BioCentury This Week

The $3 billion raised by biotechs in a series of follow-ons and PIPEs last week marked another strong showing for a sector seeking to outrun the bear market. On the latest BioCentury This Week podcast, BioCentury’s editors assess the state of fundraising for biotechs and their performance in the after-market. They also preview a forthcoming analysis of preclinical papers published in the Distillery, BioCentury’s coverage of translational science, describe the latest on anti-China bills in Congress and Inflation Reduction Act litigation, and discuss Closed Loop Medicine’s program that seeks to bring precision medicine to obesity.

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Asia’s emerging “Arc of Innovation” spans from China, Japan and South Korea through the turf-neutral gateway of Singapore and west to India, with the ecosystems of these countries contributing to the arsenal of therapeutics and diagnostics that benefit patients globally.
On a special edition of the BioCentury This Week podcast, Aslan’s Carl Firth, McKinsey’s Franck Le Deu and Wendy Pan of BayHelix and Goodwin join BioCentury on the eve of next week’s BioCentury-BayHelix Biopharma Summit in Singapore to discuss innovation across Asia, rising East-West deal flow and the opportunities and challenges faced by the region’s various biotech ecosystems. They also detail highlights among the speakers, panels and fireside chats of the three-day event.

Join BioCentury, BayHelix and McKinsey March 4-6 in Singapore or virtually for the third East-West Biopharma Summit.

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 Arch Venture Partners’ Bob Nelsen is excited about AI’s potential in biotech and convinced the U.S. healthcare system could do a far better job delivering on the promise of the biopharma industry’s innovations. On the latest BioCentury This Week podcast, BioCentury’s editors discuss takeaways from Nelsen’s appearance on The BioCentury Show, including how the longtime investor in China’s life sciences sector has adopted a more cautious stance on the country given increasing geopolitical tensions. BioCentury’s editors also discuss whether TL1A inhibitors are poised to bring precision medicine to large inflammatory and autoimmune indications, and why participants in a Feb. 21 Reagan-Udall Foundation workshop hope the meeting could help establish precedents that will revitalize the development of effective treatments for extremely rare diseases. 

Music for The East-West Biopharma Summit: Singapore teaser:
Composed by: Moa Michaeli
Produced by: Samuel Aneheim Ulvenäs, Albin Lewin, Epidemic Sound via Getty Images

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Off switches and non-viral delivery technologies may be the solution to CAR T therapies’ most recent safety problem. On the latest BioCentury This Week podcast, BioCentury’s editors discuss alternative CAR T technologies already in development that avoid or reduce the risk of secondary malignancy.
The editors also discuss the world-first approval of Iovance's tumor-infiltrating lymphocyte (TIL) therapy, highlights from BioCentury’s most recent survey of the translational literature in the Distillery, and the path to approval for Sarepta's Elevidys delandistrogene moxeparvovec, a gene therapy for Duchenne muscular dystrophy.

Music for The East-West Biopharma Summit: Singapore teaser:
Composed by: Moa Michaeli
Produced by: Samuel Aneheim Ulvenäs, Albin Lewin, Epidemic Sound via Getty Images

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Anti-China biotech bills are raising alarms at U.S. biotechs, with CEOs worried they could lose access to CDMOs WuXi AppTec and WuXi Biologics, and that legislation could imperil collaboration with Chinese companies more broadly. BIO has warned Congress the bills “would immediately and negatively” affect the U.S. biotech ecosystem. On this special edition of the BioCentury This Week podcast BioCentury Washington Editor Steve Usdin and colleagues discuss the pending legislation.

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Innate immunity is getting another shot at cancer through antibody-drug conjugates, with immunostimulatory antibody-drug conjugates moving from concept to clinical product. On the latest BioCentury This Week podcast, BioCentury’s editors discuss how the therapies work and what sets them apart from conventional ADCs.
The editors also survey the companies developing psychedelic therapies that aim to overcome the difficulties of the business model, and assess Gilead's $4.3 billion takeout of liver disease company CymaBay, and the performance of IPOs by genomic editing tools company Metagenomi and immunology company Kyverna.

