BioCentury This Week

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...

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. I...

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...

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 takeaway...

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...

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 vehicle...

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 M...

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 BioCent...

The ruling on abortion drug mifepristone issued Friday by Texas District Judge Matthew Kacsmaryk could destabilize drug regulation, opening up every FDA approval to second guessing by any court in the U.S., Washington Editor Steve Usdin said on the latest BioCentury This Week podcast. Usdin assesses the implications of the decision and sheds light on the thinking of former senior FDA attorneys reg...

On the latest BioCentury This Week podcast, BioCentury’s editors assess the implications of the FTC’s challenge to the $7.1 billion acquisition of cancer screening company Grail by next-generation sequencing company Illumina. They also discuss what’s at stake as the U.S. Supreme Court weighs arguments in the patent dispute over anti-PCSK9 mAbs between Sanofi and Amgen, and how CEOs of gene therapy...

On the latest BioCentury This Week podcast, BioCentury’s editors assess responses to their VC survey regarding the collapse of Silicon Valley Bank in light of First Citizens’ acquisition of SVB. BioCentury’s editors also discuss how FDA’s advisory committee meeting for tofersen from Biogen and Ionis bolsters the case for neurofilament as a surrogate endpoint in amyotrophic lateral sclerosis, and w...

 On the latest BioCentury This Week podcast, BioCentury’s editors assess how companies are upending pipeline and business strategies due to the Inflation Reduction Act, along with other takeaways from a survey on the IRA’s implications, conducted by BioCentury with the support of BIO. They also discuss CMS’s memo outlining how it intends to implement the IRA’s price-setting provisions, the T cell...

On a special edition of the BioCentury This Week podcast, Editor in Chief Simone Fishburn and Director of Biopharma Intelligence Stephen Hansen assess the priorities for VCs and their portfolio companies in the immediate aftermath of the collapse of Silicon Valley Bank. They also discuss the gap left in the biotech ecosystem given SVB’s unique relationship with VCs and small companies, and what th...

On the latest BioCentury This Week podcast, BioCentury’s editors assess the fallout from the collapse of SVB and the sale of SVB UK to HSBC. BioCentury’s editors also discuss the proposed $43 billion acquisition of Seagen by Pfizer, takeaways from CDER Director Patrizia Cavazzoni’s conversation with Washington Editor Steve Usdin on The BioCentury Show and Editor in Chief Simone Fishburn’s call for...

On the latest episode of the BioCentury This Week podcast, BioCentury’s editors assess the challenges and opportunities facing Christopher Viehbacher as he begins to implement his vision for Biogen. The team also analyzes the state of play among NK cell therapy companies and discusses highlights from BioCentury’s Emerging Company Profile of Paratus Sciences Corp., a well-funded biotech being built...

Leaked drafts of legislation overhauling Europe’s pharmaceutical laws are causing consternation at biopharma companies. BioCentury’s editors discuss how the revised framework could cut IP protections and why any benefits from the legislation are not sufficient to attract investment to Europe. They also discuss the potential implications of an imminent ruling in a Texas lawsuit challenging FDA’s ap...

On the latest BioCentury This Week podcast, BioCentury’s editors discuss what the latest payment models from CMS could mean for cell and gene therapies, and how a new model could incentivize the completion of confirmatory trials for drugs with accelerated approval. BioCentury's editors also discuss the outlook for China's public markets and details around the genetic medicine delivery te...

Last week’s Oncologic Drugs Advisory Committee meeting to discuss PD-1 inhibitor Jemperli offered insights into new endpoints, single-arm studies and the future of FDA advisory committee panels. On the latest BioCentury This Week podcast, BioCentury’s editors assess how GSK's standout dataset in a rare form of rectal cancer could qualify the program for exceptions to FDA’s standard practices...

Via new guidance and its Project Optimus, FDA is pushing companies to do dose-optimization studies instead of maximum-tolerated dose studies, BioCentury Executive Director Lauren Martz said on the latest BioCentury This Week podcast. Martz and colleagues discuss the burdens and benefits of the shift, in particular for biotechs. BioCentury’s editors also assess new challenges and opportunities for...

BIO’s push for FDA to be more flexible on accelerated approval requirements is unlikely to resonate at the agency, Washington Editor Steve Usdin said on the latest BioCentury This Week podcast. Usdin explains why BIO is concerned about the “erosion” of accelerated approval as FDA considers whether requiring confirmatory trials to be under way at the time of approval should be the default policy. H...

New manufacturing systems for CAR Ts aren’t just about speed, Executive Director for Biopharma Intelligence Lauren Martz said on the latest BioCentury This Week podcast. Martz and colleagues discuss the safety, efficacy and access benefits from rapid manufacturing platforms, and how these systems are set to change the way CAR T cells are delivered to patients. BioCentury’s editors also analyze the...

Investors broadly agree that biotech indexes won’t revisit the lows seen last year, but they’ll need their portfolio companies to survive until the industry begins its comeback, said Director of Biopharma Intelligence Stephen Hansen on the latest BioCentury This Week podcast. Discussing key takeaways from BioCentury’s 2023 Financial Markets Preview, Hansen detailed reasons to be positive in the ye...

A trio of billion dollar deals for late-stage and commercial assets featuring contingent value rights were among the highlights of the first day of the J.P. Morgan Healthcare Conference in San Francisco on Monday. BioCentury's editors discuss AstraZeneca's takeout of CinCor, Ipsen's buy of Albireo and Chiesi's acquisition of Amryt as well as other takeaways from JPM, the CERSI...

The U.K. government is signaling that life sciences companies will be shielded from changes to an R&D tax relief policy that would otherwise leave small biotechs losing millions of pounds, Washington Editor Steve Usdin said on the latest BioCentury This Week podcast. Usdin and his BioCentury colleagues discuss the behind-the-scenes initiative by the U.K. BioIndustry Association to protect comp...

Phase III results for resmetirom from Madrigal Pharmaceuticals are more than enough for a regulatory submission in non-alcoholic steatohepatitis, said BioCentury Director of Biopharma Intelligence Paul Bonanos. Bonanos and colleagues discuss what Madrigal got right in running its trial for the challenging NASH indication, and what’s next in the pipeline. BioCentury’s editors also assess highly ant...