BioCentury This Week

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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