Obesity readouts continue to be hot for biotech with new top-line data from both injectable and oral therapies pushing the boundaries on efficacy. On the latest BioCentury This Week podcast, BioCentury’s analysts break down last week’s readouts from Eli Lilly, Structure  and Wave Life Sciences, and discuss a deal in the space by Pfizer.
Lilly reported the latest for its triple agonist contender retatrutide for best-in-class weight loss, while strong Phase IIb data put Structure back in the oral GLP-1 race. Meanwhile, Pfizer added an oral GLP-1R agonist via a deal). Structure and Wave parlayed their data into follow-on cash, as did Kymera after posting data for its STAT6 program KT-621 that hints at a new era for degraders in immunology.
The analysts then detailed the results of BioCentury’s industry sentiment survey on FDA, which found that politicization of the agency’s leadership, volatility and uncertainty are casting a long shadow over investor and drug developer sentiment. Finally, they discuss the impact of the congressional stalemate over the U.S. Small Business Innovation Research (SBIR) program.

View full story: https://www.biocentury.com/article/657880

#ObesityDrugDevelopment #TargetedProteinDegradation #STAT6 #FDARegulation #SBIRFunding

00:00 - Introduction
01:45 - Obesity Data
12:17 - Kymera's Breakthrough
21:45 - FDA Survey Results
29:41 - SBIR Funding Stalemate

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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Fueled by cancer, obesity and cardiovascular deals, $1 billion-plus takeouts in biotech are at their highest level in a decade with three weeks to go in the year. On the latest BioCentury This Week, BioCentury’s analysts discuss the rise in large M&A deals and what the trends among the 37 acquisitions say about biopharma dealmaking.
The analysts assess first-in-human in vivo CAR T data at the American Society of Hematology meeting from Kelonia Therapeutics, which showcase the promise of the modality and justify the growing pipeline. They also break down readouts from Praxis in developmental and epileptic encephalopathy from the American Epilepsy Society Annual Meeting and from Novo Nordisk, which presented full data at the Clinical Trials on Alzheimer’s Disease meeting on semaglutide’s failure to treat Alzheimer’s disease.
Washington Editor Steve Usdin analyzes a roller-coaster week at FDA in which Richard Pazdur resigned as director of FDA’s Center for Drug Evaluation and Research and Tracy Beth Høeg became acting CDER director, a move that Usdin says will prompt staff departures, ease restraints on FDA leaders

View full story: https://www.biocentury.com/article/657781

#BiotechMA #CARTTherapy #EpilepsyResearch #AlzheimersDisease #FDA

02:37 - Biotech M&A
06:39 - In vivo CAR T
10:08 - Semaglutide for Alzheimer's
16:17 - Praxis
22:11 - FDA

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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Novo Nordisk’s highly anticipated data for semaglutide in Alzheimer’s dashed hopes that the GLP-1 therapy could become a game changer in the disease. On the latest BioCentury This Week podcast, Executive Editor Selina Koch discusses the Phase III readout including what it says about the mechanism’s use in the neurodegenerative disease, Novo’s decision to skip Phase II and enroll a large patient group in a later stage trial, and what other datasets for GLP-1s in the indication have shown.
Washington Editor Steve Usdin explains why FDA’s new vaccine policies, driven by CBER Director Vinay Prasad, could have impacts more far-reaching than expected, including making it more difficult to develop or modify vaccines. And Lauren Martz, Executive Director of Biopharma Intelligence, analyzes the bleak investment outlook for cell and gene therapy companies in the U.S. and why China’s biotech ecosystem offers a glimmer of hope for sponsors of these assets.

View full story: https://www.biocentury.com/article/657721

#Semaglutide #GLP1Therapies #VaccinePolicy #CellAndGeneTherapy #AlzheimersResearch

00:00 - Introduction
01:53 - Novo's Alzheimer’s Miss
13:19 - FDA's New Vaccine Policy
19:53 - Funding C&GT Biotechs

