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UP­DAT­ED: Agenus calls out FDA for play­ing fa­vorites with Mer­ck, pulls cer­vi­cal can­cer BLA at agen­cy's re­quest

2 days ago
FDA+

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

3 days ago
People

So — that pig-to-hu­man trans­plant; Po­ten­tial di­a­betes cure reach­es pa­tient; Ac­cused MIT sci­en­tist lash­es back; and ...

Yesterday
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Xilio Ther­a­peu­tics goes pub­lic as bio­phar­ma IPOs rum­ble for­ward in Q4

2 days ago
Financing

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Vivek Ra­maswamy and Matt Gline pen share­hold­er let­ters about the changes now un­der­way at Roivant

9 months ago
People

A new Treg play­er emerges with $46M and back­ing from Take­da

2 days ago
Financing
Startups

On­copep­tides stock craters as it pulls can­cer drug Pepax­to from the mar­ket

2 days ago
Pharma
FDA+

Oc­u­lar Ther­a­peu­tix ham­mered by a PhII fail­ure in dry eye dis­ease — shares tank

2 days ago
R&D

Pfiz­er pitch­es its Covid-19 vac­cine for younger chil­dren ahead of ad­comm next week

2 days ago
FDA+
Coronavirus

No, sci­en­tists are not any clos­er to pig-to-hu­man trans­plants than they were last week

2 days ago
R&D
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People

For­mer MIT sci­en­tist David Saba­ti­ni fires back at ac­cuser, White­head In­sti­tute for 'false' ha­rass­ment al­le­ga­tions

2 days ago

Carl June lends 'wings' to Chi­nese CAR-T start­up led by for­mer post­doc, pur­su­ing off-the-shelf ap­proach with CRISPR ...

4 days ago

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

4 days ago
Financing

Pfiz­er throws its weight be­hind LNP play­er eye­ing mR­NA treat­ments for CF, PCD

3 days ago

As AI con­tin­ues to en­tice Big Phar­ma, a Car­lyle-led drug­mak­er syn­di­cate shells out $430M for cloud com­put­ing play­er

3 days ago

Ven­tyx sprints to Wall Street less than a year af­ter emerg­ing from stealth

3 days ago
Startups

A new Schrödinger-backed start­up emerges from the sci­en­tist who mapped the first hu­man GPCR

4 days ago

Cri­net­ics spins out ra­dio­phar­ma ef­forts in­to a new com­pa­ny, high­light­ing the grow­ing field­'s al­lure

6 days ago

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

Last week
Deals

Bris­tol My­ers pledges to sell its Ac­celeron shares as ac­tivist in­vestors cir­cle Mer­ck­'s $11.5B buy­out — re­port

3 days ago

Hedge fund jumps in with Avoro ac­tivists in an at­tempt to de­rail Mer­ck­'s $11B Ac­celeron buy­out

4 days ago

'No ex­cuse': ICER de­ter­mines As­traZeneca's new mon­ey­mak­er Soliris is vast­ly over­priced

4 days ago

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

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Some can­cer pa­tients now have to find oth­er op­tions as Bris­tol My­er­s' Abrax­ane falls in­to short­age from man­u­fac­tur­ing woes

When Beth Hogan, a metasta­t­ic pan­cre­at­ic can­cer pa­tient, showed up for her in­fu­sion at Yale's Smilow Can­cer Hos­pi­tal in New Haven, CT on Oct. 11, she said she was in­formed that day that she ...

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Man­u­fac­tur­ing woes for No­vavax’s Covid jab bad­ly dis­rupt plans for roll­out to the poor — re­port

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FDA re­jects Unit­ed's po­ten­tial PAH drug due to a man­u­fac­tur­ing is­sue

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4 days ago

Up­dat­ed: Bio­gen sells just $300K worth of Aduhelm in Q3, as ques­tions on long-term vi­a­bil­i­ty re­main

Bare­ly any­one is ac­cess­ing Bio­gen's con­tro­ver­sial Alzheimer's treat­ment, with the com­pa­ny re­port­ing just $0.3 mil­lion in Aduhelm sales in the third quar­ter. Al­though in­vestors will be ...

