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 podcasts@biocentury.com.

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This week’s deal between GSK and Jiangsu Hengrui is a prime example of how Western biopharmas have begun to recognize the innovation and opportunities being fostered in China — and how it’s no longer all about fast followers.
On the latest BioCentury This Week podcast, BioCentury’s analysts put the collaboration between GSK and Jiangsu Hengrui Pharmaceuticals, two of the most active cross-border dealmakers, into the context of East-West dealmaking over the past 30 months, assessing the innovation that is driving the rush to partner with biotechs in China, Japan, South Korea and beyond, and the types of companies looking to Asia for assets.
BioCentury’s analysts also discuss Steve Bates’ outsized role in building the U.K. biotech hub, as he readies to take on a new role in the U.K. government. They examine new VC funds from Omega Funds and Brandon Capital, FDA’s new national priority voucher pilot program, and fallout from how FDA and  Sarepta Therapeutics handled the deaths of four patients who had received the biotech’s gene therapies. This episode of BioCentury This Week is sponsored by IQVIA Biotech.

View full story: https://www.biocentury.com/article/656592

#biotech #biopharma #pharma #lifescience #EastWestDealmaking #ChinaBiotech #UKBiotech #FDAPolicy

00:01 - Sponsor Message: IQVIA Biotech
02:48 - Asia Deals Landscape
17:32 - Steve Bates & U.K. Biotech
25:46 - FDA's New Voucher Pilot
31:01 - New VC Funds
35:28 - Sarepta

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

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Last week’s public disclosure that a gene therapy from Sarepta had caused a third death led FDA to ask the company to stop distributing its DMD gene therapy Elevidys, a move the biotech has resisted. The deaths, and disputes between FDA and Sarepta, raise questions about the future of AAV gene therapies, as well as the future of FDA’s platform technology designation. On the latest BioCentury This Week podcast, BioCentury’s analysts unpack the events surrounding Sarepta’s gene therapies and discuss how FDA, industry and patient groups should come together to learn the lessons from the tragic, avoidable deaths.
BioCentury’s analysts also assess Monday’s appointment of Stanford professor and biotech executive George Tidmarsh to lead FDA’s Center for Drug Evaluation and Research, and check in on the latest trends in venture financings. This episode of BioCentury This Week is sponsored by IQVIA Biotech.

View full story: https://www.biocentury.com/article/656537

#biotech #biopharma #pharma #lifescience #GeneTherapy #AAVTherapy #Sarepta #Elevidys

00:01 - Sponsor Message: IQVIA Biotech
02:03 - Gene Therapy
17:59 - Leading CDER
27:00 - Venture Report

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

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Chinese biotech is the lone bright spot for the biopharma financial markets in 1H25, as macro concerns about the most favored nation (MFN) pricing policy and FDA weigh on the prospects for biotech elsewhere. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the positives — and negatives — impacting investor sentiment headed into the second half of the year. The team also discuss where the quantum computing revolution could have its biggest impact on drug development, and review the proposals and accomplishments of FDA Commissioner Marty Makary over his first 100 days in office. This episode of BioCentury This Week was sponsored by IQVIA Biotech.

View full story: https://www.biocentury.com/article/656482

#biotech #biopharma #pharma #lifescience #financialmarkets #FDA #quantumcomputing

00:01 - Sponsor Message: IQVIA Biotech
04:43 - Q25 Financial Markets Preview
22:20 - Quantum Computing Impact on Biopharma
30:07 - Makary's First 100 Days

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Grand Rounds heads to Europe: first meeting Sept. 17 in Cambridge, U.K.

There are many reasons why it may be the European biomedical ecosystem’s moment to shine, and advances at the academia-industry interface are a core part of that story, particularly in Cambridge, U.K. — the site of the inaugural BioCentury Grand Rounds – Europe conference.

On a special edition of the BioCentury This Week podcast, BioCentury’s analysts are joined by four leaders in the Cambridge, U.K., life sciences community to preview the Sept. 17-19 meeting: Kathryn Chapman, executive director of Innovate Cambridge; Anne Horgan, partner, Cambridge Innovation Capital (CIC); Sally Mardikian, business development director, Astrazeneca plc (LSE:AZN; NASDAQ:AZN); and Kristin-Anne Rutter, executive director of Cambridge University Health Partners (CUHP).

