Podcasts about keytruda

A breast cancer patient self funding her treatment has said it's unfair she has to pay GST on the drugs that are already costing her ten of thousands of dollars. Wellington woman Amanda Broughton has stage 3 breast cancer and has had nine of 17 Keytruda infusions as part of her treatment. The drug is only funded for late stage cancers. Even after a discount from the drug company the mum of two is fundraising to cover the six figure bill hat's after. However, 15 % of that is GST, or tax, going to the government. Amanda Broughton spoke to Lisa Owen.

Broadcast from KSQD, Santa Cruz on 6-12-2025: Dr. Dawn opens with alarming news about NIH budget cuts devastating cancer research just as breakthrough CAR-T cell therapy shows promise for gastrointestinal cancers. This personalized immunotherapy extracts patients' T cells, engineers them to target specific cancer antigens, and makes them essentially immortal before reinfusion. While previously successful only for blood cancers like leukemia and lymphoma, researchers achieved tumor shrinkage in 25% of solid GI tumor patients. However, devastating layoffs forced removal of two patients from trials due to staff shortages and supply chain disruptions. Dr. Dawn emphasizes how pregnancy can worsen hidden cancers due to immune suppression, explaining why aggressive metastasized cancers often appear shortly after childbirth. Dr. Dawn takes a call from Bob about concerning forehead growths his dermatologist examined. She speculates they're likely seborrheic keratoses - benign, stuck-on appearing growths common in sun-exposed areas that look like crumpled brown paper "spit-wads". These aging-related changes are harmless and can even be picked off, though she warns against repeatedly traumatizing any skin area as this increases cancer risk through accumulated DNA damage. She explains how repetitive trauma in occupational settings creates statistically higher cancer risks, comparing it to filling a bingo card of cellular errors. She addresses an email about Joe Tippens' cancer cure protocol involving fenbendazole, an anti-parasitic drug. Dr. Dawn explains this viral social media phenomenon began when Tippens claimed his lung cancer was cured by fenbendazole, but he was simultaneously receiving Keytruda immunotherapy at MD Anderson. The story spread rapidly in South Korea, causing pharmacy shortages. Unvalidated internet health information can spread dangerously. Dr. Dawn compares it to old-fashioned medicine show scams. trend Dr. Dawn warns about a recent vitamin B6 toxicity misdiagnosis trend affecting her patients who were told they had dangerous levels of B6 despite lacking neuropathy symptoms. Accuracy requires fasting 12 hours before blood draws, otherwise creating false elevations from recent vitamin consumption. More critically, she alerts listeners about biotin(Vitamin B7) interference with laboratory tests using biotin-streptavidin techniques. High-dose biotin supplements are often used in hair and nail health growth formulas. This can falsely alter tests for thyroid hormones, vitamin D, sex hormones, cortisol and dangerously, troponin levels that diagnose heart attacks. This could lead to missed myocardial infarctions in emergency rooms, potentially causing fatal outcomes. Dr. Dawn takes a call from Richard seeking information about a previous radio program guest. She guides him to use on-line resources at ksqd.org to find program details, pivoting into praise for libraries as community centers offering far more than internet access. She emphasizes libraries provide serendipitous discovery that algorithms can't match, encouraging people to explore their local library systems for events, historical collections, and personal assistance from knowledgeable librarians eager to help visitors navigate both physical and digital resources. She discusses the concerning trend of giving melatonin to children, calling it "the Grinch that stole children's bedtime." While used prescription-only for severe developmental disorders in Denmark and EU countries, American children receive melatonin gummies regularly, with one in five preteens using it occasionally. Dr. Dawn explains melatonin is a hormone affecting pancreas, heart, fat tissue, and reproductive organs still developing in children. Supplemental doses create blood levels 10 times higher than natural peaks, representing an uncontrolled medical experiment on developing brains and bodies. Poison control calls for melatonin ingestion increased 530% between 2012-2021, with one tragic case involving a three-month-old death where 20 melatonin bottles were found in the home. Dr. Dawn concludes by debunking food expiration date myths, explaining that Americans waste a third of food ($7 billion annually) due to misunderstanding labels. Most shelf-stable foods simply degrade in quality rather than becoming dangerous after printed dates. She notes acidic dairy products like yogurt resist bacterial contamination due to protective bacteria,and even surface mold can be scraped off safely. However, she emphasizes trusting expiration dates on lunch meats and deli products, which pose real listeria risks when stored improperly. California will soon simplify labeling laws to reduce confusion between quality and safety dates.

