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De­spite mixed da­ta in Alzheimer's ag­i­ta­tion, Ax­some will still seek FDA ap­proval
Axsome Therapeutics on Monday reported data for two Phase 3 studies in Alzheimer’s-related agitation, saying one trial ...
ENDPOINTS NEWS3d
FDA ap­proves sub­cu­ta­neous ver­sion of Bris­tol My­er­s' Op­di­vo
A decade after Bristol Myers Squibb first won approval for its PD-1 checkpoint inhibitor Opdivo, the cancer drug has been ...
ENDPOINTS NEWS3d
BioN­Tech set­tles with NIH, UPenn in Covid vac­cine dis­putes and will pay roy­al­ties
BioNTech settles with NIH and UPenn over Comirnaty royalties, paying $750M to NIH and $400M to UPenn for 2020-2023, with ...
ENDPOINTS NEWS3d
WuXi AppTec will sell cell and gene ther­a­py busi­ness to pri­vate eq­ui­ty firm
WuXi Apptec will sell its Advanced Technologies unit to the US private equity firm Altaris for an undisclosed amount, a ...
ENDPOINTS NEWS7d
Fed­er­al ap­peals court says Te­va must delist Or­ange Book in­haler patents
The Federal Trade Commission is praising an appeals court decision calling for Teva to delist five inhaler patents from the ...
ENDPOINTS NEWS7d
Three drug­mak­ers sue US over 340B dis­counts to STD clin­ics they al­lege don’t qual­i­fy
Amgen, Eli Lilly and UCB sued the federal government, claiming that several STD clinics getting drug discounts under the ...
ENDPOINTS NEWS10d
Ap­plied Ther­a­peu­tics CEO steps down af­ter rare dis­ease drug re­jec­tion
Applied Therapeutics CEO Shendelman exits; CFO Funtleyder becomes interim CEO after FDA rejects govorestat. Company withdraws ...
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Ex­clu­sive: Col­or Health alums raise $10M for new start­up, us­ing AI for reg­u­la­to­ry work
Employees Nos. 1 and 2 of the $4.6 billion health tech startup Color Health have started their own company, aiming to tackle ...
ENDPOINTS NEWS7d
Bris­tol My­er­s' TYK2 in­hibitor suc­ceeds in pair of Phase 3 pso­ri­at­ic arthri­tis tri­als
Bristol Myers Squibb's Sotyktu succeeds in Phase 3 psoriatic arthritis trials, as company leads TYK2 race against Takeda & ...
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CMS ex­plains what went in­to its first round of drug price ne­go­ti­a­tions
The Centers for Medicare and Medicaid Services on Friday released detailed but heavily redacted explanations of how it ...
ENDPOINTS NEWS7d
Sum­it­o­mo’s over­ac­tive blad­der drug adds an­oth­er in­di­ca­tion
Sumitomo Pharma’s oral treatment for overactive bladder symptoms has won an expanded label from the FDA, and is now approved ...
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Ver­tex gets 'van­za triple' ap­proval and Trikaf­ta ex­pan­sion — with boxed warn­ings
The FDA on Friday issued two simultaneous cystic fibrosis approvals for Vertex Pharmaceuticals, but included boxed safety ...