The BioCentury team and its Cambridge counterparts discuss the conference’s themes and how they relate to the region’s strengths, and offer both some tough love and a warm invitation to early-stage innovators looking for science-forward investors and partners.

View full story: https://www.biocentury.com/article/656373

#biotech #biopharma #pharma #lifescience #Discovery #Translation #BioCenturyGrandRoundsEurope

00:00 - Introduction
01:53 - Grand Rounds Cambridge Themes
10:14 - Why Cambridge?
23:43 - Tough Love
28:02 - Join us at GlastonGeek

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

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Oncology regulation has been less affected by recent changes in FDA leadership than other parts of the agency. On a special sponsored edition of the BioCentury This Week podcast, BioCentury’s analysts assess what has and hasn’t changed at FDA when it come to regulating cancer therapeutics.
Special Guest Liz O’Brien joins BioCentury’s analysts to discuss how biotechs can navigate FDA’s Project Optimus and EMA’s Joint Clinical Assessment as well as the differences between the two agencies. O’Brien is a former EMA regulator who is now therapeutic expert, oncology and women’s health, drug development solutions at BioCentury This Week sponsor ICON Biotech.

View full story: https://www.biocentury.com/article/656371

#biotech #biopharma #pharma #lifescience #FDA #cancer #CAR_T

00:01 - Sponsor Message: ICON Biotech
02:30 - FDA Cancer Regulations
07:48 - Project Optimus
25:12 - CAR T REMS Removal

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

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Treg-based cell therapies are nearing a clinical proof-of-concept inflection point, but in an environment that has dramatically shifted with the advent of CAR T therapies for autoimmune diseases. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss what these cell therapies need to show to be relevant in the fast-changing I&I world, and which types of indications may best suit the cells’ unique profile.
The team also explores the biotech sector’s ongoing struggle to capture the interest of generalist investors, and what the next major theme might be to draw them back.
The analysts then break down the key provisions in the recently passed U.S. reconciliation tax bill, highlighting the positive and negative developments, as well as the missed opportunities for the industry. This episode of BioCentury This Week was sponsored by IQVIA Biotech.

View full story: https://www.biocentury.com/article/656376

#biotech #biopharma #pharma #lifescience #CellTherapy #TregTherapy #CAR_T

00:01 - Sponsor Message: IQVIA Biotech
01:19 - Treg Inflection Point
10:57 - Biotech's Next Big Story
22:36 - Tax Bill Consequences

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The Trump administration’s overhaul of FDA is still underway, but the agency has already veered away from its decades-long trajectory in ways that will profoundly reshape medical product development and the lives of U.S. patients. On the latest BioCentury This Week podcast, BioCentury’s analysts assess who the winners and losers are likely to be as FDA changes shape.
The analysts discuss a pair of in vivo CAR T companies: Esobiotec, whose story offers a case study in product-focused strategy, and Capstan Therapeutics, whose in vivo CAR T platform for immunological disorders attracted a buyer in Abbvie. The team also analyzes why data from Compass Pathways for psilocybin therapy COMP360 disappointed investors despite hitting the endpoint, and how molecular glues could be the future of selective CDK2 targeting. This episode of BioCentury This Week was sponsored by ICON Biotech.

View full story: https://www.biocentury.com/article/656341

#biotech #biopharma #pharma #lifescience #RandD #drugapproval

00:01 - Sponsor Message: ICON Biotech
02:26 - BioCentury Grand Rounds Europe
05:02 - FDA's Future
15:03 - Psychedelics
22:53 - Esobiotech's Fast Exit
31:37 - Molecular Glues and CDK2
34:43 - Abbvie's Capstan Buy

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

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Publicly traded U.K. investment firm and company builder Syncona is restructuring its fund amid ongoing market challenges in the biopharma industry. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss how the firm will steer its portfolio toward returns for shareholders, while aiming to build a new fund away from public markets. The analysts then assess Eli Lilly's takeout of cardiovascular base editing company Verve, and what Washington Editor Steve Usdin calls FDA’s new “two-track” future for evaluating new therapies for approval — those with clear-cut benefits and those with ambiguous efficacy safety and efficacy profiles — in light of the many departures of senior FDA staff. They also discuss NASDAQ’s largest biopharma IPO — by Caris —  in two years, the latest obesity readouts, FDA Commissioner Marty Makary’s priority pathway and Usdin’s Q&A with new BIO Chair Fritz Bittenbender. This episode of BioCentury This Week was sponsored by ICON Biotech.

