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9 April, 2026 |
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sponsored by
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Integrated CDMO Expertise, Built to Keep Programs Moving
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| Avid Bioservices delivers integrated CDMO solutions that carry programs seamlessly from early development through commercial manufacturing. Our Early Phase Center of Excellence enables rapid starts, fewer handoffs, and smooth scale‑up, helping innovators move faster with confidence. |
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The FDA today formally pulled the approval of GSK's leucovorin, just a month after adding a new indication, at FDA’s request, for the rare genetic condition Cerebral Folate Deficiency. Although the removal of GSK’s version won’t affect other generics on the market, it’s another twist in the saga of a drug GSK initially pulled in 1999 due to lackluster sales, and that FDA in September
touted as a potential autism treatment. |
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Zachary Brennan |
Senior Editor, Endpoints News
@ZacharyBrennan
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by Zachary Brennan
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The FDA is again looking into the safety of the abortion drug mifepristone following a Louisiana court order and calls from Republican lawmakers to investigate the drug. In an update posted on Wednesday, the agency said its nearly one-year-long study will help determine whether to change the Risk Evaluation and Mitigation Strategy, or REMS, for the drug, which currently allows women to obtain it without an in-person doctor visit. The FDA in 2021 said that it would continue the pandemic-era practice of
allowing the drug to be dispensed via telehealth providers. The FDA had found no differences in adverse events when the drug was delivered in-person or virtually. | |
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by Nicole DeFeudis
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AbbVie filed suit against the federal government on Wednesday over its interpretation of the word “patient” under the 340B federal drug discount program. The lawsuit is the latest twist in the pharma industry’s fight to rein in 340B, which has rapidly expanded in recent years. When the program started in 1992, about 1,000 health centers were participating, AbbVie wrote in its lawsuit. By 2021, there were more than 50,000. AbbVie alleged that the government’s “overly broad interpretation” of which patients may receive discounted drugs “facilitates widespread 340B program
abuse.” If the company wins, it could bring into question how drug discounts are administered more broadly. “Should AbbVie have its way, there will be a lot of confusion,” said Andrew Twinamatsiko, director of the O’Neill Institute’s Center for Health Policy and the Law at Georgetown University. “Because there won't be a single definition of what a patient means.” | |
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by Drew Armstrong
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Deals deals deals. Biopharma M&A is having one of its best stretches in years, as big pharma buyers snap up smaller biotechs. We'll be talking live about what's going on and how this
time seems different from prior signs of life in the merger market. Tune in on YouTube Friday at 1:15 p.m. ET. I'll be joined by our deals and financing expert Kyle LaHucik as we interview Emily Field, head of US biopharmaceuticals equity research at Barclays. We'll talk about why big
companies are buying now, what type of assets they're going after, what counts as a "big" deal these days and what all the cash coming back to investors means for the startup market. | |
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Andrew Hirsch, C4 Therapeutics CEO |
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by Kyle LaHucik
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While antibody-drug conjugates have had their moment in the sun for the past few years, a degrader twist on the hot cancer modality is gathering steam. Roche is further delving into its decade-long partnership with C4 Therapeutics in a new collaboration that seeks to create degrader-antibody conjugates, or DACs, for treating cancers. The
expanded tie-up, disclosed Thursday morning, includes $20 million upfront and the potential for about $1 billion if various milestones are hit across discovery, development and commercial stages. DACs have attracted a few large drugmakers, including one this week. Although the bulk of Gilead's $3.15 billion attention on Tubulis earlier this week was likely geared toward the German startup's two clinical-stage ADCs, a preclinical DAC could rise to the fore in the coming years. Bristol Myers Squibb is also in the game, and protein degrader legend Craig Crews is cooking up his next startup. | |
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