Music for The East-West Biopharma Summit: Singapore teaser:
Composed by: Moa Michaeli
Produced by: Samuel Aneheim Ulvenäs, Albin Lewin, Epidemic Sound via Getty Images

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As it approaches a steep patent cliff, Bristol Myers is charting its course to bridge a transition period and return to growth. On the latest BioCentury This Week podcast, BioCentury’s editors assess the pharma’s pipeline and recent M&A, outlining the clinical and commercial successes the company needs to navigate the next few years.
The editors also discuss what’s behind bills in Washington that target four Chinese companies identified by Congress as “biotechnology companies of concern," the latest biotech IPOs, and the innovation behind last year’s biotech series A raisers.

Music for The East-West Biopharma Summit: Singapore teaser:
Composed by: Moa Michaeli
Produced by: Samuel Aneheim Ulvenäs, Albin Lewin, Epidemic Sound via Getty Images

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NASDAQ’s first biotech public listings of 2024 provided hopeful signs for a rebound in the biotech IPO market. On the latest BioCentury This Week podcast, BioCentury’s editors assess the performance of IPOs by CG Oncology and ArriVent and what’s next for the IPO market. They also discuss the growing IL-18 field, look ahead to the schizophrenia milestones coming this year, and size up the Singapore biotech ecosystem and what the country needs to do to cement a position on the global biotech map.

Music for The East-West Biopharma Summit: Singapore teaser:
Composed by: Moa Michaeli
Produced by: Samuel Aneheim Ulvenäs, Albin Lewin, Epidemic Sound via Getty Images

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Biotech investors are looking to catalysts that can create, or dramatically expand, commercial markets as they look ahead to a long-awaited recovery for industry. On the latest BioCentury This Week podcast, BioCentury’s editors assess the milestones on buysiders’ radar for 2024, including in areas such as obesity, pain and metabolic-associated steatohepatitis (MASH). They also discuss the influence of biopharma critic Arnold Ventures, a philanthropy that has reshaped the drug pricing public policy landscape; lung cancer data for Gilead's Trodelvy; and the week's expected biotech IPOs. 

Music for The East-West Biopharma Summit: Singapore teaser:
Composed by: Moa Michaeli
Produced by: Samuel Aneheim Ulvenäs, Albin Lewin, Epidemic Sound via Getty Images

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Investors and bankers are as upbeat about biotech’s prospects heading into 2024 as they have been since 2020, but maintaining the momentum that began building in 4Q23 is contingent on the Fed meeting expectations that it will ease interest rates. On the latest BioCentury This Week podcast, BioCentury’s editors assess the environment for financings and M&A in the year ahead. They also discuss Janet Woodcock’s legacy at FDA as she readies to step down at the end of the month and the latest developments in the abortion drug case.

Music for the 24th Bio€quity Europe teaser produced by:
Thomas de Paula Eby, Andreas Unge, Epidemic Sound via Getty Images

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Cautious optimism was the theme during a J.P. Morgan Healthcare Conference week that featured patchy skies, large-but-not-mega deals and a surfeit of sideline summits around San Francisco’s Union Square. BioCentury’s editorial team discusses the week’s M&A deals, including J&J's $2 billion takeout of ADC company Ambrx, and Merck & Co. acquiring T cell engager biotech Harpoon for nearly $700 million; takeaways from the Sachs Neuroscience Innovation Forum and other adjacent forums; and investor sentiment heading into the New Year.

Music for the 24th Bio€quity Europe teaser produced by:
Thomas de Paula Eby, Andreas Unge, Epidemic Sound via Getty Images

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A flurry of large acquisitions to close out 2023 is likely to carry into the New Year as pharmas continue to show appetite for late-stage assets. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the latest trends in biotech M&A, potential takeout targets for 2024 and the impact on dealmaking of a more aggressive FTC. They also assess sentiment heading into next week’s J.P. Morgan Healthcare Conference, analyze future drivers of innovation in biotech, and preview the year ahead in regulation and public policy.

