BioCentury This Week

The U.K.’s life sciences ecosystem boasts “palpable energy at the very innovation end of the spectrum in biotech, with a lot of really quality science,” BioCentury Editor in Chief Simone Fishburn says on the latest BioCentury This Week podcast. Fishburn assesses the maturation of the country’s biotech industry, including the need for an influx of capital to catalyze the sector’s growth. Washington Editor Steve Usdin discusses the latest developments for the Inflation Reduction and the Biosecure acts as well as the benefits of the breakthrough therapy pathway. Also on BioCentury.com, listeners may want to check out Danielle Golovin’s analysis of LNP innovation and Paul Bonanos’ take on Monday’s $3.2 billion M&A move by Eli Lilly. This episode of BioCentury This Week was sponsored by Nxera Pharma.View full story: https://www.biocentury.com/article/65289800:01 - Sponsor Message: Nxera Pharma01:24 - U.K. Biopharma08:14 - IRA10:28 - Biosecure Act14:49 - Breakthrough Designation PathwayReach us by sending a text

The impact on FDA and the biopharma industry of the Supreme Court’s move to overturn the legal doctrine that courts defer to federal agencies’ interpretations of ambiguous laws will take years to come into focus; for now, the clearest effects of the Chevron ruling will be on disputes over exclusivity and other non-science issues. On the latest BioCentury This Week podcast, BioCentury’s editors analyze the court’s decision, including how FDA could adjust how it operates. The editors also discuss tumor cell surface targets off the beaten path, and BioCentury’s Q&A with Lurie Prize winner Howard Chang about how his lab, and the five companies he has co-founded, have turned serendipitous discoveries about poorly understood nucleic acid types into translational strategies. This episode of BioCentury This Week was sponsored by Nxera Pharma.View full story: https://www.biocentury.com/article/65284500:01 - Sponsor Message: Nxera Pharma04:49 - Chevron Ruling's Impact10:32 - Tumor Cell Surface Targets15:48 - Lurie Winner: Howard ChangReach us by sending a text

A biomarker breakthrough could shave years off the development of therapies for a group of devastating, progressive ultrarare diseases. On the latest BioCentury This Week podcast, BioCentury’s editors discuss FDA’s agreement to allow biopharma companies to use a biomarker as the basis for accelerated approval of neuronal mucopolysaccharidoses therapies, which marks an important inflection point, both for MPS and rare diseases in general. The editors also assess FDA’s decision to grant full approval to and expand the label of Sarepta DMD gene therapy Elevidys delandistrogene moxeparvovec, igniting another controversy over the agency's decision-making; discuss how human genetics is promising to remove some of the risk from neurology drug development; and preview BioCentury’s new conference, Grand Rounds, which takes place in September in Nashville, at the interface of academia and industry. This week’s podcast is sponsored by Nxera Pharma.View full story: https://www.biocentury.com/article/65278900:01 - Sponsor Message: Nxera Pharma02:05 - Introducing BioCentury's Grand Rounds06:46 - An MPS Breakthrough14:12 - Sarepta ApprovalReach us by sending a text

BioCentury editors discuss the impact of the Biosecure Act on Chinese CDMOs in the US. The delay in legislation raises questions about its future. Biotech sector debates the implications and strategies for navigating restrictions amid US-China tensions.

The avian flu outbreak is a fire drill that is showing how poorly the U.S. is prepared for the next pandemic. On the latest BioCentury This Week podcast, BioCentury's editors recap last week’s BioCentury Show conversation with Rick Bright, including the former BARDA director’s insights on the opportunities for biotechs to help fill voids in surveillance, point-of-care diagnostics, vaccines and therapeutics and the need for the government to provide leadership and funding to empower industry. They also discuss new SEC rules that will make reverse mergers less attractive; the Supreme Court’s mifepristone ruling and a trio of neuro-focused stories -- one on FDA’s guidance on presymptomatic Alzheimer’s, another on an advisory committee’s discussion about Eli Lilly's anti-amyloid therapy donanemab and a third focused on what neuroscience biotech companies need to consider when pitching VCs and pharmas. This week’s podcast is sponsored by Nxera Pharma.0:01 - Sponsor Message: Nxera Pharma01:40 - Pandemic Prep Problems11:11 - Reverse Mergers15:43 - Alzheimer's25:31 - SCOTUSReach us by sending a text

