New clin­i­cal tri­al sys­tem to soon be­come manda­to­ry in Eu­rope

3 years ago
Pharma
FDA+

Man­u­fac­tur­ing roundup: FDA, Swissmedic ink deal on phar­ma GMP; SK biotech con­tracts with Charles Riv­er for RNA ...

3 years ago
Manufacturing

Small-cap CNS out­fit inks API deal for pre­clin­i­cal MEK in­hibitor

3 years ago
Deals
Manufacturing

In­tas Phar­ma­ceu­ti­cals un­der FDA scruti­ny over 'cas­cade of fail­ure' in over­sight of GMP doc­u­ments

3 years ago
Pharma
Manufacturing

In bid to ad­vance man­u­fac­tur­ing ca­pa­bil­i­ties, In­scrip­ta buys out two biotechs

3 years ago
Manufacturing

Genen­tech touts pos­i­tive Phase III da­ta for Tecen­triq/Avastin com­bo in liv­er can­cer

3 years ago
R&D
Pharma

Rep. Frank Pal­lone wants FDA and NIH to act on phar­ma's non­com­pli­ance with tri­al records law

3 years ago
FDA+

Af­ter hy­per­ten­sion com­peti­tor gets bought, Min­eralys lines up IPO plans

3 years ago
Financing
Startups

Caris gets $400M loan from Or­biMed and Braid­well; blue­bird stock sales brings in $120M

3 years ago
News Briefing

Amarin, Saris­sa con­tin­ue play­ing out ac­tivist at­tack

3 years ago
People

Off Ed­i­tas’ shelves, iNK cell ther­a­pies float to Shore­line

3 years ago
Startups
Deals

Sun Phar­ma buys out Con­cert, and its alope­cia drug, for $576M

3 years ago
Deals
R&D

Af­ter hash­ing out come­back plans, De­ci­phera looks to raise $125M from stock sale

3 years ago
Financing

By sum­mer sol­stice, we'll know the fate of In­ter­cep­t's NASH drug

3 years ago
Pharma
FDA+

Hori­zon claims mid-stage vic­to­ry in rare dis­ease, lines up PhI­II for new own­ers at Am­gen

3 years ago
R&D

Ipsen has go/no-go de­ci­sion to make af­ter biotech part­ner's Parkin­son's drug flunks PhI­Ib

3 years ago
R&D

Don't pack your sun­glass­es: No plans to move JP Mor­gan con­fer­ence, bank says

3 years ago
R&D

Mer­ck dis­cov­ers 'root cause' of ni­trosamine lev­els in block­buster di­a­betes drugs

3 years ago
Pharma

Sun Phar­ma picks 'Dr. Pim­ple Pop­per' for ed­u­ca­tion­al ac­ne cam­paign

3 years ago
Pharma
Marketing

Am­gen tar­gets physi­cians with biosim­i­lars ed­u­ca­tion cam­paign in ad­vance of ex­pect­ed 2023 break­out

3 years ago
Pharma
Marketing

Up­dat­ed: FDA slaps Op­tum In­fu­sion with a warn­ing let­ter over 'in­san­i­tary' pro­duc­tion con­di­tions

3 years ago
Pharma
Manufacturing

Bris­tol My­ers de­buts first Op­du­alag cam­paign, adds to its two-com­bo can­cer drug mar­ket­ing

3 years ago
Pharma
Marketing

Drug­mak­ers seek tweaks to FDA guid­ance on mea­sur­ing de­vel­op­ment in pe­di­atric tri­als

3 years ago
R&D
FDA+

FDA+ roundup: Lessons learned from two qual­i­ty rat­ings pi­lots; Ex­pand­ed FDA col­lab with or­gan-on-a-chip com­pa­ny

3 years ago
FDA+
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