Music for the 24th Bio€quity Europe teaser produced by:
Thomas de Paula Eby, Andreas Unge, Epidemic Sound via Getty Images

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Signals from the Fed that rate cuts are on the way rallied biotech indexes last week, but is the uptick more than a blip? On the latest BioCentury This Week podcast, BioCentury’s editors discuss how interest rate cuts could spur a risk-on rotation back into the sector by generalist investors, the possibility of biotech outperformance in 2024, and what it will take for the IPO window to open. They also assess progress demonstrated by companies’ with next-generation gene editors at this year’s American Society of Hematology (ASH) meeting, as well as BioCentury’s analysis of new targets at the conference. The editors also offer their picks for the highlights (and lowlights) of 2023 and predictions for what’s in store in the New Year.

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FDA’s decision to approve two gene therapies for sickle cell diseases could be transformative for patients, but both multimillion-dollar drugs will face access issues. On the latest BioCentury This Week podcast, BioCentury’s editors discuss what’s next for the companies, and for patients, following the approvals. The editors also analyze how AbbVie is restocking its pipeline via M&A, including its second multibillion deal in a week, a takeout of Cerevel, and why the acquisition is important beyond the pharma’s own portfolio. And Washington Editor Steve Usdin assesses BIO’s decision to name John Crowley as its new CEO and why the Biden administration’s new march-in policy is likely to affect very few drugs. 

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Biopharma’s latest pair of multibillion-dollar takeouts come in two of industry’s hottest areas: ADCs and obesity. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the move by Roche into obesity via its acquisition of Carmot Therapeutics and the winding journey of ADC company ImmunoGen to its $10.1 billion buyout by AbbVie. BioCentury’s editors discuss what FDA’s statement on the risk of T cell malignancy following BCMA- or CD19-directed CAR T cell therapy means for companies operating in the space.

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Radiopharmaceuticals have experienced a resurgence over the past decade, with a series of approvals, billion-dollar deals and growing sales. On the latest BioCentury This Week podcast, Director of Biopharma Intelligence Karen Tkach Tuzman previews her upcoming analysis of the space, discussing the multidimensional nature of the technology’s evolution, and the field’s next-wave targets behind PSMA and SSTR2. BioCentury’s editors also discuss the legacies of two U.S. lawmakers who won’t stand for re-election, Reps. Anna Eshoo (D-Calif.) and Michael Burgess (R-Texas); the latest move by BioNTech to grow its global footprint; and the November rise in the XBI.

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The world’s first approval of a CRISPR-based gene editing therapy, granted by the U.K.’s MHRA, was a milestone for the technology that was just discovered about 12 years ago. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the implications of the landmark and the challenges that still face partners Vertex Pharmaceuticals and CRISPR Therapeutics in launching and scaling the rollout of Casgevy exagamglogene autotemcel (exa-cel) in the U.K. and beyond. The editors also discuss the unintended consequences of the Inflation Reduction Act (IRA) on the development of orphan drugs and new legislation that aims to address the problem by providing an exemption to price negotiations for therapies that are approved only for orphan indications, regardless of how many. The team also reflects on the legacy of FDA’s Janet Woodcock ahead of her planned retirement next year; the sentiment coming out of last week’s Jefferies Healthcare Conference in London; and the aftermarket performance of two market debuts last week from antibody-drug conjugate CMO WuXi XDC Cayman and Mural Oncology.

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Verve achieved the first proof of concept for an in vivo base editing therapy, but investor concerns weighed on the company’s stock, clouding the readout’s reception. On the latest BioCentury This Week podcast, BioCentury’s editors dissect the data for VERVE-101 in heterozygous familial hypercholesterolemia and discuss how the choice of initial target and indication for a new modality or technology can have a major impact on how POC data are perceived by investors. The editors also assess the latest developments related to the Inflation Reduction Act and assess a selection of biopharma deals and IPOs.

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The controversy around Sarepta continues as the company’s executives were confident last week that the data from the Phase III EMBARK trial of Duchenne muscular dystrophy gene therapy Elevidys were enough to warrant full approval despite missing the study’s primary endpoint. On the latest BioCentury This Week podcast, BioCentury’s editors analyze the pitfalls facing FDA as the agency considers whether to apply regulatory flexibility in its decision-making and the impact its decision could have for patients and future therapies that are submitted to the agency with less than clear-cut positive data. The editors also discuss innovations around new endpoints and technologies for clinical trials and the tepid reception for the latest biotech IPO, the debut by Lexeo.

