PDU­FA VII ne­go­ti­a­tions near fin­ish line with plans to re­vamp CBER and staff up

5 years ago
Pharma
FDA+

Eli Cas­din and Kei­th Meis­ter dive back in­to the SPAC well with $480M haul just weeks af­ter So­ma­Log­ic re­verse merg­er

5 years ago
Financing

Eye­ing stan­dard of care sta­tus in 3rd-line TNBC, Gilead nails down full OK for Trodelvy with a slight­ly broad­er la­bel

5 years ago
Pharma
FDA+

Ver­sant-backed Ven­tus scores $100M round to tur­bocharge its dual-plat­form play at 'drug­ging the un­drug­gable'

5 years ago
Financing

Am­gen CEO Bob Brad­way takes home $20M+ pay pack­age amid bang-up year for sales

5 years ago
People

The End­points 100 sur­vey: CEOs changed the way biotechs op­er­ate dur­ing the pan­dem­ic. Things will nev­er be the same ...

5 years ago
People
Special

Vac­citech con­fi­den­tial­ly files for Nas­daq IPO — re­port; Sanofi recom­mits to so­cial caus­es, launch­es glob­al ...

5 years ago
News Briefing

EMA finds link be­tween ‘very rare’ but some­times fa­tal blood clots and As­traZeneca vac­cine

5 years ago
FDA+
Coronavirus

The con­tin­u­ing CRISPR patent saga

5 years ago
Biotech Voices

FDA and EMA sig­nal an op­por­tu­ni­ty to har­mo­nize ad­vanced ther­a­py reg­u­la­tions

5 years ago
Cell/Gene Tx
FDA+

Covid-19 roundup: As­traZeneca paus­es vac­cine tri­al for chil­dren as blood clot probe con­tin­ues; EMA to in­ves­ti­gate ...

5 years ago
Coronavirus

David David­son’s R&D odyssey takes him out of blue­bird to an­oth­er biotech start­up with big plans to trans­form ...

5 years ago
People

Icosavax keeps up the ex­cite­ment for its VLP 'soc­cer balls,' earn­ing the RA Cap­i­tal stamp of ap­proval in $100M Se­ries ...

5 years ago
Financing
Coronavirus

FDA push­es eczema de­ci­sion for Eli Lil­ly's Olu­mi­ant, Pfiz­er's abroc­i­tinib back 3 months — rais­ing more ques­tions ...

5 years ago
Pharma
FDA+

No­var­tis taps DNA dam­age spe­cial­ist Ar­tios in $1.3B dis­cov­ery deal to com­ple­ment grow­ing ra­di­oli­gand port­fo­lio

5 years ago
Deals
Discovery

Fi­bro­Gen shares take a beat­ing as CEO re­veals safe­ty da­ta ma­nip­u­la­tion for its block­buster con­tender rox­adu­s­tat

5 years ago
R&D
FDA+

Near­ly 70% of Akcea's work­force is on the chop­ping block as Io­n­is ex­e­cutes ma­jor re­struc­tur­ing

5 years ago
People

Can em­ploy­ers man­date Covid-19 vac­cines un­der emer­gency au­tho­riza­tions? It’s com­pli­cat­ed

5 years ago
FDA+
Coronavirus

Catal­ent pledges to in­crease pro­duc­tion of Mod­er­na vac­cine at its In­di­ana fill-fin­ish plant

5 years ago
Deals
Manufacturing

In 1-2 punch, Mol­e­c­u­lar Tem­plates cuts first-gen can­di­date and los­es a Big Phar­ma part­ner; Charles Riv­er teams up ...

5 years ago
News Briefing

As­traZeneca’s big ADC part­ner pledges to pour $13.6B in­to can­cer R&D over next 5 years — and En­her­tu looms large

5 years ago
Pharma

Covid-19 roundup: EMA of­fi­cial says 'clear' link be­tween As­traZeneca shot and blood clots — re­port; No­vavax al­lows ...

5 years ago
Coronavirus

Af­ter No­var­tis walks on last STING drug, Chi­nook spits out or­phan Aduro as­sets

5 years ago
Deals

Min­eralys emerges with a new take on an old idea for the treat­ment of hy­per­ten­sion and $40M to play with

5 years ago
Financing
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