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

4 months ago
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

4 months ago
R&D
FDA+

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

4 months ago
People
R&D

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

4 months ago
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

4 months ago
Deals

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

5 months ago
FDA+

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

5 months ago
FDA+

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

5 months ago
Bioregnum

Pri­or­i­ty re­view vouch­er up­dates: Who's won PRVs, who's bought them, and how much they're sell­ing for

5 months ago
R&D
FDA+

mGx M&A? Mod­er­na ex­ecs are lever­ag­ing their Covid cash on gene edit­ing, gene ther­a­py deals

5 months ago
Deals
Bioregnum

Jeff Blue­stone just raised $265M to de­vel­op cu­ra­tive cell ther­a­pies. We asked him how

5 months ago
People
Startups

When is a drug in­tend­ed for a spe­cif­ic use? Not just when it's pro­mot­ed as such, FDA says in long-await­ed fi­nal rule

5 months ago
Pharma
FDA+

FDA's on­col­o­gy head Rick Paz­dur de­fends the ac­cel­er­at­ed ap­proval path­way, claim­ing it is 'un­der at­tack'

5 months ago
Pharma
FDA+

In Cure­Vac's fail­ure, a pos­si­ble ver­dict on the past (and fu­ture) of mR­NA vac­cines

5 months ago
R&D
In Focus

How one start­up fore­told the neu­ro­science re­nais­sance af­ter '50 years of shit­show'

5 months ago
R&D
In Focus

6 top drug­mak­ers of­fer per­spec­tives on FDA's new co­vari­ates in RCTs guid­ance

6 months ago
R&D
Pharma

In­side Bio­gen's scram­ble to sell Aduhelm: Pro­ject 'Javelin' and pres­sure to ID as many pa­tients as pos­si­ble

6 months ago
Pharma

In­dus­try groups warn of drug short­ages linked to wide­spread car­cino­gen test­ing as FDA dou­bles down on its ap­proach

6 months ago
FDA+
Manufacturing

UP­DAT­ED: Cy­to­ki­net­ics is get­ting its shot at a ma­jor PhI­II show­down with Bris­tol My­ers af­ter post­ing pos­i­tive da­ta for a rare car­dio dis­ease. Shares rock­et up

6 months ago
R&D

Till­man Gern­gross is bet­ting well over $500M that the pan­dem­ic will nev­er re­al­ly end. Here’s the IPO pitch

6 months ago
Financing
Bioregnum

IPOs and ven­ture in­vest­ing rock on in Q2 as SPAC at­tack takes a break. But what hap­pened to the deals and M&A?

6 months ago
Bioregnum

In­ter­view with Phlow CEO: How soon will es­sen­tial drug man­u­fac­tur­ing come to the US?

6 months ago
Manufacturing

The top 10 pipeline blowups, set­backs and sna­fus for H1 2021

6 months ago
R&D
Special

Guid­ance bo­nan­za: FDA, EMA, MHRA, Health Cana­da and PIC/S of­fer new ad­vice on a range of phar­ma is­sues

6 months ago
R&D
FDA+
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