Pharma channel feed

Ky­owa Kirin gets some added love from the FDA, win­ning their sec­ond drug OK in 4 months

7 years ago

Cell­tri­on re­ceives Form 483 for trou­bled Ko­re­an site

7 years ago

Trump ad­min­is­tra­tion opens the door to low­er drug prices as Medicare Ad­van­tage plans are pushed to step ther­a­py ap­proach

7 years ago

14-year-old par­tial hold comes back to haunt Gem­phire, bat­ter­ing shares and wreck­ing time­lines

7 years ago
R&D

New re­port sin­gles out Big Phar­ma play­ers for ring­ing their block­busters with patents while hik­ing prices for years

7 years ago

Boehringer or­ga­nizes a coali­tion in search of first CF gene ther­a­py, work­ing with re­search, man­u­fac­tur­ing part­ners

7 years ago
R&D

Block­buster dreams quashed, Iron­wood drops As­traZeneca's $1.3B gout drug dis­as­ter

7 years ago

With PD-1 OK loom­ing, Re­gen­eron antes $100M on blue­bird al­liance for next-gen TCR cell ther­a­py pact

7 years ago

Roche gets some reg­u­la­to­ry love for its break­through quest on a PhI­II Hunt­ing­ton's drug

7 years ago

EMA: More staff than an­tic­i­pat­ed quit ahead of Brex­it re­lo­ca­tion

7 years ago

No­var­tis dis­patch­es two more can­cer drug castoffs to a part­ner in Chi­na

7 years ago
R&D

The bar low­ers yet again for PRV prices, with Ky­owa/Ul­tragenyx sell­ing at $80.6M

7 years ago

As NDA talks loom, FDA hands Dai­ichi Sankyo a ‘break­through’ on its $410M AML drug quizar­tinib

7 years ago

FDA hus­tles through a quick OK for Sh­ionogi's new throm­bo­cy­tope­nia drug

7 years ago

FDA ap­proves can­cer ra­di­a­tion drug Aze­dra, send­ing Prog­en­ics stock north

7 years ago

We've sched­uled your Type T meet­ing with FDA com­mish Scott Got­tlieb, where you can learn the art of rapid fire R&D

7 years ago
R&D

As it fights loom­ing com­pe­ti­tion on Sub­ox­one, In­di­v­ior gets FDA OK on new schiz­o­phre­nia drug

7 years ago

FDA out­lines a laun­dry list of sur­ro­gate end­points with an eye to ex­pand­ing the ros­ter for drug de­vel­op­ers

7 years ago

Kick­back, bribery and rack­e­teer­ing charges are fol­lowed by a CRL for opi­oid spray at scan­dal-plagued In­sys

7 years ago

FDA fi­nal­izes guid­ance clos­ing pe­di­atric study loop­hole

7 years ago

Af­ter an epic bat­tle of block­busters, Mer­ck leapfrogs Bris­tol-My­ers to take the lead on PD-1/L1 mar­ket

7 years ago
R&D

Bris­tol-My­ers takes an­oth­er hit on Op­di­vo/Yer­voy com­bo as CHMP turns thumbs down on front­line kid­ney can­cer

7 years ago

On top of ex­pir­ing Her­ceptin patents, Roche faces huge roy­al­ty loss­es in 2019

7 years ago

Look­ing to mount an R&D turn­around, GSK gets slapped down at the FDA for a weak stab at COPD

7 years ago
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