BIO’s annual meeting took place amid heightened industry concerns regarding the Biosecure Act, which took yet another unexpected turn this week. On a special edition of the BioCentury This Week recapping the meeting, BioCentury's editors discuss the latest on the anti-China biopharma legislation, including misperceptions of what the bill seeks to accomplish.Special guest Chris Cargill, the CEO of Nxera Pharma, joins the podcast to discuss the expanded APAC presence at this year’s BIO; Japan’s push to build the biotech ecosystem in the country; and how Nxera (formerly Sosei) is evolving. And finally, BioCentury’s editors deliver the takeaways from Karen Tkach Tuzman’s BIO panel focused on radiopharmaceuticals, including debate on the merits of long- versus short-lived radioisotopes. This week’s podcast is sponsored by Nxera Pharma.View full story: https://www.biocentury.com/article/65268600:01 - Sponsor Message: Nxera Pharma02:34 - BIO Wrap: Biosecure 09:12 - Japan & Nxera18:52 - Radiopharma Reach us by sending a text

A snub by an FDA advisory committee for an MDMA-psychotherapy combination is unlikely to read through to other psychedelic therapies in the pipeline. On the BioCentury This Week podcast, BioCentury’s editors discuss the shortcomings of the Lykos Therapeutics product’s clinical development program and why other psychedelics likely won’t face the same hurdles. The editors also assess FDA’s new platform technology designation and the first-in-human clinical trials described at this year’s American Society of Clinical Oncology (ASCO) meeting. This week’s podcast is sponsored by Nxera Pharma.View full story: https://www.biocentury.com/article/65263900:01 - Sponsor Message: Nxera Pharma01:41 - Psychedelic Setback12:38 - FDA's Platform Play21:39 - ASCO InnovationsReach us by sending a text

Four takeouts with upfront payments north of $1 billion to close out May mark the latest run of VC exits from biotech M&A and help expand the pipelines of large biopharmas in renal, ophthalmic and immunologic indications. On the latest BioCentury This Week podcast, BioCentury’s editors discuss how two of the takeouts -- Asahi Kasei’s buy of Calliditas and Biogen’s acquisition of HI-Bio -- showcase how the renal field is on the rise. Turning to Washington, the editors explain why the House Select Committee on the Chinese Communist Party is expanding its remit to Chinese therapeutic developers and commercial competitiveness — with an initial focus on Legend and GenScript. And, finally, they assess data from ASCO that demonstrate how immunotherapies are making progress in “cold” colorectal cancers. This week’s podcast is sponsored by Nxera Pharma.View full story: https://www.biocentury.com/article/65259700:01 - Sponsor Message: Nxera Pharma1:35 - Biotech M&A11:40 - Biosecure Act23:00 - ASCOReach us by sending a text

A theme among late-breaker presentations at this year’s American Society of Clinical Oncology meeting is the push by companies to move targeted therapies into earlier lines of treatment. On the latest BioCentury This Week podcast, BioCentury’s editors discuss what they’re watching for in ASCO’s headline presentations and deliver highlights from abstracts released late last week as the oncology meeting readies to kick off on Friday. The editors also discuss the interest by FDA’s Janet Woodcock in a new approval pathway for ultrarare therapies, the Foundation for the National Institutes of Health’s initiative to support development of therapies and diagnostics for ALS, and Biogen's $1B+ acquisition of HI-Bio. This week’s podcast is sponsored by Nxera Pharma. View full story: https://www.biocentury.com/article/6525310:01 - Sponsor Message: Nxera Pharma1:43 - ASCO6:46 - Ultrarare Diseases14:52 - FNIH's ALS Push20:27 - Biogen M&AReach us by sending a text

New BIO CEO John Crowley is reorganizing BIO in a bid to reshape how the organization communicates and enhance its focus on patients. BioCentury’s editors also recap the 24th annual Bio€quity Europe conference that was held in San Sebastián, Spain last week, as well as highlights from last week’s American Society of Gene and Cell Therapy conference. The editors also discuss impressive early data from Endeavor BioMedicines in idiopathic pulmonary fibrosis and Phase Ib obesity data from Roche. This week’s podcast is sponsored by Nxera Pharma.View full story: https://www.biocentury.com/article/6524530:01 - Sponsor Message: Nxera Pharma1:08 - BioEquity Europe recap7:08 - Shake up at BIO13:37 - ASGCT highlights20:39 - Endeavor IPF data22:20 - Roche obesity dataReach us by sending a text