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Rare dis­ease hub at CDER and CBER faces new re­al­i­ty with staff crunch

2 hours ago
Pharma
FDA+

‘This is self-in­flict­ed’: Leerink’s David Risinger on the mar­ket shock and hits to bio­phar­ma

4 hours ago
People
FDA+

Drug tool and pack­ag­ing mak­ers to feel brunt of Trump tar­iffs, an­a­lysts say

4 hours ago
Pharma
Manufacturing

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Stock mar­ket melts down over Trump’s tar­iffs, and biotech's pain keeps grow­ing

6 hours ago
Financing
Pharma

HHS says it may re­vis­it an­ti-obe­si­ty drug poli­cies af­ter drop­ping Biden-era pro­pos­al

1 hour ago
Pharma
Marketing

Min­neso­ta fed­er­al judge dis­miss­es chal­lenge from Ab­b­Vie, As­traZeneca to state's 340B law

2 hours ago
Pharma
Law

PureTech re­jects cash ex­it pro­pos­al from Nordic Cap­i­tal, in­vest­ment firm says it won't make an of­fer

2 hours ago
Deals
Pharma
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People

Q&A: A con­ver­sa­tion with GLP-1 co-dis­cov­er­er Jens Ju­ul Holst on the fu­ture of in­cretin-based drugs

Yesterday

Q&A: David Liu talks about sci­ence un­der pres­sure, teas­es “dis­ease-ag­nos­tic” gene edit­ing

Yesterday

Re­lay Ther­a­peu­tics does third round of lay­offs in nine months, af­fect­ing about 70 em­ploy­ees

3 days ago
Financing

Im­munol­o­gy start­up RayThera se­cures $110M in Se­ries A raise

6 hours ago

ADC start­up Du­al­i­ty­Bio seeks Hong Kong IPO amid pre­car­i­ous mar­ket

10 hours ago

PIPEs, bio­phar­ma’s fa­vorite fi­nanc­ing ve­hi­cle, freeze amid mar­ket strug­gles

4 days ago
Startups

Ex­clu­sive: Neu­rona bags $102M to treat epilep­sy with cell ther­a­py

4 days ago

Eli Lil­ly adds obe­si­ty start­up known­well to its di­rect-to-con­sumer ser­vice

5 days ago

At­se­na gets Bain's sup­port in $150M Se­ries C to thwart blind­ness with gene ther­a­py

5 days ago
Deals

GSK’s newest neu­ro pact is with ABL Bio, a Sanofi-part­nered South Ko­re­an biotech

16 hours ago

Eli Lil­ly pays strug­gling Sang­amo $18M up­front to tap gene ther­a­py cap­sid

3 days ago

F-star man­age­ment takes com­pa­ny pri­vate, two years af­ter $161M cash ex­it to Sino's in­voX

3 days ago

In FocusSee all

‘Peo­ple will die’: End of NIH grants guts work be­tween aca­d­e­mics and com­pa­nies to counter next pan­dem­ic

Last week
R&D

Il­lu­mi­na was built on DNA. Its fu­ture could be bi­ol­o­gy’s next big wave

3 weeks ago
Diagnostics

A Cal­i­for­nia health tech com­pa­ny is let­ting AI run med­ical vis­its, from in­take to di­ag­no­sis

3 weeks ago
AI
Health Tech

Ahead of FDA de­ci­sion, Al­ny­lam faces the big ques­tion: Can it make mon­ey?

3 weeks ago
Pharma
FDA+

Endpoints Standouts

How the world's biggest phar­ma and biotech com­pa­nies paid their typ­i­cal work­er in 2023

9 months ago
People
Pharma

In biotech's un­even re­cov­ery, 50 star­tups raised megarounds in first half of 2024

9 months ago
Financing
Startups

Bio­phar­ma lead­ers chart­ing a path for the in­dus­try's LGBTQ+ com­mu­ni­ty

9 months ago
People
Special

Pe­ter Marks sin­gle-hand­ed­ly ap­proved Sarep­ta’s gene ther­a­py — what does that mean for every­one else?

9 months ago
Pharma
Cell/Gene Tx

Peer review See all

Apr
4

No­vo Nordisk ad­justs its lead­er­ship team; Dyne alums mi­grate to Cres­cent Bio­phar­ma

Mar
28

On the heels of staff cuts, CRISPR Ther­a­peu­tics COO de­parts; Changes ga­lore at Bi­cy­cle

Mar
21

Bridge­Bio, Ed­i­tas fi­nance chiefs de­part; For­mer FDA No. 2 joins Re­cur­sion's board

Mar
14

Mer­ck di­ver­si­ty leader to re­tire this sum­mer; Geron seeks com­mer­cial chops for next CEO

Mar
7

Tune’s CEO search ends as John McHutchi­son takes top spot; More from Pfiz­er’s lead­er­ship makeover

Pharma channel feed

5 hours ago

RFK Jr. won’t tes­ti­fy be­fore key Sen­ate com­mit­tee this week on HHS over­haul

HHS Sec­re­tary Robert F. Kennedy Jr. won’t be ap­pear­ing be­fore a Sen­ate pan­el on Thurs­day to tes­ti­fy on the mas­sive re­struc­tur­ing of the health agency, de­spite an in­vi­ta­tion from the ...

