Covid-19 roundup: Swiss biotech halts in-pa­tient PhII study; Hous­ton-based vac­cine and Chi­nese mR­NA shot nab EUAs in ...

3 years ago
Coronavirus

Re­cent­ly out-of-stealth neu­ro­science out­fit un­veils cash raise, more de­tails on Lil­ly, North­west­ern pro­grams

3 years ago
Financing
R&D

Sol­id Bio gets a new CEO, $75M cash and drops lead drug as big in­vestors ju­ry-rig a merg­er deal

3 years ago
Deals
Cell/Gene Tx

Chi­na’s Yisheng­Bio is go­ing to Nas­daq, mak­ing the tran­si­tion via $230M SPAC ma­neu­ver

3 years ago
Financing
China

Bio­Marin re­turns to FDA with a new pitch for he­mo­phil­ia gene ther­a­py — and a promise to get to the bot­tom of ...

3 years ago
Cell/Gene Tx
FDA+

'Don't eat me' up­start taps Take­da vet on path to the clin­ic; Greg Mayes leaves An­tios for Cana­di­an psy­che­delics ...

3 years ago
Peer Review

Up­dat­ed: Af­ter long and wind­ing road, FDA ap­proves Amy­lyx's ALS drug in vic­to­ry for pa­tients and ad­vo­ca­cy groups

3 years ago
FDA+

FDA's ad­vanced ther­a­pies of­fice pro­vides more clar­i­ty on gene ther­a­py CMC con­sid­er­a­tions

3 years ago
Pharma
Cell/Gene Tx

CMS spent more than $18B in four years on ac­cel­er­at­ed ap­provals with in­com­plete con­fir­ma­to­ry tri­als, in­spec­tor ...

3 years ago
Pharma
FDA+

Some­one old, some­one new: Mod­er­na pro­motes CTO, raids No­var­tis for re­place­ment amid pipeline push

3 years ago
People
Pharma

Sanofi, Re­gen­eron’s Dupix­ent scores an­oth­er in­di­ca­tion with first-ever ap­proval for nodu­lar skin dis­or­der

3 years ago
Pharma
FDA+

Sen­ate pass­es bill to re­work an­i­mal test­ing re­quire­ments for drug de­vel­op­ers

3 years ago
FDA+
Law

Pa­tient re­port finds con­sti­pa­tion con­di­tion not well-man­aged, open­ing door for bet­ter ed­u­ca­tion from phar­ma

3 years ago
Pharma
Marketing

Cell and gene ther­a­pies from acad­e­mia: EMA to help 5 projects go­ing af­ter un­met clin­i­cal needs

3 years ago
Cell/Gene Tx
FDA+

Gilead names 'k­ing­pin­s' in coun­ter­feit HIV med law­suit

3 years ago
Pharma
Law

Vor Bio opts to keep man­u­fac­tur­ing op­er­a­tions in-house for de­vel­op­ing stem cell, CAR-T ther­a­pies

3 years ago
Pharma
Manufacturing

Aim­ing for fourth nod, Sarep­ta files an­oth­er DMD gene ther­a­py to FDA; Ax­some head­ed to­ward mi­graine re­sub­mis­sion

3 years ago
News Briefing

Siga nabs $10.7M from the US gov­ern­ment in deal for its mon­key­pox an­tivi­ral

3 years ago
Deals

As Amy­lyx de­ci­sion waits in the wings, Bio­haven’s ALS drug sinks (again) in plat­form tri­al

3 years ago
R&D

Almi­rall part­ners up with Sim­cere in po­ten­tial $500M+ deal — with plans to take IL-2 can­di­date glob­al

3 years ago
Deals
China

Man­u­fac­tur­ing roundup: Ace­to re­brands to Actylis; WuXi STA opens an­oth­er fa­cil­i­ty

3 years ago
Manufacturing

Tar­sus looks to raise aware­ness of eye­lid mite dis­ease in cam­paign aimed at eye­care spe­cial­ists

3 years ago
Pharma
Marketing

Ali­gos co-founders shoot back at J&J IP com­plaint with one of their own al­leg­ing fraud

3 years ago
R&D

Ax­cel­la touts in­ter­im NASH da­ta but needs cash to stay afloat for 2024 topline read­out

3 years ago
R&D
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