War in Ukraine may re­quire sig­nif­i­cant tri­al changes, EMA says in new guid­ance

4 years ago
Pharma

When OS is the 'ul­ti­mate safe­ty end­point': FDA lead­ers ques­tion sin­gle-arm tri­als amid scruti­ny of PI3K drugs for ...

4 years ago
FDA+

A po­ten­tial tar­get for Alzheimer's treat­ment? Re­searchers un­earth new im­mune re­sponse path­way

4 years ago
Discovery

Bris­tol My­ers inks $11M deal to set­tle an­ti­com­pet­i­tive claims in HIV suit

4 years ago
Pharma
Law

A medtech com­pa­ny's SPAC merg­er falls flat, miss­ing on nine-fig­ure val­u­a­tion

4 years ago
Financing

Imara re­duced to six em­ploy­ees as the biotech, once again pre­clin­i­cal, ex­plores its op­tions

4 years ago
People

Fore­site's Jim Tanan­baum yanks $250M SPAC, as an RA-backed Ox­ford spin­out braves the chop­py IPO wa­ters

4 years ago
Financing

With more than 30 on­col­o­gy part­ners, Gilead lays out its 2030 vi­sion of 20 new ap­provals

4 years ago
R&D
Pharma

Guest col­umn: What hap­pened with Es­pe­ri­on — and what de­fines suc­cess or fail­ure?

4 years ago
Biotech Voices

Hit by 2 more flops, Bris­tol My­ers and Nek­tar wind down IL-2/PD-1 pro­gram at the cen­ter of $3.6B deal

4 years ago
Deals

TG Ther­a­peu­tics with­draws U2 ap­pli­ca­tion — and its com­po­nen­t's ap­provals — one week be­fore ad­comm

4 years ago
R&D
FDA+

Gilead­'s Im­munomedics set­tles over-hyped AS­CO da­ta mishap for $4M

4 years ago
Law

Zoom­ing in on a biotech lay­off; $1.9B buy­out to fill M&A void; Covid win­ners ap­point new fi­nance chiefs; and more

4 years ago
Weekly

DOJ in­ves­ti­gat­ing Bausch Health over plaque pso­ri­a­sis drug mar­ket­ing — re­port

4 years ago
Pharma
FDA+

Achilles joins Cen­ter for Break­through Med­i­cines site near Philadel­phia; Catal­ent adds new suites at Kansas City ...

4 years ago
Manufacturing

US judge rules that 'Texas two-step' bank­rupt­cy can't help J&J stop a new pro­posed talc law­suit

4 years ago
Pharma
Law

An­oth­er batch of in­sulin re­called by Vi­a­tris due to a la­bel­ing is­sue

4 years ago
Manufacturing

Q&A: Biospring co-founder ex­plains re­cent in­vest­ment in San Diego CD­MO

4 years ago
Manufacturing

FDA tweaks and fi­nal­izes bioavail­abil­i­ty study guid­ance, but most­ly ig­nores Pfiz­er and Mer­ck sug­ges­tions

4 years ago
FDA+

Covid-19 roundup: UK au­tho­rizes 6th vac­cine with Val­neva's OK; FDA de­lays BLA for Re­gen­eron's halt­ed mAb com­bo

4 years ago
Coronavirus

Ma­gen­ta feels the biotech blues, an­nounces lay­offs and clin­i­cal tri­al cuts

4 years ago
People
R&D

With Ed­i­tas' third CEO in as many years, ex­pect a new CMO and new de­vel­op­ment part­ners

4 years ago
People
Cell/Gene Tx

Alzheimer's biotech Alzheon nets $50M Se­ries D; Evelo puts PhI atopic der­mati­tis pro­gram on hold

4 years ago
News Briefing

Mer­ck wins break­through ther­a­py des­ig­na­tion for po­ten­tial pneu­mo­coc­cal vac­cine suc­ces­sor

4 years ago
Pharma
FDA+
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