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The European Society for Medical Oncology (ESMO) had everything from practice changing Phase III data readouts to new solid tumor targets. On the latest BioCentury This Week podcast, BioCentury’s editors recap the biggest data presentations from last week’s annual ESMO meeting, including the impact of Phase III data for ADCs and bispecifics on the treatment landscape for tumors such as urothelial cancer and EGFR-mutant non-small cell lung cancer (NSCLC). The editors also discussed takeaways from the most recent progress in the confirmation of Monica Bertagnolli as director of the National Institutes of Health (NIH), and the latest step CMS has taken in implementing the Inflation Reduction Act (IRA). They also discussed Abingworth’s new $356 million co-investment fund, which, coupled with its 2021 vintage co-development fund, brings the VC firm’s firepower for investing in late-stage development programs to nearly $1 billion.

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Daiichi Sankyo has drawn more value from its antibody-drug conjugate pipeline via a $4 billion deal with Merck & Co. On the latest BioCentury This Week podcast, BioCentury’s editors analyze the deal in the context of the burgeoning ADC space and size up the assets that Merck is in-licensing as well as how the deal fits with Daiichi’s pipeline strategy.
The editors break down Monday’s $7.1 billion deal by Roche for the Telavant subsidiary of Roivant Sciences, the latest in the evolving TL1A space; and offer highlights from BioCentury’s deep dive into how academics and biotechs are expanding the therapeutic potential of base editors.

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BayHelix’s Guo-Liang Yu and McKinsey’s Josie Zhou join the BioCentury This Week podcast to discuss cross-border innovation and deal flow in the biopharma sector during a preview of the BioCentury-BayHelix China Healthcare Summit. The summit kicks off at a time of record cross-border deals and validating comments from the leaders of MNCs such as Pfizer, Novartis and Sanofi that innovation by China biopharmas is world class. The 10th annual BioCentury-BayHelix China Healthcare Summit is Nov. 2-3 in Shanghai. Digital passes are also available.

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Now that Vas Narasimhan has finished the major dismantling of Novartis, he’s turning his attention to fixing R&D. On the latest BioCentury This Week podcast, BioCentury’s editors discuss what’s next for the Swiss pharma now that Narasimhan has focused it down to what he calls a pure play innovative medicines company.
The editors also analyze the European Parliament’s proposed changes to the first major overhaul of European pharmaceutical law in 20 years, including suggested adjustments related to data exclusivity, orphan drugs and antimicrobials.
They also discuss what Novo Nordisk gains via a deal with Singapore’s KBP BioSciences and how the Inflation Reduction Act has prompted Relay Therapeutics to delay development of lirafugratinib (RLY-4008) to treat cholangiocarcinoma in favor of a larger indication

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BMS’s acquisition of Mirati for up to $5.8 billion not only gives the big pharma a potential best-in-class KRAS inhibitor in a field that appears to be opening up, but also a clinical program against one of the hottest targets in precision cancer, PRMT5. On the latest BioCentury This Week podcast, BioCentury’s editors discuss what Bristol Myers Squibb stands to gain from its acquisition of Mirati Therapeutics, which had rumors swirling about its potential takeout last week. 
BioCentury’s editors also discuss their 4Q23 Public Markets Preview, including how private biopharma companies looking to go public in the next 12 months should be managing their path to that transition. Following last week’s analysis of the companies leading the transition of CAR T therapies into the autoimmune space, BioCentury’s editors also touch on the targets and technologies coming up behind the leading programs that could expand use of CAR Ts to a wider set of autoimmune indications. 
They also discuss takeaways from ICER’s report on how CMS might approach drug price negotiation under the Inflation Reduction Act.

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Biopharma companies are moving quickly to figure out how to optimize CAR T cell therapies for autoimmune diseases now that it’s becoming clear the modality has clinical activity and possibly even curative potential in the disease area. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the trigger for this surge of interest, the indications, targets and companies in play and whether the technology can meet the higher safety bar in autoimmune indications.
BioCentury’s editors also discuss takeaways from BioCentury’s recent conversation with Sanofi CEO Paul Hudson; the latest developments for the Inflation Reduction Act; and notable biotech financings, including a $300 million private placement for Structure Therapeutics.

