February 17, 2024

Sen­a­tors across both sides of the aisle are call­ing for a “swift” up­date to the FDA’s guid­ance on pre­scrip­tion drug pro­mo­tion. Sens. Mike Braun (R-IN)

Ab­b­Vie’s Hu­mi­ra is get­ting swapped out for Organon’s biosim­i­lar Hadli­ma on the US De­part­ment of Vet­er­ans Af­fairs’ na­tion­al for­mu­la­ry. The move marks a big win

Three phar­ma com­pa­nies have agreed to delist some of the patents chal­lenged by the Fed­er­al Trade Com­mis­sion in No­vem­ber, part of a push by the

The Eu­ro­pean Med­i­cines Agency is gear­ing up to make changes to its decades-old guide­lines for how drug spon­sors should use non-in­fe­ri­or­i­ty and equiv­a­lence stud­ies to

Phar­ma com­pa­nies are ex­press­ing fears that the FDA’s new ad­vanced man­u­fac­tur­ing tech des­ig­na­tion guid­ance could “bur­den” the agency, ac­cord­ing to com­ments re­cent­ly made pub­lic. The

The FDA on Fri­day signed off on an ex­pand­ed la­bel for No­var­tis and Roche’s block­buster Xo­lair (oma­l­izum­ab) and on Thurs­day con­vert­ed the ac­cel­er­at­ed to full

Sarep­ta Ther­a­peu­tics could soon notch an­oth­er reg­u­la­to­ry win. De­spite the com­pa­ny and its Duchenne gene ther­a­py get­ting dogged by de­bate, and then a failed con­fir­ma­to­ry

Law­suits over the In­fla­tion Re­duc­tion Act’s drug price ne­go­ti­a­tions are pick­ing up, with lawyers for As­traZeneca and the gov­ern­ment duk­ing it out in Delaware fed­er­al

Sanofi and De­nali Ther­a­peu­tics’ part­ner­ship ran in­to yet an­oth­er stum­bling block af­ter their ALS pro­gram failed a Phase II study. DNL788 did not achieve the

Ma­ha Katabi has had a great three months. The Sofinno­va gen­er­al part­ner has been in the board­room of two re­cent M&A ex­its: ra­dio­phar­ma­ceu­ti­cals mak­er Rayze­Bio,