As BioN­Tech pre­dicts a drop in its moth­er lode of Covid sales, ex­ecs hint at com­ing M&A deals

4 years ago
Pharma

Try­ing to avoid a CRL? New FDA draft guid­ance talks ben­e­fit-risks on qual­i­ty as­sess­ments

4 years ago
Manufacturing

Il­lu­mi­na forced to pay al­most $334M as it los­es DNA se­quenc­ing patent case

4 years ago
Pharma
Law

Scoop: Ex­e­Vir hits pause on lla­ma-de­rived Covid an­ti­body amid Omi­cron vari­ants, shifts fo­cus to sec­ond-gen work

4 years ago
Startups
R&D

Months lat­er, Log­icBio ex­its FDA clin­i­cal hold for gene edit­ing drug but won't restart tri­al un­til next quar­ter

4 years ago
Cell/Gene Tx
FDA+

Pso­ri­a­sis and pso­ri­at­ic arthri­tis drugs criss­cross cat­e­gories, but derm and rheum docs split on pref­er­ences

4 years ago
Pharma
Marketing

Ex-Sanofi CEO on board, a new $158M SPAC de­buts look­ing to shake up the Eu­ro­pean CD­MO mar­ket

4 years ago
Pharma
Manufacturing

My­ovan­t's Myfem­bree sN­DA gets new PDU­FA af­ter CRL spec­u­la­tion; In­xMed bags more funds for piv­otal stud­ies

4 years ago
News Briefing

Bel­gian eye biotech gets ham­mered by in­vestors af­ter PhII tri­al fails ef­fi­ca­cy on key end­points

4 years ago
R&D

Is this Sil­i­con Val­ley duo the fu­ture of biotech?

4 years ago
People
AI

Ameet Mallik finds green­er turf as new head of ADC Ther­a­peu­tics fol­low­ing ill-fat­ed first CEO stint

4 years ago
People

Ex­clu­sive: As­pen Neu­ro­science col­lects large Se­ries B to com­pete against Bay­er's Parkin­son's cell ther­a­py

4 years ago
Financing
Startups

FDA's Pe­ter Marks to Con­gress: Youngest kids vac­cine won't need to hit 50% ef­fi­ca­cy mark

4 years ago
FDA+
Coronavirus

Sweep­ing re­org at Ori­on — cen­tered around can­cer and pain — claims 30 staffers

4 years ago
People
Pharma

J&J ends he­pati­tis B and HPV por­tions of Bavar­i­an Nordic col­lab

4 years ago
Deals
Pharma

In wake of do­mes­tic vi­o­lence al­le­ga­tion, long­time Seagen CEO Clay Sie­gall goes on leave

4 years ago
People
R&D

A record num­ber of small biotechs are now trad­ing be­low cash. Is this the bot­tom yet?

4 years ago
Deals

Bio­gen's shake­up from the top; How to build a biotech to­day; David Saba­ti­ni backs out of NYU; and more

4 years ago
Weekly

French reg­u­la­tors re­fer in­sti­tute run by out­spo­ken hy­droxy ad­vo­cate for crim­i­nal charges

4 years ago
Pharma
Law

That big R&D PARP win Clo­vis CEO Ma­haffy tout­ed a few weeks ago? The FDA is­n't buy­ing it

4 years ago
Bioregnum
FDA+

FDA and its re­search take aim at thy­roid as­so­ci­a­tion's guide­line on not us­ing levothy­rox­ine gener­ics

4 years ago
FDA+

Con­sor­tium to au­to­mate cell ther­a­py man­u­fac­tur­ing wel­comes Ther­mo Fish­er and Charles Riv­er Labs

4 years ago
Pharma
Manufacturing

J&J new so­cial me­dia se­ries sup­ports and cel­e­brates ‘war­rior’ nurs­es in pul­monary hy­per­ten­sion

4 years ago
Pharma
Marketing

De­fy­ing biotech bears, Sanofi man­u­fac­tur­ing spin­off surges on Paris de­but

4 years ago
Financing
Pharma
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