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Bristol Myers Squibb is dropping at least $3.5 billion to jointly develop the bispecific antibody, which will race with Summit Therapeutics, Merck and Pfizer in the crowded PD-1/PD-L1xVEGF space.
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An FDA committee’s September 2024 vote to limit the use of Merck’s Keytruda and BMS’ Opdivo in stomach and esophageal cancers based on PD-L1 expression levels reflects an emerging trend that leverages ever-maturing datasets.
Among the 55 novel drugs that crossed the regulatory finish line last year were notable new mechanisms of action, coming particularly in the oncology and neurosciences spaces.
Licensing deals have risen in prominence in a restrained market environment. Is it desperation, or an important part of the biotech ecosystem? Experts weigh in.
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Takeda announced financial results for the third quarter of fiscal year 2023. With year-to-date strong momentum in its Growth & Launch Products offsetting the significant revenue impact of generic entrants, Takeda remains on track towards its full-year Management Guidance.
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During the COVID-19 pandemic, Health Secretary Robert F. Kennedy Jr.—along with FDA Commissioner Marty Makary and CBER Director Vinay Prasad—argued against vaccine mandates, partly because they limited medical choice. This week, the FDA under their leadership approved updated COVID-19 vaccines with restrictions that do the same.
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Disruptive conditions are typical in non-Western markets. The U.S. industry, thrown into a period of significant change as the Trump administration overhauls HHS and considers implementing tariffs, could learn a thing or two by looking overseas.
Dupixent, which was rejected by the FDA for chronic spontaneous urticaria in October 2023, is now approved as the first new targeted therapy for the indication in more than 10 years.
President Donald Trump in February threatened top pharma leaders, including Eli Lilly CEO David Ricks, with tariffs unless they reshore their manufacturing operations.
In an interview with former Fox News journalist Megyn Kelly, FDA Commissioner Marty Makary introduced a new mechanism-driven pathway that could be leveraged by rare disease therapies while saying that autism could potentially be driven by certain environmental factors.
BML Capital Management, an activist investor that owns 9.9% of Elevation’s shares, is urging the company to wind down operations given “the current state of the public equity market.”
Alis Biosciences’ plan is a familiar tactic in the private equity world, but the firm will instead be listed on the public markets “in due course.”
Losing the FDA’s senior negotiators would slow the renewal of the user fee programs “considerably,” according to policy and regulatory expert Steven Grossman.
Industry representatives will still be allowed at these meetings, but they will no longer have a spot on the advisory committee.
Like they say about the weather in Iceland, if you don’t like an action taken by the new administration, wait five minutes; it’ll probably change. The markets, it seems, don’t react kindly to that kind of policymaking.
With tariffs pushing manufacturing home to the U.S., Pitchbook warns of reduced M&A activity and venture capital funding.