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Af­ter years of de­lay, BeiGene fi­nal­ly lands FDA ap­proval for its PD-1 drug

Last year
China
Pharma

FDA ad­comm votes in fa­vor of Geron's ane­mia drug for can­cer pa­tients de­spite ques­tions on risk

Last year
Pharma
FDA+

FDA ap­proves Madri­gal’s NASH drug, mark­ing the first-ever treat­ment for the liv­er dis­ease

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FDA+

Eu­ro­pean Par­lia­ment to dig in­to phar­ma leg­isla­tive re­vi­sion next week

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Pharma

Phar­ma mass-mar­ket TV ad­ver­tis­ing fad­ing in fa­vor of per­son­al­ized me­dia, agency says

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Pharma
Marketing

Law­mak­ers amp up calls for PBM re­forms to be in­clud­ed in next week's fund­ing pack­age

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Pharma
FDA+

UK's NICE says it's not ready to rec­om­mend Ver­tex's Cas­gevy for sick­le cell

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Pharma
Cell/Gene Tx

BeiGene looks be­yond Chi­na as it se­cures new API source, nears open­ing of US site

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Manufacturing

An API pro­duc­er’s $250M ex­pan­sion; No­ram­co launch­es US API sup­ply; A pack­ag­ing com­pa­ny’s 47% sales jump

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Manufacturing

Co­herus' new fo­cus on on­col­o­gy leads to re­struc­tur­ing, 30% lay­offs

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People

Fe­male in­vestors track progress, call for more women on boards and in lead­er­ship roles

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Financing

OcuTer­ra’s di­a­bet­ic retinopa­thy drug fails PhII; Bet­ter Ther­a­peu­tics to shut down

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News Briefing

Pfiz­er-backed UK biotech rais­es £25M to ad­vance mi­tophagy pipeline

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Financing
Startups

The Change Health­care hack could be a cat­a­lyst for re­al health­care cy­ber­se­cu­ri­ty im­prove­ment

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Ger­man ADC biotech Tubu­lis rais­es $138M to en­ter the clin­ic and ex­pand in US

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Financing
Startups

Spruce Bio­sciences’ stock plum­mets in wake of PhI­Ib flop, biotech to cut staff

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R&D

As­traZeneca eyes rare en­docrinol­o­gy mar­ket with $1.05B buy­out of Amolyt Phar­ma

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Deals
R&D

Swedish biotech rais­es €30M Se­ries A to de­vel­op off-the-shelf gene ther­a­py for sol­id tu­mors

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Financing
Startups

Mirum ex­pands la­bel for rare liv­er dis­ease drug, serv­ing up more com­pe­ti­tion for Ipsen's Byl­vay

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FDA+

BIO to cut ties with WuXi af­ter trade group was ac­cused of act­ing as a for­eign agent

Last year
China
Pharma

FDA rais­es con­cerns of 'ear­ly death­s' in Abec­ma and Carvyk­ti mul­ti­ple myelo­ma tri­als

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Pharma
FDA+

Al­ny­lam takes a fam­i­ly road trip to talk about health his­to­ry and hered­i­ty in new rare dis­ease cam­paign

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Pharma
Marketing

Fed­er­al ap­peals court rules in fa­vor of Arkansas in PhRMA's suit over 340B ex­pan­sion

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Law

Phar­ma in­dus­try rep­u­ta­tion re­mains steady at a ‘new nor­mal’ af­ter Covid, Har­ris Poll finds

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