EMA signs off on 3 drugs re­cent­ly re­ject­ed by FDA, in­clud­ing Bio­Mar­in's new he­mo­phil­ia gene ther­a­py

3 years ago
Pharma
FDA+

Joe Pa­pa re­signs as chair of Bausch Health as bil­lion­aire John Paul­son takes over

3 years ago
People
Pharma

Scoop: Lit­tle-known Or­biMed-backed biotech clos­es $160M round to start gene ther­a­py tri­al

3 years ago
Financing
Startups

Sanofi, GSK tout 72% Omi­cron ef­fi­ca­cy in PhI­II tri­al of next-gen, bi­va­lent shot — with an eye to year-end roll­out

3 years ago
R&D
Coronavirus

Bear mar­ket hits an­oth­er biotech as Red­Hill Bio­phar­ma lays off a third of US sales­force

3 years ago
People
Pharma

CAR-T in, IPF drug out: Gala­pa­gos bails on biotech part­ner­ship amid pipeline re­vamp

3 years ago
Deals
R&D

Alarmed by side ef­fect, FDA slaps clin­i­cal hold on Sarep­ta's next-gen Duchenne drug

3 years ago
FDA+

Af­ter sev­en months of search­ing, Lan­dos hires a CEO; Mar­ty Du­vall re-emerges from ill-fat­ed On­copep­tides tenure

3 years ago
Peer Review

CD­C's ACIP rec­om­mends high­er dose, Se­qirus, Sanofi flu vac­cines in adults 65 and old­er

3 years ago
Pharma

When will the FDA re­scind a break­through des­ig­na­tion? New draft guid­ance spells out the com­pli­cat­ed de­tails

3 years ago
Pharma
FDA+

Ab­b­Vie shells out $440M on two PRVs for la­bel ex­pan­sions of its block­buster Rin­voq

3 years ago
Pharma
FDA+

EU to launch vac­cine de­vel­op­ment and man­u­fac­tur­ing part­ner­ship with Latin Amer­i­can and Caribbean coun­tries

3 years ago
Financing
Manufacturing

Man­u­fac­tur­ing roundup: GSK opens a new fa­cil­i­ty at Barnard Cas­tle lo­ca­tion; Tenaya Ther­a­peu­tics com­pletes build­out of ...

3 years ago
Manufacturing

FDA warns Mex­i­can glyc­erin man­u­fac­tur­er for re­fus­ing an in­spec­tion

3 years ago
FDA+
Manufacturing

Fight over where to house ARPA-H still brews with House bil­l's pas­sage

3 years ago
FDA+
Law

Con­gress lays out its de­mands for FDA in 2023 — on every­thing from ma­chine learn­ing to im­munother­a­pies

3 years ago
FDA+

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

3 years ago
Pharma
Marketing

In trou­bled Hunt­ing­ton’s space, uniQure’s gene ther­a­py shows ear­ly promise

3 years ago
R&D
Cell/Gene Tx

For­mer Im­munomedics staffer pleads guilty in in­sid­er trad­ing scheme af­ter get­ting in­fo from ex-CFO Us­ama Ma­lik

3 years ago
People
Law

F-star bought out in $161M all-cash deal as Hong Kong's Sino Bio­pharm looks to­ward in­ter­na­tion­al ex­pan­sion

3 years ago
Deals
China

#Can­nes­Lions2022: Mar­ket­ing lead­ers stress im­por­tance of em­pa­thy in da­ta use

3 years ago
Pharma
Marketing

Xenon jumps on pos­i­tive da­ta-to-im­me­di­ate pub­lic of­fer­ing train to bankroll PhI­II epilep­sy study

3 years ago
Financing
R&D

#Can­nes­Lions2022: Why does di­ver­si­ty mat­ter in cre­ativ­i­ty? Olympic gold medal­ist and VM­LY&R ex­plain

3 years ago
Pharma
Marketing

#Can­nes­Lions2022: Ad­dress­ing clin­i­cal tri­al di­ver­si­ty prob­lems will take 're­al work now,' pan­elists say

3 years ago
Pharma
Marketing
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