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Roche's triplet in­volv­ing Tecen­triq clears the PFS bar for melanoma when added to BRAF/MEK com­bo

6 years ago
R&D
Pharma

Sarep­ta was stunned by the re­jec­tion of Vyondys 53. Now it's stun­ning every­one with a sur­prise ac­cel­er­at­ed ap­proval

6 years ago
R&D
FDA+

Stephen Hahn con­firmed as new FDA chief

6 years ago
FDA+

Bris­tol-My­er­s' strat­e­gy, BD chief Paul Bion­di ex­it­ed the com­pa­ny — just ahead of the $74B Cel­gene deal close

6 years ago
People

House pass­es Pelosi drug pric­ing bill on par­ty-line vote

6 years ago
Pharma

Kite Phar­ma's ex-CEO con­tra­dicts founder as CAR-T patent tri­al heats up, with con­flict­ing val­u­a­tions

6 years ago
Cell/Gene Tx

Eveni­ty fi­nal­ly wins EU ap­proval; US-Chi­na bi­o­log­ics CD­MO rais­es $60M

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KRAS analy­sis vaults Mer­ck­'s flag­ship Keytru­da back in­to the spot­light

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As­traZeneca joins Mer­ck, Bris­tol-My­ers in Chi­na's check­point race as reg­u­la­tors OK first PD-L1

6 years ago
China
Pharma

On the heels of promis­ing MCL da­ta, Kite hus­tles its 2nd CAR-T to the FDA as the next big race in the field draws to ...

6 years ago
R&D

Cor­re­vio is putting it­self up on the auc­tion block af­ter FDA re­view pan­el points to an­oth­er re­jec­tion

6 years ago
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In a key step for psy­che­del­ic re­search, mag­ic mush­room com­pound clears first clin­i­cal safe­ty hur­dle

6 years ago
R&D

Al­pham­ab On­col­o­gy rounds out HKEX's sec­ond biotech IPO year with $230M raise and high lo­cal in­ter­est

6 years ago
Financing
China

For sale: Long-act­ing PhI­II GLP-1 di­a­betes drug that’s way be­hind ri­vals, now spurned by Sanofi

6 years ago
R&D

Parkin­son's trans­plants emerge as stem cell pi­o­neer Jeanne Lor­ing joins R&D race

6 years ago
Startups

FDA slaps down Alk­er­mes for mis­lead­ing Viv­it­rol ads — don't for­get vul­ner­a­bil­i­ty to opi­oid over­dose

6 years ago
FDA+

FDA in-house re­view spot­lights an is­sue with one of Hori­zon's end­points but notes ef­fi­ca­cy for lead drug

6 years ago
R&D

Seat­tle Ge­net­ics de­tails pos­i­tive OS and PFS da­ta for tu­ca­tinib in breast can­cer

6 years ago
R&D

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6 years ago
News Briefing

Bat­tered, cash hun­gry In­tec feels the burn of No­var­tis re­jec­tion

6 years ago
Deals

What does $6.9B buy these days in on­col­o­gy R&D? As­traZeneca has a land­mark an­swer

6 years ago
R&D

Bris­tol-My­ers shows off a low-pro­file AML con­tender it gained from Cel­gene buy­out — and they’re tak­ing it ...

6 years ago
R&D

De­sert­ed by Astel­las and Mer­ck, lit­tle Cor­re­vio still can't win over FDA pan­el con­cerned with its AFib drug's safe­ty

6 years ago
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New trade deal knocks out long-sought bi­o­log­ics pro­tec­tions for drug­mak­ers

6 years ago
R&D
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