BioCentury This Week

Marty Makary wasn’t the only official on the outs at FDA last week in another tumultuous turn of events for the regulatory agency. On the latest BioCentury This Week podcast, BioCentury Washington Editor Steve Usdin discusses who’s in, who’s out and what’s next at FDA — and why the changes may mean more conservative decision-making at the agency in the near term. BioCentury’s analysts also discuss...

China’s speed in generating first-in-human data has catalyzed a race across the globe to reshape regulatory requirements to compete. BioCentury’s analysts, along with special guests Detlev Mennerich, head of Boehringer Ingelheim Venture Fund, and Mehdi Ainouche, partner at Jeito Capital, discussed where Europe fits in that landscape and other takeaways from the 26th annual Bio€quity Europe confere...

Marty Makary’s hold on the top job at FDA is slipping , with White House leaks about President Donald Trump’s displeasure with the FDA commissioner shifting the question from whether he will be fired to when. On the latest BioCentury This Week podcast, Washington Editor Steve Usdin discusses the pressures on Makary, how long he will hold onto his post, and the leading candidates to succeed him. Bi...

UCB is the latest biopharma player to consummate a multibillion-dollar deal amid a surge in biotech M&A activity, acquiring Ken Song’s Candid Therapeutics, one of the leading T cell engager companies. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the $2 billion takeout and the opportunity in the TCE space. They also assess the drug development landscape for leukodys...

More than 175 new oncology targets surfaced at this year’s American Association for Cancer Research annual meeting in San Diego, with the focus on new ways to enhance the immune response against solid tumors and to make existing immunotherapies more effective. On the latest BioCentury This Week podcast, BioCentury’s analysts assess the new targets identified among the thousands of abstracts at AAC...

Bispecific antibodies and dual-payload antibody-drug conjugates were in the spotlight at this year’s American Association for Cancer Research meeting in San Diego as biotechs unveiled their latest preclinical and first-in-human oncology data. On a special edition of the BioCentury This Week podcast, IQVIA Biotech CMO James Kyle Bryan joins BioCentury’s analysts to discuss what AACR revealed about...

The past week has delivered the largest M&A deal ever for a private, venture-backed biopharma, the second-largest follow-on ever for a NASDAQ-traded biotech and what could soon become the largest biotech IPO ever on NASDAQ. On the latest BioCentury This Week , BioCentury’s analysts discuss Eli Lilly's $3.25 billion takeout of in vivo CAR T company Kelonia, the market debut by obesity play...

A pathway proposed by FDA to cut the time it takes biopharma companies to get to first-in-human trials is more ambitious than similar policies in Australia, China and the U.K. On the latest BioCentury This Week podcast, BioCentury’s analysts assess the proposal , as well as a concession for the biopharma industry on first-in-human studies in PDUFA reauthorization negotiations with FDA. The analyst...

Biotech has been resilient as the financial markets teeter under global volatility. For now, M&A and financings, if not IPOs, are continuing, but will the Mideast conflict halt biotech’s recovery? On the latest BioCentury This Week podcast, BioCentury’s Stephen Hansen breaks down the near-term and long-term outlook for a biotech industry hoping to continue the growth of 2H25. BioCentury’s anal...

Biotech innovators around the world are finding speed to be the driver for investment and partnering — speed to early human data and speed to de-risk assets. The new momentum from Asia, in particular China, has added a fresh challenge for European biotech on top of falling equity and R&D investment in Europe and a complex drug pricing landscape. On a special edition of the BioCentury This Week...

A flurry of deals, several with sizable upfront payments, has energized the biotech sector in March. On the latest BioCentury This Week podcast, BioCentury’s Paul Bonanos assesses last week’s deals by Merck, which is laying out $6.7 billion to acquire Terns, and Gilead, which is buying Ouro for about $1.7 billion up front. Gilead’s deal comes as the Foster City, Calif.-based biotech is looking to...

After 20 years of platform building and resets, Arrowhead Pharmaceuticals is making a bid to become a large-cap biotech. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss how the company has built a pipeline and set of enabling technologies that could enable a steep period of value creation based on RNAi. The team then analyzes the $2 billion deal between Synnovation and No...