On this week's episode, Brad Loncar, Eric Schmidt, and Sam Fazeli kick off with a look at Sanofi's $9 billion acquisition of Blueprint Medicines, highlighting the move as a mature, strategic bet for Sanofi and a positive sign for investment in biotech. On the data front, the group highlights the Phase 3 HARMONi trial from Summit and Akeso in non-small cell lung cancer, which is the first to include both U.S. and Chinese patients in a head-to-head comparison with Keytruda. Vera Therapeutics' positive Phase 3 data in IgA nephropathy was also discussed. The conversation shifts to ASCO 2025, spotlighting early-stage data in targeted protein degraders and novel therapies in breast cancer and myeloma. Despite some volatility in share prices and lack of bold headlines coming out of ASCO, overall sentiment remains optimistic about the pace of innovation in oncology. Next, they dive into TIGIT developments from Roche and AstraZeneca, noting AstraZeneca's ambitious 10 Phase 3 trials. The episode wraps with Bicara Therapeutics' updated data in HPV-negative head and neck cancer, targeting a subgroup identified through translational research. *This episode aired on June 6, 2025.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in the Pharma and Biotech world.Jefferies predicts an increase in small tuck-in deals in the biotech industry as companies face challenges accessing capital. Companies and industry groups are offering solutions to mitigate the impact of Trump tariffs on rare disease, cell, and gene therapy. Pitchbook suggests a shift towards more sustainable investing in biotech VC firms. Gilead is gearing up to challenge J&J in the $20 billion multiple myeloma CAR-T market. PTP's generative AI is revolutionizing data summaries for biotech QC workflows. Sanofi recently acquired Blueprint for $9.5 billion, while BMS has committed up to $11 billion with Biontech. Lilly has signed a deal worth up to $870 million, and Regeneron is investing nearly $2 billion in a Chinese obesity drug. Merck's CEO is emphasizing diversity in operations following the defeat of an anti-DEI measure. Immuno-oncology drugs Keytruda and Opdivo may face scrutiny in the near future.In other news, Vigil Neuroscience's Trem2 antibody for a rare brain disease failed in a Phase II trial shortly after Sanofi's acquisition of the company. Analysts believe the results were not surprising and should not impact the deal. Lilly has signed a deal worth up to $870 million to develop a long-acting GLP-1 obesity drug, while the FDA is committed to making rare disease drugs available at the first sign of promise. Pharma tuck-in deals are increasing after a slow first quarter for small biotechs. BioAgc Biologics will be attending Bio International in Boston to discuss their global drug production capabilities.Stay tuned for more updates on investing in research, welcoming global talent, the biotech VC cycle, Gilead's challenge to J&J in the multiple myeloma CAR-T market, and much more. Upcoming events and job listings in the pharmaceutical industry are also featured in our newsletter.Thank you for tuning in to Pharma and Biotech daily.

CCTV footage of Rover rushing back to his house. New research finds Keytruda can help treat throat cancer caused by oral sex. Republican lawmaker in Louisiana is trying to pass a law banning "chemtrails."