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BayHelix’s Guo-Liang Yu and McKinsey’s Olivier Leclerc join the BioCentury This Week podcast to discuss cross-border innovation and deal flow in the biopharma sector and preview the upcoming BioCentury-BayHelix East-West Summit. Yu discusses the importance of the event for BayHelix, and Leclerc previews McKinsey’s second East-West Summit report, which will focus on the impact of AI on the sector. BioCentury co-founder, President and CEO Dave Flores, Editor in Chief Simone Fishburn, and head of BD Josh Berlin also join the podcast to discuss the importance of globalization for biopharma and patients, the growth of cross-border dealmaking, and panel topics and speakers at the East-West Summit, which takes place Oct. 2-4 in Kendall Square.

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That a broad swath of new money flowed into last week’s IPOs by RayzeBio and Neumora is a good sign for biotech and a departure from deals done last year, BioCentury's Stephen Hansen said on the latest BioCentury This Week podcast. Hansen and colleagues assess the offerings and the companies’ aftermarket performance alongside NASDAQ’s six other top biotech IPOs of the year for signs of what’s next for companies looking to go public.
BioCentury’s editors also discuss what new regulatory requirements in China mean for Chinese biotechs hoping to debut on a stock exchange in the near future, as well as the latest developments in lawsuits related to the Inflation Reduction Act and an upcoming hearing on the IRA in the House.

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Constructing deal terms to take advantage of both the translational research benefits in China and the market opportunity in the U.S. is slowly emerging as a strategy to advance CAR T cell innovation. On the latest BioCentury This Week podcast, BioCentury’s editors discuss how deals for the technology have evolved since the 2017 partnership between Legend and Janssen for Carvykti and the opportunity for East-West collaborations to drive CAR T cell development.
BioCentury’s editors also assess why the FTC made a deal with Amgen that will allow the company’s $27.8 billion acquisition of Horizon Therapeutics to proceed, and how an agreement by Regeneron on international pricing of a COVID-19 mAb could clear the path to confirmation of Monica Bertagnolli as the next NIH director.

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What are the criteria that enable companies to achieve the kind of success that leads to a jump in market cap tier? On the latest BioCentury This Week podcast, BioCentury’s editors discuss Back to School 2023, which examines the ingredients for building long-term, sustainable, high-value biotech companies.

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Circular RNA’s durability could convey efficacy and manufacturing advantages over therapies based on linear mRNA. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the rising therapeutic modality, with a look at the technology, companies and investors in the space. They also assess the pipeline of psychedelic therapies as the product candidates move toward proof of concept, homing in on psilocybin-based product candidates, which are the most abundant and some of the most advanced. BioCentury Head of Business Development Josh Berlin joins the podcast to preview BioCentury’s upcoming conferences, the Oct. 2-4 BioCentury-BayHelix East West Summit in Cambridge, Mass., and the Nov. 2-3 China Healthcare Summit in Shanghai.

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There’s a tectonic shift happening in obesity research and drug development, BioCentury Editor in Chief Simone Fishburn said on the latest BioCentury This Week podcast. Fishburn and colleagues discuss how the success of obesity therapies from Novo Nordisk and Eli Lilly targeting the incretin axis has galvanized a wave of drug development with different molecular targets as well as last week’s threshold-setting cardiovascular outcomes trial data from Novo and recent obesity deals by the two companies.
BioCentury’s editors also discuss takeaways from Fishburn’s conversation with Flagship Pioneering’s Noubar Afeyan on The BioCentury Show, plus the Scleroderma Research Foundation’s plans to bring the platform trial model to scleroderma.

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A complete response letter from FDA in major depressive disorder could severely dent the commercial prospects for Zurzuvae zuranolone even as the drug gained approval for postpartum depression. On the latest BioCentury This Week podcast, BioCentury’s editors assess what the agency’s decision, which included a request for at least one additional study, means for Biogen and its partner Sage Therapeutics. BioCentury’s editors also discuss the thawing market for biotech IPOs, zeroing in on the dozens of companies that raised crossover cash before markets turned sour, as well as the digital transformation under way at Sanofi, which aims to use AI and data science to drive everything from candidate discovery to clinical trial planning, manufacturing optimization and supply chain management.