Biotechs have been pricing follow-ons at a steady pace, with some companies parlaying data into upsized deals, and others even beginning to debut on NASDAQ — but will geopolitical tensions and war in the Middle East scuttle the forward momentum? On the latest BioCentury This Week podcast, BioCentury’s analysts take the temperature of the markets for biotech." They also discuss last week’s lat...

Biotechs in South Korea and other regions of Asia outside of China need to lean into innovation to distinguish themselves from their Chinese counterparts. On a special edition of the BioCentury This Week podcast, BioCentury’s analysts are joined by industry guests Ya-Ting Lei and Luther (Ruizhe) Zhao to discuss why the best path for biotechs in Korea and Japan is to lean into target, biology and m...

The second ousting of Vinay Prasad from FDA in the past eight months won’t lead to major changes at the agency, other than selecting a successor tasked with keeping FDA out of the news ahead of the coming midterm elections. On the latest BioCentury This Week podcast, Washington editor Steve Usdin lays out why the former CBER director was pushed out at FDA and what’s next for the agency following h...

Can a strong U.S. biopharma industry be reconciled with the successful emergence of China? And can China be a catalyst of positive change across the global industry, even if this implies some level of rebalancing away from the U.S.? On the latest BioCentury This Week podcast, BioCentury’s analysts discuss a Guest Commentary by McKinsey Senior Partner Emeritus Franck Le Deu, who argues that a multi...

Gilead is acquiring Arcellx for $7.8 billion up front three years after forging a partnership with the biotech around a cell therapy for multiple myeloma. On the latest BioCentury This Week podcast, BioCentury’s analysts assess what the deal does for the Foster City, Calif.-based biotech’s pipeline. The analysts also discuss the case for using ctDNA as a surrogate endpoint for early cancer trials....

As targeted protein degradation gains momentum, oral selective estrogen receptor degraders are emerging as one of its most advanced proving grounds. On the latest BioCentury This Week podcast, BioCentury’s Lauren Martz assesses how the oral SERD landscape is evolving. Washington Editor Steve Usdin then discusses setbacks at FDA for an orphan therapy from Disc Medicine and a vaccine from Moderna, a...

2025 marked the end of a four-year slide in series A financings for biotechs, with 144 biotechs raising an aggregate of $8 billion, up $1 billion from the prior two years. On the latest BioCentury This Week podcast, BioCentury’s Danielle Golovin assesses which companies VCs backed last year and what their investments say about where technology is headed. Washington Editor Steve Usdin offers a pers...

RNAi and exon-skipping therapies headline the list of regulatory and pivotal data catalysts in 2026, while new lipid-lowering mechanisms, modalities, and precision medicines define cardiovascular disease catalysts this year. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the most important milestones of the year in new modalities, CV and renal diseases. The analysts also...

New rules in China will accelerate the country’s cell and gene therapy sector by reshaping how investigator-initiated trials are conducted and commercialized. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the new framework and why it will create a powerful incentive for deploying new gene and cell therapies. Executive Editor Selina Koch discusses which milestones she is...

The biotech bull is back, and buysiders believe this market has staying power for the first time in nearly five years. On a special episode of the BioCentury This Week podcast, Director of Biopharma Intelligence Stephen Hansen and colleagues discuss Hansen’s 2026 Public Markets Preview , which found interest rates, policy in Washington and fundamentals finally aligning and a wave of launches and M...

Next-generation induced proximity technologies are coming of age after a decade of industry focus on PROTACs. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss Senior Biopharma Analyst Danielle Golovin’s four-part analysis of how next-generation targeting chimeras (TACs) are evolving. The analysts assess the $2.2 billion takeout of Rapt Therapeutics by GSK, which gave the p...

The J.P. Morgan Healthcare Conference kicked off this week with sunny skies over San Francisco and more financial momentum than the biotech industry has seen in years. On a special “on the road” edition of the BioCentury This Week podcast, recorded on the sidelines of the annual JPM conference, special guests joined BioCentury’s analysts to discuss the biotech ecosystems in Asia. The wide-ranging...

Riding the tailwind of a strong 2H25, the days leading up to biotech’s annual kickoff meeting in San Francisco delivered billions in capital raised and more than two dozen deals announced. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss two of the largest deals announced at the start of the J.P. Morgan Healthcare Conference, a partnership for a bispecific between AbbVie a...