FDA slaps back small-cap's bid to re­pur­pose 50-year-old chemother­a­py

4 years ago
FDA+

Jeff Blue­stone just raised $265M to de­vel­op cu­ra­tive cell ther­a­pies. We asked him how

4 years ago
People
Startups

Arde­lyx chops a third of its staff af­ter stock-crush­ing fail­ure in chron­ic kid­ney dis­ease

4 years ago
People
FDA+

Am­gen halts a PhI for FLT3 BiTE while re­sum­ing dos­ing on an­oth­er

4 years ago
R&D

Syn­bio uni­corn Zymer­gen jet­ti­sons found­ing CEO, cuts guid­ance as cus­tomers re­port lead prod­uct does­n't work

4 years ago
People
R&D

Roche's PD-L1 fran­chise play­er nabs pri­or­i­ty re­view; One of world's first psy­che­delics re­search in­sti­tutes opens in ...

4 years ago
News Briefing

Fast-grow­ing BeiGene blue­prints 42-acre R&D and man­u­fac­tur­ing cam­pus in the US, with plans to hire 'hun­dred­s'

4 years ago
R&D
Manufacturing

Eli Lil­ly: As do­nanemab fil­ing ap­proach­es, ex­ecs 'even more con­fi­den­t' in da­ta pack­age

4 years ago
R&D
Pharma

Sage drops a pair of late-stage tests for Bio­gen-part­nered de­pres­sion drug, rais­ing the stakes on a fi­nal tri­al

4 years ago
R&D

Go­ing so soon? Schol­ar Rock CEO makes swift ex­it, leav­ing Nagesh Ma­han­thap­pa back at the helm

4 years ago
People

Opin­ion: Pric­ing in­fo with new drug ap­provals: Time for trans­paren­cy

4 years ago
FDA+
Opinion

J&J, GV back a new sin­gle-cell ap­proach for tack­ling in­flam­ma­to­ry dis­eases and hack­ing the tu­mor mi­croen­vi­ron­ment

4 years ago
R&D

FDA lifts year-plus hold on No­var­tis' Zol­gens­ma, set­ting the stage for new PhI­II

4 years ago
Cell/Gene Tx
FDA+

Cy­to­Dyn faces DOJ, SEC sub­poe­nas af­ter pro­mot­ing failed Covid-19 drug

4 years ago
R&D

Rare dis­ease drug­mak­ers to Con­gress: Don't gut the ac­cel­er­at­ed ap­proval path­way

4 years ago
FDA+

Af­ter strug­gling with its sole drug for years, Mar­i­nus rides pos­i­tive da­ta to a com­mer­cial­iza­tion deal in Eu­rope

4 years ago
Deals
FDA+

Sanofi buys mR­NA play­er Trans­late Bio for $3.2B. And the price fits a pop­u­lar range for biotech M&A

4 years ago
Deals

Bris­tol My­ers pulls lym­phoma in­di­ca­tion for Is­to­dax af­ter con­fir­ma­to­ry tri­al falls flat

4 years ago
Pharma

FTC pulls re­main­ing case against Ab­b­Vie; New EU clin­i­cal tri­als sys­tem com­ing in 2022; Abing­worth bets big on CymaBay

4 years ago
News Briefing

Ab­cam brings a long­time col­lab­o­ra­tor in house as part of $340M buy­out pact

4 years ago
Deals
Outsourcing

With clin­i­cal tri­als lined up for Zen­tal­is drugs, Chi­na's Zen­tera sets its sights on more deal­mak­ing and an IPO

4 years ago
Financing
China

What hap­pens when you give a mouse a hu­man self-anti­gen? In­vestors bet $110M to find out

4 years ago
Financing

Mod­er­na takes on a low-risk pact with CAR-T play­er Au­to­lus for mR­NA-based can­cer drugs

4 years ago
Deals

A glob­al pan­dem­ic fi­as­co sets the stage for Till­man Gern­gross to in­tro­duce his biotech uni­corn to Wall Street

4 years ago
Bioregnum
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