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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A baffling decision by FDA to issue a complete response letter for a pediatric medicine the medical community stood behind is just the latest example raising concerns that the agency is shifting the regulatory goalposts amid a lack of transparency. On the latest BioCentury This Week podcast, Washington Editor Steve Usdin explains how the absence of advisory committee meetings at FDA is in part to blame for a lack of consistency in decision-making and divergence from decisions taken by other global regulatory agencies. VP and Editor-in-Chief Simone Fishburn then discusses the takeaways from Franck Le Deu’s guest commentary on how China’s biotech ecosystem is evolving, and whether government support for the sector is helping or hindering its overall health. BioCentury’s analysts also discuss whether conventional CRISPR therapies will ever be commercially successful, and what’s next for NLRP3 inhibitors to treat obesity following the first set of Phase II data for the class.
We'd also like to invite our listeners to participate in our important survey about their experiences interacting with FDA. To take the survey, please go to BioCentury's FDA Sentiment Survey. This episode of the BioCentury This Week podcast is brought to you by Voyager Therapeutics.

View full story: https://www.biocentury.com/article/657698

#FDARegulation #CRISPRTherapies #NLRP3Inhibitors #ChinaBiotech #DrugApproval

00:01 - Sponsor Message: Voyager Therapeutics
01:31 - FDA Sydnexis CRL
07:36 - CDC Vaccine Claims
09:55 - China’s Innovation Arc
16:49 - CRISPR Commercial Viability 
26:39 - NLRP3 for Obesity

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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There is cautious optimism around continued M&A momentum and the public equities markets as biotech heads into the New Year. On a special edition of the BioCentury This Week podcast recorded in London during London Life Sciences Week, BioCentury’s Simone Fishburn and Stephen Hansen were joined by a trio of guests to discuss their key takeaways from the week and expectations for next year, including trends in M&A and creative deal structures for business development.
The group also discussed the potential for biotech venture investing to make a comeback as a key asset class for LPs, especially in the U.K., as the government continues to encourage pension funds to invest more broadly.
The three guests joining BioCentury included Luciana Griebel from law firm Morgan Lewis, James Critchley from PJT Partners, and Carmine Circelli from the British Business Bank.
The podcast was recorded Nov. 19 on stage at the Victoria House in London as part of the 3rd Biotech CEO & Investor Reception.
BioCentury’s next recording “on the road” will take place on the sidelines of the annual J.P. Morgan Healthcare Conference in San Francisco in January at the 11th East West Healthcare Reception hosted by BioCentury, Panacea Venture and Maytech Global Investments.

View full story: https://www.biocentury.com/article/657686

#BiotechMandA #DrugDevelopment #VentureCapital #LifeSciences #LondonLifeSciencesWeek

00:00 - Introduction
02:24 - Market Recovery
08:02 - Growth and Influence
16:24 - Creative Dealmaking
21:40 - Role of CVRs
25:52 - Pension Funds and Venture Capital
30:09 - AI Bubble
34:17 - Accelerating Clinical Trials

Morgan Lewis has prepared its materials for this podcast for general informational purposes only. They do not and are not intended to constitute legal advice. This podcast was recorded on Nov. 19. Morgan Lewis does not guarantee the accuracy or timeliness of the information contained in these materials and disclaims any obligation to advise you of any changes in the law. You should always refer to original source documents for complete information and consult directly with an attorney for advice, including on the latest developments in this rapidly changing area of the law.

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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Voyager CEO and former head of R&D at Biogen Al Sandrock is more optimistic than ever about the prospect of bringing clinically meaningful solutions to patients with Alzheimer’s disease and other neurodegenerative disorders. The threads of progress are finally coming together, he said in a special episode of the BioCentury This Week podcast. From the first disease-modifying therapies for Alzheimer’s disease, to a growing biomarker toolkit, to an expanding set of genetically validated targets in other neurodegenerative conditions — and, crucially, to delivery vehicles capable of broadly and deeply penetrating the brain — neurology drug development may be poised to accelerate. This episode of the BioCentury This Week podcast is brought to you by Voyager Therapeutics.

