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 - PI Amit Sachdev
13:55 - Insights from RemeGen's Qing Zuraw
18:03 - AACR: Targets and Trends

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

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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

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

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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

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

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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

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

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Biotech indexes are tumbling after one of FDA’s last veteran leaders was pushed out by HHS Secretary RFK Jr. and the threat of tariffs weigh on a key biotech index. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the factors driving down the XBI, which has now crossed into bear market territory and the latest turmoil at FDA, now that CBER Director Peter Marks has been ousted. Plus, inflammation and immunology companies are finding ways beyond precision medicine to boost responses. BioCentury’s editors assess one approach — bispecific antibodies that block two inflammatory pathways instead of one.

View full story: https://www.biocentury.com/article/655488

00:00 - Introduction
00:51 - XBI's Return to the Bear Market
11:26 - Marks Ouster & Turmoil at FDA
18:07 - Bispecifics for I&I

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

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European venture firm Sofinnova Partners is expanding the reach of its Biovelocita accelerator beyond Italy to stretch across the greater continent. On the latest BioCentury This Week podcast, BioCentury’s editors discuss how Biovelocita became the largest life sciences accelerator in Europe. The editors also discuss Novo Nordisk's latest addition to its obesity pipeline via a deal in China, and how the partnership reflects the state of cross-border dealmaking more broadly. And Washington Editor Steve Usdin assesses President Trump’s threat to impose 25% tariffs on pharmaceutical imports and provides an update on how FDA’s staff is navigating the policies of the new administration. Finally, Editor in Chief Simone Fishburn discusses BioCentury's upcoming Grand Rounds meetings.

View full story: https://www.biocentury.com/article/655438

00:00 - Introduction
02:25 - Sofinnova’s Pan-European Accelerator
08:27 - China Biotechs
14:59 - Trump Tariffs

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

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BIO is engaging with President Donald Trump to protect and improve FDA. It’s also hoping biopharmas can dodge tariffs and find paths to modify the Inflation Reduction Act and reinstate pediatric priority review vouchers. On the latest BioCentury This Week podcast, Washington Editor Steve Usdin delivers takeaways from his conversation with John Crowley, CEO of the industry trade group.
BioCentury’s editors also discuss how autoimmune CAR T companies are competing for resources and the end-to-end radiopharma ambitions of Telix Pharmaceuticals. A 2023 landscape on the radiopharma space can be found here.

View full story: https://www.biocentury.com/article/655370

00:00 - Introduction
02:09 - BIO's Trump 2.0 Plan
14:00 - Autoimmune CAR Ts
21:05 - Telix's Radiopharma Play

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

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While the culling of companies in the biotech bear market may have yet to subside, creative cross-border deal-making on innovative assets is spreading across Asia’s Arc of Innovation. Sciwind Biosciences Co. Ltd.’s Jing Shu and A*Star’s Lisa Ooi join BioCentury to wrap up the 4th annual BioCentury-BayHelix East-West Biopharma Summit in Singapore by discussing deal-making trends, the rise of new technologies and the deepening of biotech ecosystems from India to Japan.

View full story: https://www.biocentury.com/article/655318

00:00 - Introduction
01:58 - Key Takeaways
08:42 - Innovation in Japan and India
12:54 - Building Biotech Ecosystems
31:14 - NewCo Model

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

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The almost certain confirmation of Marty Makary as FDA commissioner this month will cap a transition marked by internal upheaval and political infighting. On the latest BioCentury This Week podcast, BioCentury’s editors discuss Thursday’s confirmation hearing for President Donald Trump’s pick to lead the agency and Makary's hints at what we can expect from his agenda.
The editors also discuss whether the advantages of amylin agonists could help the therapies outshine GLP-1 in obesity, why the latest weight loss data from CagriSema weighed on shares of Novo Nordisk, and a call to deliver on the meritocracy ideal, now that DEI is dead.

View full story: https://www.biocentury.com/article/655302

00:00 - Introduction
01:10 - Makary’s FDA Agenda
10:50 - Amylin in Obesity
24:21 - Life After DEI

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

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The track record of biotechs launched to create curative therapies using CRISPR-Cas9 provides new insights into the old debate over whether platform companies should validate their technology on established targets or pursue new ones. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the lessons learned by this small group of companies since their launch a decade ago. They also discuss the entrance of AbbVie into the obesity race via a $350 million deal with Gubra for a clinical stage amylin agonist — does it signal AbbVie’s belief in amylin monotherapy, or will the company be hunting for more obesity assets? The editors also talk about recommendations to streamline the early-stage development of rare disease therapies in the U.S.

