Af­ter a 5-year re­peat PhI­II so­journ, Lund­beck and Ot­su­ka say they're fi­nal­ly ready to pur­sue OK to use Rex­ul­ti ...

3 years ago
R&D

A Mer­ck part­ner is sucked in­to the fi­nan­cial quag­mire as key lender calls in a note

3 years ago
Financing
Deals

Biden and G7 na­tions of­fer funds for vac­cine and med­ical prod­uct man­u­fac­tur­ing project in Sene­gal

3 years ago
Financing
Manufacturing

Fed­er­al judge de­nies Bris­tol My­er­s' at­tempt to avoid Cel­gene share­hold­er law­suit

3 years ago
Pharma
Law

Take­da, Ar­row­head spot­light da­ta from small tri­al show­ing RNAi works in a rare liv­er con­di­tion

3 years ago
R&D

Mi­to­chon­dria biotech re­ceives Morn­ing­side buy­out of­fer af­ter PhII fail; On­col­o­gy mi­cro­cap with­draws IPO plans

3 years ago
News Briefing

Capri­cor hits pri­ma­ry end­point in Duchenne ex­ten­sion study, ready­ing its FDA pitch

3 years ago
Pharma
Cell/Gene Tx

FDA places par­tial clin­i­cal hold on David Hung biotech af­ter cer­tain can­cer pa­tients ex­pe­ri­ence eye in­flam­ma­tion

3 years ago
R&D
FDA+

Bat­tle-test­ed biotech ex­ecs turn to an ex­pe­ri­enced in­dus­try god­fa­ther for some board­room guid­ance

3 years ago
People
Bioregnum

Re­lay builds out case for an­ti-FGFR drug, shoot­ing for first ac­cel­er­at­ed ap­proval on 'mo­tion-based' drug dis­cov­ery ...

3 years ago
R&D

No stranger to gene ther­a­py woes, Astel­las runs in­to an­oth­er safe­ty-re­lat­ed clin­i­cal hold

3 years ago
Cell/Gene Tx
FDA+

Up­dat­ing the Covid-19 vac­cine: FDA of­fers a qual­i­fied thumbs-up ahead of ad­comm

3 years ago
FDA+
Coronavirus

Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

3 years ago
R&D

Ipsen snags an ap­proved can­cer drug in $247M M&A deal as an­oth­er bat­tered biotech sells cheap

3 years ago
Deals

GSK says its drug for chron­ic hep B could ‘lead to a func­tion­al cure’ — but will it be alone or in com­bi­na­tion?

3 years ago
R&D

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; and more

3 years ago
Weekly

De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

3 years ago
Pharma

FDA un­veils new draft guid­ance to help with oligonu­cleotide ther­a­peu­tics de­vel­op­ment

3 years ago
FDA+

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

3 years ago
Law

Am­ryt Phar­ma sub­mits a for­mal dis­pute res­o­lu­tion to the FDA over re­ject­ed skin dis­ease drug

3 years ago
Pharma
FDA+

VC firms take os­teo­poro­sis drug­mak­er Ra­dius Health pri­vate for al­most $900M

3 years ago
Financing
Deals

In­tel­li­a's CRISPR pro­gram that ed­its genes di­rect­ly in pa­tients shows dura­bil­i­ty in AT­TR amy­loi­do­sis

3 years ago
R&D
Cell/Gene Tx

Phar­ma-friend­ly sen­a­tor calls on FDA for a third time to show patent pro­tec­tions should­n't be blamed for high drug ...

3 years ago
Pharma
FDA+

New re­port de­tails se­quence of events lead­ing up to death of man who re­ceived pig heart trans­plant

3 years ago
R&D
Pharma
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