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Amy­lyx's ALS drug gets a three-month PDU­FA de­lay, set­ting up the piv­otal de­ci­sion for Sep­tem­ber

4 years ago
R&D
FDA+

Bris­tol My­ers jumps in­to the M&A game with a $4B on­col­o­gy buy­out. And weary biotech an­a­lysts could­n't be any hap­pi­er

4 years ago
Deals

Days af­ter dis­clos­ing tri­al flop, stem cell ther­a­py de­vel­op­er ax­es 70% of work­force while search­ing for cash

4 years ago
People

All in on ear­ly-stage, Qim­ing US bags $260M, re­cruits Atara founder Isaac Ciechanover for Fund III

4 years ago
Financing

Time Pas­sages: Bruce Gold­smith out at Jim Wilson's gene ther­a­py biotech; Flag­ship re­veals Michael Sev­eri­no’s CEO ...

4 years ago
Peer Review

Re­gen­eron inks $1B+ deal for glob­al rights to Sanofi-part­nered PD-1 Lib­tayo

4 years ago
Deals
Pharma

Pfiz­er, like Mod­er­na, fires back at Al­ny­lam suit over Covid-19 vac­cine patents

4 years ago
Pharma
Coronavirus

No­var­tis re­sumes re­mote busi­ness in Ukraine af­ter safe­ty pro­to­col re­view

4 years ago
Pharma

An­oth­er refuse-to-file for a small biotech — is the FDA us­ing RTFs to man­age its work­load?

4 years ago
FDA+

Organon de­buts mu­rals cre­at­ed by women around the world, plus am­bi­tious ESG plan, on first an­niver­sary

4 years ago
Pharma
Marketing

Gilead poach­es new phar­ma de­vel­op­ment and man­u­fac­tur­ing chief from cell ther­a­py 2.0 play­er

4 years ago
R&D
Manufacturing

FDA com­pli­ance vet heads to In­dia-based Lupin af­ter long pub­lic ca­reer

4 years ago
People
FDA+

Man­u­fac­tur­ing roundup: Lon­za col­lab­o­rates with a VC in Is­rael; Pi­ra­mal up­dates one fa­cil­i­ty while open­ing a new one

4 years ago
Manufacturing

The tar­get is the sys­tem: Con­den­sates biotech as­pires to ‘rewrite the rule­book’ on drug dis­cov­ery

4 years ago
Financing

Bio­gen, Sam­sung Bioepis look to carve up a block­buster Roche fran­chise with deep dis­count biosim­i­lar

4 years ago
Marketing

Civi­ca nabs tri­al part­ner as it forges ahead to cre­ate more af­ford­able in­sulins

4 years ago
R&D
Manufacturing

Centes­sa ax­es lead pro­gram af­ter a pa­tient in kid­ney dis­ease safe­ty study is hos­pi­tal­ized

4 years ago
R&D

Af­ter fil­ing for bank­rupt­cy, re­ject­ed mi­graine drug de­vel­op­er Zosano’s val­ue more than halved

4 years ago
People

San­thera rene­go­ti­ates mile­stone pay­ment, in­creas­es liq­uid­i­ty run­way in­to 2023 pend­ing NDA fil­ing

4 years ago
Financing
R&D

Im­mat­ics imag­ines broad­er CAR-T pipeline with an­oth­er Bris­tol My­ers pact and ad­di­tion to 2019 TCR deal

4 years ago
Deals
Cell/Gene Tx

Evonik to make a mul­ti­mil­lion-dol­lar in­vest­ment at their In­di­ana site

4 years ago
Manufacturing

Cam­brex se­cures ac­qui­si­tion in Ire­land, in­creas­ing their Eu­ro­pean foot­print

4 years ago
Manufacturing

Sana banks on $100M sav­ings as it shifts man­u­fac­tur­ing plans to Wash­ing­ton state

4 years ago
Manufacturing

Pre­ci­sion drug + di­ag­nos­tics biotech scores mod­est Se­ries A, retro­fitting ex­ist­ing drug for new in­di­ca­tion

4 years ago
Financing
Diagnostics
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