View full story: https://www.biocentury.com/article/657678

#AlzheimersDisease #AAVGeneTherapy #BloodBrainBarrier #TauTargeting #Neurodegeneration

00:01 - Sponsor Message: Voyager Therapeutics 
03:41 - Voyager's Approach to Gene Therapy
15:07 - Alzheimer's Disease
25:25 - Big Biotech to Small Biotech
29:21 - Neurodegenerative Diseases
31:19 - FDA Flexibility

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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Richard Pazdur took the top job at FDA’s Center for Drug Evaluation and Research after receiving vows that he would be leading CDER free from political interference. On the latest BioCentury This Week podcast, BioCentury's analysts discuss the issues that could prove to be flashpoints between Pazdur and the heads of FDA and HHS, including personnel, RSV mAbs, puberty blockers and SSRIs.
BioCentury's analysts assess bispecific innovation at the annual meeting of the Society for Immunotherapy of Cancer (SITC) and the growing field of companies pursuing RNAi, many of which have multiple unpartnered assets. Also featured in this week's episode: new funds from European VCs Medicxi and Sofinnova Partners, FDA’s new plausible mechanism pathway and the Trump administration’s “most favored nation” drug-pricing plan, which is turning out to be much more less onerous to drug companies than its original description suggested. This episode of the BioCentury This Week podcast is brought to you by Voyager Therapeutics.

View full story: https://www.biocentury.com/article/657631

#RNAiTherapeutics #BispecificAntibodies #CD3TCellEngagers #MechanismOfAction #ImmunoOncology #PlausibleMechanismPathway #RegulatoryScience #ClinicalTranslation

00:01 - Sponsor Message: Voyager Therapeutics 
03:08 - FDA's Richard Pazdur
13:08 - Plausible Mechanism Pathway
19:30 - Most Favored Nation
23:12 - Takeaways from SITC
28:05 - RNAi in China
33:21 - European VCs

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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Today’s South Korean biotechs have a risk-on mentality, a willingness to partner, and strategies focused on globalization. On a special edition of the BioCentury This Week podcast recorded at Venture Café Cambridge, BioCentury is joined by a quartet of investors and executives with deep knowledge of Korea’s life sciences ecosystem to discuss Korea biotech’s push to globalize and the opportunities in the country for Western companies. The four guests joining BioCentury were Aram Hong, CEO of Korean start-up Apollon; investors Spencer Nam and Debra Peattie; and Boehringer Ingelheim GmbH's Andy Whittle.
The podcast was recorded Nov. 6 on stage at the Venture Café Cambridge during the K-Blockbuster Night hosted by KHIDI, the Korea Health Industry Development Institute. BioCentury analyses discussed during the podcast include one on Asian deals and another on the speed of clinical trials in China. BioCentury returns to Asia early next year for the 5th East-West Summit, March 9-11 in Seoul. This episode of the BioCentury This Week podcast is brought to you by KHIDI.

View Full story: https://www.biocentury.com/article/657558

#KoreaBiotech #Globalization #LifeSciences #BiotechEcosystem #PharmaDeals #ClinicalDevelopment #Innovation #BiotechLeadership

00:01 - Sponsor Message: KHIDI
05:08 - Asia Deals and Korea's Role
09:12 - Boehringer's Perspective
13:51 - Apollon's Journey
17:24 - Building Relationships
23:20 - Investors' View 

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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With ObesityWeek yielding eye-catching amylin data and a bidding war that ran to $10 billion for Metsera, weight loss companies were center stage in biotech last week. On the latest edition of the BioCentury This Week podcast, BioCentury’s analysts explained why Pfizer's victory for the start-up over European rival Novo Nordisk doesn’t necessarily mean a broader U.S. policy shift against foreign acquisitions of domestic biotechs.
Turning to ObesityWeek readouts, they discuss Eli Lilly's data for amylin monotherapy eloralintide, arguing that just as Lilly did with GLP-1 agonists, the company is again setting the benchmark by which all other molecules in the class will be measured.
BioCentury's analysts also discuss takeaways from Washington Editor Steve Usdin's Commentary, which finds FDA in a crisis of politicized decisions, plummeting morale, and a hollowed workforce, and highlights from BioCentury's interview with gene therapy pioneer Jim Wilson as he rethinks the funding model for ultrarare disease therapies to keep his mission on track. This episode of the BioCentury This Week podcast is brought to you by Voyager Therapeutics.

View full story: https://www.biocentury.com/article/657545

#ObesityWeek #Amylin #GLP1 #Eloralintide #DrugMechanism #FDA #RareDisease #GeneTherapy

00:01 - Sponsor Message: Voyager Therapeutics 
01:53 - Pfizer Wins Metsera
08:48 - Lilly's Amylin Data
13:06 - Funding Ultrarare Therapies
20:51 - What's Next for FDA

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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Novo Nordisk’s unsolicited $8.5 billion bid for Metsera has thrown a wrench into Pfizer’s plans to return to the obesity race via its acquisition of the New York-based start-up. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the details of the competing bids and what’s at stake for the pair of suitors.
The analysts also assess the reasons behind the abrupt departure of Center for Drug Evaluation and Research Director George Tidmarsh from FDA and a surge in activity on the Hong Kong stock exchange. This episode of the BioCentury This Week podcast is brought to you by Voyager Therapeutics.

