FDA warns Bris­tol My­ers Squibb for im­prop­er­ly in­ves­ti­gat­ing con­t­a­m­i­na­tion at site that makes Abrax­ane

3 years ago
FDA+
Manufacturing

Al­tos Labs founders Bar­ron and Klaus­ner: 'There are mech­a­nisms in the cell where you can re­set not the stress curve, ...

3 years ago
R&D

Key to biosim­i­lar com­pe­ti­tion will come from in­ter­change­abil­i­ty, FDA of­fi­cials say

3 years ago
FDA+

Scoop: A Soft­Bank-backed biotech rais­es more funds af­ter bag­ging $100M+ for fun­gi min­ing

3 years ago
Financing
Startups

Supreme Court toss­es Bris­tol My­er­s' bid to re­vive $1.2B CAR-T case against Gilead

3 years ago
Cell/Gene Tx
Law

Two for­mer Stan­ford re­searchers nab a $41M launch round to learn the se­crets of the ‘se­cre­tome’

3 years ago
Startups
R&D

Min­ing from plants and fun­gi, CNS start­up takes leap in­to psy­choac­tive drugs — com­plete with $30M to kick things ...

3 years ago
Financing
Startups

An­oth­er road­block looms for Bio­Mar­in's he­mo­phil­ia A gene ther­a­py — but it might not take too long

3 years ago
Cell/Gene Tx
FDA+

Lon­nie Moul­der’s new biotech play grabs $118M, steer­ing in­to PhI­II and more deals

3 years ago
Deals

FDA and PTO look to shore up in­con­sis­ten­cies around phar­ma patents

3 years ago
Pharma
FDA+

SCO­TUS to re­view Am­gen-Sanofi patent bat­tle as a proxy for how nar­row­ly phar­ma patents will need to be writ­ten

3 years ago
Pharma
Law

FDA ten­ta­tive­ly hints at EUA, with a tri­al re­quire­ment, for Veru's new Covid drug ahead of ad­comm

3 years ago
FDA+
Coronavirus

ONO ex­er­cis­es Fate CAR-T op­tion in lat­est twist to part­ner­s' four-year deal

3 years ago
Pharma
Cell/Gene Tx

Astel­las sig­nals on­col­o­gy as­pi­ra­tions to health­care providers in ‘Change­mak­ers’ cam­paign

3 years ago
Pharma
Marketing

Mer­ck con­tin­ues rare breast can­cer cam­paign fo­cused on chal­lenges for Black women

3 years ago
Pharma
Marketing

For $700M+, Vi­a­tris nabs two biotechs as eye dis­ease em­pha­sis comes in­to view

3 years ago
Deals

With all hands on deck for lead sick­le cell tri­al, Beam pulls back clin­i­cal plans for sec­ond base edit­ing ther­a­py

3 years ago
R&D
Cell/Gene Tx

Sen­so­ri­on nabs rare pe­di­atric des­ig­na­tion for gene ther­a­py; Ava­lo sells off re­main­ing drug rights for $5M

3 years ago
News Briefing

Ku­ra On­col­o­gy se­cures up to $150M in Bris­tol My­ers eq­ui­ty in­vest­ment, loan from Her­cules Cap­i­tal

3 years ago
Financing

As Roche pre­pares to take a kid­ney dis­ease drug in­to PhI­II, Io­n­is flesh­es out the da­ta

3 years ago
R&D

Up­dat­ed: Verve's land­mark base edit­ing tri­al for car­dio drug runs in­to FDA hold

3 years ago
R&D
Cell/Gene Tx

GSK re­ports PhI­II flop for BC­MA drug — rais­ing ques­tions about its fu­ture and up­ping the stakes on com­bos

3 years ago
R&D

Am­gen maps a PhI­II jour­ney for its lat­est great car­dio drug hope­ful. Can it suc­ceed this time?

3 years ago
R&D

Lat­est news on pa­tient death in n-of-1 CRISPR tri­al; Good news for RSV; Vac­cine R&D rev­o­lu­tion; and more

3 years ago
Weekly
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