House pass­es two bills on con­tin­u­ous man­u­fac­tur­ing, stock­pil­ing ahead of fu­ture pan­demics

4 years ago
Manufacturing

FDA re­jects Unit­ed's po­ten­tial PAH drug due to a man­u­fac­tur­ing is­sue

4 years ago
FDA+
Manufacturing

Re­call re­port: Glass found in Mer­ck an­tibi­ot­ic threat­ens 22,000 vials

4 years ago
Manufacturing

No­var­tis ex­pands Covid-19 vac­cine man­u­fac­tur­ing deal with Pfiz­er/BioN­Tech; Exacis links with CCRM for NK cell ...

4 years ago
Manufacturing

Fu­ji­film breaks ground on mas­sive NC site, open­ing the path to be­come a man­u­fac­tur­ing pow­er­house

4 years ago
Manufacturing

Short­ly af­ter pump­ing $50M in­to In­di­ana site, Catal­ent will hire up to 600 new em­ploy­ees

4 years ago
Manufacturing

Lian­Bio an­nounces terms for IPO next week; NIH and White House of­fi­cials dis­cuss hy­po­thet­i­cal bio-med re­search agency

4 years ago
News Briefing

How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

4 years ago
FDA+

Eli Lil­ly or­dered to pay roy­al­ties on block­buster di­a­betes drugs, though ex­act dam­ages are un­clear

4 years ago
Pharma

Sen­a­tors back FDA's plan to re­quire manda­to­ry pre­scriber ed­u­ca­tion for opi­oids

4 years ago
FDA+

Covid-19 roundup: Pfiz­er/BioN­Tech say boost­er is 95.6% ef­fec­tive; Eu­ro­pean Par­lia­ment calls for more vac­cine ...

4 years ago
Coronavirus

Te­va ap­peals to court to keep 'in­cred­i­bly dam­ag­ing' Hol­ly­wood par­o­dy videos un­der wraps in New York opi­oid case

4 years ago
Pharma
Marketing

Pfiz­er throws its weight be­hind LNP play­er eye­ing mR­NA treat­ments for CF, PCD

4 years ago
Financing
Cell/Gene Tx

As AI con­tin­ues to en­tice Big Phar­ma, a Car­lyle-led drug­mak­er syn­di­cate shells out $430M for cloud com­put­ing play­er

4 years ago
Financing
Deals

Ven­tyx sprints to Wall Street less than a year af­ter emerg­ing from stealth

4 years ago
Financing

Bris­tol My­ers pledges to sell its Ac­celeron shares as ac­tivist in­vestors cir­cle Mer­ck­'s $11.5B buy­out — re­port

4 years ago
Deals
Pharma

Ep­i­darex, Sofinno­va dou­ble down on a par­al­lel take on 3rd-gen CAR-T — aim­ing straight at ovar­i­an can­cer

4 years ago
Financing
Cell/Gene Tx

Boost­er bo­nan­za: FDA en­dors­es 'mix-and-match' scheme, and Mod­er­na and J&J too

4 years ago
Coronavirus

Hedge fund jumps in with Avoro ac­tivists in an at­tempt to de­rail Mer­ck­'s $11B Ac­celeron buy­out

4 years ago
Deals

Covid-19 roundup: Biden plans for ear­ly No­vem­ber roll­out of vac­cines for kids; EMA eval­u­ates Re­gen­eron's an­ti­body ...

4 years ago
Coronavirus

'No ex­cuse': ICER de­ter­mines As­traZeneca's new mon­ey­mak­er Soliris is vast­ly over­priced

4 years ago
Deals
Pharma

J&J dives deep­er in­to bis­pecifics; Spring­Works an­nounces re­search deal over Stan­ford pro­fes­sor's work

4 years ago
News Briefing

FDA slaps As­traZeneca's MCL-1 can­cer drug with a hold af­ter safe­ty is­sue — 2 years af­ter Am­gen axed a trou­bled ...

4 years ago
R&D
FDA+

FDA shoots down a biotech’s last-stand pa­tient pitch af­ter fault­ing da­ta

4 years ago
FDA+
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