BioCentury This Week

New Parkinson’s disease programs aim to move beyond the historical norm of symptom management, branching into targeted therapeutics and cell therapies. On the latest BioCentury This Week podcast, BioCentury’s analysts review the most promising targets and trends shaping the Parkinson’s treatment landscape.
The team then turns to AstraZeneca’s build-out of its obesity portfolio, followed by FDA’s Operation TrialBlazer and what the reforms mean for reducing the time to launch a clinical trial in the U.S. — and whether they can help close the gap with China.
Finally, the analysts review recent FDA reversals of controversial regulatory decisions made under former Commissioner Marty Makary’s leadership and whether companies and investors can expect this reversion to the mean to carry forward.

View full story: https://www.biocentury.com/article/659958

#ParkinsonsDisease #ObesityDrugDevelopment #FDA #ClinicalTrials #DrugDevelopment

00:00 - Introduction
01:40 - Parkinson's New Targets
11:43 - AstraZeneca's Obesity Pipeline
18:37 - FDA's Operation TrialBlazer
27:33 - FDA Leadership Outlook

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
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AbbVie's $10.9 billion deal to acquire Apogee will expand its immunology pipeline by delivering assets for atopic dermatitis and asthma. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the takeout and the assets AbbVie gains.
The analysts then discuss moves by FDA to reverse controversial setbacks that occurred under the agency’s former leadership and assess Acting CDER Director Michael Davis’ memo outlining how his predecessor repeatedly overruled career staff to quash a drug approval. The analysts also discuss continuing signs of political involvement at FDA.
Finally, they discuss China NMPA’s first-ever approval of a CAR T for solid tumors, satricabtagene autoleucel (satri-cel) from Carsgen.

View full story: https://www.biocentury.com/article/659864

#BiotechMA #Immunology #FDA #CART #ChinaBiotech

00:59 - AbbVie Buys Apogee
05:20 - uniQure U-turn
09:02 - FDA Reversals
12:32 - Tzield Memo
20:53 - Solid Tumor CAR T Approval

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
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Biotech IPOs that are getting out remain hot — but will that continue into the fall? On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the market for fresh biotech paper on NASDAQ, including the $770 million debut by  Parabilis, the largest IPO in the sector’s history.
The analysts also discuss the Biosecure Act and U.S. policy toward China; the cachexia pipeline; and BioCentury’s updated Innovation Distillery.

View full story: https://www.biocentury.com/article/659773

#BiotechIPO #NASDAQ #BiosecureAct #Cachexia #ChinaBiotech 

00:36 - Innovation Distillery
03:56 - Biotech IPOs
10:13 - Biosecure Act, WuXi AppTec
16:03 - Cachexia Pipeline
22:03 - Ouster for RFK Jr.?

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
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Getting into the clinic fast to de-risk assets has become the name of the game in biotech, and at the academia-industry interface, too.
From AI to NAMs to starting a Phase I trial in the U.S., BioCentury’s 3rd Grand Rounds-U.S. conference brought together academic innovators, biopharma leaders and early-stage investors to debate key bottlenecks in translation and how to make early-stage R&D investible.
Sam Blackman, entrepreneur in residence at GV and co-founder of Day One Biopharmaceuticals, and Aaron Coe, managing director of innovation for the Allen Institute, joined BioCentury’s analysts on stage last week in Seattle for a podcast recording to wrap up Grand Rounds and discuss key takeaways from the event.

Editor’s note: We invite you to join BioCentury and Regional Host Chairs Forbion and BGV at our next edition of BioCentury Grand Rounds, scheduled for Sept. 23-25 in Amsterdam.

View full story: https://www.biocentury.com/article/659729

#TranslationalScience #DrugDevelopment #BiopharmaInnovation #AcademicInnovation #GrandRoundsUS

00:53 - World-Class Regional Hosts
02:56 - Building Grand Rounds Community
05:21 - Two Nobels, One City
07:43 - AI Goes End-to-End
09:47 - The Data Problem
14:12 - AI, Animals, Australia
19:53 - Study Startup Bottlenecks
26:11 - Early Science Investability

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
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FDA’s new leadership is sailing the agency into calmer waters amid a search for a permanent commissioner and permanent center directors. On the latest BioCentury This Week podcast, BioCentury Washington Editor Steve Usdin discusses how FDA’s new, interim leaders have changed the tone at the agency and why they are putting medicines derailed under former FDA Commissioner Marty Makary back on track. Usdin also highlights FDA’s new real-time clinical trials initiative.
BioCentury’s analysts then turn to deals, including an analysis of the 20 deals Eli Lilly has done this year; Servier’s move to expand in neurology via BD; and Monday’s billion-dollar deals by Incyte, which will acquire Vega Therapeutics, and Johnson & Johnson, which is buying Firefly Bio.
The team also discusses Grand Rounds U.S., held last week in Seattle, including the conference’s Rising Star prize winner Sylvain Simon of Fred Hutchinson Cancer Center.

View full story: https://www.biocentury.com/article/659699

#FDA #BiopharmaDeals #ClinicalTrials #BiotechMA #GrandRoundsUS

01:23 - Grand Rounds Seattle Takeaways
04:43 - FDA's New Leaders
11:48 - FDA's Real Time Trials Pilot
20:40 - Servier Bets on Neuro
25:33 - Lilly's Deal Spree
30:21 - Dealmaking Roundup

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