Charlie made a drastic change in his appearance. Faux hawks. JLR was knocked out of the ring while refereeing a wrestling match. Time limits, receipts, and having your finger measured. A flight attendant on the way to London found dancing naked in the bathroom. Did Charlie swap out his and Jeffrey's drug tests? Meeting up with ladies. Rover had a diarrhea accident. CCTV footage of Rover rushing back to his house. New research finds Keytruda can help treat throat cancer caused by oral sex. Republican lawmaker in Louisiana is trying to pass a law banning "chemtrails." A friend of Duji's believes she needs to go inside when she sees "chemtrails" because she is trying to get pregnant. The Trans-Human-Agenda. Charlie got his photos back from his London trip.

CCTV footage of Rover rushing back to his house. New research finds Keytruda can help treat throat cancer caused by oral sex. Republican lawmaker in Louisiana is trying to pass a law banning "chemtrails." See omnystudio.com/listener for privacy information.

Charlie made a drastic change in his appearance. Faux hawks. JLR was knocked out of the ring while refereeing a wrestling match. Time limits, receipts, and having your finger measured. A flight attendant on the way to London found dancing naked in the bathroom. Did Charlie swap out his and Jeffrey's drug tests? Meeting up with ladies. Rover had a diarrhea accident. CCTV footage of Rover rushing back to his house. New research finds Keytruda can help treat throat cancer caused by oral sex. Republican lawmaker in Louisiana is trying to pass a law banning "chemtrails." A friend of Duji's believes she needs to go inside when she sees "chemtrails" because she is trying to get pregnant. The Trans-Human-Agenda. Charlie got his photos back from his London trip.See omnystudio.com/listener for privacy information.

The 2025 American Society of Clinical Oncology (ASCO) Annual Meeting featured five days of presentations and educational sessions on all types of cancer. Dr. Eleonora Teplinsky, a board-certified medical oncologist at the Valley-Mount Sinai Comprehensive Cancer Center in Paramus, NJ, summarizes the top breast cancer research. Listen to the episode to hear Dr. Teplinsky discuss: The SERENA-6 trial, which found that if metastatic hormone receptor-positive, HER2-negative breast cancer develops ESR1 mutations during first hormonal therapy treatment, switching to camizestrant from an aromatase inhibitor before the cancer grows improves outcomes. Results from the DESTINY-Breast09 trial showing that the combination of Enhertu (chemical name: fam-trastuzumab-deruxtecan-nxki) and Perjeta (chemical name: pertuzumab) is a better first treatment for metastatic HER2-positive breast cancer than the current standard of THP chemo.  The ASCENT-04/KEYNOTE-D19 trial, which found that people with metastatic, PD-L1-positive, triple-negative breast cancer fared better with the combo of Trodelvy (chemical name: sacituzumab govitecan-hziy) and Keytruda (chemical name: pembrolizumab) as a first treatment compared to people who received chemotherapy and Keytruda.