View full story: https://www.biocentury.com/article/657475

#Biotech #PharmaDeals #ObesityDrugs #MergersAndAcquisitions #FDA #LifeSciences #GlobalBiotech #HongKongMarket

00:01 - Sponsor Message: Voyager Therapeutics
01:53 - Metsera M&A
15:23 - Tidmarsh Ouster
25:12 - Hong Kong IPOs

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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China is setting a new bar for the speed of clinical development and redefining the time it takes an asset to get to the clinic. On a special edition of the BioCentury This Week podcast recorded on stage at the 12th BioCentury BayHelix China Healthcare Summit in Shanghai, BioCentury's Simone Fishburn argued that China’s emerging new standard for swift entry to the clinic could upend the bottleneck of translational development and usher in a new paradigm that could have a “massive impact globally.”
Fishburn and her BioCentury colleagues Joshua Berlin and Jeff Cranmer were joined by a trio of cross-border KOLs — John Zhu, CEO of antibody-drug conjugate company DualityBio; Matt Hewitt, CTO of  Charles River Laboratories' manufacturing business division; and Bing Wang, CFO of Akeso — to discuss the speed of generating first-in-human data, Innovent’s $1.2 billion deal with Takeda, an evolving biotech talent pool, and the state of the financial markets.
“For me, it really feels like 2025 is the year that biotech globally woke up to China,” Fishburn said.

BioCentury returns to Asia early next year for the 5th East-West Summit, March 9-11 in Seoul. Register today as a delegate or apply to join the Presenting Company Class to take advantage of early bird rates.

#ChinaInnovation #DrugDevelopment #PharmaDeals #GlobalBiotech #PharmaInnovation #siRNA #BrainToVein

00:00 - Introduction
02:49 - China Speed
12:27 - Clinical Trails 
17:34 - Global Strategy
26:59 - Financial Markets IPOs
36:52 - Talent

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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Novartis’ biggest deal in more than a decade gives the Swiss pharma three programs for muscular dystrophies that are close to the finish line. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the $12 billion deal for Avidity in the context of Novartis’ recent acquisitions and the antibody-oligonucleotide conjugate platform it is gaining.
The team dives into RNA versus DNA modalities, noting antisense and siRNA approaches appear to be gaining traction with major pharmas as traditional gene therapy and gene editing approaches hit rocky times. Still, they note hopeful progress among base editing therapies given the promising early track records of over a dozen base editors in the clinic. They also discuss BioCentury’s conversation with base editing inventor David Liu; Alkermes’ $2.1 billion acquisition of Avadel; and β-catenin data from Parabilis. This episode of BioCentury This Week is sponsored by Evotec.

View full story: https://www.biocentury.com/article/657412

#AntibodyOligonucleotideConjugates #RNAtherapeutics #BaseEditing #MuscularDystrophy #WntPathway #BetaCatenin #Orexin2Receptor #PrecisionMedicine

00:01 - Sponsor Message: Evotec 
02:04 - 12th China Healthcare Summit
08:11 - Novartis' $12B Deal
16:58 - Alkermes M&A
20:01 - David Liu Base Editing
25:02 - Parabilis' Data

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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Next-generation platforms and technologies are getting closer to cracking one of biopharma’s biggest problems: delivering medicines, and mAbs in particular, to the brain. On the latest BioCentury This Week podcast, BioCentury’s Selina Koch details the latest innovations in blood-brain-barrier shuttles and how the technologies could transform the treatment of neurological diseases.
BioCentury’s Lauren Martz discusses her conversation with Tony Wood, CSO of GSK, which included the pharma’s strategy for indication expansion, why it prefers RNA modalities over AAV-based gene therapies, and how its quest for causal biology has evolved over the years.
Washington Editor Steve Usdin discusses the first set of FDA’s new commissioner’s national priority review vouchers, and why the voucher program is unlikely to function as an incentive capable of steering future behavior. Usdin also discusses the potential impact of FDA staffing reductions on the sector. This episode of BioCentury This Week is sponsored by Evotec.

