BioCentury This Week

Constructing deal terms to take advantage of both the translational research benefits in China and the market opportunity in the U.S. is slowly emerging as a strategy to advance CAR T cell innovation. On the latest BioCentury This Week podcast, BioCentury’s editors discuss how deals for the technology have evolved since the 2017 partnership between Legend and Janssen for Carvykti and the opportunity for East-West collaborations to drive CAR T cell development.BioCentury’s editors also assess why the FTC made a deal with Amgen that will allow the company’s $27.8 billion acquisition of Horizon Therapeutics to proceed, and how an agreement by Regeneron on international pricing of a COVID-19 mAb could clear the path to confirmation of Monica Bertagnolli as the next NIH director.Reach us by sending a text

What are the criteria that enable companies to achieve the kind of success that leads to a jump in market cap tier? On the latest BioCentury This Week podcast, BioCentury’s editors discuss Back to School 2023, which examines the ingredients for building long-term, sustainable, high-value biotech companies.Reach us by sending a text

Circular RNA’s durability could convey efficacy and manufacturing advantages over therapies based on linear mRNA. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the rising therapeutic modality, with a look at the technology, companies and investors in the space. They also assess the pipeline of psychedelic therapies as the product candidates move toward proof of concept, homing in on psilocybin-based product candidates, which are the most abundant and some of the most advanced. BioCentury Head of Business Development Josh Berlin joins the podcast to preview BioCentury’s upcoming conferences, the Oct. 2-4 BioCentury-BayHelix East West Summit in Cambridge, Mass., and the Nov. 2-3 China Healthcare Summit in Shanghai.Reach us by sending a text

There’s a tectonic shift happening in obesity research and drug development, BioCentury Editor in Chief Simone Fishburn said on the latest BioCentury This Week podcast. Fishburn and colleagues discuss how the success of obesity therapies from Novo Nordisk and Eli Lilly targeting the incretin axis has galvanized a wave of drug development with different molecular targets as well as last week’s threshold-setting cardiovascular outcomes trial data from Novo and recent obesity deals by the two companies.BioCentury’s editors also discuss takeaways from Fishburn’s conversation with Flagship Pioneering’s Noubar Afeyan on The BioCentury Show, plus the Scleroderma Research Foundation’s plans to bring the platform trial model to scleroderma.Reach us by sending a text

A complete response letter from FDA in major depressive disorder could severely dent the commercial prospects for Zurzuvae zuranolone even as the drug gained approval for postpartum depression. On the latest BioCentury This Week podcast, BioCentury’s editors assess what the agency’s decision, which included a request for at least one additional study, means for Biogen and its partner Sage Therapeutics. BioCentury’s editors also discuss the thawing market for biotech IPOs, zeroing in on the dozens of companies that raised crossover cash before markets turned sour, as well as the digital transformation under way at Sanofi, which aims to use AI and data science to drive everything from candidate discovery to clinical trial planning, manufacturing optimization and supply chain management.Reach us by sending a text

An analysis of pharma deal trends over the past year shows a focus on first-in-class assets with autoimmune diseases being a major focus of interest. On the latest BioCentury This Week podcast, BioCentury’s editors discuss what the deal trends mean for prospective pharma partners and whether the expected focus on late-stage products, and a material increase in valuation for late-stage programs, is supported by the data. BioCentury’s editors also talk about a recent conversation with Genentech Inc. CEO Alexander Hardy, and his perspective on how the Inflation Reduction Act (IRA) may impact future decision-making on drug development for small molecules. They also discuss takeaways from a Q&A with Leerink Partners’ Jeffrey Leerink and Dan Dubin, what’s next in BIO’s hunt for a permanent CEO, and the case of Stealth BioTherapeutics Corp. and whether the company’s regulatory experience raises questions about if FDA should improve the consistency with which it applies regulatory flexibility.Reach us by sending a text

A hypertension deal with Roche will help Alnylam execute on its growth strategy of moving into more prevalent diseases. On the latest BioCentury This Week podcast, BioCentury’s editors discuss what the deal does for both companies and why plans for a cardiovascular outcomes trial (CVOT) before the launch of zilebesiran are critical for maximizing the program’s commercial opportunity.BioCentury’s editors also preview this week’s episode of The BioCentury Show, in which Washington Editor Steve Usdin speaks with Alkermes about the politics and policy environment around drug pricing and the Inflation Reduction Act and assess the latest developments in industry litigation against the IRA and new FTC guidelines on antitrust rules.Reach us by sending a text

With investors seeing the worst days fading into the rearview mirror, the sector has begun to chart a path out of the biotech bear market. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the indicators to watch for a recovery as described in the 3Q23 Financial Markets Preview. They also analyze the latest data from Alzheimer’s therapy donanemab from Eli Lilly, noting it sheds light on which patients stand to benefit from the therapy, and they discuss the pharma’s takeout of Versanis Bio to expand its obesity portfolio and improve the quality of weight loss it can achieve.Reach us by sending a text

Full approval of Leqembi lecanemab-irmb will unlock reimbursement and energize Alzheimer’s R&D, but the launch will be slow, said BioCentury Washington Editor Steve Usdin on the latest BioCentury This Week podcast. Usdin and colleagues break down the takeaways from BioCentury’s interview with Chris Viehbacher, CEO of Biogen, and discuss the challenges of launching a product for a disease that has until now been untreatable.BioCentury’s editors also discussed the prospects for the IPO window in the second half now that the market for follow-on financings is showing signs of life, and the controversy surrounding Elevidys delandistrogene moxeparvovec, the gene therapy from Sarepta Therapeutics for Duchenne muscular dystrophy that Usdin argued in an Editor’s Commentary shows flaws in evidence generation and regulatory processes.Reach us by sending a text

FDA Commissioner Rob Califf’s biggest legacy could be his reform of FDA’s advisory committee process. But what is uncertain is whether his review can bring together enough consensus among agency leaders to drive a meaningful change, said Washington Editor Steve Usdin on the latest BioCentury This Week podcast. Usdin and colleagues discuss the areas of the U.S. regulator’s advisory committee process where there is — and isn’t — agreement on needed changes, and what could make this time different from a lengthy history of calls for change. BioCentury’s editors also preview an upcoming discussion with Polaris Partners’ Amy Schulman regarding why Singapore, the funding scene, and women in leadership. Usdin then discusses why reimbursing the recently approved DMD gene therapy from Sarepta Therapeutics through state Medicaid plans won’t be so simple.Reach us by sending a text