Led by CBER Director Peter Marks, FDA is moving forward with policies that aim to improve access to gene therapies for patients with rare diseases. On the latest BioCentury This Week podcast, BioCentury’s editors discuss how FDA plans to use regulatory policies to overcome barriers that are slowing gene therapy, as well as how Pfizer hopes to ensure access to its newly approved hemophilia gene therapy. The editors also assess the $2.4 billion acquisition of Massachusetts oncology company...

A “drive-by analysis of accelerated approval is intellectual malpractice,” argues Washington Editor Steve Usdin on the latest BioCentury This Week podcast. Usdin and his BioCentury colleagues explain why a paper on the expedited regulatory pathway written by researchers at the Program on Regulation, Therapeutics, and Law (PORTAL) at Brigham and Women’s Hospital misleads the public about the value of drugs granted accelerated approval. The paper also fails to grasp the pathway’s purpose, which...

Vertex Pharmaceuticals' acquisition of Alpine Immune Sciences will bolster a growing kidney disease franchise that could help diversify Vertex’s business beyond its blockbuster cystic fibrosis franchise. On the latest BioCentury This Week podcast, BioCentury’s editors discuss what attracted Vertex to Alpine and why it believes its newly acquired therapy can outshine others for IgA nephropathy. The editors discuss how Goldman Sachs aims to scale private biotechs via its venture strategy and...

M&A has been driving a recovery for biotech, with $62 billion in takeouts in the past six months restocking specialist investors’ coffers for their next wave of investments. On the latest BioCentury This Week podcast, BioCentury’s editors assess the state of the public markets heading into the second quarter, including the outsize role PIPEs have had in financing industry’s comeback. They also discuss their takeaways from analyzing nearly 7,000 abstracts from the American Association for...

Upcoming catalysts could drive value creation at NASDAQ’s newest biotech, Boundless Bio, after it stumbled in its trading debut last week. On the latest BioCentury This Week podcast, BioCentury’s editors discuss Boundless’ IPO in the context of the current market for fresh paper and profile the “sweat equity” model of Avalon, the VC firm led by Jay Lichter. Turning to Washington, BioCentury’s editors assess possible outcomes for the Supreme Court case on abortion drug mifepristone, and why...

Bills seeking to rein in Chinese CDMOs and genomics companies will deal a massive blow to biotech companies, if passed in their current form, according to results from an industry survey conducted by BioCentury. On The latest BioCentury This Week podcast, BioCentury’s editors discuss results from the survey, including responses that underscore executives’ concerns that the legislation would cause delays in drug development and a majority’s displeasure with BIO’s about-face to support the...

Putting patients at center stage is at the core of John Crowley’s vision for BIO as he begins his tenure leading the biotech trade group. On the latest BioCentury This Week podcast. Washington Editor Steve Usdin details Crowley’s plans to revitalize BIO at a time when effective representation in Washington is more important than ever. BioCentury’s editors also discuss FDA’s landmark approval of Madrigal's liver disease drug and a decision by FDA’s Oncologic Drugs Advisory Committee to support...

A congressional committee meeting last week on biotech and national security provided a glimmer of hope that lawmakers could be persuaded to consider taking steps to bolster the U.S. bioeconomy, BioCentury Washington Editor Steve Usdin explains why the at times cartoonish spectacle of lawmakers pushing anti-China biotech bills highlights the need for scientists and entrepreneurs to build relationships in Washington. Plus: Editor in Chief Simone Fishburn argues that the future of diversity...

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...

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...

 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...

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...

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. For free...

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...

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,"...

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...

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...

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...

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;...

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...

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...

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...

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...

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...