View full story: https://www.biocentury.com/article/655214

00:00 - Introduction
00:36 - CRISPR Companies
09:22 - AbbVie Enters Obesity Race
17:19 - Rare Disease Drug Challenges

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

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Once pharma’s oncology powerhouse, Roche is charting a new course that extends beyond its traditional stronghold in cancer therapeutics. On the latest BioCentury This Week podcast, BioCentury’s editors discuss how the Swiss pharma has reshaped its strategy for long-term growth. They also discuss another tumultuous weekend for staff at FDA and NIH, as well as the challenges of precision medicine for psychiatric conditions.

View full story: https://www.biocentury.com/article/655157

00:00 - Introduction
00:45 - Roche Reboot
08:47 - Precision Medicine in Psychiatry
13:07 - 5 Things on Trump 2.0

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

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Rather than fretting over increasing competition from Chinese life sciences companies, biotechs in the U.S. should rise to the challenge and learn from their competitors. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the increasing pace of innovation from China and how U.S. biotechs need to meet the moment, delivering key takeaways from Editor in Chief Simone Fishburn’s fireside chat with industry leader John Maraganore at the BIO CEO & Investor Forum in New York last week. The team also discusses the fallout from staffing cuts at FDA — severely damaged morale among remaining staff and the potential for a higher approval bar, among others — leadership at the agency and the state of biotech IPOs on NASDAQ and in Korea.

View full story: https://www.biocentury.com/article/655112

00:00 - Introduction
00:58 - Competing with China
14:13 - FDA, NIH Staff Cuts
20:16 - Biotech IPOs 

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

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Western VCs are paying more attention than ever to innovation emerging from Asia — from antibody-drug conjugates to bispecifics, AI and beyond — as the NewCo Model becomes the latest trend to bridge talent, assets and venture money across the Pacific and on to North America and Europe. On a special edition of BioCentury This Week podcast, a trio of leaders from Asia’s life sciences ecosystem — Khoo Shih of Singaporean investor ClavystBio, McKinsey & Company’s Anirudh Roy Popli and Wendy Pan of Goodwin and BayHelix — join the BioCentury team to set the stage for the fourth BioCentury-BayHelix East-West Biopharma Summit. They discuss the innovations driving the deal flow from East to West, including the creation of start-ups in the West formed around assets from Asia. The summit takes place March 3-5 in Singapore.

View full story: https://www.biocentury.com/article/655108

00:00 - Introduction
04:49 - The Newco Model and Industry Trends
09:13 - BayHelix and Cross-Border Transactions
11:31 - McKinsey's Perspective on Asian Innovation
26:58 - Final Thoughts and Registration Information

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

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White House plans to slash FDA and NIH risk decimating two agencies at the core of U.S. biomedical innovation. On the latest BioCentury This Week podcast, BioCentury’s editors assess draft plans by the Trump administration that seek to halve FDA staff, cut NIH, and reduce overhead payments to academic institutions. The policy addressed in a recent Guest Commentary for BioCentury, “Defending the NIH, the NSF and the foundation of American science,” by the Scleroderma Research Foundation’s Luke Evnin, Peter Rubin of No Patient Left Behind, and Ra Capital’s Peter Kolchinsky.
BioCentury’s team also discusses how biotechs are becoming increasingly successful at navigating the obstacles to get precision therapies across the FDA finish line.

View full story: https://www.biocentury.com/article/655034

00:00 - Introduction
00:59 - FDA, NIH & Trump 2.0
16:26 - Biotechs & Precision Medicine

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

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The boom in the creation of companies that were launched in the West based on assets sourced in Asia signals China’s galloping speed of innovation. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the “NewCo Model,” who the players are, from CEOs and companies to investors; the areas of innovation the start-ups are tackling; and the evolution of the trend. (Read about the company that kicked off the trend, Arrivent, here.)
The editors also assess how personnel losses at FDA from the Trump administration’s plans to slash government payrolls are likely to cause short- and long-term harm for the agency and the drug approval process. And a new pain therapy from Vertex is in the spotlight as the CF specialist enters new turf.