欢迎收听雪球出品的财经有深度，雪球，国内领先的集投资交流交易一体的综合财富管理平台，聪明的投资者都在这里。今天分享的内容叫60亿美金，何以落至三生制药头上？来自醉酒看股。该来的总会来，何况是一个BD老手。2025年5月20日，中国生物医药行业迎来历史性时刻——三生制药自主研发的PD-1/VEGF双抗药物SSGJ-707，以“首付款12.5亿美元、潜在总金额60亿美元”的价格，将海外权益卖给辉瑞。必须强调的是，这一金额突破不仅发生在特朗普对中国生物制药领域实施高压制裁的严峻背景下，更以中国双抗药物成功进军全球市场的里程碑式进展，实现了对行业认知的颠覆性突破。一笔交易，三重颠覆我们细拆这BD背后的定价逻辑的颠覆可以发现，此前的国产创新药海外授权，首付款多在1-5亿美元区间。而三生制药此次首付直接翻倍至12.5亿美元，相当于辉瑞提前锁定了这款药物的“Best-in-class”潜力。另外，在这笔BD中，还让技术估值得到形象化。因为辉瑞在协议中额外支付1亿美元认购三生制药股权，这在过往交易中极为罕见。国际巨头用真金白银投票，实质上是对CLF2双抗平台技术壁垒的一种认可。此外，这次三生的商业权益似乎也得到“保留”。按文件，三生制药既保留中国市场的主动权，又能通过销售分成享受全球收益。这种“两头吃肉”的授权结构的确是体现了谈判中的“硬”。当然，这种"硬实力"并非小Biotech能够轻易复刻。回溯其发展轨迹：2013年6月完成纳斯达克私有化退市，2015年转战港交所主板上市，在投资者20多年的“教育”下，三生制药已构建起独特的竞争优势。其一，在产能布局与CDMO领域展现超群实力。旗下德生生物配置的19.9万升全球领先的生物药产能集群，成功承接基石药业PD-1单抗药物的商业化生产，充分验证了其国际水准的大规模生产体系。这为辉瑞实现SSGJ-707全球供应链的降本增效提供了坚实基础。其二，构建了深度渗透的渠道网络。依托覆盖2000家三级医院及1.4万家基层医疗终端的营销矩阵，其核心产品特比澳、赛普汀已建立起亿元级单品商业化标杆。值得注意的是，三生在非小细胞肺癌等重大适应症领域的渠道积淀，将有效助推辉瑞PD-1/VEGF双抗产品的市场渗透进程。凭什么是SSGJ-707？这款双抗药物能打动辉瑞，大概率是在于临床数据和技术设计的双重突破：一是疗效碾压单抗疗法。在非小细胞肺癌II期试验中，SSGJ-707单药治疗的客观缓解率达45%，比Keytruda同类数据提升60%；二是结构设计降维打击：采用“四臂对称”结构，分子稳定性较竞品提升3倍。另外，联用想象空间巨大。与百利天恒EGFR/HER3双抗ADC联用的临床前数据显示，肿瘤完全缓解率提升至70%，临床数据无疑“勇猛”。藏在交易背后的“阳谋”对三生制药而言，这笔交易不仅是财务胜利，更是战略卡位。从2024年的财报来看，三生制药公司全年实现收入91.08亿元，同比增长6.53%；归母净利润20.9亿元，同比增长34.93%；经调整的经营性归母净利润约23.18 亿元，同比增长18.8%。但海外收入占比以不足为3%。且需要注意的是，2019年以来三生制药净利润表现为较大波动，且面临商誉减值、市场竞争加剧以及研发、政策变动等诸多难题。此外，为了赢得市场信心，三生制药近些年先后斥资近10亿元用来回购公司股份。而此次潜在总金额60亿美元的BD足以为公司长期遭受质疑的“投入产出比”问题提供了有力成功佐证。CLF2技术平台成功完成验证后，其孵化的CD3×BCMA双特异性抗体项目估值实现跨越式增长，市场预期从5亿美元飙升至12亿美元。北美CDMO生产基地运营效率持续攀升，当前产能利用率稳定在90%高位，2024年已成功斩获辉瑞等国际药企战略订单，合同金额突破3亿美元大关。60亿美元量级的战略储备金池已形成规模效应，为基因编辑疗法、核酸药物创新等战略新兴板块的高强度研发投入提供充足弹药。当然，辉瑞的算盘同样精明——通过绑定三生制药，既能补齐双抗管线短板，又能借助中国药企的研发效率，对抗默沙东Keytruda等老对手的围剿。三生制药与辉瑞的这次握手，或许意味着中国药企只会做“技术搬运工”的游戏规则正在被改写。而娄竞似乎又打赢了一个“翻身战”。

