FDA+ roundup: Ad­comm date set for Cy­to­ki­net­ics heart drug; New gener­ic drug guid­ance to re­duce fa­cil­i­ty de­lays

3 years ago
FDA+

FDA re­jects Eiger's emer­gency use re­quest for re­pur­posed Covid-19 treat­ment

3 years ago
FDA+
Coronavirus

Eliem says ear­li­er drug ex­po­sure is­sues have been re­solved, drops one epilep­sy in­di­ca­tion

3 years ago
R&D

Af­ter Covid set­back, Val­ne­va lines up $100M for Pfiz­er-al­lied Ly­me dis­ease PhI­II

3 years ago
Financing
Pharma

A dozen years in the mak­ing, a UC Berke­ley spin­out nabs funds to take on the eye

3 years ago
Financing
Startups

GSK touts topline win for PD-1 in head-to-head with Keytru­da — while steer­ing next big check­point drug in­to PhI­II

3 years ago
R&D

Car­olyn Bertozzi, re­peat biotech founder and launch­er of a field, shares in chem­istry No­bel win

3 years ago
People

It’s time we talked about bio­phar­ma — live in Lon­don next week

3 years ago
Bioregnum

Pen­ny stock, Mer­ck part­ner lays off 45% of staff to reach PhII read­out by ear­ly 2023

3 years ago
People
R&D

Amy­lyx snatched the land­mark ap­proval for its ALS drug. Now it’s seek­ing cash to foot the launch bill

3 years ago
Financing

Leo Phar­ma looks 'be­yond the skin' in atopic der­mati­tis aware­ness cam­paign

3 years ago
Pharma
Marketing

Vlad Coric charts course for new Bio­haven with neu­ro­science push and Big Phar­ma vets on board

3 years ago
Pharma

As­traZeneca de­buts an­noy­ing pur­ple ‘Phil’ crea­tures, per­son­i­fied asth­ma eosinophils ‘be­hav­ing bad­ly’

3 years ago
Pharma
Marketing

Lentivi­ral vec­tor ramp-up: J&J and Leg­end to in­vest $500M in New Jer­sey man­u­fac­tur­ing to sup­port Carvyk­ti

3 years ago
Pharma
Manufacturing

Kite Phar­ma gets FDA to sign off on new Cal­i­for­nia-based vec­tor man­u­fac­tur­ing fa­cil­i­ty

3 years ago
Cell/Gene Tx
Manufacturing

Biotech bil­lion­aire Bob Dug­gan flies the white flag as Sum­mit hunts a new own­er, or part­ner, for sole clin­i­cal-stage ...

3 years ago
Deals

User fees in ac­tion: FDA un­veils new short­ened sup­ple­ment re­view, rare dis­ease pi­lots

3 years ago
FDA+

Mar­ket­ingRx roundup: No­var­tis re­cruits NFL coach for Leqvio cam­paign; Pfiz­er pro­motes ‘Sci­ence’ merch on so­cial ...

3 years ago
Pharma
Marketing

Q&A: No­vo Nordisk dig­i­tal in­no­va­tion chief Amy West dis­cuss­es phar­ma pain points and a health­care 'easy but­ton’

3 years ago
Pharma
Marketing

Astel­las, Pan­th­er­na add or­gan to mR­NA tie-up; Rock­et launch­es sale of six fig­ures worth of stock

3 years ago
R&D
News Briefing

Paul Hud­son and Tri­alSpark's mu­tu­al de­sire to speed up de­vel­op­ment con­verges in three-year, six-drug goal

3 years ago
Deals
Pharma

KalVista ends a PhII study ear­ly af­ter pa­tients suf­fer se­vere and life-threat­en­ing side ef­fects

3 years ago
R&D

Pen­ny stock play­er to re­view all op­tions to try stay­ing afloat af­ter clin­i­cal tri­al fail

3 years ago
R&D

Look­ing to push CAR-T in sol­id tu­mors, Bay Area biotech goes pub­lic in SPAC flip — with slight name change

3 years ago
Financing
Deals
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