View full story: https://www.biocentury.com/article/654946

00:00 - Introduction
01:20 - Asia's NewCo Model
16:22 - FDA Tipping Point
20:27 - Vertex's Pain Drug

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

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Psychiatric drug development has had major wins over the past year-and-a-half — think Karuna Pharmaceuticals' $14 billion takeout by Bristol Myers Squibb and the subsequent launch of a new schizophrenia therapy — but targeted neuropsychiatric drug development is still in its infancy. On a special edition of the BioCentury This Week podcast, BioCentury’s editors detail the promise of precision medicine in the space and break down what recent setbacks for key players mean for next steps in the clinic. The team is joined by special guest Peter Schueler, SVP of drug development solutions, neurosciences, at ICON, who delivers takeaways from this month’s the ECNP Roadmap Meeting on Precision Psychiatry in Frankfurt and a recent white paper by ICON. This episode of BioCentury This Week was sponsored by ICON Biotech.

View full story: https://www.biocentury.com/article/654903

00:01 - Sponsor Message: ICON Biotech
02:20 - Precision Neuropsychiatry
06:39 - Insights from ICON's Peter Schueler
15:59 - Challenges in Neuropsych

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

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BioCentury’s analysis of the technologies behind last year’s biotech series A raisers sees progress in nanoparticles, CAR cell therapies, degraders and antibody-drug conjugates. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the trends spotted in 2024’s crop of more than 150 series A rounds — from top therapeutic areas and modalities to the leading investors funding the innovation.
The editors turn to Washington for takeaways from BioCentury’s “exit interview” with Patrizia Cavazzoni, the recently departed director of FDA’s Center for Drug Evaluation and Research, and checks in on FDA and NIH’s turbulent transition under Trump 2.0.
Finally, the podcast team previews BioCentury’s upcoming fourth East-West Summit, which will focus on globalizing Asia innovation and the red-hot “Newco Model” in Singapore March 3-5, and the twenty-fifth Bio€quity Europe, which will be held in Belgium in May. This episode of BioCentury This Week was sponsored by ICON Biotech.

View full story: https://www.biocentury.com/article/654837

00:01 - Sponsor Message: ICON Biotech
01:57 - Series As: Trends in Innovation
12:18 - BioCentury Conferences Preview
18:45 - Insights from FDA's Cavazzoni
21:58 - Turbulence at FDA, NIH

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

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With political uncertainty overshadowing market sentiment going into 2025, BioCentury’s editorial team assesses the bull and bear arguments for biotech in the New Year on the BioCentury This Week podcast’s Public Markets Preview. Will continued uncertainty drive biotech sentiment in the coming months, or will the bear arguments fail to manifest, stymied by M&A and other positive factors?
In the second part of the 2025 Preview, BioCentury’s editors highlight some of the key catalysts in bispecifics, immunology and inflammatory (I&I), new modalities, and neurology and obesity they are watching in the year ahead. Finally, the editors discuss how VC firms focused on AI-driven drug development are thinking about the resources and strategies needed to turn promise into reality. This episode of BioCentury This Week was sponsored by ICON Biotech.

View full story: https://www.biocentury.com/article/654772

00:01 - Sponsor Message: ICON Biotech
02:33 - Market Uncertainty
12:50 - Biotech Catalysts
21:12 - Obesity
22:57 - Neurology
28:54 - AI: VC Perspectives

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

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Sunshine and a stream of deals brightened the mood at this year’s J.P. Morgan Healthcare Conference, offering a pleasant counterpoint to continued pessimism over the state of the capital markets. On the latest BioCentury This Week podcast, BioCentury’s editors deliver their takeaways from biotech’s annual kick-off event from megarounds and Asian newcos to the new state of M&A and pending change at FDA.

View full story: https://www.biocentury.com/article/654723

00:00 - Introduction
01:52 - Market Sentiments and Deal Expectations
04:42 - Cross-Border Deals and Asia's Growing Influence
07:12 - Neurology and Innovation in Biotech
14:44 - VC Trends and Megarounds
20:00 - Upcoming East West Singapore

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

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J&J’s $14.6 billion takeout of neurology play Intra-cellular Therapies headlined a buzzy start to the J.P. Morgan Healthcare Conference, where a flurry of deal announcements recalled the conference’s pre-pandemic days. On the latest BioCentury This Week podcast, BioCentury's editors discuss the takeout of Intra-cellular, the third 11-digit neuro M&A in the past 13 months, as well as M&A involving Idrx and GSK, and Scorpion Therapeutics and Eli Lilly. Turning to Washington, the team explores what’s behind BIO CEO John Crowley’s visit to Mar-a-Lago to meet with President-elect Donald Trump, impending changes at FDA under Trump 2.0 and key takeaways from Rep. Jake Auchincloss appearance on BCTW’s sister podcast, The BioCentury Show. The team also breaks down the key trends in the past year in FDA approvals. This episode of BioCentury This Week was sponsored by ICON Biotech.

