'Hands may be tied': FDA slaps Ver­ri­ca with 3rd CRL due to prob­lems with con­tract man­u­fac­tur­er

4 years ago
FDA+

Bris­tol My­ers Squibb sues No­var­tis for roy­al­ties sur­round­ing the use of trans­genic mice

4 years ago
Pharma
Law

West Vir­ginia man faces prison time for threat­en­ing emails to Fau­ci, oth­er health of­fi­cials

4 years ago
People
Pharma

Phar­ma com­pa­ny con­tin­ues its FDA law­suit spree, this time af­ter agency de­nies fast-track des­ig­na­tion

4 years ago
FDA+

Mod­er­na chief Ban­cel to do­nate about $355M worth of ear­ly stock to char­i­ty

4 years ago
People
Pharma

Mod­er­na seeks to dis­miss Al­ny­lam suit over Covid-19 vac­cine com­po­nent, claim­ing wrong venue

4 years ago
Coronavirus
Law

GSK avoids strike as UK work­ers ac­cept pay ne­go­ti­a­tion

4 years ago
People
Pharma

Cracks in the fa­cade: Is phar­ma's pan­dem­ic ‘feel good fac­tor’ wan­ing?

4 years ago
Pharma
Marketing

Mar­ket­ingRx roundup: GSK in­vites al­ler­gy suf­fer­ers to cre­ate cus­tom mon­sters; Merz kicks off soc­cer spon­sor­ship

4 years ago
Pharma
Marketing

Geno­cea reach­es end of road, delist­ing from Nas­daq and let­ting go of re­main­ing staff

4 years ago
People

They sold their last biotech to Mer­ck. Now they're back with a PARP out­fit named af­ter a Lon­don street

4 years ago
Startups

Af­ter pri­vate and state in­vest­ment, Am­pli­fy­Bio plans to ex­pand to an­oth­er Colum­bus, OH lo­ca­tion

4 years ago
Outsourcing
Manufacturing

Covid-19 roundup: Serum In­sti­tute eyes Africa for glob­al ex­pan­sion — re­port; Jun­shi an­tivi­ral hits pri­ma­ry end­point ...

4 years ago
Coronavirus

FDA ac­cepts pri­or­i­ty re­view of CSL-uniQure he­mo­phil­ia B gene ther­a­py; Fo­s­un Phar­ma nets an­oth­er deal

4 years ago
News Briefing

Plan­ning ahead for crowd­ed ul­cer­a­tive col­i­tis mar­ket, Pfiz­er spells out PhI­II da­ta on $6.7B Are­na drug

4 years ago
R&D

Pfiz­er spin­out Spring­Works will ship its first drug to the FDA be­fore year’s end with PhI­II win

4 years ago
R&D

With top­i­cal ap­proval, Der­ma­vant looks to bring new stan­dard-of-care to plaque pso­ri­a­sis pa­tients

4 years ago
FDA+

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

4 years ago
R&D
In Focus

Man­u­fac­tur­ing con­cerns spur clin­i­cal hold on small biotech's Alzheimer's tri­al — shares plunge

4 years ago
FDA+

House Re­pub­li­cans at­tack Chi­na-on­ly da­ta in FDA sub­mis­sions, seek new in­ves­ti­ga­tion in­to re­search in­spec­tions

4 years ago
China
FDA+

Blam­ing Covid dis­rup­tion, sup­ply short­ages, mi­cro­cap biotech hits the brakes on cell ther­a­py tri­al

4 years ago
R&D
Cell/Gene Tx

Lil­ly's mirik­izum­ab, once a con­tender for pso­ri­a­sis, bol­sters case for UC in­di­ca­tion in main­te­nance tri­al da­ta ...

4 years ago
R&D
Pharma

Up­dat­ed: FDA calls for non­in­fe­ri­or­i­ty tri­als for an­tibac­te­ri­als, thanks to new drugs for re­sis­tant in­fec­tions

4 years ago
FDA+

Co­pay coupons gone wrong, again: Pfiz­er pays al­most $300K to set­tle com­plaints in four states

4 years ago
Pharma
Law
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