PhRMA and BIO seek changes in FDA’s guid­ance to mit­i­gate drug short­ages

3 years ago
R&D
Manufacturing

J&J coughs up $40.5M in New Hamp­shire opi­oid set­tle­ment, evad­ing up­com­ing tri­al

3 years ago
Law

Mer­ck spells out ac­cess, en­vi­ron­men­tal goals in lat­est ESG re­port

3 years ago
Pharma
Marketing

Two years af­ter a refuse-to-file, Y-mAbs lands an FDA ad­comm for its 2nd neu­rob­las­toma treat­ment

3 years ago
FDA+

Shang­hai-based cell ther­a­py biotech nabs new funds; Col­orado biotech nets an ac­qui­si­tion

3 years ago
Financing
China

French start­up Abi­vax rais­es $49M to cross the PhI­II fin­ish line for ul­cer­a­tive col­i­tis drug

3 years ago
Financing

Small Is­raeli biotech flops a PhI­II test in post-surgery in­fec­tions — shares crushed

3 years ago
R&D

Am­neal asks FDA to ap­prove an­oth­er new for­mu­la­tion of Parkin­son’s com­bo drug 

3 years ago
Pharma
FDA+

Azu­ri­ty Phar­ma­ceu­ti­cals con­tin­ues its win streak as it bags an­oth­er ap­proval from the FDA

3 years ago
Pharma
FDA+

Top Boehringer In­gel­heim drug gets FDA ap­proval in rare skin dis­ease

3 years ago
Pharma
FDA+

Jay Brad­ner’s NI­BR ex­it sets off a suc­ces­sion plan at Mer­ck; Dyne and Mor­phoSys fill ma­jor R&D roles

3 years ago
Peer Review

Pfiz­er reshuf­fles top lead­er­ship to hone com­mer­cial strat­e­gy, leav­ing room for new rare dis­ease chief

3 years ago
People
Pharma

Spe­cial­ty drug mar­ket jumps, dri­ven by new users — not high­er price tags — and more biosim­i­lar up­take

3 years ago
Pharma
Marketing

Il­lu­mi­na pre­vails over FTC's chal­lenge of $8B Grail buy­out

3 years ago
Deals
Pharma

As Fiona Mar­shall makes her move to NI­BR, Mer­ck is ready with a key re­place­ment play­er

3 years ago
People
R&D

Man­u­fac­tur­ing roundup: As­pen teams up with the Serum In­sti­tute; Por­ton se­cures sev­er­al strate­gic part­ner­ships

3 years ago
Manufacturing

Fol­low­ing FDA, CHMP gives thumbs-up on Pfiz­er, BioN­Tech Omi­cron boost­er

3 years ago
Pharma
Coronavirus

Gener­ic Adder­all short­ages con­tin­ue as sev­er­al man­u­fac­tur­ers stare down sup­ply squeezes

3 years ago
Pharma
Manufacturing

Gink­go Bioworks ap­points a vet­er­an as its new SVP of bio­phar­ma man­u­fac­tur­ing

3 years ago
People
Manufacturing

Thrills, chills, a fi­nal of­fer from Bob Brad­way and a hard­ball threat from 'Par­ty E': the in­sid­er look at the $4B ...

3 years ago
Deals

Foghorn co-founder re­signs from board; Guardant and Mer­ck KGaA team up again

3 years ago
News Briefing

Arc­turus touts $63M BAR­DA award for new mR­NA in­fluen­za vac­cine, hop­ing to prep against fu­ture pan­demics

3 years ago
Financing
R&D

Proven­tion Bio takes a $125M loan to ad­vance Eli Lil­ly’s once-re­ject­ed di­a­betes drug

3 years ago
Financing

One week af­ter Take­da walked away, Finch faces sec­ond round of lay­offs, pipeline prun­ing

3 years ago
People
R&D
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