View full story: https://www.biocentury.com/article/657326

#BloodBrainBarrier #Neurology #DrugDelivery #MonoclonalAntibodies #RNAtherapeutics #CausalBiology #FDA

00:01 - Sponsor Message: Evotec
01:57 - Brain Shuttles
13:57 - GSK Q&A
20:08 - FDA Vouchers

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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It’s been a tough year for cell and gene therapy — patient deaths, high-profile companies pulling out of the space, and sour investment sentiment. But the field has had some promising readouts in the clinic recently, and it continues to mature, showing steady progress despite challenging market conditions. On the latest BioCentury This Week podcast, Evotec’s Bernd Mühlenweg joins BioCentury’s analysts to give his view of the field and offer takeaways from this month’s Cell & Gene Meeting on the Mesa in Phoenix. This episode of BioCentury This Week is sponsored by Evotec. 

View full story: https://www.biocentury.com/article/657278

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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Biotech’s fourth quarter began with a familiar feeling, with indicators pointing toward an improving public market even as political and regulatory uncertainty has buysiders reluctant to say industry has returned to sustainable growth. On the latest BioCentury This Week podcast, BioCentury’s analysts assess the state of biotech’s public markets. The analysts discuss the Senate’s move to limit access to Chinese CDMOs, the latest developments in the White House’s “most favored nation” drug pricing negotiations, and the U.K.'s attempt to win over pharma companies via adjusting thresholds at NICE. Finally, they analyze a pair of billion-dollar-plus M&A deals: the $4.7 billion deal by Novo Nordisk to acquire liver disease company Akero and the $1.5 billion takeout of in vivo cell therapy company Orbital by Bristol Myers. This episode of BioCentury This Week is sponsored by Evotec.

View full story: https://www.biocentury.com/article/657260

#biotech #biopharma #pharma #lifescience #drugpricing #MFN

00:01  Sponsor Message: Evotec
02:12  4Q Markets Preview
13:25  China CDMOs
24:35  Drug Pricing Deals NHS
31:22  Drug Pricing Deals M&A

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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The short-term consequences for Pfizer from its “most favored nation” drug pricing deal with the White House are negligible, but the long-term effects on the industry could be profound and permanent.
On the latest BioCentury This Week podcast, BioCentury Washington Editor Steve Usdin discusses why the deal by Pfizer Inc. (NYSE:PFE) changes everything — and nothing — and what’s next in wrangling over drug pricing between industry and the Trump administration.
The analysts also discuss PDUFA negotiations between FDA and leaders of BIO and PhRMA, how multi-site IITs could help bridge the academia-industry gap, and how TCG X plans to deploy its new $1.3 billion fund. This episode of BioCentury This Week is sponsored by Evotec.

View full story: https://www.biocentury.com/article/657192

#biotech #biopharma #pharma #lifescience #financialmarkets #drugpricing #MFN

00:01  Sponsor Message: Evotec
03:31  Pfizer MFN Deal
16:05  PDUFA Reauthorization
20:31  Investigator-Initiated Trials

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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Genmab's $8 billion acquisition of multispecifics company Merus is the Danish biotech’s largest step toward marketing its own pipeline. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the evolution of Genmab, which, for many years, relied on a partnership model that delivered blockbuster revenues but now is making a change as a patent cliff looms.
The analysts also assess the tenure of Emma Walmsley the longtime CEO of GSK, and what’s next for the U.K. pharma under incoming CEO Luke Miels. Turning to the U.S., Washington Editor Steve Usdin discusses President Donald Trump’s looming tariff threat on imports of branded drugs, which Usdin says would hurt small biotechs the most. Usdin also analyzes the response of multinational pharmaceutical companies to the president’s demand that they make “most favored nation” price concessions, now that Monday’s deadline has passed. This episode of BioCentury This Week is sponsored by IQVIA Biotech.

