industry as it grows in popularity among investors and innovators are discussed. Shortages of brand-name diabetes and obesity medications from Novo Nordisk and Eli Lilly, such as Ozempic and Mounjaro, are due to high demand. Efforts are being made to ramp up manufacturing and develop new medications. Lilly recently made a billion-dollar deal with Haya Therapeutics to develop genetic obesity medications. The revival of drugs for Huntington's disease after initial trial failures is mentioned. Challenges in turning new drugs into successful assets even after FDA approval are highlighted, along with a poll on which presidential candidate would support policies favorable to the pharma industry. Information on staying compliant with the EU GMP Annex 1 revision is also provided.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.Clinical trials often fail to meet their enrollment goals and schedules, leading to significant financial losses. A new playbook offers solutions to address common challenges in clinical trial recruitment, including strategies for identifying additional participants, engaging and empowering individuals, and refining protocol criteria. The playbook provides insights on how to rescue trials when misalignment occurs, aiming to help brands in the biopharma industry tell compelling stories, build trust, and drive demand.Penumbra has decided to exit the virtual reality business, resulting in the layoff of 71 employees, as the company shifts its focus back to its core thrombectomy business. Qiagen and AstraZeneca have expanded their companion diagnostic partnership beyond cancer, allowing specialty care providers to perform genotyping during routine clinical examinations. Illumina has received FDA approval for a companion diagnostic cancer test that can identify patients eligible for treatment with specific medications targeting genetic features. Johns Hopkins, CareFirst, and Techstars have launched a healthcare AI accelerator program to support up to 12 startups working on AI tools. Medical sales teams are increasingly investing in training and skills development to adopt a more human-centered approach to sales.Biopharmaceutical company BioMarin has announced its second round of layoffs this year, with 225 employees globally being let go. This comes after changes to the company's C-suite last week and a previous round of 170 job cuts in May. In other news, Novartis is expanding its Sirna therapy Leqvio after successful Phase III study results, while Merck has ended two late-stage studies of Keytruda due to disappointing data. Regeneron is suing Sandoz in federal court to block a biosimilar of its drug Eylea. The pharma industry continues to see changes and challenges, with companies making strategic decisions based on clinical trial results and market conditions.Cognition Therapeutics, a small biotech company, recently announced positive results from a mid-stage Alzheimer's study. However, despite the promising results, the company's share price plummeted, puzzling many. The conflicting narratives surrounding the study highlight the significance of presenting scientific results in a way that reassures investors about the risks involved. The success of clinical trials is crucial for small biotechs in the competitive field of Alzheimer's research. Investor support is essential for advancing treatments for Alzheimer's, as progress cannot be made without adequate funding.The Health and Human Services (HHS) plans to appeal a lawsuit decision regarding online tracking technology. The Northwell-Nuvance merger has been approved by state attorneys general with certain conditions, while McLaren Health Care has restored its network after a ransomware attack. The shortage of mental health providers is being addressed with digital tools, and efforts to combat burnout in healthcare are ongoing.Neurocrine's mixed schizophrenia data disappoint Wall Street despite "positive" results, leading to a 20% slide in shares. The FDA rejection of the first MDMA therapy signals challenges in the psychedelic drug field. Bayer partners with RNA drugmaker Nextrna Therapeutics to develop new cancer therapies. A study suggests that covering Wegovy for heart risk could cost Medicare tens of billions each year.Pfizer has partnered with Flagship's Quotient to utilize genetics in targeting heart and kidney diseases. Moderna is facing tough competition as it tries to determine its next move in the biopharmaceutical industry. Neurocrine Biosciences saw a drop in shares despite meeting the primary endpoint in a mid-stage schizophrenia trial.Lykos Therapeutics faced a setback when the FDA rejected its MDMA therapy for PTSD and laun

