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Take­da slammed with sur­prise PhI­II fail­ure on 'break­through' blood can­cer drug, im­plod­ing launch plans

4 years ago
R&D

Rule­mak­ing au­thor­i­ty re­stored at FDA as a show of sup­port in a tu­mul­tuous time

4 years ago
FDA+

Roche schiz­o­phre­nia drug that failed PhI­II gets a new life in rare dis­or­der as Or­biMed leads $90M for start­up

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Financing
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Ab­b­Vie's stock and next megablock­buster take hits fol­low­ing new JAK warn­ings from FDA

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Pharma
FDA+

FDA warns of heart-re­lat­ed events, can­cer, blood clots, and death for JAK in­hibitors

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FDA+

An FTC re­view of the Sanofi/Trans­late merg­er has a new dead­line af­ter agency calls for more time

4 years ago
Deals
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With drug pric­ing re­form po­ten­tial­ly clos­er than ever, Pub­lic Cit­i­zen pens new let­ter call­ing for change

4 years ago
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A Lon­za vet­er­an takes the helm of new Swiss CD­MO of­fer­ing man­u­fac­tur­ing know-how to star­tups

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Manufacturing

Astel­las paus­es Au­den­tes' gene ther­a­py pro­gram again af­ter 'ab­nor­mal' liv­er tests in yet an­oth­er set­back

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Cell/Gene Tx

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Opin­ion: Time for Biden to ex­plain the po­lit­i­cal med­dling in Covid vac­cine re­views

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Covid-19 roundup: Pfiz­er, Mer­ck start late-stage tri­als for Covid-19 pills; Mer­ck be­gins PhI­II study on post-ex­po­sure ...

4 years ago
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FDA ex­tends full ap­proval for Mer­ck­'s Keytru­da in 1st-line blad­der can­cer af­ter mixed ad­comm vote

4 years ago
Pharma
FDA+

Cau­tious­ly op­ti­mistic, AC Im­mune de­liv­ers a mixed set of Alzheimer's da­ta — but in­vestors love it

4 years ago
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SR One leads $55M round for nasal al­ter­na­tive to EpiPen; Sanofi pulls web­site over ac­cu­ra­cy con­cerns

4 years ago
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In a ma­jor blow to vac­cine ef­forts, se­nior FDA lead­ers step­ping down

4 years ago
People
FDA+

An­tivi­ral nasal drop mak­er does the Nas­daq shuf­fle as part of mi­nor SPAC re­verse merg­er

4 years ago
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ARCH-backed George Church spin­out shuts down af­ter gene ther­a­py tech strug­gles in an­i­mal mod­els

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4 years ago
Pharma
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