Eu­ro­pean Com­mis­sion preps for ma­jor over­haul of phar­ma leg­is­la­tion

5 years ago
Pharma
FDA+

With fresh in­vestor cash in hand, Volas­tra part­ners with Mi­crosoft to de­vel­op metasta­t­ic can­cer bio­mark­er plat­form

5 years ago
Financing
Deals

Big Phar­ma R&D vet­er­an with block­buster cre­den­tials re­turns to his biotech roots as Prothena's new CMO

5 years ago
People

MHRA kicks off new ac­cel­er­at­ed drug ap­proval path­way with ‘in­no­va­tion pass­ports’

5 years ago
Pharma
FDA+

With one pan­dem­ic still rag­ing, J&J bets $780M on a po­ten­tial flu ther­a­py for the next

5 years ago
Deals

Covid-19 roundup: FDA up­dates Mod­er­na vac­cine dose per vial counts; Vir's an­ti­body shows promise against vari­ants

5 years ago
Coronavirus

2,400 peo­ple re­main with­out rare dis­ease drug as Take­da man­u­fac­tur­ing woes con­tin­ue

5 years ago
Pharma
Manufacturing

Hav­ing shipped its first bench­top gene edit­ing de­vices, In­scrip­ta draws an­oth­er $150M from deep in­vestor well

5 years ago
Financing

Watch out, Bris­tol My­ers — J&J is right be­hind you; Blake By­ers leaps out from GV to do his own thing

5 years ago
News Briefing

Rain Ther­a­peu­tics head­lines newest slate of IPO-bound biotechs with $100M pen­ciled in for lead on­col­o­gy pro­gram

5 years ago
Financing

Mar­tin Shkre­li push­es back on life­time pub­lic com­pa­ny ban from prison cell in bid to get back to busi­ness

5 years ago
People

FDA un­veils top 5 pri­or­i­ties for re­work­ing its Covid-19 re­sponse mov­ing for­ward

5 years ago
FDA+
Coronavirus

Pe­ter Thiel jumps aboard Al­loy's lat­est $75M round, adding some heft to the an­ti­body dis­cov­ery out­fit's nascent ...

5 years ago
Financing

An­oth­er day, an­oth­er de­lay: FDA push­es back a sec­ond re­view for Ab­b­Vie's Rin­voq, this time in atopic der­mati­tis

5 years ago
FDA+

Su­per­nus bat­tles back from CRL, scor­ing the FDA's ap­proval for non-stim­u­lant AD­HD med Qel­bree

5 years ago
FDA+

Take­da, CSL Behring fold big plas­ma al­liance af­ter PhI­II flop — join­ing a slew of an­ti­bod­ies that failed to help ...

5 years ago
R&D
Coronavirus

Aca­dia preps for bat­tle as the FDA re­jects a po­ten­tial block­buster ap­pli­ca­tion

5 years ago
FDA+

Af­ter mil­lions of Covid vac­cine dos­es were botched, the feds hand con­trol of a trou­bled Emer­gent Bio fa­cil­i­ty to J&J

5 years ago
Coronavirus
Manufacturing

Leg­endary biotech leader pass­es away, re­newed ten­sion around ad­u­canum­ab, Mer­ck­'s rare de­feat, and more

5 years ago
Weekly

Al­ca­mi ap­points new CEO in Patrick Walsh, the ex­ec­u­tive who helped lead the CD­MO's pre­de­ces­sor com­pa­ny

5 years ago
People
Manufacturing

Pfiz­er breaks ground on ster­ile in­jecta­bles plant in Michi­gan, plans to add around 450 jobs to the re­gion

5 years ago
Manufacturing

Covid-19 man­u­fac­tur­ing roundup: Catal­ent gets the FDA's go-ahead on J&J shot; As­traZeneca taps a new con­trac­tor

5 years ago
Coronavirus
Manufacturing

It's time: Af­ter 19 years, leg­endary Koch In­sti­tute di­rec­tor Tyler Jacks pass­es the torch to Matthew Van­der Hei­den

5 years ago
People

Stu­art Lip­ton of­fers a new pos­si­ble rea­son why all the Alzheimer's drugs have failed

5 years ago
Discovery
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