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

Yesterday
R&D

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

2 days ago
Coronavirus

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

2 days ago
R&D

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

3 days 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?

5 days ago
Bioregnum

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

Last week
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

Last week
Deals
Bioregnum

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

3 weeks ago
Outsourcing
In Focus

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

3 weeks 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 weeks ago
FDA+

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

4 weeks ago
Startups

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

4 weeks ago
People
Bioregnum

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

4 weeks ago
Bioregnum

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

5 weeks 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

Last month
People
Startups

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

Last month
Cell/Gene Tx

FDA posed a sprawl­ing set of ques­tions for two-day gene ther­a­py hear­ing. Here's what com­pa­nies and ex­perts will be watch­ing for

Last month
Cell/Gene Tx
FDA+

Af­ter 2 damn­ing CRLs and 3 de­nied dis­pute-res­o­lu­tion re­quests, an ail­ing, one-time uni­corn has on­ly a glim­mer of hope left with the FDA

Last month
R&D
FDA+

From bench to board­room: 20 of the most in­flu­en­tial bio­phar­ma R&D ex­ec­u­tives in drug de­vel­op­ment

Last month
People
R&D

Next user fee deal re­veals where in­dus­try won at the ne­go­ti­at­ing ta­ble with FDA

Last month
FDA+

Ex­clu­sive: Roche tees up $3B+ for Shape's RNA edit­ing plat­form, with the bold promise of 'one-time' cures for Alzheimer's, Parkin­son's

Last month
Deals

PDU­FA VII: What's new, and what's sig­nif­i­cant in the next user fee deal

Last month
FDA+

FDA+ roundup: New un­ti­tled let­ter for web ads with­out risk in­fo; PAN­DAs and reg­u­la­to­ry un­cer­tain­ty

Last month
FDA+

Scoop: Adam Kop­pel's Bain team has an­oth­er $1.9B to wa­ger on life sci com­pa­nies. And he likes their odds

2 months ago
Bioregnum
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