#AAO22: J&J’s first look at com­mon eye dis­ease port­fo­lio pads the case for PhII of gene ther­a­py

Yesterday
R&D
Pharma

Land­mark Amy­lyx OK spurs de­bate; Some... pos­i­tive? Alzheimer's da­ta; Can­cer tri­al bot­tle­neck; Sanofi's CRISPR bet; ...

Yesterday
Weekly

#AAO22: Iver­ic Bio, un­de­terred by loom­ing PDU­FA for com­peti­tor, touts sub­group da­ta on GA drug

2 days ago
R&D

#AAO22: In bid for first FDA nod in ge­o­graph­ic at­ro­phy, Apel­lis claims an­oth­er first in eye dis­ease field

2 days ago
R&D
Pharma

George Church, Wyss sci­en­tists and North­pond chal­lenge con­ven­tion­al RNA man­u­fac­tur­ing with new biotech

2 days ago
People
Financing

BioCryst launch­es aware­ness cam­paign around man­age­ment of rare vas­cu­lar dis­ease

2 days ago
Pharma
Marketing

EMA makes new rec­om­men­da­tions for Im­bru­vi­ca, med­i­cines with ter­li­pressin over res­pi­ra­to­ry and car­dio­vas­cu­lar risks

2 days ago
Pharma

Up­dat­ed: Al­ny­lam re­in­forces APOL­LO-B patisir­an da­ta be­fore head­ing to the FDA

2 days ago
R&D
FDA+

New in­fla­tion-linked drug re­bates go in­to ef­fect on Sat­ur­day

2 days ago
Pharma
Law

Eu­ro­pean phar­ma group wants to cre­ate PRV-like sys­tem to spur an­tibi­otics R&D

2 days ago
R&D

In­dus­try groups call to block WTO IP waiv­er ex­pan­sion to Covid-19 ther­a­peu­tics

2 days ago
Coronavirus
Law

Mer­ck cel­e­brates an­oth­er win in Janu­via patent bat­tle against Vi­a­tris

2 days ago
Pharma
Law

Ad­vo­cates, ex­perts cry foul over Amy­lyx's new ALS drug, cit­ing is­sues with price, PhI­II com­mit­ment

2 days ago
FDA+

In­ter­cep­t's OCA fails a PhI­II NASH tri­al, rais­ing fresh doubts about its years­long quest for an OK

2 days ago
R&D

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

2 days ago
Coronavirus

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

2 days ago
Financing
R&D

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

2 days ago
Deals
Cell/Gene Tx

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

2 days ago
Financing
China

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

2 days 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 ...

2 days ago
Peer Review

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

3 days ago
FDA+

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

3 days ago
Pharma
Cell/Gene Tx

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

3 days ago
Pharma
FDA+

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

3 days ago
People
Pharma
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