Questions to Ministers Rt Hon CHRIS HIPKINS to the Prime Minister: Does he stand by all his Government's statements and actions? NANCY LU to the Minister of Finance: What approach is the Government taking to managing spending and reprioritisation in Budget 2025? CHLÖE SWARBRICK to the Prime Minister: Does he stand by all his Government's statements and actions? Hon BARBARA EDMONDS to the Minister of Finance: Does she stand by her statement, "Our Budget was very deliberate in the funding of core priorities because our priorities are the same priorities as New Zealanders"; if so, is she concerned that her priorities are disconnected from everyday New Zealanders? GRANT McCALLUM to the Minister of Education: What evidence has she seen to support her recent announcement on Make it Count, an action plan to transform maths education in New Zealand? DEBBIE NGAREWA-PACKER to the Prime Minister: Does he stand by all of his Government's statements and actions? Hon WILLIE JACKSON to the Minister for Arts, Culture and Heritage: Does he think it is appropriate that te reo Maori be used in an invitation for Matariki, a distinct holiday to celebrate the Maori New Year; if not, why not? Dr CARLOS CHEUNG to the Minister of Justice: What actions is the Government taking to reduce harm caused by gangs and make communities safer? Hon Dr AYESHA VERRALL to the Minister of Health: Is it correct that he was advised of Health New Zealand's plan to block early access to the cancer drug Keytruda on Friday 2 August, and that he did not take action to address this issue until after it was made public? TODD STEPHENSON to the Minister of Internal Affairs: What recent announcements has she made about passports? KAHURANGI CARTER to the Minister for Children: Does she stand by the Government's Budget description of the Oranga Tamariki Contracting Service Costs savings initiative that "This initiative improves the efficiency of service delivery, with no reduction in frontline services"; if so, how is Oranga Tamariki ensuring no reduction in frontline service provision? Hon Dr DEBORAH RUSSELL to the Minister for Tertiary Education and Skills: Does she stand by her statement that "the previous government's Te Pukenga mega-merger has been nothing but an abject disaster"; if so, why?

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world. GSK's vaccine sales are slowing down, while Merck's Gardasil sales dropped in China, leading to a slide in Merck's shares. Keytruda reached a sales milestone of $7 billion. Leqembi was voted down by European regulators. Bristol Myers' beat completes a strong week of pharma earnings. Vertex's pain drug received speedy FDA review, and trends in the obesity drug market are discussed. Eisai plans to appeal the negative recommendation for their Alzheimer's drug. Overall, the pharma industry is experiencing various developments and challenges, with companies adjusting their forecasts and strategies to navigate the changing landscape.Stryker plans to be "very active" in mergers and acquisitions, with the CEO hinting at potential interest in soft tissue robots after a record quarter of orthopedic robot installations. Labcorp is expanding its Ultima pact to boost genomic diagnostics by using Ultima Genomics' machine to sequence genomes for $100. The FDA sent a warning letter to defibrillator battery manufacturer Amco, which supplies batteries to companies like Philips, Stryker, and Zoll. At the FDA's first home health hub meeting, a patient shared a day in the life with diabetes, aiming to improve health equity by considering living conditions in device design. FDA officials outlined the benefits of AI lifecycle management, presenting a seven-stage diagram for monitoring artificial intelligence software development. Other news includes Flo Health reaching unicorn status with a $200 million raise, Google cutting ties with Amazon's One Medical, and a study finding that a blood test accurately diagnosed Alzheimer's 90% of the time.Humana is expected to lose a 'few hundred thousand' Medicare Advantage members next year after reducing its plan footprint for 2025. CHS is selling 3 hospitals and exiting Pennsylvania as part of plans to offload assets worth $1 billion this year. Google has cut ties with Amazon's One Medical, which was a major setback for the company. North Carolina is offering enhanced Medicaid funds to hospitals that help eliminate medical debt, with experts calling it a "win-win" for patients and providers. Additionally, a data breach at Healthequity could affect 