FDA au­tho­rizes about 10M J&J vac­cine dos­es, trash­es 60M more from trou­bled Emer­gent plant

4 years ago
FDA+
Coronavirus

Au­to­lus claims a CAR-T win at EHA; Ima­go touts two PhII tri­al wins for rare dis­ease drug

4 years ago
News Briefing

The IPO 4-1-1: Four fil­ings, a pric­ing and a with­draw­al head­line this week's Nas­daq ac­tion as raise ap­proach­es $7.5B

4 years ago
Financing

In­ter­cept re­tools C-suite with a pair of new­com­ers; Charles Ryan moves past Alzheimer's flops with an­oth­er CEO ...

4 years ago
Peer Review

Months af­ter FDA re­jec­tion, Sanofi touts piv­otal win for rare dis­ease drug su­tim­limab as it preps to re­file

4 years ago
R&D
Pharma

An ex­pen­sive watch, shell com­pa­nies and fake in­voic­es: How two Is­raeli traders tapped in­to a $100M glob­al biotech ...

4 years ago
People
FDA+

Fresh off $598M deal with No­vo Nordisk, a Japan­ese stem cell com­pa­ny is on its way to the clin­ic with a dif­fer­ent ...

4 years ago
Financing

Covid-19 roundup: 60 mil­lion J&J dos­es from Emer­gent to be tossed; EMA up­dates As­traZeneca vac­cine warn­ings

4 years ago
Coronavirus

Ver­tex and CRISPR Ther­a­peu­tics un­veil more pos­i­tive gene ther­a­py da­ta, but busul­fan again casts a shad­ow over the ...

4 years ago
R&D
Cell/Gene Tx

Sen­a­tors lam­bast new Alzheimer’s drug’s price but give Janet Wood­cock a free pass on the ap­proval de­ci­sion

4 years ago
Pharma

Har­vard’s Aaron Kessel­heim re­signs from ex­pert pan­el in wake of ad­u­canum­ab OK, blast­ing FDA for ‘worst drug ...

4 years ago
FDA+

Ver­tex strikes out on its lat­est big shot at a rare ge­net­ic dis­ease. But they're go­ing to keep on swing­ing

4 years ago
R&D

Covid-19 man­u­fac­tur­ing roundup: BioN­Tech an­nounces plans to pro­duce mR­NA vac­cines in Africa; As­traZeneca de­liv­er­ies ...

4 years ago
Coronavirus
Manufacturing

An API firm with a his­to­ry of J&J fund­ing scores a ma­jor loan to ad­vance its port­fo­lio

4 years ago
R&D
Manufacturing

With its con­tro­ver­sial ad­u­canum­ab ap­proval in hand, Bio­gen gears up for a quick US roll­out

4 years ago
R&D
Manufacturing

A Wash­ing­ton CMO is dou­bling its man­u­fac­tur­ing ca­pac­i­ty, less than 5 years in­to its ex­is­tence

4 years ago
Manufacturing

Ex­e­lead inks deal to man­u­fac­ture lipid nanopar­ti­cles for Pfiz­er/BioN­Tech vac­cine

4 years ago
Outsourcing
Manufacturing

No­var­tis cuts jobs at Swiss plant as a UK fa­cil­i­ty sits in a hold­ing pat­tern with 200 po­si­tions on the line — ...

4 years ago
Outsourcing
Manufacturing

Verona signs Chi­na deal for PhI­II COPD drug; Te­va con­tin­ues le­gal bat­tle with Eli Lil­ly, al­leg­ing new patent ...

4 years ago
News Briefing

A sec­ond ad­comm mem­ber aban­dons his post in af­ter­math of con­tro­ver­sial ad­u­canum­ab de­ci­sion

4 years ago
Pharma
FDA+

Bris­tol My­er­s' CAR-T Breyanzi busts out a win in ear­li­er-line lym­phoma, po­ten­tial­ly crack­ing open an ex­pand­ed mar­ket

4 years ago
R&D
Pharma

Ju­bi­lant Hol­lis­ter­Sti­er plots out ex­pan­sion at WA ster­ile in­jecta­bles plant amid work on Covid-19 vac­cines

4 years ago
Outsourcing
Manufacturing

AGC adds an­oth­er ma­jor Covid-19 vac­cine mak­er to the client list with BioN­Tech pact for plas­mid DNA

4 years ago
R&D
Manufacturing

FDA plans new stud­ies on ac­cel­er­at­ed ap­proval dis­clo­sures in bio­phar­ma ads

4 years ago
FDA+
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