View full story: https://www.biocentury.com/article/654694

00:01 - Sponsor Message: ICON Biotech
02:38 - JPM Deal Buzz
11:20 - Washington Update
16:08 - Rep. Auchincloss’ Take on Biopharma
21:01 - FDA Regulatory Decisions

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

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Can biotech break free of the macro factors that have buffeted the industry of late? On the first BioCentury This Week podcast of 2025, BioCentury’s editors offer their predictions for the New Year and — exploring the themes from Simone Fishburn’s latest Letter from the Editor — ask whether biotech can overcome the financing environment, policy concerns and geopolitical tension that have been hammering the industry to deliver on the meaningful strides companies have been taking to deliver innovations to patients.
Plus, Washington Editor Steve Usdin discusses what U.S. policymakers need to do now in the wake of a year’s worth of wrangling over the Biosecure Act, and Executive Editor Selina Koch breaks down readouts from Neumora on its KOR antagonist navacaprant to treat major depressive disorder and Axsome Therapeutics for its AXS-05 to treat agitation in Alzheimer’s patients. This episode of BioCentury This Week was sponsored by ICON Biotech.

View full story: https://www.biocentury.com/article/654620

00:01 - Sponsor Message: ICON Biotech
01:51 - Biotech's Repeating Challenges
10:52 - Biotech in the New Year
23:07 - Beyond Biosecure
28:10 - Neurology Readouts

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

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Preview: In his five decades at FDA, Robert “Bob” Temple helped revolutionize the ways medical products are developed and regulated. On the latest BioCentury This Week podcast, Washington Editor Steve Usdin reflects on the legacy of Temple. Temple, who is retiring, crafted the modern clinical trial paradigm, created the accelerated approval pathway, and set precedents for incorporating patient perspectives in regulatory decisions. Usdin also discusses the opportunities and threats for the agency under Trump 2.0.BioCentury's editors also discuss China’s academic innovation, arguing that a wave of new target biology is now coming from Chinese university labs and the underwhelming results from CagriSema’s latest readout. Phase III data for the most important weight loss candidate from  Novo Nordisk A/S (CSE:NOVO-B; NYSE:NVO) failed to differentiate the product from Eli Lilly's Zepbound.

View full story:https://www.biocentury.com/article/654574/temple-s-fda-legacy-plus-chinese-innovation-novo-obesity-data-a-biocentury-podcast

00:00 - Introduction
02:03 - Bob Temple's Legacy
16:13 - China's Academic Innovation
26:20 - CagriSema Obesity Data

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

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With most of the highly attractive late-stage assets already scooped up, pharmas are turning their sights to Phase II companies, and lining up their case to make an attractive offer and move fast. About 40% of the M&A deals in 2023-24 were completed in less than six weeks, from approach to announcement, according to Lazard’s data. Michael Kingston and Dale Raine, global co-heads of biopharma at Lazard, joined The BioCentury Show this week to discuss the M&A outlook amid the still-precarious biotech financing landscape.

The BioCentury Show, featuring BioCentury one-on-one with an industry KOL, is available on Apple, Spotify and wherever you listen to your favorite podcasts and in video podcast format on BioCentury’s YouTube channel.

View full story: https://www.biocentury.com/article/653858

00:00 - Introduction
03:01 - Capital Markets Outlook
06:01 - M&A
15:19 - Breaking Down Deals
24:29 - Asia

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

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Lately, it appears some biotech VCs have hit a ceiling, capping their new funds at or below the amount of their previous vehicles, says Paul Bonanos on the latest BioCentury This Week. Bonanos and his BioCentury editorial colleagues discuss what’s behind the trend as they assess VC fundraising in this post-‘supercycle’ era. The editors also evaluate the state of play for venture-backed obesity plays and which VCs are active in the space, as well as takeaways from the latest BioCentury Show podcast featuring Aoife Brennan, CEO of Climb Bio. Finally, the team features the new book from long-time biotech executive and current SV Health Investors partner Tim Harris, In Pursuit of Unicorns: A Journey through 50 Years of Biotechnology.

View full story: https://www.biocentury.com/article/654488

00:00 - Introduction
02:08 - Trends in VC Funds
12:16 - Obesity Start-ups
19:46 - The BioCentury Show with Aoife Brennan
26:50 - Tim Harris' New Book: In Pursuit of Unicorns

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

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