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An analysis of pharma deal trends over the past year shows a focus on first-in-class assets with autoimmune diseases being a major focus of interest. On the latest BioCentury This Week podcast, BioCentury’s editors discuss what the deal trends mean for prospective pharma partners and whether the expected focus on late-stage products, and a material increase in valuation for late-stage programs, is supported by the data. BioCentury’s editors also talk about a recent conversation with Genentech Inc. CEO Alexander Hardy, and his perspective on how the Inflation Reduction Act (IRA) may impact future decision-making on drug development for small molecules. They also discuss takeaways from a Q&A with Leerink Partners’ Jeffrey Leerink and Dan Dubin, what’s next in BIO’s hunt for a permanent CEO, and the case of Stealth BioTherapeutics Corp. and whether the company’s regulatory experience raises questions about if FDA should improve the consistency with which it applies regulatory flexibility.

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A hypertension deal with Roche will help Alnylam execute on its growth strategy of moving into more prevalent diseases. On the latest BioCentury This Week podcast, BioCentury’s editors discuss what the deal does for both companies and why plans for a cardiovascular outcomes trial (CVOT) before the launch of zilebesiran are critical for maximizing the program’s commercial opportunity.BioCentury’s editors also preview this week’s episode of The BioCentury Show, in which Washington Editor Steve Usdin speaks with Alkermes about the politics and policy environment around drug pricing and the Inflation Reduction Act and assess the latest developments in industry litigation against the IRA and new FTC guidelines on antitrust rules.

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With investors seeing the worst days fading into the rearview mirror, the sector has begun to chart a path out of the biotech bear market. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the indicators to watch for a recovery as described in the 3Q23 Financial Markets Preview. 
They also analyze the latest data from Alzheimer’s therapy donanemab from Eli Lilly, noting it sheds light on which patients stand to benefit from the therapy, and they discuss the pharma’s takeout of Versanis Bio to expand its obesity portfolio and improve the quality of weight loss it can achieve.

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Full approval of Leqembi lecanemab-irmb will unlock reimbursement and energize Alzheimer’s R&D, but the launch will be slow, said BioCentury Washington Editor Steve Usdin on the latest BioCentury This Week podcast. Usdin and colleagues break down the takeaways from BioCentury’s interview with Chris Viehbacher, CEO of Biogen, and discuss the challenges of launching a product for a disease that has until now been untreatable.
BioCentury’s editors also discussed the prospects for the IPO window in the second half now that the market for follow-on financings is showing signs of life, and the controversy surrounding Elevidys delandistrogene moxeparvovec, the gene therapy from Sarepta Therapeutics for Duchenne muscular dystrophy that Usdin argued in an Editor’s Commentary shows flaws in evidence generation and regulatory processes.

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FDA Commissioner Rob Califf’s biggest legacy could be his reform of FDA’s advisory committee process. But what is uncertain is whether his review can bring together enough consensus among agency leaders to drive a meaningful change, said Washington Editor Steve Usdin on the latest BioCentury This Week podcast. Usdin and colleagues discuss the areas of the U.S. regulator’s advisory committee process where there is — and isn’t — agreement on needed changes, and what could make this time different from a lengthy history of calls for change. BioCentury’s editors also preview an upcoming discussion with Polaris Partners’ Amy Schulman regarding why Singapore, the funding scene, and women in leadership. Usdin then discusses why reimbursing the recently approved DMD gene therapy from Sarepta Therapeutics through state Medicaid plans won’t be so simple.

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Emer Cooke may have already cemented her legacy as executive director of EMA through her leadership of the European regulator during the COVID-19 crisis. But she still faces a big task in navigating the agency through Europe’s new pharma legislation, said Washington Editor Steve Usdin on the latest BioCentury This Week podcast. 
Usdin and colleagues discuss a wide-ranging fireside chat held last week in Amsterdam with Cooke, including how the agency adapted post-Brexit and the differences that need to be appreciated between the European and U.S. regulators.
BioCentury’s editors also discuss the future of induced pluripotent stem cells (iPSCs) in cell therapies, a conversation with Forbion’s Wouter Joustra, a management buyout of SVB Securities, and why Senate Democrats are holding back on confirming a new NIH director.