View full story: https://www.biocentury.com/article/656266

#biotech #biopharma #pharma #lifescience #finance #CV #FDA

00:01 - Sponsor Message: ICON Biotech
02:14 - Syncona Restructures Fund
10:08 - Lilly's $1B Verve Takeout
21:45 - FDA's 2-Track Future

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The tragic death of a second non-ambulatory DMD patient treated with Sarepta's Elevidys gene therapy marks a turning point for the field and should drive all stakeholders to come together to figure out how to safely treat patients with this new modality. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the opportunity FDA, companies and patient advocates have to share data and identify a safe path forward for the gene therapy field, both in DMD and beyond.
The analysts also review promising early data for amylin agonists to treat obesity from Metsera and Eli Lilly, and discuss the vision for FDA’s future laid out by Commissioner Marty Makary and CBER director Vinay Prasad. This episode of BioCentury This Week was sponsored by ICON Biotech.

View full story: https://www.biocentury.com/article/656214

#biotech #biopharma #pharma #lifescience #obesity #FDA #DMD

00:01 - Sponsor Message: ICON Biotech
01:19 - Gene Therapy Safety
11:55 - Amylin in Obesity
18:17 - FDA's Future

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With federal funding at risk and VCs increasingly focused on de-risked assets, academia is facing unprecedented headwinds despite rapid advancements in innovation.
One potential bright spot: Pharma, which is turning to academia to access first-in-class innovation. But many in pharma complain it is difficult to work with academia.
On a special Grand Rounds edition of the BioCentury This Week podcast, BioCentury analysts and special guests discuss a new way of thinking and a new era of collaboration between academia and industry.

View full story: https://www.biocentury.com/article/656177

#biotech #biopharma #pharma #lifescience #Discovery #Translation #BioCenturyGrandRounds

00:00 - Introduction
02:38 - Key Findings
07:42 - Collaboration and Opportunities
25:52 - BioCentury Grand Rounds Europe

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Translational trends at this year’s ASCO meeting featured new and selective ways to target cell surface receptors on solid tumors. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the findings from Executive Director of Biopharma Intelligence Lauren Martz’s deep dive into first-in-human studies at the American Society of Clinical Oncology meeting, including how immunocytokines, solid tumor CAR Ts and Chinese innovation are thriving in early trials.
The analysts also examine the signs of strain and resilience in biotech’s crossover investors, as well as FDA’s plans for revamping rare disease regulation. This episode of BioCentury This Week was sponsored by ICON Biotech.

View full story: https://www.biocentury.com/article/656139

#biotech #biopharma #pharma #lifescience #RandD #DrugDevelopment

00:01 - Sponsor Message: ICON Biotech
02:11 - ASCO’s First-in-Human Trials
12:46 - Crossover Investor Health Check
22:54 - FDA's Rare Disease Plans

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

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Dealmaking by a pair of pharmas has given the biotech industry its best day of transactions in months, tallying nearly $13 billion in guaranteed payments across two deals. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss how the takeout of Blueprint Medicines for $9.1 billion up front gives Sanofi a drug for a rare immunological disorder and bolsters the French pharma’s already strong presence in immunology.
The analysts also assess the $3.5 billion partnership between BioNTech and Bristol Myers Squibb for an asset targeting cancer’s hottest target, PD-(L)1 x VEGF, and underwhelming data from the leading asset against the target, PD-1 x VEGF bispecific ivonescimab, from Summit and Akeso Inc. Those data coincided with the kick-off of the American Society of Clinical Oncology (ASCO) meeting in Chicago, where almost a dozen companies were presenting readouts for another hot target, CLDN18.2. Evopoint is among the companies; its program recently attracted Astellas as a partner.
Meanwhile, the biopharma industry is racing to counter the White House’s most favored nation drug pricing strategy. BioCentury’s Washington analyst, Steve Usdin, explains the urgency and details some of industry’s options.