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 predicts a brighter future for Wegovy with the end of the semaglutide shortage, but analysts remain skeptical as Eli Lilly's Zepbound gains ground in sales. The new HHS vaccine requirement has raised questions about its true intentions, with leading vaccine physician Paul Offit criticizing the lack of clarity. Meanwhile, pharmaceutical imports from Ireland are on the rise, biotech stocks fell after Vinay Prasad was named to succeed Marks at CBER, and Lotte Biologics' ADC facility in Syracuse offers end-to-end services for antibody manufacturing. CRISPR's Casgevy is gaining traction with more gene therapy proof of concept expected in 2025, impacting M&A and IPOs in the biotech industry. Summit Pharmaceuticals is nearing the first global phase III data for Keytruda, set to lose exclusivity in 2028 and potentially face competition from biosimilars. A report suggests that low-price drug nations are benefiting from US innovation, undervaluing innovative medicines by 90%. VC financing in biopharma declined by 20% in Q1, but megarounds kept the median deal size high. M&A and IPOs faced challenges due to policy issues, leading to an increase in licensing deals. Novo vows to improve market access for Wegovy, while Trump orders FDA to ease US plant expansion and increase inspections of foreign facilities. BMS pledges a $40 billion investment in the US, Novartis makes M&A moves, and Lilly remains unfazed by CVS's decision to side with Novo in the obesity market battle. Some drugmakers are stockpiling products in the US amid Trump's trade war. NGM terminates half of its staff as its lead asset moves through a registrational study. Job opportunities in clinical quality assurance audit, RBQM central statistical monitoring, and field medical capabilities are available.

En este episodio, repasamos los temas más importantes del día: • Wall Street en pausa optimista: Los futuros avanzan con $SPX +0.2%, $US100 +0.2%, $INDU +0.2% ante posibles anuncios de Trump sobre aranceles y datos clave del consumidor (confianza 87.7 esperada) y JOLTS (7.49M). El bono a 10 años sube a 4.24%. • Trump alivia presión sobre autos: El presidente anunciará hoy una reducción parcial de aranceles en autopartes y exención adicional a vehículos ya gravados. Las automotrices recibirán reembolsos de hasta 3.75% por producción doméstica. $GM, $F y $STLA suben en premarket. • Amazon lanza competencia a Starlink: $AMZN despliega 27 satélites del Proyecto Kuiper, iniciando su constelación de internet. El plan incluye +3,200 satélites y 80 lanzamientos, con socios como $ULA y Blue Origin. La mitad debe estar en órbita para julio de 2026. • Merck invierte $1B en biológicos: $MRK comienza la construcción de un centro en Delaware para manufactura local de tratamientos como Keytruda. Generará hasta 1,500 empleos y responde a la nueva presión arancelaria sobre la industria farmacéutica. Un episodio para entender cómo Washington, la innovación espacial y la salud impulsan el mercado en medio de señales de descompresión comercial. ¡No te lo pierdas!

