In an­nu­al re­port, FDA de­tails how it han­dled drug short­ages in 2022

3 years ago
Pharma
Manufacturing

Te­va joins fel­low phar­mas in re­strict­ing 340B dis­counts

3 years ago
Pharma

Ei­sai cy­ber at­tack leads to in­ves­ti­ga­tion of po­ten­tial da­ta leaks amid grow­ing in­dus­try threat

3 years ago
Pharma

Bris­tol My­ers cell ther­a­py man­u­fac­tur­ing site gets thumbs-up from FDA

3 years ago
Cell/Gene Tx
Manufacturing

Phar­ma finds TV ads are a hard habit to break. It's still putting 65% of ad dol­lars in­to TV

3 years ago
Pharma
Marketing

As­traZeneca flesh­es out piv­otal da­ta on $930M rare blood dis­or­der drug it wants to pair with Soliris, Ul­tomiris

3 years ago
R&D

FDA wants more da­ta from Abeona Ther­a­peu­tics as it push­es for BLA

3 years ago
R&D
Cell/Gene Tx

Oslo biotech finds an­oth­er merg­er part­ner af­ter share­hold­ers re­ject­ed No­vem­ber of­fer

3 years ago
Financing
Deals

Sec­ond round of in­fla­tion-re­lat­ed re­bates hits 43 drugs from Am­gen, Seagen, Ab­b­Vie and oth­ers

3 years ago
Pharma
Law

Lyn­dra Ther­a­peu­tics eyes $180M Se­ries D for po­ten­tial 2026 launch of once-week­ly schiz­o­phre­nia med

3 years ago
Financing
Startups

Disc Med­i­cine claims PhII win for re­pur­posed ex-Roche drug in rare blood dis­or­der

3 years ago
R&D

Ed­i­tas gives first look at CRISPR da­ta in sick­le cell, be­ta tha­lassemia six months af­ter lay­offs, re­fo­cus

3 years ago
R&D

FDA sets De­cem­ber ap­proval de­ci­sion for first CRISPR ther­a­py, with 94% of pa­tients free of sick­le cell crises

3 years ago
R&D
Cell/Gene Tx

Chemomab changes CEOs, sus­pends mid-stage tri­al; Ex-FDA vac­cine of­fi­cial lends more help to Mesoblast

3 years ago
Peer Review

As­traZeneca en­lists UK Treg biotech for type 1 di­a­betes, in­flam­ma­to­ry bow­el dis­ease deal fea­tur­ing $85M up­front

3 years ago
Deals
Cell/Gene Tx

FDA ad­comm votes unan­i­mous­ly in fa­vor of As­traZeneca's pre­ven­tive mAb for RSV in in­fants

3 years ago
FDA+

Amid AD­HD drug short­age, Ak­ili aims for adults with over-the-counter video game treat­ment

3 years ago
Pharma
Marketing

San­doz an­tic­i­pates ad­di­tion­al $3B in po­ten­tial net sales over five years in pipeline ex­pan­sion

3 years ago
Pharma

Good clin­i­cal prac­tices: FDA opens up­dat­ed ICH draft guid­ance for com­ments

3 years ago
R&D

Q2 deal ac­tiv­i­ty points to po­ten­tial 'bumper year' for phar­ma — re­port

3 years ago
Deals
Pharma

FDA shakes up top lead­er­ship around gener­ic drugs

3 years ago
People
FDA+

No­var­tis joins the film fes­ti­val cir­cuit with doc­u­men­tary se­ries on mis­un­der­stood skin dis­ease

3 years ago
Pharma
Marketing

Al­ca­mi ap­points new CEO as for­mer chief Patrick Walsh an­nounces re­tire­ment

3 years ago
People
Manufacturing

Man­u­fac­tur­ing roundup: Eu­roAPI to in­vest $50M+ in Hun­gary site; WuXi to ex­pand Ger­man fa­cil­i­ty

3 years ago
Manufacturing
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