4.3 million individuals.GSK is cutting vaccine forecasts due to slower U.S. sales of their shingles vaccine, while predicting faster overall growth. Pfizer's CEO remains confident in the company's position with an obesity drug, despite delays. Merck's shares dropped as sales of Gardasil decreased in China. Vertex's pain drug is getting a speedy FDA review, Keytruda hit a sales milestone, and biotech startup Airna raised $60 million for RNA editing medicines.GSK has lowered its full-year vaccine guidance for 2024 due to disappointing Q2 sales and challenges with updated CDC guidelines on RSV shots for seniors. The Biosecure Act could impact biotech and biopharma markets in the US and China. Other top stories include new data on Leqembi, rising biopharma investment activity, and updates on various companies in the industry.Experian has launched a retail media solution for networks looking for richer data, while Shapermint's AI ad tool is helping drive profits. Retail media networks are expanding their scope, potentially leading to challenges. Creators and marketers are advised to protect themselves while using AI. NBCUniversal has broken Olympics ad records, with over $1.2 billion in ad sales.Pharma companies are facing penalties for raising drug prices faster than the rate of inflation, with the negotiation period for price talks with Medicare set to expire soon. These penalties are part of the Inflation Reduction Act, which has been met with resistance from the pharma world.The Biosecure Act could have significant implications for biopharma marketSupport the Show.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.GSK is relying on its flagship program to help find new drugs and vaccines, following disappointments with Ventyx's tyk2 drug suffering setbacks. New Amsterdam's heart drug hits trial goals but disappoints investors, and Boehringer adds to its cancer drug pipeline with a deal for startup Nerio. The industry is exploring the use of eClinical technology to improve clinical trials, while stakeholders are looking for more efficient ways to innovate with real-world evidence. Overall, the biopharma industry is facing challenges and setbacks, but also opportunities for growth and development in various areas of research and development.Boehringer Ingelheim has acquired Nerio Therapeutics for $1.3 billion in order to strengthen its immuno-oncology pipeline with novel immune checkpoint inhibitors. Additionally, Adaptimmune is preparing for potential approval of their first-in-class engineered T cell therapy. In other news, Wuxi Apptec's U.S. revenue dropped slightly as the Biosecure Act looms, while the FDA has flagged safety risks of compounded versions of Novo Nordisk's semaglutide. AbbVie's Skyrizi has received EU approval for ulcerative colitis, and Merck's Keytruda in combination with Padcev has been granted a positive opinion by CHMP for urothelial carcinoma. Other updates include FDA approvals for new oral Alzheimer's therapy and expanded labels for Grifols' SCIG therapy. The biopharma industry is also experiencing layoffs at companies such as Cue, Anokion, and Glycomimetics. Biogen is facing challenges with its neuro drugs, including a recent EU regulatory rejection for Leqembi due to concerns about brain swelling. The company also had a setback with an essential tremor treatment developed with Sage Therapeutics. Despite these failures, Biogen and Sage will continue to work together as part of a two-drug development deal. The industry is exploring preclinical modeling as a potential solution to improve the success rate of neuro drug development. Overall, Biogen's development pipeline is under pressure, especially following the withdrawal of the Alzheimer's drug Aduhelm earlier in the year. The company is facing obstacles in gaining traction with its treatments in both the US and European markets.Optum is planning to lay off over 500 workers in California, affecting various healthcare facilities and remote workers. CHS posted a $13 million loss in the second quarter, despite increases in surgical and outpatient volumes. Lawmakers are urged to support nursing home staffing regulations to protect the elderly, rather than overturning them. The resumption of the VA Oracle EHR rollout is being questioned at a subcommittee hearing. Healthcare leaders are encouraged to use digital tools to address the shortage of mental health providers and meet the growing need for mental health services. Overall, the healthcare industry is facing challenges related to patient communication, staffing regulations, and financial losses.Support the Show.

Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.CDRH Director Jeff Shuren is set to step down after 15 years, with Michelle Tarver serving as acting director of the FDA's medical devices unit. Boston Scientific predicts strong growth for Farapulse following a successful launch. The top 5 medtech deals in the first half of 2024 include Johnson & Johnson's $13.1 billion takeover of Shockwave Medical. ICU Medical is closing a Minnesota facility and cutting 83 jobs, while Cook Medical plans to sell its reproductive health business to a private equity firm. Medline is exploring an IPO in 2025, Magenta securing $105 million for trials of the world's smallest heart pump, and robotic aid improving balance and gait in children with cerebral palsy.Transitioning to healthcare news, HCA reported $17.5 billion in revenue in the second quarter and raised its full-year guidance. Humana's Centerwell plans to open 23 primary care clinics at Walmart stores. Maternal health quality varies by state, with states with more restrictive abortion bans having fewer maternal health providers and higher maternal death rates. Pharmacy benefit managers, including CVS Caremark, Optum Rx, and Express Scripts, faced scrutiny from Congress over drug pricing policies. AI is being used to transform unstructured patient data into structured reports in healthcare systems.Moving on to updates in pharmaceuticals, Pfizer's hemophilia gene therapy met its late-stage study goal, but questions remain about the long-term potential of hemophilia treatments. Biogen's tremor drug, Sage-324, failed a key trial, and the FDA's medical device chief, Shuren, is stepping down after 15 years. Novartis is investing in bispecifics for cancer, while Autobahn raised $100 million for neuropsych drugs. Bob Langer steps down from Moderna's board, and PBMs are facing bipartisan scrutiny over drug pricing policies.In the biopharma sector, Biogen and Sage Therapeutics have discontinued a phase II trial for an investigational neuroactive steroid for essential tremor after it failed to significantly improve upper limb tremors. Pfizer's gene therapy for hemophilia A has shown positive results in a phase III trial. The FDA has raised concerns about potential overtreatment with AstraZeneca's Imfinzi for resectable non-small cell lung cancer. There is speculation about whether Merck should buy out Moderna to strengthen their partnership on Keytruda-cancer vaccine.Lastly, in marketing news, Google's ad revenue remains strong despite transitions in technology, with AI implementations and cookie changes. Albertsons' retail media business is incorporating AI and in-store technology to improve operations. Coca-Cola and Delta are 'olympicizing' their campaigns with NBCUniversal, as advertisers spend over $1.2 billion for the Olympics. Google has become the official search AI partner of Team USA, leveraging its products for NBCUniversal's Olympics coverage.The marketing landscape is evolving with a focus on technology, data-driven strategies, and partnerships between brands and media companies like NBCUniversal and Google.

Each June, the American Society of Clinical Oncology (ASCO) hosts a conference that gathers physicians, researchers and the cancer community to share their latest research on treatments, technologies and more.  The Fierce team is always on the ground at the ASCO meeting, and this year, Fierce Biotech's Gabrielle Masson and Fierce Pharma's Angus Liu covered the event.  In this week's episode of "The Top Line," they discuss the most talked-about data drops at ASCO and share on-the-ground details, including their experience with Gilead's virtual reality Trodelvy ride.  To learn more about the topics in this episode:  Akeso, Summit's Keytruda win draws 'explosive' interest at ASCO. But what does Merck think? ASCO: After Keytruda, Merck builds 3-pronged cancer strategy starring Moderna-partnered vaccine ASCO: Cautious Big Pharmas double down on past wins—steering clear of radioligands and cell therapy See omnystudio.com/listener for privacy information.