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A lawsuit over the Inflation Reduction Act by Merck & Co. suit signals to Republicans that the pharma has no compunctions about attacking Democrats, the Biden administration and the president himself, said BioCentury Washington Editor Steve Usdin on the latest BioCentury This Week podcast. Usdin and colleague discussed the significance of the move by Merck, its likelihood of success and why the pharma chose its combative tone for the first lawsuit challenging the Medicare drug price-setting provisions of the IRA.
BioCentury’s editors also assessed remarks at the BIO convention by FDA Commissioner Rob Califf related to the accelerated approval pathway, takeaways from Friday’s FDA panel on Alzheimer’s drug Leqembi and data presented at the American Society of Clinical Oncology annual meeting for multicancer early detection tests. This week’s podcast is sponsored by Cancer Research Horizons.

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ASCO’s kickoff included blunt comments from two CEOs who said the IRA is causing their companies to delay launches of cancer drugs for smaller indications, BioCentury Washington Editor Steve Usdin said on the latest BioCentury This Week podcast. Usdin and his BioCentury colleagues discussed remarks at the American Society of Clinical Oncology conference by Novartis' Vasant Narasimhan and Genentech's Alexander Hardy regarding how the Inflation Reduction Act is forcing the companies to make difficult decisions regarding their pipelines and patients’ access to their therapies.
The podcast team also assessed highlights from ASCO’s data presentations, including antibody-drug conjugate readouts from partners AstraZeneca and Daiichi Sankyo, and Kelun Pharmaceutical and Merck & Co., as well as the emergence of Alkeus, which has attracted $150 million in series B money for its Stargardt program and Joshua Boger to its executive chairman position. This week’s podcast is sponsored by Cancer Research Horizons.

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Two Phase I checkpoint inhibitor readouts due at ASCO 2023 are bringing excitement back to immuno-oncology, said BioCentury’s Lauren Martz on the latest BioCentury This Week podcast. Martz and her editorial team colleagues discuss what stands out about the data for LAG3 inhibitor fianlimab from Regeneron and anti-TIGIT mAb tiragolumab from Genentech.
The editors also break down takeaways from BioCentury's conversation on precision neuropsychiatry with Husseini Manji, co-chair of the U.K. Mental Health Mission, and assess BIO’s call for CMS to provide more clarity about its plans for implementing provisions in the Inflation Reduction Act that give some small biotechs a temporary exemption from Medicare drug price negotiation. This week’s podcast is sponsored by Cancer Research Horizons.

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If FDA approves Sarepta's gene therapy for Duchenne muscular dystrophy, patients will soon face the difficult choice between taking this treatment or waiting for a better option among the “unprecedented” amount of innovation ahead in DMD, as taking both may not be an option, BioCentury Executive Director Lauren Martz said on the latest BioCentury This Week podcast. Martz and colleagues assess the landscape for DMD gene therapies ahead of the May 29 PDUFA date for delandistrogene moxeparvovec.
Also on the show, BioCentury Washington Editor Steve Usdin discusses takeaways from his conversation with FDA's Peter Marks; three tasks for Monica Bertagnolli to prioritize at NIH; and what the debt ceiling means for the life sciences. And on the heels of Bio€quity Europe, Editor in Chief Simone Fishburn delivers her insights from BioCentury’s European conference.
This week’s podcast is sponsored by Cancer Research Horizons.

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As biotechs continue to find their footing in the new normal of capital scarcity, the industry is beginning to see “green shoots” in M&A activity and preclinical deals, Ysios Capital’s Guillem Laporta said on a special edition of the BioCentury This Week podcast featuring takeaways from the 2023 Bio€quity Europe conference in Dublin. In conversation with BioCentury and Gilde Healthcare’s Joep Muijrers, Laporta described a fundraising environment where disruptive, innovative companies are continuing to get funded. The group also discussed Gilde’s plans for deploying its recent record VC fund, Ysios portfolio company Mineralys’ successful NASDAQ IPO and next year’s Bio€quity Europe conference, scheduled for May 2024 in San Sebastián, Spain.

