BioCentury This Week

Preview: In his five decades at FDA, Robert “Bob” Temple helped revolutionize the ways medical products are developed and regulated. On the latest BioCentury This Week podcast, Washington Editor Steve Usdin reflects on the legacy of Temple. Temple, who is retiring, crafted the modern clinical trial paradigm, created the accelerated approval pathway, and set precedents for incorporating patient perspectives in regulatory decisions. Usdin also discusses the opportunities and threats for the agency under Trump 2.0.BioCentury's editors also discuss China’s academic innovation, arguing that a wave of new target biology is now coming from Chinese university labs and the underwhelming results from CagriSema’s latest readout. Phase III data for the most important weight loss candidate from  Novo Nordisk A/S (CSE:NOVO-B; NYSE:NVO) failed to differentiate the product from Eli Lilly's Zepbound.View full story:https://www.biocentury.com/article/654574/temple-s-fda-legacy-plus-chinese-innovation-novo-obesity-data-a-biocentury-podcast00:00 - Introduction02:03 - Bob Temple's Legacy16:13 - China's Academic Innovation26:20 - CagriSema Obesity DataTo submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

With most of the highly attractive late-stage assets already scooped up, pharmas are turning their sights to Phase II companies, and lining up their case to make an attractive offer and move fast. About 40% of the M&A deals in 2023-24 were completed in less than six weeks, from approach to announcement, according to Lazard’s data. Michael Kingston and Dale Raine, global co-heads of biopharma at Lazard, joined The BioCentury Show this week to discuss the M&A outlook amid the still-precarious biotech financing landscape.The BioCentury Show, featuring BioCentury one-on-one with an industry KOL, is available on Apple, Spotify and wherever you listen to your favorite podcasts and in video podcast format on BioCentury’s YouTube channel.View full story: https://www.biocentury.com/article/65385800:00 - Introduction03:01 - Capital Markets Outlook06:01 - M&A15:19 - Breaking Down Deals24:29 - AsiaTo submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

Venture capital in biotech is hitting a ceiling, leading to smaller fund sizes amidst economic challenges. The podcast explores the surge of obesity start-ups focusing on innovative treatments that prioritize muscle preservation and tolerability. It also highlights insights from Aoife Brennan of Climb Bio and discusses the significance of strategic planning for biotech leaders navigating tough market conditions. Additionally, a new book by Tim Harris offers a retrospective on 50 years of biotechnology, enriching the discussion with historical perspectives.

A pair of lawmakers have dealt the Biosecure Act a setback that could derail the legislation, even as Congress continues its push to reduce reliance on China in the life sciences. On the latest BioCentury This Week podcast, Washington Editor Steve Usdin explains why Sen. Rand Paul (R-Ky.) and Rep. Jamie Raskin (D-Md.) refused to sign off on inclusion of the anti-China biotech bill in the must-pass National Defense Authorization Act, what provisions the defense bill has that seek to enhance U.S. biotech supply chain resilience and whether Biosecure can be resurrected. And in the latest in neurology, Executive Editor Selina Koch discusses Novartis and PTC's $1 billion deal for the biotech’s Huntington disease therapy, and how several biotechs are poised to take therapies against the long undruggable KCC2 to the clinic for neurological disorders. Heads up: BioCentury’s JPM Guide 2025 is out now.View full story: https://www.biocentury.com/article/65442000:00 - Introduction01:42 - Biosecure Setback10:01 - Novartis' $1B PTC Deal 16:28 - KCC2 ActivationTo submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

The discussion kicks off with insights into Jay Bhattacharya's potential leadership at the NIH and its implications for the biopharma industry. The hosts delve into the exciting advancements in multi-targeted CAR T therapies, aiming to tackle solid tumors more effectively. They also highlight the latest FDA approval trends, showcasing biotech's growing independence in getting drugs approved. Additionally, they touch on Novartis' hefty investment in Huntington's disease therapy, signaling strategic moves expected to influence the industry.

Positive vibes about biotech emanating from the Jefferies Healthcare Conference were overshadowed by the uncertainty that is ahead because of the result of the U.S. elections. On the latest BioCentury This Week, BioCentury’s editors discuss how the unconventional cabinet nominations of the incoming Trump administration have cast a pall over what had been growing enthusiasm for the prospects of the biotech sector. Washington Editor Steve Usdin also discusses what the nomination of Marty Makary as the next FDA Commissioner could mean for the sector, and recaps the latest update on the Biosecure Act. The BioCentury editors also discuss which pharmas are in or out in making a challenge to Eli Lilly and Novo Nordisk in the obesity market.View full story: https://www.biocentury.com/article/65431900:00 - Introduction00:32 - Jefferies Conference Takeaways06:25 - Trump Nominations17:41 - Biosecure Act Update21:01 - Pharma in ObesityTo submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

The discussion opens with a critical examination of Robert F. Kennedy Jr.'s potential nomination as head of HHS, highlighting the serious implications for public health. The conversation shifts to the comeback of GSK's Blenrep in cancer therapy, with new data suggesting it may play a vital role in earlier treatment stages. Finally, the podcast covers exciting deals in the pharmaceutical landscape, particularly collaborations between Western and Chinese firms focused on innovative bispecific therapies, underscoring the evolving regulatory framework and its impact on patient care.

The podcast dives into the intriguing dynamics of the biopharma industry as political shifts create both opportunities and challenges. It debates the ethical implications of disclosing APOE4 genetic risks to Alzheimer's trial participants, while analyzing the unfolding investigations into AstraZeneca's leadership in China. Additionally, it tackles misconceptions among scientists, academics, and industry leaders, urging better collaboration for drug development. The discussion also touches on public health dynamics, reflecting on possible regulatory changes under a new administration.

It’s too soon to conclude anti-amyloid therapies are safe for use by Alzheimer’s patients in the real world, even as early reports are encouraging, argues BioCentury Executive Editor Selina Koch on the latest BioCentury This Week podcast. Koch and colleagues discuss takeaways from this year’s Clinical Trials on Alzheimer’s Disease annual meeting, including conclusions from adverse event data for Leqembi lecanemab and what the true test of appropriate use and safety for the drug might look like.BioCentury’s editors also assess Phase II data presented at CTAD by UCB that provide some of the first clues about what species of tau to target and in which patients. And they discuss what results of Tuesday’s presidential contest in the U.S. will mean for FDA, as well as the state of play for China biotech as the industry continues to grind out its first bear market.View full story: https://www.biocentury.com/article/65407500:00 - Introduction01:23 - CTAD: Anti-amyloids14:22 - CTAD: UCB's tau data19:47 - FDA & the Election28:16 - China Summit DebriefTo submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

Explore the fascinating advances in EGFR-targeted cancer therapies, focusing on how new treatments are overcoming resistance. The importance of best-in-class strategies highlights their significant impact on market growth and patient care. A thought-provoking discussion on the FDA’s political independence reveals the delicate balance the agency must maintain amidst external pressures. Insights from industry professionals provide a glimpse into the future of biopharma deal-making and emerging trends shaping the landscape.