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Te­va and Alvotech's in­ter­change­able Hu­mi­ra biosim­i­lar joins the par­ty

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Pharma
FDA+

Ab­b­Vie’s next CEO; $100B club re­fresh; Top 100 VCs, 2023; More hope for CAR-T in au­toim­mune; and more

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Weekly

Bi­par­ti­san group of law­mak­ers op­pos­es Biden's plan to use 'march-in' to low­er drug prices

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Law

Gilead set­tles with Mary­land dis­trib­u­tor over al­leged coun­ter­feit HIV drugs

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Law

Eu­ro­pean reg­u­la­tor rec­om­mends ap­proval of Carvyk­ti in ear­li­er lines of mul­ti­ple myelo­ma

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FDA+

Pfiz­er and No­var­tis chiefs lead phar­ma's CEO in­flu­encers on so­cial me­dia, analy­sis finds

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Marketing

FDA de­clines to is­sue fines for non­com­pli­ant tri­al re­port­ing

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FDA+

Bio­Mar­in's Roc­ta­vian, once fore­cast to sell $50M to $150M last year, on­ly pulls in a frac­tion of that

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Cell/Gene Tx

FDA for­mal­ly pulls On­copep­tides' can­cer drug af­ter pro­longed back-and-forth

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FDA+

Am­gen wants in on obe­si­ty. But it's still work­ing on rare dis­ease, too

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Clade Ther­a­peu­tics cuts staff and ap­pears to shut down Eu­ro­pean sub­sidiary

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People
R&D

Once a sci­en­tif­ic back­wa­ter, pro­tein re­search at­tracts bil­lion-dol­lar deals and high-pro­file pub­li­ca­tions

Last year
Discovery
In Focus

FDA re­jects Melin­ta, Ve­na­torx’s UTI an­tibi­ot­ic over CMC is­sues

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FDA+
Manufacturing

Karuna push­es back KarXT da­ta read­outs; Vir, GSK end flu col­lab­o­ra­tion; Si­lence’s $10M mile­stone pay­ment

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Abridge, an AI start­up for med­ical notes, rais­es $150M

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Due to in­creas­ing com­pe­ti­tion, Gala­pa­gos’ CAR-T ex­its au­toim­mune dis­eases

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There­sa Heah en­ters the bat cave at Para­tus; Eli Lil­ly ex­ec takes CFO job at Jazz Phar­ma­ceu­ti­cals

Last year
Peer Review

FDA grants pri­or­i­ty re­view for Dupix­ent in COPD, sets June ap­proval de­ci­sion dead­line

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R&D
FDA+

Fron­tier Med­i­cines rais­es $80M, en­ters clin­ic and eyes po­ten­tial IPO in Q4 or ear­ly 2025

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Financing
Startups

Clin­i­cal tri­al starts slowed to be­low pre-pan­dem­ic lev­els last year, IQVIA analy­sis finds

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Cell/Gene Tx

Organon ex­pands 'Her Plan is Her Pow­er' re­pro­duc­tive health ini­tia­tive

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Pharma
Marketing

US prices of some pso­ri­a­sis drugs need to be low­ered to match ben­e­fits, new study says

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Mod­er­na wants an ac­cel­er­at­ed ap­proval for its can­cer vac­cine — but it's wait­ing on three things

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Al­ny­lam CEO de­fends changes to cru­cial AT­TR tri­al: 'We re­al­ly are play­ing to win'

Last year
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