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For many private European biotechs, flat or down valuations have become the new normal as they struggle to raise money despite having quality science, +ND Capital’s Dani Bach said on a special edition of the BioCentury This Week podcast featuring takeaways from the 2023 Bio€quity Europe conference in Dublin. Investors, he said, are flocking to a handful of outsize fundraising rounds out of fear. In conversation Monday with Jeff Cranmer and Stephen Hansen of BioCentury and Poolbeg’s Jeremy Skillington, Bach described a bipolar fundraising environment in which the “bulk of companies are struggling for money and a few are getting massive amounts of money even beyond their wild expectations.” Bach, Skillington and BioCentury's editors also discuss Ireland's burgeoning biotech ecosystem, Europe's biopharma hubs and the performance of U.K.'s biotechs listed on the London Stock Exchange. This episode is sponsored by Jeito Capital.

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This year’s Bio€quity Europe conference aims to define what European biotech’s “playbook for success” should be in the industry’s “new normal,” BioCentury co-founder, President and CEO David Flores said on a special edition of the BioCentury This Week podcast previewing the twenty-third incarnation of the May 14-16 meeting in Dublin. Seroba Life Sciences’ Alan O'Connell and Avectas' Mary Martin joined Flores and BioCentury Editor-in-Chief Simone Fishburn to outline the opportunities and challenges faced by Ireland’s biopharma ecosystem and preview some of the conference’s events and panel discussions, and EBD's Tina Elder detailed what to expect in terms of attendees at the event.

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Acelyrin last week parlayed a late-stage asset for hidradenitis suppurativa and veteran leadership into one of biotech’s largest-ever NASDAQ IPOs. On the latest BioCentury This Week podcast, BioCentury’s editors discussed how Acelyrin generated outsized demand for its offering and assessed Alzheimer’s data for Eli Lilly's donanemab, the promise and challenges of digital endpoints and takeaways from the latest BioCentury Show, which featured incoming FogPharma CEO Mathai Mammen in conversation with Editor in Chief Simone Fishburn. This week’s podcast is sponsored by Cancer Research Horizons.

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Biopharma companies believe a draft law that seeks to overhaul European pharmaceutical policy for the first time in years is out of sync with innovation, Washington Editor Steve Usdin said on the latest BioCentury This Week. Usdin and colleagues assessed the EC’s proposals in the legislation, as well as what’s changed since a version of the draft was leaked earlier this year. BioCentury’s editors also discussed the implications of FDA’s acceptance of NfL as a surrogate endpoint for amyotrophic lateral sclerosis for companies with clinical neurodegeneration programs, plus the $5.9 billion takeout of geographic atrophy company Iveric bio by Astellas, and a deal by Sanofi to license rights to a Pompe therapy from Maze Therapeutics.

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Top-tier European VCs are still attracting capital to deploy, Director of Biopharma Intelligence Stephen Hansen said on the latest BioCentury This Week podcast, with LPs looking at funds’ track record and the track record for biotech. Hansen discusses how Forbion and Gilde will deploy their newly announced funds as well as what’s new in their strategies as they raise some of the biggest VC vehicles ever in Europe. BioCentury’s editors also discuss the U.S. Supreme Court’s mifepristone ruling and comments filed by the biopharma industry about CMS’s draft guidance on implementing the Inflation Reduction Act.

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BioCentury’s analysis of AACR 2023 abstracts found new targets light on immuno-oncology, said Executive Director Lauren Martz on a special edition of the BioCentury This Week podcast. Martz and colleagues debated whether the findings suggest immuno-oncology is losing its luster, and assessed abstracts on next-generation PRMT5 inhibitors and first-in-human studies, as well as the latest data from Merck & Co. and Moderna on their neoantigen vaccine in melanoma.

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M&A such as Monday’s proposed takeout of Prometheus by Merck & Co. is one of the few factors that can help reverse the negative sentiment hanging over biotech, Director of Biopharma Intelligence Stephen Hansen said on the latest BioCentury This Week podcast. Hansen and colleagues discuss Monday’s deal in the context of the prolonged market downturn as they assess the takeaways from BioCentury’s 2Q23 Financial Markets Preview. BioCentury’s editors also discuss the implications for FDA of court rulings on abortion drug mifepristone and how Gilead is building its oncology franchise.

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