CDER lead­ers ready to im­ple­ment swifter ac­cel­er­at­ed ap­proval with­draw­al process

3 years ago
FDA+

In a new look at Novo's We­govy da­ta, re­searchers spell out weight loss for teens

3 years ago
R&D
Pharma

Ab­b­Vie tack­les ‘gut­sy’ con­ver­sa­tion in so­cial me­dia se­ries for IBD suf­fer­ers

3 years ago
Pharma
Marketing

Man­u­fac­tur­ing roundup: Juno Phar­ma­ceu­ti­cals ac­quires Omega Lab­o­ra­to­ries; Pfiz­er halts dis­tri­b­u­tion of four med­i­cines

3 years ago
Manufacturing

Man­u­fac­tur­ing-cen­tric SPAC makes a deal to com­bine with French CD­MO

3 years ago
Deals
Manufacturing

Mus­tang Bio to sell Mass­a­chu­setts CAR-T man­u­fac­tur­ing fa­cil­i­ty

3 years ago
Deals
Cell/Gene Tx

Eye­Point sells re­main­ing rights to eye im­plant, piv­ots to tack­le an­ti-VEG­Fs

3 years ago
Deals
R&D

SCO­TUS rules unan­i­mous­ly in fa­vor of Sanofi and Re­gen­eron in PC­SK9 patent spat with Am­gen

3 years ago
Pharma
Law

Short­ly af­ter Clay Sie­gall’s ar­rival, Philip Low’s Mor­phim­mune nabs funds for twist on can­cer ther­a­pies

3 years ago
Financing
Startups

Am­gen can close Hori­zon deal by Sep­tem­ber if no rul­ing from courts on FTC suit

3 years ago
Pharma
Law

As­traZeneca beefs up cell ther­a­py tool kit with gene edit­ing deal

3 years ago
Deals
Cell/Gene Tx

Ca­balet­ta lands $84M from stock sale af­ter FDA clears INDs for CD19 CAR-T in au­toim­mune dis­eases

3 years ago
Financing

I'm host­ing some (live!) pan­els and fire­sides for our up­com­ing Boston biotech sum­mit. Please join me there

3 years ago
Editor's note

Ex­clu­sive: Myeloid Ther­a­peu­tics rais­es $73M, bring­ing in ARCH ahead of in vi­vo pro­gram en­ter­ing the clin­ic

3 years ago
Financing

Ex­clu­sive: Cell and gene ther­a­py biotech cre­ator Re­play plucks Al­lo­gene CMO Arun Bal­aku­maran to lead clin­i­cal tri­als

3 years ago
People
Cell/Gene Tx

FDA's Pe­ter Marks talks re­im­burse­ment of gene ther­a­pies that win ac­cel­er­at­ed ap­proval

3 years ago
Cell/Gene Tx

Acor­da TV stream­ing ad for Parkin­son’s drug res­onates with view­ers

3 years ago
Pharma
Marketing

EMA makes rec­om­men­da­tions to man­u­fac­tur­ers as it aims to stem drug short­ages

3 years ago
Pharma
Manufacturing

In­ter­cep­t's NASH hope­ful gets pre­lim­i­nary thumbs down in FDA brief­ing docs

3 years ago
R&D
FDA+

Mer­ck de­fends an­tibi­otic's ap­proval from 2019 as BMJ in­ves­ti­ga­tion points to 'de­cline' in FDA stan­dards

3 years ago
FDA+

Pfiz­er shakes up agency ros­ter un­der new mar­ket­ing chief

3 years ago
Pharma
Marketing

Am­gen's CEO says he's 'con­fi­den­t' their $28B deal with Hori­zon can close de­spite FTC law­suit

3 years ago
Deals
Law

PTC claims PhI­II win in rare ge­net­ic dis­ease

3 years ago
R&D

X4 touts more pos­i­tive PhI­II da­ta for its WHIM syn­drome treat­ment

3 years ago
R&D
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