View full story: https://www.biocentury.com/article/656097

#biotech #biopharma #pharma #lifescience #deals

00:00 - Introduction
04:39 - Sanofi Buys Blueprint
09:22 - BMS-BioNTech
20:01 - Hot Targets
23:40 - Drug Pricing

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

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Dutch biotech Merus’ EGFR x LGR5 bispecific antibody has caught investors’ attention in the run-up to ASCO as a new approach to block EGFR signaling. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss Phase II data from Merus for petosemtamab as they preview the American Society of Clinical Oncology’s upcoming annual meeting. The analysts also assess a setback in a gene therapy trial for Rocket Pharmaceuticals, renewed interest in cancer target EpCAM, and a flurry of biopharma activity on the Hong Kong stock exchange. Finally, the team previews BioCentury’s second annual Grand Rounds R&D meeting, which takes place next week in Chicago. This episode was sponsored by Jeito Capital.

View full story: https://www.biocentury.com/article/656038

#biotech #biopharma #pharma #lifescience #RandD #DrugDevelopment

00:01 - Sponsor Message: Jeito Capital
24:52 - HK IPOs
07:12 - ASCO
16:37 - EpCAM
20:16 - Rocket

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Political and market turmoil has raised questions whether the U.S. can retain its biopharma leadership position, and in turn presents Europe with an opportunity to attract talent back to the continent with an offer of a more stable biomedical funding and regulatory environment. Jeito Capital’s Ksenija Pavletic and Cambridge Innovation Capital’s Anne Horgan join BioCentury’s analyst to wrap up the 25th annual Bio€quity Europe conference in Bruges, Belgium, by discussing their key takeaways from the two-day event. This episode was sponsored by Jeito Capital.

View full story: https://www.biocentury.com/article/655998

#biotech #biopharma #pharma #lifescience #networking

00:01 - Sponsor Message: Jeito Capital
02:10 - Key Takeaways
09:13 - Challenges and Opportunities for Europe
19:23 - Capital Efficiency and Success Stories
28:27 - Leadership, Teams & Talent

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The turbulence that has come with the Trump administration’s policies related to the U.S. biopharmaceutical industry is creating an opening for Europe to bolster its life sciences industry. On the latest BioCentury This Week podcast, BioCentury’s editors look at how Europe can capitalize on staffing cuts at FDA and NIH and an uncertain policy environment to lure back talent to bolster regulatory agencies and biotech R&D engines and attract assets and partners from China.
The editors also discuss two biotech deals driven by former leaders of BD at Roche, Biomarin's James Sabry and Sophie Kornowski at Boston Pharmaceuticals. Under the leadership of Sabry and CEO Alexander Hardy, Biomarin delivered its first takeout in a decade by acquiring Inozyme as it positions itself to take advantage of a regulatory and policy environment that they believe is favorable to their rare disease strategy. CEO Kornowski, meanwhile, executed on a plan to focus her company on a single liver disease asset that GSK acquired for $1.2 billion up front. Finally, BioCentury’s editors discuss the management shake-up at obesity company Novo Nordisk, where Lars Fruergaard Jørgensen, the leader who spearheaded Novo Nordisk’s transformation into a dominant player in obesity, is stepping down.
Chan Zuckerberg Chicago Biohub is hosting an exclusive, invite-only reception on June 3 — the eve of BioCentury's Grand Rounds conference — gathering top voices in biotech innovation and investment to exchange bold ideas, spark new collaborations and channel the energy of Chicago’s thriving innovation ecosystem. If you’re interested in attending, please register here. This episode was sponsored by Jeito Capital.

View full story: https://www.biocentury.com/article/655964

#biotech #biopharma #pharma #lifescience #politics #policy #law

00:01 - Sponsor Message: Jeito Capital
05:05 - European Biotech's Moment?
19:00 - Boston Pharma, Biomarin Deals
29:41 - Novo Nordisk CEO

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

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Biopharmas developing therapies for obesity are looking to a future where the quality of weight loss matters as much as the quantity — what targets and programs could help realize that vision? On the latest BioCentury This Week podcast, BioCentury’s editors discuss the signaling pathways that may exclusively target fat mass while preserving, or even increasing, lean mass — and which companies are playing in the space.
The editors also assess what Vinay Prasad’s past comments say about how he might lead FDA’s Center for Biologics Evaluation and Research (CBER) — and examine how investors are evaluating the possibility that he might move the bar for regulatory approvals. The team then introduces the first in a new BioCentury series, with a look at a Literature Dive into ovarian cancer “atlases” — large-scale molecular profiling studies that point to predictive signatures and patient stratification strategies. This episode was sponsored by Jeito Capital.

