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Af­ter steer­ing Lund­beck through buy­outs, lay­offs and big ap­proval, Deb­o­rah Dun­sire will step down

Last year
People

Look­ing to ex­pand Pyrukynd la­bel, Agios treks to­ward PhI­II in sick­le cell dis­ease

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R&D

Lon­za, Ver­tex to build a new cell ther­a­py man­u­fac­tur­ing fa­cil­i­ty for the biotech’s type 1 di­a­betes ther­a­pies

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Manufacturing

Biotech ex­ecs urge in­dus­try to sup­port ac­cess to gen­der-af­firm­ing care, as­sist work­ers amid rush of an­ti-LGBTQ bills

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Bio­gen share­hold­ers elect biotech ex­ec Su­san Langer to the board af­ter ro­man­tic part­ner de­parts

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Ava­lo fails asth­ma PhII with lead can­di­date, shares crater

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Fi­bro­Gen re­ports third PhI­II fail­ure in two months, this time in id­io­path­ic pul­monary fi­bro­sis

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Pfiz­er picks GLP-1 tablet win­ner: Danuglipron for PhI­II

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Pharma

Sh­iono­gi takes an­tibi­ot­ic mak­er un­der its wing in $100M cash buy­out

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Deals

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AI

Sagimet Bio­sciences files again for an IPO af­ter re­leas­ing NASH da­ta

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Financing
Startups

No­vo Nordisk's oral semaglu­tide on par with in­jectable ver­sion in weight loss and safe­ty

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Moon­Lake's PhII da­ta on skin dis­ease set it up against Cosen­tyx, UCB and oth­ers in IL-17 field

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Eli Lil­ly's tirzepatide is the king of the GLP-1s, but oth­er op­tions are com­ing

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Sarep­ta's Duchenne gene ther­a­py wins OK; FDA spurns NASH drug; Eli Lil­ly buys DICE for $2.4B; The new an­titrust ...

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Weekly

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CHMP rec­om­mends Ab­b­Vie's mi­graine drug, GSK's ane­mia treat­ment

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FDA is­sues draft guid­ance for clin­i­cal re­search in­to psy­che­delics

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Discovery
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Marketing

Medicare spells out what the new Alzheimer's drug reg­istries will col­lect

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FDA's Pe­ter Marks over­rode re­view­ers’ call to re­ject Sarep­ta’s new Duchenne gene ther­a­py

2 years ago
Cell/Gene Tx
FDA+

Sarep­ta's gene ther­a­py to be man­u­fac­tured at Catal­ent plant with 'op­er­a­tional chal­lenges' this spring

2 years ago
Cell/Gene Tx
Manufacturing

On­colyt­ic virus start­up Ca­li­di se­cures $25M to­ward Se­ries B round

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