Roche to re­file sub­cu­ta­neous Tecen­triq ap­pli­ca­tion with FDA be­fore year’s end on the back of man­u­fac­tur­ing tweaks

Last year
FDA+
Manufacturing

Ex­elix­is li­cens­es small mol­e­cule from In­sil­i­co for $80M up­front; Ver­tex buys GPCR from Septer­na

Last year
Deals

Aval­on's lat­est biotech clos­es $58M round as it pur­sues treat­ments for au­toim­mune brain con­di­tions

Last year
Financing

Ahead of ad­comm, FDA ques­tions ef­fi­ca­cy of Al­ny­lam's patisir­an in dis­abling rare con­di­tion AT­TR-CM

Last year
R&D

Renibus brings Se­ries B to­tal to $72M, se­cur­ing reg­is­tra­tional de­vel­op­ment for lead heart surgery can­di­date

Last year
Financing

Up­dat­ed: 2sev­en­ty lays off 40% of staff, prunes CAR-T pipeline as Nick Leschly steps down as CEO

Last year
People
Cell/Gene Tx

San Diego biotech starts clin­i­cal study of self-repli­cat­ing RNA vac­cine for ra­bies

Last year
R&D

Bi­o­Lin­eRx’s Aphex­da ap­proved to aid stem cell trans­plants for mul­ti­ple myelo­ma pa­tients

Last year
Pharma
FDA+

Lyra touts pos­i­tive topline PhII da­ta for chron­ic rhi­nos­i­nusi­tis drug

Last year
R&D

Rome Ther­a­peu­tics ad­vances dark genome drug af­ter com­plet­ing $72M Se­ries B ex­ten­sion backed by Big Phar­ma

Last year
Financing
R&D

Di­anthus marks Nas­daq de­but with PhI hit; Ar­bu­tus shuts oral RNA and coro­n­avirus pro­grams

Last year
News Briefing

Ac­tio locks in $55M Se­ries A raise to ad­vance rare dis­ease pipeline based on hu­man ge­net­ic plat­form

Last year
Financing
R&D

Ace­lyrin's IL-17 in­hibitor fails to hit pri­ma­ry end­point in key study af­ter splashy IPO

Last year
R&D

As­traZeneca ad­dress­es re­port that CEO Pas­cal So­ri­ot plans to de­part

Last year
People
Pharma

Om­ni­com Health agency Har­ri­son and Star goes back to sci­ence roots with new lead­ers and new pur­pose

Last year
Pharma
Marketing

What about No­vavax? Vac­cine com­pa­ny's boost­er is left out of FDA ac­tion on Pfiz­er, Mod­er­na shots

Last year
Coronavirus

DOJ and Dan­co Lab­o­ra­to­ries pe­ti­tion Supreme Court over mifepri­s­tone re­stric­tions

Last year
Pharma
Law

San­doz and Sam­sung Bioepis ink com­mer­cial­iza­tion agree­ment for Ste­lara biosim­i­lar

Last year
Pharma

FDA green­lights up­dat­ed Covid shots, mak­ing fall boost­er roll­out im­mi­nent

Last year
Pharma
FDA+

Roche CEO out­lines new R&D strat­e­gy af­ter years of late-stage tri­al fail­ures

Last year
R&D
Pharma

En­livex halts on­col­o­gy re­search, lays off 50% of staff; Mod­er­na warns against TRC Cap­i­tal mi­ni-ten­der

Last year
News Briefing

Neumo­ra, Rayze­Bio look to each raise $200M+ in IPOs

Last year
R&D

Take­da says TYK2 drug it pur­chased for $4B has passed an­oth­er mid-stage test

Last year
R&D

Bernie Sanders lifts hold on NIH nom­i­nee fol­low­ing Re­gen­eron price con­ces­sions

Last year
People
Coronavirus
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