View full story: https://www.biocentury.com/article/655898

#biotech #biopharma #pharma #obesity #FDA #CBER #LifeScience #OvarianCancer

00:01 - Sponsor Message: Jeito Capital
03:22 - Obesity: Quality over Quantity
15:47 - Prasad at FDA
27:58 - Ovarian Cancer Atlases

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

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This year’s Bio€quity Europe conference — the 25th edition of the event — will focus on what’s next for Europe amid biotech’s current complex moment, Editor in Chief Simone Fishburn said on a special edition of the BioCentury This Week podcast previewing the meeting, which kicks off May 12 in Bruges, Belgium. McKinsey & Co.’s Alexandra Zemp and Henk Joos, an investment specialist at Medvia, which fosters health innovation in Flanders, joined BioCentury to discuss the state of Belgium’s biopharma ecosystem and preview some of the conference’s networking events, fireside chats and panel discussions. Claire Macht, portfolio director, Europe, of BioCentury’s conference partner EBD Group, also joined the podcast to detail what to expect in terms of one-on-one partnering meetings at the event.
Bio€quity Europe 2025 is sold out, but space on the waitlist remains, and digital passes are available. See the conference website for more information.

View full story: https://www.biocentury.com/article/655883

#biotech #biopharma #pharma #networking #LifeScience

00:00 - Introduction
01:25 - What's Next for Europe?
06:58 - Belgium's Biotech Ecosystem
10:29 - McKinsey on European Biotech
15:27 - Partnering, Panels of Note

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

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Among the formerly undruggable targets gaining translational momentum, SMARCA2 has intrigued researchers for its potential to treat challenging solid tumors. On the latest BioCentury This Week podcast, BioCentury's editors zero in on preclinical research supporting different degraders of SMARCA2 at this year’s American Association for Cancer Research (AACR) annual meeting.
They also discuss takeaways from Editor in Chief Simone Fishburn’s conversation with David Baker, the Nobel-prizewinning pioneer in protein design, and Steve Usdin reports that pharmaceutical industry executives are in a state of alarm over President Trump’s push to include a “most favored nation” policy for Medicaid drug purchases in budget reconciliation legislation. Usdin also discusses why industry executives are confident of a fix for the Inflation Reduction Act’s “pill penalty” and FDA Commissioner Marty Makary’s decision to reject proposals to reorganize the agency. This episode was sponsored by Jeito Capital.

View full story: https://www.biocentury.com/article/655851

#biotech #biopharma #pharma #LifeScience #RandD #DrugDevelopment #AACR #SMARCA2

00:01 - Sponsor Message: Jeito Capital
03:01 - AACR Spotlight
11:21 - David Baker Protein Design
19:12 - Trump's Drug Pricing Plan

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

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Belief in tau — both as a target and surrogate endpoint — for Alzheimer’s is building among leaders in the field. On the latest BioCentury This Week podcast, Executive Editor Selina Koch discusses how tau could be reaching a tipping point. Also on this week’s episode, Washington Editor Steve Usdin details how political moves have begun to intrude into the Trump administration’s regulation of vaccines, a topic that’s also taken up by Phil Krause and Luciana Borio in a BioCentury Guest Commentary published Monday. BioCentury’s editors then discuss delays for drug regulation at FDA, Merck KGaA's $3.9 billion deal to acquire Springworks, and why biotech IPOs could soon have a moment in Hong Kong. This episode of BioCentury This Week podcast is sponsored by RemeGen.

View full story: https://www.biocentury.com/article/655780

#biotech #biopharma #pharma #lifescience #alzheimers #RandD #DrugDevelopment #IPO

00:01 - Sponsor Message: RemeGen Co.
02:06 - Tau Time for Alzheimer's
13:10 - Vaccine Drama at FDA
23:32 - Merck KGaA's SpringWorks Buy
24:52 - Hong Kong Biotech IPOs

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Biopharma companies are vying to dethrone Vyvgart as a leading therapy for myasthenia gravis, with the latest data for therapies treating the rare autoimmune neuromuscular disease coming at this month’s American Academy of Neurology. On a special episode of the BioCentury This Week podcast, BioCentury’s editors discuss the landscape for MG therapies, including anti-BLyS and APRIL therapy telitacicept from Remegen. Joining BioCentury’s editors are Qing Zuraw, chief development officer of podcast sponsor RemeGen, and Amit Sachdev, PI on global trials of the biotech’s therapy. BioCentury’s editors also preview the American Association for Cancer Research annual meeting, where degraders and bispecifics are defining translational trends at this year’s event. This episode of BioCentury This Week podcast was sponsored by RemeGen.