View full story: https://www.biocentury.com/article/657131

#biotech #pharma #deals #FGF21 #MASH #Interleukin5 #asthma #PhRMA #PBM #tarriff #MFN

00:01 - Sponsor Message: IQVIA Biotech
02:26 - Genmab's Merus Buy
09:43 - CEO Switch at GSK
17:22 - Trump Tariff Threat
21:17 - MFN Drug Pricing

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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AI is bringing sweeping changes to drug development, from how targets are discovered to optimizing clinical trials to maximize an asset’s chance for success. On a special edition of the BioCentury This Week podcast, IQVIA’s Greg Lever joins BioCentury’s analysts to discuss agentic AI’s short- and long-term prospects to help biotechs discover new targets, predict success in preclinical development, and enhance clinical operations. This episode of BioCentury This Week is sponsored by IQVIA Biotech.

View full story: https://www.biocentury.com/article/657086

#Biotech #Biopharma #DrugDevelopment #ClinicalTrials #TargetDiscovery #AgenticAI #GraphRAG #DeRisking

00:01 - Sponsor Message: IQVIA Biotech
01:22 - AI in Biotech
05:01 - Machine Learning
06:21 - Generative AI and Language Models
08:37 - Agentic AI
12:43 - AI in Target Discovery
23:44 - AI in Clinical Trial Design

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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Is this the U.K.’s moment to capitalize on its biotech ecosystem? That was one of the primary themes discussed at the debut Grand Rounds — Europe conference last week in Cambridge, U.K. BioMarin's James Sabry and Astex's Michelle Jones joined BioCentury’s analysts on a special edition of the BioCentury This Week podcast recorded live at the event to discuss their key takeaways from the two-day conference.
Beyond the state of the U.K. biopharma ecosystem, the analysts discussed the meeting’s major science themes, including what’s next for DNA damage repair pathway targets, both inside and outside of cancer; whether obesity should be recast as a brain disease; and the cutting edge of small molecule design.

View full story: https://www.biocentury.com/article/657082

#UKBiotech #TranslationalMedicine #DrugPricing #GlobalCollaboration #Aging #Biologics #SmallMolecules #Biobanking

00:00 - Introduction
00:35 - Key Takeaways
02:14 - The State of the U.K. Biotech Ecosystem
09:01 - Scientific Highlights & Panel Takeaways
22:44 - Closing Remarks and Future Events

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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A takeout that could be worth as much as $7.3 billion has Pfizer back in the obesity drug development race. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss Pfizer’s acquisition of Metsera and its obesity assets. Plus: Editor in Chief Simone Fishburn gives a recap of BioCentury’s Grand Rounds — Europe meeting, which included a fireside chat with Patrick Vallance on the state of the life sciences ecosystem in the country. The BioCentury analysts also assess the state of hot-button policy issues in Washington, such as drug pricing and China. Finally, they analyze the state of play among therapies for narcolepsy on the heels of the World Sleep Congress in Singapore. Check out BIO Chairman Fritz Bittenbender’s conversation with BioCentury Washington Editor Steve Usdin on BioCentury This Week’s sister podcast, The BioCentury Show. This episode of BioCentury This Week is sponsored by IQVIA Biotech.

View full story: https://www.biocentury.com/article/657065

#ObesityDrugs #PharmaDeals #BiotechDeals #MergersAndAcquisitions #DrugDevelopment #Narcolepsy

00:01 - Sponsor Message: IQVIA Biotech
03:46 - Pfizer’s Obesity M&A
14:54 - U.K. in Focus
28:20 - U.S. Drug Pricing, China Policy
40:07 - Narcolepsy Pipeline

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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Merck's announcement that it is moving its R&D out of the U.K. highlights concerns about the country’s life sciences policies. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the life sciences ecosystem in the U.K., including MHRA CEO Lawrence Tallon’s plans to create a world-class regulatory environment. They also discuss a bill passed by the U.S. House of Representatives that would end most U.S.-China academic research collaborations, and the recent success of 40-year-old biotech Insmed. This episode of BioCentury This Week is sponsored by IQVIA Biotech.

View full story: https://www.biocentury.com/article/656997

#biotech #biopharma #pharma #lifescience #MHRA #China #RandD #DrugDevelopment

00:01 - Sponsor Message: IQVIA Biotech
01:25 - U.K. Biopharma
04:40 - Grand Rounds Cambridge
09:45 - SAFE Research Act
18:01 - Spotlight on Insmed
26:32 - Sen. Cassidy's Vaccine Callout

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Molecular biologist and Nobel Prize winner David Baltimore made foundational contributions to the biopharma industry and was the essential figure behind such research institutions as the Whitehead Institute for Biomedical Research and the Broad Institute. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the legacy of Baltimore, who passed away this past weekend at 87.
The analysts also discuss Atlas Venture’s new $400 million opportunity fund, the clinical development pipelines for metabolic-associated steatohepatitis (MASH) and chronic urticaria, and late-stage atopic dermatitis data from Sanofi. This episode of BioCentury This Week is sponsored by IQVIA Biotech.

