The renowned drug hunter, the Wash­ing­ton in­sid­er, the MIT strate­gist: How did one low-pro­file biotech en­list a dream team of top biotech ad­vi­sors?

2 months ago
Bioregnum
Cell/Gene Tx

FDA+ roundup: FDA chief sci­en­tist de­parts to be deputy sur­geon gen­er­al; New trans­paren­cy on on­col­o­gy ac­cel­er­at­ed ap­provals

2 months ago
FDA+

An­ti­sense tech­nol­o­gy changed one dev­as­tat­ing dis­ease. Why has­n't it trans­formed oth­ers?

2 months ago
R&D
In Focus

FDA+ roundup: CDER's break­through des­ig­na­tion re­quests see steep de­cline in 2021; Drug­mak­ers call to ex­pand FDA guid­ance on PD-(L)1 dos­ing

2 months ago
FDA+

A qui­et car­dio up­start makes some noise, get­ting $300M from Bain and div­ing deep in­to the clin­ic — with some re­al mon­ey for pipeline deals

2 months ago
Financing

Ex­clu­sive: Athi­ra CEO Leen Kawas re­signs af­ter in­ves­ti­ga­tion finds she ma­nip­u­lat­ed da­ta

3 months ago
People

How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

3 months ago
FDA+

No­vo CEO Lars Fruer­gaard Jør­gensen on R&D risk, the deal strat­e­gy and tar­gets for gen­der di­ver­si­ty

3 months ago
R&D

No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

3 months ago
R&D

Q&A: Till­man Gern­gross ex­plains why his Covid mAb will have an edge over an al­ready crowd­ed field

3 months ago
Coronavirus

As­traZeneca on­col­o­gy R&D chief Su­san Gal­braith: 'Y­ou're go­ing to need or­thog­o­nal com­bi­na­tion­s'

3 months ago
R&D

FDA+ roundup: Marks on Wood­cock­'s tenure as act­ing com­mis­sion­er; FDA lead­ers of­fer per­spec­tive on bar­ri­ers to di­ver­si­ty in re­search

3 months ago
R&D

The End­points 100 gives a C-suite thumbs down on 'crip­pling' price pro­pos­als and Aduhelm. Plus: Is any­one go­ing to JP Mor­gan?

3 months ago
Bioregnum
Special

FDA+ roundup: Sen. Burr on strength­en­ing FDA's readi­ness; ICH guide­line adop­tion; Long­time FDA lawyer re­tires and more

3 months ago
FDA+

Is the biotech boom start­ing to fade? The roar­ing ‘20s starts to look a lit­tle fa­tigued. Plus: Top 5 deals, IPOs, pacts of Q3

3 months ago
Deals
Bioregnum

Con­tract re­search is hav­ing a mo­ment right now. Will M&A splash­es dri­ve the in­dus­try to even greater heights?

3 months ago
Outsourcing
In Focus

The coro­n­avirus vac­cine that the world for­got could still help save it

3 months ago
Coronavirus
In Focus

FDA+ roundup: Bs­U­FA III ready for show­time, court tells FDA to re-work com­pound­ing plan, new guid­ance up­dates and more

4 months ago
FDA+

The End­points 11: They've got mad mon­ey and huge am­bi­tions. It's time to go big or go home

4 months ago
Startups

So what hap­pened with No­var­tis Gene Ther­a­pies? Here's your an­swer

4 months ago
People
Bioregnum

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

4 months ago
Bioregnum

The biggest ques­tions fac­ing gene ther­a­py, the XLMTM com­mu­ni­ty, and Astel­las af­ter fourth pa­tient death

4 months ago
Cell/Gene Tx
FDA+

Ex­clu­sive: Prison and multi­bil­lion dol­lar buy­outs lat­er, Sam Wak­sal is all in on the biotech game, with some big-name back­ers

4 months ago
People
Startups

'A missed op­por­tu­ni­ty': The biggest take­aways from the FDA's un­der­whelm­ing gene ther­a­py hear­ing

4 months ago
Cell/Gene Tx
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