ENDPOINTS NEWS5h
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 NEWS6d
Ca­griSe­ma’s weight loss da­ta dis­ap­point­ed. What does No­vo do next?
Novo Nordisk's CagriSema fell short of weight loss goals, causing 17% stock drop. Drug shows similar results to Eli Lilly's ...
ENDPOINTS NEWS7d
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 high-lev­el safe­ty warn­ings for both.
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 FDA’s Or­ange Book.
ENDPOINTS NEWS7d
No­vo Nordisk’s once-dai­ly he­mo­phil­ia drug Al­he­mo ap­proved in US
No­vo Nordisk fi­nal­ly won US ap­proval for its he­mo­phil­ia drug Al­he­mo fol­low­ing the prod­uct’s re­jec­tion by the FDA last year.
ENDPOINTS NEWS7d
Sum­it­o­mo’s over­ac­tive blad­der drug adds an­oth­er in­di­ca­tion
Sum­it­o­mo Phar­ma’s oral treat­ment for over­ac­tive blad­der symp­toms won an ex­pand­ed la­bel from the FDA, and is now ap­proved to treat men who are si­mul­ta­ne­ous­ly … ...
ENDPOINTS NEWS7d
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 de­ter­mined new prices for the first 10 … ...
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 fed­er­al 340B aren’t ac­tu­al­ly el­i ...