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Galera shares take a nose­dive in the wake of un­ex­pect­ed PhI­II flop

4 years ago
R&D

Take­da, Wave Life Sci­ences re­vise their $230M R&D col­lab­o­ra­tion, drop­ping dis­cov­ery work

4 years ago
Deals
R&D

Roche-Atea’s Covid-19 pill fails mid-stage tri­al, cloud­ing fu­ture for close­ly watched pro­gram

4 years ago
R&D
Coronavirus

Covid-19 roundup: FDA to give OK for mix-and-match boost­er shots — re­port; WHO group leads cam­paign to ac­quire ...

4 years ago
Coronavirus

Sofinno­va hauls in $548M to build and scale star­tups — as Eu­ro­pean VCs step up their bio­phar­ma game

4 years ago
Financing

Can an IDO/PD-L1 com­bo ever work? No­vo-backed com­pa­ny spells out how in biotech's lat­est IPO fil­ing

4 years ago
Financing

Still reel­ing from PhII fail­ure, Calithera beefs up its on­col­o­gy port­fo­lio with a lit­tle help from Take­da

4 years ago
Deals

With hun­dreds of mil­lions spent on failed ac­cel­er­at­ed ap­provals, re­searchers call for faster FDA with­drawals

4 years ago
FDA+

Sen­ate spend­ing bill slash­es funds for Biden's planned break­through drug ac­cel­er­a­tor at NIH

4 years ago
FDA+

Cri­net­ics spins out ra­dio­phar­ma ef­forts in­to a new com­pa­ny, high­light­ing the grow­ing field­'s al­lure

4 years ago
Financing
Startups

FDA OKs an in­haled ver­sion of smok­ing ces­sa­tion drug Chan­tix — for a com­mon eye dis­ease

4 years ago
Pharma
FDA+

Langer, Ciechanover god­fa­ther the lat­est AI up­start; Ipsen forges $446M AML de­vel­op­ment pact

4 years ago
News Briefing

Es­pe­ri­on gets out the bud­get ax, chop­ping 170 staffers as its big drug launch sput­ters

4 years ago
People
Pharma

Omeros plunges deep­er af­ter FDA re­jects rare dis­ease drug, ask­ing for more in­for­ma­tion

4 years ago
FDA+

Third time's the charm: Adamis nabs ap­proval of high-dose nalox­one in­jec­tion af­ter two CRLs

4 years ago
FDA+

Two drug­mak­ers hit with PDU­FA date de­lays from FDA amid back­log of in­spec­tions

4 years ago
Manufacturing

Phath­om's old Take­da drug bests Pre­vacid in a PhI­II GI tri­al. Next stop? The FDA

4 years ago
R&D

Ver­tex gets much-need­ed win with ‘ex­tra­or­di­nary’ first pa­tient re­sults on po­ten­tial di­a­betes cure

4 years ago
R&D
Cell/Gene Tx

Small biotech says its Covid-19 vac­cine spurs more an­ti­bod­ies than As­traZeneca’s. Will sup­ply deals come now?

4 years ago
R&D
Coronavirus

FDA re­jects Re­vance's pitch for Botox com­peti­tor as biotech blames man­u­fac­tur­ing is­sues

4 years ago
FDA+

Boehringer nabs FDA's first in­ter­change­abil­i­ty des­ig­na­tion for its Hu­mi­ra com­peti­tor — but will it mat­ter?

4 years ago
Pharma
FDA+

Bio­gen hit by ALS set­back with PhI­II fail­ure for tofersen — but fol­lows a fa­mil­iar strat­e­gy high­light­ing the ...

4 years ago
R&D

Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s ...

4 years ago
Weekly

Roche's Tecen­triq cross­es the fin­ish line first in ad­ju­vant lung can­cer, po­ten­tial­ly kick­ing off gold rush

4 years ago
Pharma
FDA+
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