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Rhythm touts Phase 3 win for rare obe­si­ty drug in peo­ple with brain dam­age

10 hours ago
R&D

Trump ad­min­is­tra­tion leaves obe­si­ty cov­er­age ex­pan­sion out of new Medicare rule

3 days ago
FDA+
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GSK and Pfiz­er re­solve RSV vac­cine patent fight

3 days ago
Law

No­vavax’s held-up ap­proval pack­age may sig­nal warn­ing for Covid vac­cine mak­ers

3 days ago
R&D
FDA+

FTC chair­man seeks to re­vive PBM case

3 days ago
Law

Chi­na's re­tal­ia­to­ry tar­iffs on US could mean more head­winds for drug­mak­ers

3 days ago
China
Manufacturing

States sue NIH over 'dev­as­tat­ing' grant dis­rup­tions amid health agency shake­up

3 days ago
Law
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Marketing channel feed

6 days ago

RFK Jr. has long crit­i­cized drug ads. He just slashed the FDA of­fice that reg­u­lates them

HHS Sec­re­tary Robert F. Kennedy Jr. has made clear that he would like to ban di­rect-to-con­sumer drug ad­ver­tise­ments on tele­vi­sion and else­where. In­stead, on Tues­day, he got rid of many of ...

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J&J touts new sur­vival da­ta pit­ting lung can­cer com­bo against As­traZeneca's ri­val

Last week
R&D
Pharma

No­vo Nordisk slash­es We­govy price by near­ly two-thirds for cash-pay­ing pa­tients

Last month
Pharma
latest in Marketing

Mis­lead­ing ex­hib­it booth pan­el lands NJ drug­mak­er an un­ti­tled let­ter from FDA

Last month
FDA+

Eli Lil­ly ex­pands Zep­bound sin­gle-dose vial op­tions at low­er price

Last month
Pharma

J&J's new can­cer com­bo beats As­traZeneca's Tagris­so on sur­vival in lung tri­al

3 months ago
Pharma

Drugs are ap­proved — and made avail­able — faster in US than most of EU, da­ta show

3 months ago
Pharma
FDA+

No­var­tis bol­sters Fab­hal­ta da­ta in com­pe­ti­tion with As­traZeneca

4 months ago
R&D
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FDA+ channel feed

3 days ago

Marks was asked to pro­vide non-ex­is­tent vac­cine risk da­ta: WSJ

Oust­ed FDA bi­o­log­ics and vac­cine chief Pe­ter Marks was asked to pro­vide non-ex­is­tent da­ta on the risk from measles vac­cines, he told the Wall Street Jour­nal in an in­ter­view de­scrib­ing the ...

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Kennedy team de­fends Marks fir­ing, while 20% of staff cuts may be 'mis­takes'

3 days ago
Law

Sen­ate con­firms Dr. Oz to lead Medicare agency amid HHS over­haul

4 days ago
People
Pharma
latest in FDA+

FDA ap­proves Am­gen's Up­liz­na in IgG4-re­lat­ed dis­ease

4 days ago
Pharma

Trump has tout­ed Right to Try as a life­saver. Sev­er­al gov­ern­ment staff sup­port­ing it were just let go

4 days ago

House and Sen­ate com­mit­tees call for brief­in­gs on health cuts from Kennedy

4 days ago

FDA will con­sol­i­date to five 'shared ser­vices of­fices,' ac­cord­ing to memo to Hill staffers

4 days ago
Pharma

Aldeyra gets an­oth­er CRL for its dry eye dis­ease drug that Ab­b­Vie has the op­tion to co-de­vel­op

4 days ago
Pharma
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Manufacturing channel feed

11 hours ago

Cell and gene ther­a­py CD­MO Am­pli­fy­Bio shuts down over 's­carci­ty' of fund­ing

An­oth­er CD­MO has been hit by the slow­down of cell and gene ther­a­py R&D.

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SHL Med­ical opens $220M au­toin­jec­tor site; DHL ac­quires clin­i­cal tri­al firm 

4 days ago

Chaot­ic tar­iff roll­out leaves as many ques­tions as an­swers for drug­mak­ers

4 days ago
Pharma
latest in Manufacturing

Trump’s broad tar­iffs ex­empt phar­ma — but for how long?

5 days ago
Pharma
FDA+

New CD­MO emerges, ac­quires cell and gene man­u­fac­tur­er Land­mark Bio

5 days ago
Deals
Cell/Gene Tx

Mile­stone's shares dive af­ter FDA again re­jects drug for ab­nor­mal heart rhythm

Last week
Pharma

With tar­iffs on the way, gener­ic drug­mak­ing woes could hin­der Trump’s reshoring plan 

Last week
Pharma

Chiesi pours €430 in­to new Italy site; Bharat’s first CGT site in In­dia

Last week
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