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Europe’s CHMP has again ruled in contrast to FDA for a neurology product, this time on Biogen and Eisai’s Leqembi for Alzheimer’s disease. On the latest BioCentury This Week podcast, BioCentury editors discuss the similarities and differences between Leqembi lecenamab and Aduhelm aducanumab, the first anti-amyloid mAb from Biogen and Eisai and what it means for the next in line from that class, Kisunia donanemab from Eli Lilly. The editors also break down last week’s ODAC meeting, which discussed trials in perioperative cancer for checkpoint inhibitors, and talk about the looming delay in reauthorization of the rare pediatric priority review voucher program. They also assess the implications of the investigation by the House Select Committee on the Chinese Communist Party into clinical trials run in Chinese military hospitals and the Xinjiang Uyghur Autonomous region, a story broken last week by Washington Editor Steve Usdin.
View full story: https://www.biocentury.com/article/653010
02:06 - CHMP Leqembi Decision
09:53 - Perioperative Cancer
17:45 - Pediatric Review Vouchers
23:55 - Beyond Biosecure
Alpha emitters are the latest trend in the hot radioligand space, but there’s debate about which isotope offers the best attributes for optimizing safety and efficacy. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the benefits and challenges that come with developing radiopharmaceuticals using lead-212 versus its more well-known counterpart actinium-225. They also discuss Editor-in-Chief Simone Fishburn’s conversation with Susan Galbraith, EVP of Oncology R&D at AstraZeneca, the latest innovations in delivering lipid nanoparticles to specific tissues beyond the liver, and the most recent oral GLP-1 obesity data from Roche.
View full story: https://www.biocentury.com/article/653008
00:00 - Intro
05:36 - Radiopharma Alpha Emitters
12:18 - AZ’s Susan Galbraith
21:40 - Lipid Nanoparticles
25:22 - Oral GLP-1 Race
Buysiders are upbeat headed into the back half of the year, but uncertainty over the Federal Reserve’s timing on interest rate cuts is keeping that sentiment in check. On the latest BioCentury This Week podcast, BioCentury’s editors preview the public markets’ second half of 2024, discussing the appetite for biotech IPOs and M&A and what investors are looking for as they read the Fed tea leaves.
They also discuss Congress’ FDA budget squeeze, the growing momentum of the Biosecure Act — which seeks to rein in Chinese CDMOs and genomics companies in the U.S. — and the legacy of IR/PR pioneer Lisa Burns, who passed away this month after spending years advising biotech CEOs and investors.
View full story: https://www.biocentury.com/article/652968
00:00 - Intro
02:54 - 3Q Markets Preview
12:33 - Policy Update
18:40 - Remembering Lisa Burns
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/652898
00:01 - Sponsor Message: Nxera Pharma
01:24 - U.K. Biopharma
08:14 - IRA
10:28 - Biosecure Act
14:49 - Breakthrough Designation Pathway
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/652845
00:01 - Sponsor Message: Nxera Pharma
04:49 - Chevron Ruling's Impact
10:32 - Tumor Cell Surface Targets
15:48 - Lurie Winner: Howard Chang
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/652789
00:01 - Sponsor Message: Nxera Pharma
02:05 - Introducing BioCentury's Grand Rounds
06:46 - An MPS Breakthrough
14:12 - Sarepta Approval
After whisking through Washington for the first half of the year, raising alarms, mutating and causing confusion, the Biosecure Act is now on pause. On the latest BioCentury This Week podcast, BioCentury’s editors discuss what the delay for the legislation, which seeks to drive Chinese contract development and manufacturing organizations out of the U.S., means, what will happen next, and how it will impact life sciences companies.
View full story: https://www.biocentury.com/article/652771
03:09 - What's In, What's Out
05:41 - Broader Impact
11:07 - Wake-up Call
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 Pharma
01:40 - Pandemic Prep Problems
11:11 - Reverse Mergers
15:43 - Alzheimer's
25:31 - SCOTUS
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/652686
00:01 - Sponsor Message: Nxera Pharma
02:34 - BIO Wrap: Biosecure
09:12 - Japan & Nxera
18:52 - Radiopharma
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/652639
00:01 - Sponsor Message: Nxera Pharma
01:41 - Psychedelic Setback
12:38 - FDA's Platform Play
21:39 - ASCO Innovations
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