Pharma channel feed

HHS can re­quire ap­proval for drug­mak­ers to ap­ply 340B re­bate mod­els, court rules

Last week
Law

FDA pos­es ef­fi­ca­cy, safe­ty ques­tions over four can­cer drugs ahead of two-day ad­comm

Last week
FDA+

Amarin calls Hik­ma's drug la­bel ar­gu­ments 'idio­syn­crat­ic,' urges high court to de­cline case

Last week
Law

Mark Cuban com­pounder joins Trump's new man­u­fac­tur­ing ini­tia­tive

Last week
Manufacturing

Bio­Marin makes Phase 3 buy, pay­ing $270M for rare dis­ease out­fit In­ozyme

Last week
Deals

Up­dat­ed: No­vo Nordisk CEO to step down amid stock de­cline, time­line for suc­ces­sor un­known

Last week
People

RFK Jr. adopts new chikun­gun­ya vac­cine guid­ance; oth­er rec­om­men­da­tions re­main un­der re­view

Last week
R&D
FDA+

'Go ahead and do it': Top RFK Jr. deputy dares drug­mak­ers that might pull man­u­fac­tur­ing over new price pres­sure

Last week
Manufacturing

Re­gen­eron scores $400M+ ju­ry win in Am­gen cho­les­terol drug spat

Last week
Law

Ei­sai says Leqem­bi is head­ed for 'de­mand ex­pan­sion phase' in US

Last week

New CBER chief Prasad is ready­ing 'mas­sive frame­work' around vac­cines, Makary says

Last week
FDA+

Bris­tol My­ers CEO says Amer­i­ca’s bio­phar­ma pole po­si­tion is not guar­an­teed

Last week
People

Ex­clu­sive: Drug com­pounder Em­pow­er was built on risky short­cuts, ex-em­ploy­ees and in­spec­tions al­lege

Last week
In Focus
Health Tech

Up­dat­ed: Mer­ck KGaA con­tin­ues US tar­iff sur­charge but at a 'de­creased' rate 

Last week
China
Manufacturing

Bio­haven stock sinks on three-month de­lay for neu­ro drug's FDA ap­proval de­ci­sion

Last week
FDA+

Hen­grui, one of Chi­na's lead­ing biotechs, an­tic­i­pates $1.2B in pro­posed Hong Kong list­ing

Last week
Financing
China

RFK Jr. de­fends HHS staff cuts, re­or­ga­ni­za­tion plans in House, Sen­ate hear­ings

Last week
FDA+

RFK Jr. says his opin­ions of vac­cines are ‘ir­rel­e­vant.’ For­mer FDA chief Califf dis­agrees

Last week
FDA+

Sanofi touts $20B in­vest­ment in US over five years

Last week
Manufacturing

FDA gives Ab­b­Vie ac­cel­er­at­ed ap­proval for an­ti­body-drug con­ju­gate in lung can­cer

Last week
FDA+

Ab­b­Vie dou­bles down on siR­NA with $335M up­front bet on ADARx

Last week
Startups
Deals

GSK to pay $1.2B up­front to snag Boston Phar­ma’s mid-stage MASH hope

Last week
Deals

No­vo turns to Septer­na for oral obe­si­ty med­i­cines in deal worth up to $2.2B

Last week
Deals

HHS fo­cus­es on 'trans­paren­cy' in third-round IRA ne­go­ti­a­tion guid­ance

Last week
Law
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