BioCentury This Week

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

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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

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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

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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

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Dealmaking between Western and Chinese biopharmas has been one of the year’s bright spots, as a maturing biotech landscape in China converges with Western demand for innovative assets, driving record deal flow. At the same time, the Hong Kong stock exchange has emerged as the hottest market for biotech IPOs, at a time when the NASDAQ window remains shut.
These themes will be in the spotlight at the 12th BioCentury-BayHelix China Healthcare Summit Oct. 22-24 in Shanghai. On this special edition of the BioCentury This Week podcast, a trio of biopharma leaders join BioCentury’s analysts to discuss the landscape: McKinsey's Franck Le Deu, former BD executive Ji Li, and HBM Holdings' Mike Patten.
BioCentury, BayHelix and Insights Partner McKinsey & Company invite you to visit Shanghai for the 12th China Healthcare Summit at the St. Regis Shanghai Jingan. For more information, click here; to apply to join the 2025 Class of Presenting Companies click here.

View full story: https://www.biocentury.com/article/656773

#ChinaBiotech #CrossBorderDeals #HongKongIPO #BiotechInvesting #LifeSciencesFinance

00:00 - Introduction
02:09 – Key Trends
06:03 – View from McKinsey
13:36 – Evolution of Deal Landscape
20:24 – Learning from China
24:00 – China-China M&A & NewCos

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Phase III data from Lilly’s orforglipron in obesity fell short of investor expectations, but they appear to be enough to obtain approval and wide use. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss why the first-in-class oral small molecule GLP-1R agonist’s clean safety profile and clear manufacturing advantage over oral peptides give the product a leg-up in the market.
They then discuss Vinay Prasad’s return to FDA after a brief hiatus, the revamped strategy of 32-year-old San Diego biotech Acadia Pharmaceuticals, and an attempt in the Senate to revive the Biosecure Act targeting China biotechs.
Finally, the analysts preview this year’s Back to School package, which reimagines FDA. At a time of unprecedented change in government agencies, BioCentury’s 33rd Back to School asks what FDA could look like if it were reorganized from the ground up to create the regulator patients deserve and industry needs.

View full story: https://www.biocentury.com/article/656727

#orforglipron #CBER #VinayPrasad #AcadiaPharmaceuticals

00:00 - Introduction
00:49 - Prasad
07:09 - Back to School
12:29 - Lilly Obesity
21:58 - Acadia's Comeback
28:50 - Biosecure Act

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The ouster of Vinay Prasad after three months running FDA’s Center for Biologics Evaluation and Research could signal a reset is ahead for CBER. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss what the latest shakeup at the regulatory agency says about what’s next for FDA.
The analysts also assess two leading European pharmas: obesity and diabetes company Novo Nordisk, which named a new CEO last week while cutting its 2025 forecast, and Bayer, which is gearing up for launches and is revamping its pipeline to restart growth. Finally, they discuss the promising clinical data that’s reviving interest in masking technologies that conditionally activate biologics.

View full story: https://www.biocentury.com/article/656649

#FDA #CBER #NovoNordisk #ObesityDrugs #Bayer

01:05 - Prasad's Ouster
14:59 - Novo's New CEO
21:14 - Bayer's Growth Strategy
26:05 - Masked Biologics

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A handful of encouraging signals is cause for cautious optimism for biotech headed into the second half of the year — companies have been able to parlay strong data into follow-on capital and M&A activity is picking up. That said, the IPO market continues to be closed and concerns about U.S. drug pricing and FDA stability continue to weigh on expectations for a robust near-term sector recovery.
Special guest Megan Hooton from IQVIA Biotech joins BioCentury’s analysts on a special edition of the podcast to discuss key indicators of progress for the biopharma sector. Hooton is president of IQVIA Biotech, which sponsored this episode of the pod.

View full story: https://www.biocentury.com/article/656614

#biotech #biopharma #pharma #lifescience #BiotechTrends #ClinicalTrials #GeneTherapy #CellTherapy

00:01 – Sponsor Message: IQVIA Biotech
02:37 – Biotech Markets
06:41 – Clinical Highlights
10:26 – Insights from Meg Hooton
23:10 – Advanced Therapies

To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected].

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