View full story: https://www.biocentury.com/article/656942

#biotech #biopharma #DavidBaltimore #ReverseTranscriptase #MASH #Rezdiffra #GLP1 #ChronicUrticaria #Dupixent

00:01 - Sponsor Message: IQVIA Biotech
03:19 - Remembering David Baltimore
06:26 - Atlas's New Opportunity Fund
09:22 - The Growing MASH Pipeline
16:03 - Sanofi's Atopic Dermatitis Data
18:57 - Exploring Chronic Urticaria Treatments

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Two veteran biotech leaders are launching a new company with ambitions in the cardiovascular disease space. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the debut of Corsera Health, a biotech led by John Maraganore and Clive Meanwell that is developing an AI-guided early risk assessment tool alongside dual-acting therapy that could stave off heart disease.
The team then discusses how FDA has been quietly positioning itself to disrupt the childhood vaccine schedule, as well as the effects of changes to the Medicare drug negotiation program that were included in the tax and budget bill Congress passed in July.

View full story: https://www.biocentury.com/article/656897

#Corsera #DiseaseInterception #CardiovascularHealth #HeartDisease #FDA #VaccinePolicy #Medicare #DrugPricing

00:00 - Introduction
01:26 - Maraganore, Meanwell Newco
09:17 - BioCentury's Back to School
14:51 - Vaccine Disruption at FDA
26:01 - Medicare Drug Negotiations

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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There’s been a rare IPO filing on NASDAQ as LB Pharma looks to test the market during a year that has seen little activity among U.S. biotechs even as green shoots continue to appear on the Hong Kong stock exchange. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the market for biotech IPOs on NASDAQ and in Hong Kong.
The analysts then assess FDA’s about-face on Stealth BioTherapeutics' Barth syndrome therapy, putting the decision in the context of a changing regulatory agency; and a BioCentury Guest Commentary that argues that the university-industry engine that drives U.S. innovation is under attack. Also mentioned on this week’s podcast: BioCentury’s 33rd Back to School package, which reimagines FDA; the upcoming 12th China Healthcare Summit in Shanghai; the evolution of dealmaking in China; and Annalisa Jenkins’ take on MHRA and the U.K. biotech ecosystem on The BioCentury Show.

View full story: https://www.biocentury.com/article/656849

#Biotech #IPO #Pharma #FDA #RareDisease #Biopharma #DrugDevelopment #HealthcareInnovation #HongKongIPO

00:00 - Introduction 
02:48 – LB Pharma Tests IPO Market
07:01 – Hong Kong IPO Momentum
09:53 – China Summit Preview
13:40 – FDA Reversal on Stealth Bio
18:15 – Bayh-Dole Clash & Innovation Threats

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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BioCentury’s third annual analysis of pharma company deals finds that bispecifics and degraders are in, cell and gene therapies are out, and China is bringing much more than me-too assets to cross-border deals. On the latest BioCentury This Week podcast, BioCentury’s analysts assess a year’s worth of deals between pharmas and biotechs to tease out emerging trends.
The analysts also discuss last week’s FDA approval of a vector-based immunotherapy from Precigen to treat a rare respiratory disease and whether the decision will set a precedent of more flexibility for rare disease therapies. They then take stock of recent translational coverage in BioCentury, including a report by Denali of a way to avoid a key safety issue of anti-amyloid-targeting mAbs.
BioCentury’s Grand Rounds — Europe will take place in Cambridge, U.K., Sept. 17-19. The conference seeks to bridge academia, industry and investors for breakthrough innovation.

View full Story: https://www.biocentury.com/article/656802

#PharmaDeals #CrossBorderDeals #Bispecifics #TargetedProteinDegradation #RareDisease #Neurodegeneration

00:00 - Introduction
01:38 - Pharma Deals
10:41 - Precigen
14:40 - Denali's BBB Tech
25:20 - Grand Rounds Europe

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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