View full story: https://www.biocentury.com/article/655751

#biotech #biopharma #pharma #lifescience #AAN #AACR

00:01 - Sponsor Message: RemeGen Co.
01:02 - Myasthenia Gravis at AAN
08:31 - RemeGen's Telitacicept
18:03 - AACR: Targets and Trends

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The academia-industry interface is more important than ever for sustaining biomedical innovation’s forward momentum, even as the Trump administration injects turbulence into academic funding for universities. On a special edition of the BioCentury This Week podcast, BioCentury’s Simone Fishburn and Karen Tkach Tuzman preview Grand Rounds, BioCentury’s second annual R&D conference, along with special guests.
Spots are filling up for the Grand Rounds U.S. Presenting Company Class of 2025. Find out how to apply here.

View full story: https://www.biocentury.com/article/655696

#biotech #biopharma #pharma #lifescience #academia #chicago #asco

00:00 - Introduction
01:42 - Key Themes and Featured Sessions
07:37 - Chicago's Role in Biotech Innovation
15:06 - McKinsey's Insights
25:18 - Upcoming Events and Networking Opportunities

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

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The biotech community is reeling, fearful and furious about the fallout of tariff, FDA and NIH policies, according to BioCentury’s newly released Risk Sentiment survey. On the latest BioCentury This Week podcast, BioCentury’s editors discuss takeaways from the survey, which polled 328 biopharma stakeholders during April 10-14. The editors dissect the latest from Washington, including comments from FDA Commissioner Marty Makary on a new pathway for ultrarare drugs and his plans to reform advisory committee meetings, as well as last week’s executive order on drug pricing. They also discuss how China’s biotechs may have cracked one of the key bottlenecks for both speeding up and de-risking early drug development — and what this means for U.S. biotech. This episode of BioCentury This Week podcast was sponsored by RemeGen.

View full story: https://www.biocentury.com/article/655690

#biotech #biopharma #pharma #lifescience #FDA #politics #policy #law

00:01 - Sponsor Message: RemeGen Co.
02:00 - Sentiment Survey
20:18 - Makary's FDA Plans
29:51 - China Speed

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FDA’s plan to move away from animal toxicity testing could expedite INDs and cut costs for biopharma companies, while helping the U.S. maintain its position as a clinical research hub. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the agency’s new three-year road map to reduce animal safety studies for mAbs. The editors then discuss the deepening morale crisis at FDA after HHS Secretary Robert F. Kennedy Jr. accused the agency of corruption, encouraged staff to report supervisors over approval decisions they oppose, and endorsed conspiracy theories about the “deep state.” They assess the impact of whipsawing tariff policies and turmoil at FDA on biotech indexes — and why the sky isn’t falling just yet for biotech’s specialist investors. The editors also highlight recent stories on base editors’ efficiency boom and how exosomes are finding new life. This episode of BioCentury This Week podcast was sponsored by RemeGen.

View full story: https://www.biocentury.com/article/655622

00:01 - Sponsor Message: RemeGen Co.
02:38 - Replacing Animal Models
09:40 - RFK Jr. & FDA
19:36 - NIH
30:02 - BioPharma Market Pulse
33:23 - Innovation Highlights

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Loss of leadership, cuts to staffing and a proposed reorganization at FDA have heightened biotech risk amid an already turbulent macroeconomic climate, according to BioCentury’s Washington editor Steve Usdin. On the latest BioCentury This Week podcast, BioCentury’s editors discuss how the turmoil at FDA could affect a sector already grappling with the uncertainty brought by the Trump administration’s trade war.
The editors also explore the growing pipeline of VEGF-targeted bispecifics in a preview of upcoming presentations at annual meeting for the American Association for Cancer Research (AACR). And they discuss how companies may once again need to lean on their bear market survival toolkit, as part of BioCentury’s 2Q25 Financial Markets Preview. This episode of BioCentury This Week was sponsored by RemeGen Co.

View full story: https://www.biocentury.com/article/655566

00:01 - Sponsor Message: RemeGen Co. 
01:19 - FDA and Tariffs Turmoil
16:54 - AACR Preview
20:44 - Bear Market Toolkit

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