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.Akeso's drug, Ivonescimab, has received approval in China as a competitor to Merck's Keytruda. However, its prospects in the US, where Summit owns the rights, are uncertain. Merck KGaA is acquiring SpringWorks for $3.9 billion to enhance its rare disease and oncology pipelines. Keytruda has shown promising results in reducing negative events in head and neck cancer patients. The cell and gene therapy sector faces challenges post-Marks FDA exit, including tariffs and workforce cuts.Transitioning to the next news, Trilink Biotechnologies introduces custom sets of mRNA for screening studies. Steminent Biotherapeutics is set to showcase a novel therapy for spinocerebellar ataxia. The cell and gene therapy sector is facing a critical period after the exit of FDA director Peter Marks, with threats such as tariffs and workforce cuts. Experts are uncertain about the future but are hopeful that Marks' legacy will continue under new FDA commissioner Marty Makary.Moving on to the upcoming American Association for Cancer Research meeting, which will feature presentations from companies like Merck and Boehringer Ingelheim that could impact cancer treatment. The industry in the U.S. is experiencing significant changes under the Trump administration, while conditions of regulatory and economic turmoil are more common in non-western markets. Makary's first interviews as FDA commissioner have raised questions about the accuracy of his statements.Lastly, the biopharma industry is also dealing with setbacks such as disappointing trial results and safety concerns. Overall, the sector is facing challenges but remains hopeful for the future under new leadership.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.Lilly is currently involved in a legal battle with compounders over knockoff versions of tirzepatide, marketed as Zepbound for weight loss. The FDA has prohibited compounders from producing these knockoffs after confirming the end of the tirzepatide shortage in December 2024. On the other hand, BMS is facing disappointment with Cobenfy's late-stage failure in treating schizophrenia, marking their second high-profile setback in recent weeks. RFK is contemplating removing COVID-19 from the CDC's vaccine guidelines for children to align with other countries and the WHO. Biotech investors are navigating a turbulent period due to new tariffs and economic uncertainty, causing additional upheaval in an already fragile market. Trump is looking to reinstate international drug pricing policies, while Swiss ADC Biotech is opting for the SPAC route to Nasdaq.Summit's bispecific has outperformed another cancer medication, putting pressure on Keytruda's dominance. In the midst of this biotech downturn, Wacker Biotech is offering advanced therapy process development and production services. Moving on to the next news, executives in the pharmaceutical industry often receive substantial golden parachutes upon leaving a company. Pfizer is defending its cardiac blockbuster drug against competition from Alnylam and BridgeBio. The biotech sector was showing signs of a rebound until new tariffs and economic uncertainty introduced further instability.Lilly is pursuing legal action against compounders for producing counterfeit drugs, while Roche and Regeneron are committing billions to US manufacturing amidst tariff challenges. The industry is undergoing significant changes under the current administration, with opportunities to learn from global markets. Challenges such as investor pullback and market volatility are impacting the biotech sector.Janssen's departure from Galapagos and the promising future of all-American biotech companies are also discussed. Stay tuned for more updates on upcoming events and job opportunities in the field.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.Roche and Regeneron are both investing heavily in US manufacturing, with Roche committing $50 billion and Regeneron signing a $3 billion deal with Fujifilm. This move comes as Trump's tariffs threaten the industry. Meanwhile, Pfizer, Alnylam, and BridgeBio are competing in the market for ATTR-CM treatment, with Alnylam and BridgeBio vying for patients switching from Pfizer's tafamidis drug and all three companies seeking new patients.Novo Nordisk has filed for FDA approval of an oral weight loss pill, AstraZeneca and Daiichi Sankyo are pushing their drug Enhertu for frontline breast cancer treatment, and Gilead's Trodelvy in combination with Keytruda has shown promise in slowing disease progression in triple-negative breast cancer. Wacker Biotech is offering services for advanced therapies, while Tempest has recently laid off 80% of its workforce.The industry is facing regulatory challenges and economic uncertainty, with Trump's tariffs potentially impacting pharma companies. Lilly has promised to manufacture a weight-loss pill in the US following a phase III win, and Makary discusses rare disease approvals and public distrust in a new interview. Biotech's future may be more focused on American companies according to PitchBook.

What was the world's top selling drug in 2023? Maybe the magic weight losing drug semaglutide, better known as Ozempic? Or the COVID vaccine perchance? Nope. 2023's top selling drug was an antibody, Keytruda, with about $25 billion in sales. $27 billion projected for 2024. In fact, five of the top ten best selling drugs in 2023 were antibodies. Antibody therapies revolutionized medicine. We have long known they can. The problem has always been how to make them the right way and at industrial scale. Today it is done with the help of a hamster. Or rather its cells. In this video, the incredible story of the hamster that revolutionized medicine. This is one of my favorite videos of the year.

What was the world's top selling drug in 2023? Maybe the magic weight losing drug semaglutide, better known as Ozempic? Or the COVID vaccine perchance? Nope. 2023's top selling drug was an antibody, Keytruda, with about $25 billion in sales. $27 billion projected for 2024. In fact, five of the top ten best selling drugs in 2023 were antibodies. Antibody therapies revolutionized medicine. We have long known they can. The problem has always been how to make them the right way and at industrial scale. Today it is done with the help of a hamster. Or rather its cells. In this video, the incredible story of the hamster that revolutionized medicine. This is one of my favorite videos of the year.

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.

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.

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

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

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!

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!

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