Step into the captivating world of biotech innovation with the delightful MJ Huntsgood, who joins our Science Chat straight from the life sciences hub near Washington DC. MJ's journey from a bug-loving biology aficionado to a biotech manufacturing maven, intricately involved in the development of pharmaceutical marvels like Keytruda, is nothing short of inspiring. Our conversation paints a vivid picture of the science behind everyday wonders, with a splash of MJ's Spider-Man-inspired charm, lifting the veil on the complex process of vaccine manufacturing with stories that connect the dots between high-tech labs and the medications that change lives.Eager to understand what goes into making the medications you rely on? We've got the insider's take! MJ Huntsgood unravels the transformative shift in biotech manufacturing, from stainless steel tanks to single-use bioreactors, and celebrates the unsung heroes of quality control. You'll get a firsthand look at the teamwork necessary to bring life-saving treatments from the lab bench to bedside. Plus, we tackle the Johnson & Johnson COVID-19 vaccine, demystifying adenovirus vector technology, and addressing public concerns with clarity and care to reveal the meticulous science behind each vial.We round off this episode with heartfelt discussions on the profound impact vaccines have on our lives, sharing personal tales and the broader societal trust these medical advances command. I delve into my unexpected foray into speculative fiction writing, offering a peek into worlds woven from my imagination. And, of course, no episode would be complete without our weekly pet chat, where lovable cat tales and the shenanigans of Ginger the dog leave us with a sense of the joy and comfort our furry friends provide. Tune in for an episode that bridges the gap between hard science and the human heart, where curiosity meets compassion in every story told.MJ's Links:https://twitter.com/MJHuntsgoodAll MJ's Links!Bunsen and Beaker's Links:30% off the first month at Zencastr - use the code in the show!https://zen.ai/3LXIX2UYb1RLXwtWHHjryXAutdr3HS5EpVHMW80BOKgSave 10% at Bark and Beyond with the coupon code BUNSEN!The Ginger Stuffie is on presale so check the link here!Join The Paw Pack to Support The Show!https://bunsenbernerbmd.com/pages/paw-pack-plus-communityOur Website!The Bunsen and Beaker Website has adorable merch with hundreds of different combinations of designs and apparel- all with Printful- one of the highest quality companies we could find!www.bunsenbernerbmd.comSign up for our Weekly Newsletter!Bunsen and Beaker on Twitter:Bunsen and Beaker on TikTok:Bunsen and Beaker on FacebookSupport the Show.For Science, Empathy, and Cuteness!Being Kind is a Superpower.https://twitter.com/bunsenbernerbmd

In this podcast, we're going to talk about the best-selling drug in the world: Keytruda. Keytruda helps your immune system find and kill cancer cells. Keytruda is also used for autoimmune diseases and certain infections. Unlike chemotherapy, Keytruda helps kill cancer cells without killing your immune system. Keytruda works through immunomodulation. Immunomodulators increase, decrease, or block your immune system. Immunomodulator drugs have many side effects and don't work on all types of cancer. Some cancers can become resistant to immunotherapy and stronger with treatment, a phenomenon similar to antibiotic resistance. Immunomodulator drugs don't target the fuel for cancer or the raw materials necessary to build cancer cells. There are many natural immunomodulators. In fact, drug companies use research on plant chemicals to develop over 50% of medications. The following are natural immunomodulators: • Astragalus • Reishi mushrooms and other types of mushrooms • Vitamin D Dietary changes are also important. You need to eliminate foods that fuel cancer cells. Fasting is the most powerful tool to starve off cancer. It's also important to believe that you will overcome cancer. Mindset matters!

Contributor: Travis Barlock, MD Educational Pearls: Cancer-related emergencies can be sorted into a few buckets: Infection Cancer itself and the treatments (chemotherapy/radiation) can be immunosuppressive. Look out for conditions such as sepsis and neutropenic fever. Obstruction Cancer causes a hypercoagulable state. Look out for blood clots which can cause emergencies such as a pulmonary embolism, stroke, superior vena cava (SVC) syndrome, and cardiac tamponade. Metabolic Cancer can affect the metabolic system in a variety of ways. For example, certain cancers like bone cancers can stimulate the bones to release large amounts of calcium leading to hypercalcemia. Tumor lysis syndrome is another consideration in which either spontaneously or due to treatment, tumor cells will release large amounts of electrolytes into the bloodstream causing hyperuricemia, hyperkalemia, hyperphosphatemia, and hypocalcemia. Medication side effect Immunomodulators can have strange side effects. A common one to know is Keytruda (pembrolizumab), which can cause inflammation in any organ. So if you have a cancer