The FDA ob­jects to biotech bil­lion­aire Bob Dug­gan’s PhI­II plans — and he’s not budg­ing

18 hours ago
FDA+

In­side look: How a po­ten­tial part­ner­ship turned in­to a $1.9B buy­out for Sanofi

18 hours ago
Deals

Lux­tur­na in­ven­tor Jean Ben­nett starts a new gene ther­a­py com­pa­ny to tack­le rare dis­eases left be­hind by phar­ma, VCs

20 hours ago
Startups

Aerie fires CEO af­ter lead pro­gram flop, com­ments about pri­ma­ry end­points be­ing 'not re­quired'

Yesterday
People
Pharma

When ef­fi­ca­cy is bor­der­line: FDA needs to get more con­sis­tent on close-call drug ap­provals, agency-fund­ed re­search finds

Yesterday
FDA+

Div­ing deep­er in­to in­her­it­ed reti­nal dis­or­ders, No­var­tis gob­bles up an­oth­er bite-sized op­to­ge­net­ics biotech

2 days ago
Deals
Cell/Gene Tx

Zol­gens­ma patent spat brews be­tween No­var­tis and Re­genxbio as top No­var­tis gene ther­a­py ex­ec de­parts

2 days ago
Cell/Gene Tx

Ex-My­lan em­ploy­ee pleads guilty to in­sid­er trad­ing, il­le­gal­ly deal­ing on FDA ap­provals, earn­ings and Up­john merg­er

2 days ago
Pharma

As Bay­er, No­var­tis stack up their ra­dio­phar­ma­ceu­ti­cal da­ta at #ES­MO21, a key de­bate takes shape

2 days ago
R&D
In Focus

Mi­rati's KRAS drug looks like the ear­ly fa­vorite in colon can­cer with new da­ta, putting the pres­sure square on Am­gen

3 days ago
R&D

As­traZeneca, Dai­ichi Sanky­o's ADC En­her­tu blows away Roche's Kad­cy­la in sec­ond-line ad­vanced breast can­cer

4 days ago
R&D

Lat­est news: It’s a no on uni­ver­sal boost­ers; Pa­tient death stuns gene ther­a­py field; In­side Tril­li­um’s $2.3B turn­around; and more

4 days ago
Weekly

Skin tu­mors in mice force Pro­tag­o­nist to halt lead pro­gram, crush­ing stock

5 days ago
FDA+

EQRx, CStone un­furl full lung can­cer da­ta for PD-L1 drug in what the part­ners are call­ing a first

5 days ago
R&D

Eu­ro­pean study finds that Gilead­'s Covid-19 an­tivi­ral remde­sivir shows no clin­i­cal ben­e­fit

5 days ago
Coronavirus

AGC un­veils Ger­man ex­pan­sion plans as gene and cell ther­a­py man­u­fac­tur­ing com­pe­ti­tion heats up

6 days ago
Manufacturing

DNA play­er Touch­light dou­bles fundrais­ing this year with lat­est round of pri­vate back­ers on board

6 days ago
Manufacturing

A new way to in­fil­trate (and de­stroy) some of the dead­liest drug-re­sis­tant bugs

6 days ago
Discovery

The Ari­ad vets de­vel­op­ing next-gen TKIs are head­ing back to Nas­daq — and Or­biMed stands to reap the most

6 days ago
Financing
R&D

Take­da scores a win for a rare type of lung can­cer, gear­ing up for a show­down with J&J

6 days ago
FDA+

Am­gen rolls out da­ta for KRAS in­hibitor com­bo study in col­orec­tal can­cer, hop­ing to move on from ug­ly ear­ly re­sults

6 days ago
R&D

FDA ap­pears un­con­vinced by Pfiz­er's case for Covid-19 boost­er in lead up to ad­comm

Last week
R&D

Once held back, Amy­lyx ex­ecs say the FDA is now push­ing for an NDA on ALS drug

Last week
FDA+

Back-to-back piv­otal fail­ures force Ther­a­vance to lay off 270 staffers, prune R&D fo­cus

Last week
People
R&D
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