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9 April, 2026
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top stories
1. FDA plans another safety study of abortion drug after court order
2. How do you define a ‘patient'? AbbVie suggests new interpretation is necessary in 340B lawsuit
3. Live Friday at 1:15 p.m. — Biopharma M&A is back
4. Roche dips into DACs with existing partner C4 Therapeutics for $20M upfront
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news briefing
FDA lifts MacroGenics hold; Oxford and Bristol Myers team up
more stories
 
Zachary Brennan
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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

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

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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US Deals Outlook 20226: What's ahead for pharma and life sciences
US biopharma still leads the world in high-risk drug development, but the road from innovation to access has never been harder to predict. Hear from top executives and investors on how they’re navigating what’s next. Join us.
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by Drew Armstrong

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

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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News Briefing: Quick hits from the biopharma web
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by ENDPOINTS