patient on immunomodulators with any inflammatory changes (cystitis, colitis, pneumonitis, etc), talk to oncology about whether steroids are indicated. Chemotherapy can cause tumor lysis syndrome (see above), and multiple chemotherapeutics are known to cause heart failure (doxorubicin, trastuzumab), kidney failure (cisplatin), and pulmonary toxicity (bleomycin). References Campello, E., Ilich, A., Simioni, P., & Key, N. S. (2019). The relationship between pancreatic cancer and hypercoagulability: a comprehensive review on epidemiological and biological issues. British journal of cancer, 121(5), 359–371. https://doi.org/10.1038/s41416-019-0510-x Gyamfi, J., Kim, J., & Choi, J. (2022). Cancer as a Metabolic Disorder. International journal of molecular sciences, 23(3), 1155. https://doi.org/10.3390/ijms23031155 Kwok, G., Yau, T. C., Chiu, J. W., Tse, E., & Kwong, Y. L. (2016). Pembrolizumab (Keytruda). Human vaccines & immunotherapeutics, 12(11), 2777–2789. https://doi.org/10.1080/21645515.2016.1199310 Wang, S. J., Dougan, S. K., & Dougan, M. (2023). Immune mechanisms of toxicity from checkpoint inhibitors. Trends in cancer, 9(7), 543–553. https://doi.org/10.1016/j.trecan.2023.04.002 Zimmer, A. J., & Freifeld, A. G. (2019). Optimal Management of Neutropenic Fever in Patients With Cancer. Journal of oncology practice, 15(1), 19–24. https://doi.org/10.1200/JOP.18.00269 Summarized by Jeffrey Olson MS2 | Edited by Meg Joyce & Jorge Chalit, OMSII  

In this journal club episode, my guest is Dr. Peter Attia, M.D., a Stanford and Johns Hopkins-trained physician focusing on healthspan and lifespan and the host of The Drive podcast. We each present a peer-reviewed scientific paper chosen because it contains novel, interesting, and actionable data. First, we discuss a paper on how bright light exposure at sunrise and throughout the day and dark exposure at night independently improve mental health and can offset some of the major symptoms of mental health disorders such as depression and anxiety. Then, we discuss an article that explores a novel class of immunotherapy treatments to combat cancer. We also discuss some of the new data on low-calorie sweeteners and if they are safe. This episode should be of interest to listeners curious about maximizing their vitality and longevity and to anyone seeking science-supported ways to improve mental health and lifespan. For show notes, including referenced articles and additional resources, please visit hubermanlab.com. Thank you to our sponsors AG1: https://drinkag1.com/huberman Eight Sleep: https://www.eightsleep.com/huberman BetterHelp: https://betterhelp.com/huberman Joovv: https://joovv.com/huberman LMNT: https://drinklmnt.com/huberman Momentous: https://livemomentous.com/huberman Timestamps (00:00:00) Dr. Peter Attia, Journal Club (00:02:40) Sponsors: Eight Sleep, BetterHelp & Joovv (00:07:14) Light, Dark & Mental Health; Retina (00:11:16) Outdoor vs. Indoor Light, Cataracts, Sunglasses (00:16:17) Tools: Sunrise & Sunsets, Circadian Rhythm; Midday Light (00:24:55) Tools: Night & Light Exposure; Waking Before Sunrise (00:31:05) Article #1, Light/Dark Exposure & Mental Health (00:36:50) Sponsor: AG1 (00:38:18) Odds Ratio, Hazard Ratio (00:45:43) Night vs. Daylight Exposure, Mental Health Disorders (00:51:35) Major Depression & Light Exposure; Error Bars & Significance (00:59:15) Sponsor: LMNT (01:00:39) Prescriptions; Environmental & Artificial Light; Red Lights (01:08:14) Nighttime Light Exposure; Sleep Trackers & Belief Effects (01:13:54) Light Directionality, Phone, Night (01:17:21) Light Wavelengths & Sensors; Sunglasses (01:20:58) Hawthorne Effect, Reverse Causality, Genetics (01:26:26) Artificial Sweeteners, Appetite (01:31:16) Natural Light Cycles, Circadian Rhythm & Mental Health (01:39:53) Article #2, Immune System & Cancer (01:43:18) T-Cell Activation; Viruses (01:50:41) Autoimmunity; Cancer & Immune System Evasion (02:00:09) Checkpoint Inhibitors, CTLA-4 (02:06:45) Anti-CTLA-4 Study Drug (Ipilimumab), Melanoma (02:12:07) Patient Population, Randomization, GP100 (02:18:09) Response Rate (02:22:52) Overall Survival & Response (02:28:38) Median Survival vs. Overall Survival, Drug Development (02:35:45) Gender & Dose (02:40:32) Adverse Events; Autoimmunity (02:46:42) Pancreatic Cancer; Aging & Immune System Health (02:53:57) Melanoma; Lynch Syndrome, Keytruda (02:58:43) Immunotherapy & Cancer Treatment; Melanoma Risk (03:06:26) Zero-Cost Support, Spotify & Apple Reviews, YouTube Feedback, Sponsors, Momentous, Social Media, Neural Network Newsletter Disclaimer