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Sanofi, Re­gen­eron etch out an­oth­er PhI­II vic­to­ry for Dupix­ent, eas­ing se­vere itch and clear­ing le­sions

2 days ago
R&D

Eli Lil­ly or­dered to pay roy­al­ties on block­buster di­a­betes drugs, though ex­act dam­ages are un­clear

3 days ago
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FDA OKs an in­haled ver­sion of smok­ing ces­sa­tion drug Chan­tix — for a com­mon eye dis­ease

6 days ago
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Es­pe­ri­on gets out the bud­get ax, chop­ping 170 staffers as its big drug launch sput­ters

6 days ago
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6 days ago
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Roche's Tecen­triq cross­es the fin­ish line first in ad­ju­vant lung can­cer, po­ten­tial­ly kick­ing off gold rush

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As suits mount, J&J spins out talc li­a­bil­i­ties in­to Chap­ter 11 us­ing 'Texas two-step' ma­neu­ver

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4 days ago

UP­DAT­ED: FDA slaps As­traZeneca's MCL-1 can­cer drug with a hold af­ter safe­ty is­sue — 2 years af­ter Am­gen axed a trou­bled ri­val

There are new ques­tions be­ing posed about a class of can­cer drugs in the wake of the sec­ond FDA-en­forced clin­i­cal hold in the field.

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Sur­geons suc­cess­ful­ly at­tach pig kid­ney to a hu­man for the first time, us­ing tech from Unit­ed's Re­vivi­cor

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Ra­dius rock­ets high­er as Kel­ly Mar­tin boasts of a big PhI­II suc­cess — but the spoils be­long to Menar­i­ni

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As­traZeneca's for­mer an­tibi­otics unit claims a PhI­II win in drug-re­sis­tant bac­te­ria af­fect­ing sick­ly pa­tients

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UP­DAT­ED: Galera shares take a nose­dive in the wake of un­ex­pect­ed PhI­II flop

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Take­da, Wave Life Sci­ences re­vise their $230M R&D col­lab­o­ra­tion, drop­ping dis­cov­ery work

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Roche-Atea’s Covid-19 pill fails mid-stage tri­al, cloud­ing fu­ture for close­ly watched pro­gram

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Phath­om's old Take­da drug bests Pre­vacid in a PhI­II GI tri­al. Next stop? The FDA

6 days ago
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FDA+ channel feed

3 days ago

Sen­a­tors back FDA's plan to re­quire manda­to­ry pre­scriber ed­u­ca­tion for opi­oids

Three Sen­ate De­moc­rats are back­ing an FDA plan to re­quire manda­to­ry pre­scriber ed­u­ca­tion for opi­oids as over­dose deaths have risen sharply over the past decade, with al­most 97,000 Amer­i­can ...

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FDA shoots down a biotech’s last-stand pa­tient pitch af­ter fault­ing da­ta

4 days ago

FDA warns Min­neso­ta doc for run­ning two ke­t­a­mine tri­als with­out INDs, and with chil­dren and a preg­nant woman

5 days ago
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With hun­dreds of mil­lions spent on failed ac­cel­er­at­ed ap­provals, re­searchers call for faster FDA with­drawals

5 days ago

Sen­ate spend­ing bill slash­es funds for Biden's planned break­through drug ac­cel­er­a­tor at NIH

5 days ago

Omeros plunges deep­er af­ter FDA re­jects rare dis­ease drug, ask­ing for more in­for­ma­tion

6 days ago

UP­DAT­ED: Third time's the charm: Adamis nabs ap­proval of high-dose nalox­one in­jec­tion af­ter two CRLs

6 days ago

UP­DAT­ED: FDA re­jects Re­vance's pitch for Botox com­peti­tor as biotech blames man­u­fac­tur­ing is­sues

6 days ago
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