How the SCO­TUS de­ci­sion to gut the FTC could help bio­phar­ma com­pa­nies

4 months ago
Pharma
FDA+

Law pro­fes­sors call for FDA to dis­close all safe­ty and ef­fi­ca­cy da­ta for drugs

5 months ago
Pharma
FDA+

Why re­mote drug man­u­fac­tur­ing eval­u­a­tions won't re­al­ly re­duce FDA's back­log of in­spec­tions

5 months ago
FDA+
Manufacturing

Ex­clu­sive: Genen­tech's for­mer Tecen­triq 'CEO' jumps ship to head up com­mer­cial at an on­colyt­ic virus play­er

5 months ago
People

Ver­sant pulls the wraps off of near­ly $1B in 3 new funds out to build the next fleet of biotech star­tups. And this new gen­er­a­tion is built for speed

5 months ago
Financing
Startups

Q1: A flood of in­vestor cash drove biotech's num­bers to new record highs, and the tor­rent of cash is mov­ing up­stream fast

5 months ago
Deals

Re­cur­sion founders gin for­tunes as IPO back­ers show­er $436M on one of the biggest boasts in AI — based on some very small deals

5 months ago
Bioregnum
Opinion

Har­vard bil­lion­aire Tim Springer has lined up his lat­est biotech launch. And he's re­cruit­ed a star R&D ex­ec to man­age their break­through game plan

5 months ago
Startups

Ex­clu­sive in­ter­view: Pe­ter Marks on why full Covid-19 vac­cine ap­provals could be just months away

5 months ago
FDA+
Coronavirus

Near­ly a year af­ter Au­den­tes' gene ther­a­py deaths, the tri­al con­tin­ues. What hap­pened re­mains a mys­tery

5 months ago
Cell/Gene Tx
In Focus

End­points ex­clu­sive: Bob Nelsen's Re­silience snags Flori­da CD­MO work­ing with the De­fense De­part­ment on Covid-19 an­ti­body

5 months ago
Deals

Pa­trizia Cavaz­zoni named per­ma­nent di­rec­tor of CDER, adding to ques­tions around where Wood­cock will end up

5 months ago
People
FDA+

Gene ther­a­pies for neu­rode­gen­er­a­tive dis­eases: Pfiz­er, No­var­tis, Bio­gen and oth­ers seek more from FDA

5 months ago
Cell/Gene Tx
FDA+

Scoop: Fer­ring, Black­stone’s $570M gene ther­a­py ven­ture has im­plod­ed af­ter CMC is­sues stymied a once high-pro­file quest

5 months ago
FDA+
Manufacturing

The CHIC in­ter­view: Stéphane Ban­cel on Mod­er­na's overnight trans­for­ma­tion, the new time­line on vac­cine de­vel­op­ment and his one re­gret in 2020

5 months ago
People
Publisher's note

PDU­FA VII ne­go­ti­a­tions near fin­ish line with plans to re­vamp CBER and staff up

5 months ago
Pharma
FDA+

The End­points 100 sur­vey: CEOs changed the way biotechs op­er­ate dur­ing the pan­dem­ic. Things will nev­er be the same again

5 months ago
People
Special

FDA and EMA sig­nal an op­por­tu­ni­ty to har­mo­nize ad­vanced ther­a­py reg­u­la­tions

5 months ago
Cell/Gene Tx
FDA+

David David­son’s R&D odyssey takes him out of blue­bird to an­oth­er biotech start­up with big plans to trans­form ther­a­py

5 months ago
People

The 20(+1) un­der 40: In­side the next gen­er­a­tion of biotech lead­ers

5 months ago
Special

Eu­ro­pean Com­mis­sion preps for ma­jor over­haul of phar­ma leg­is­la­tion

5 months ago
Pharma
FDA+

FDA un­veils top 5 pri­or­i­ties for re­work­ing its Covid-19 re­sponse mov­ing for­ward

5 months ago
FDA+
Coronavirus

Neil Ku­mar’s Bridge­Bio team locks in a $2.4B part­ner­ship as their next drug gets a snap re­view at the FDA

5 months ago
Deals

No­var­tis and Genen­tech push for clar­i­ty from FDA on how dis­ease pro­gres­sion mod­els can be used for reg­u­la­to­ry de­ci­sions

5 months ago
Pharma
FDA+
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