Pfiz­er and Sang­amo re-open PhI­II of he­mo­phil­ia A gene ther­a­py; AEON head­ed to PhI­II

3 years ago
News Briefing

FDA's out­side ex­perts vote in fa­vor of Fer­ring's fe­cal trans­plant for C. dif­fi­cile, set­ting the stage for Seres

3 years ago
Pharma
FDA+

An­ti­bod­ies once act­ed on­ly as pro­tein block­ers. Now, sci­en­tists are find­ing new ways to make them pro­tein de­stroy­ers

3 years ago
Discovery

As­traZeneca shuts the PhI­II door for Ion­is' PC­SK9 drug de­spite pos­i­tive PhI­Ib

3 years ago
R&D

Amid mas­sive turnover, Agios hires Bio­gen alum as new CFO; Schol­ar Rock, Ever­est Med­i­cines lead the big CEO pa­rade

3 years ago
Peer Review

ODAC gives a big thumbs-down to On­copep­tides' dan­gling ac­cel­er­at­ed ap­proval in mul­ti­ple myelo­ma

3 years ago
FDA+

Knives out at ODAC with vote against ac­cel­er­at­ed ap­proval for Spec­trum lung can­cer drug

3 years ago
FDA+

Bio­gen of­floads near­ly $600M in Cam­bridge re­al es­tate — mak­ing room for a Broad In­sti­tute ex­pan­sion

3 years ago
Pharma

No­var­tis un­veils 'US-first' strat­e­gy ahead of San­doz spin­off

3 years ago
Pharma

'Prac­ti­cal­ly clean' FDA user fees reauth will be in­clud­ed in spend­ing bill wrap­ping up next week

3 years ago
FDA+

Man­u­fac­tur­ing roundup: Lon­za fin­ish­es ex­pand­ing Visp site; CBM to pro­duce jCyte’s cell ther­a­py

3 years ago
Manufacturing

Armed with cash, Bel­gian iP­SC play­er makes a play for Celyad’s cell ther­a­py man­u­fac­tur­ing site

3 years ago
Deals
Cell/Gene Tx

Mer­ck pulls a patent win for di­a­betes fran­chise in West Vir­ginia fed­er­al court

3 years ago
Pharma
Law

Glob­al Fund nets record haul of $14B to elim­i­nate HIV, TB and malar­ia

3 years ago
Pharma

Pfiz­er sacks phar­ma com­pe­ti­tion in ear­ly NFL TV ad­ver­tis­ing sea­son

3 years ago
Pharma
Marketing

Ab­b­Vie ex­pands man­u­fac­tur­ing pres­ence in Ire­land with a €60M in­vest­ment

3 years ago
Financing
Manufacturing

Up­dat­ed: Bio­gen throws it­self back in­to mud­dled da­ta ar­gu­ments with more de­tails on its an­ti­sense ALS drug

3 years ago
R&D

FDA's OCE makes the case for ac­cel­er­at­ed ap­proval rid­er in user fee reau­tho­riza­tion

3 years ago
FDA+
Law

Mer­ck and As­traZeneca get Lyn­parza OK in Chi­na for new in­di­ca­tion; BAR­DA ex­er­cis­es first op­tion with Mar­i­nus

3 years ago
News Briefing

WPP taps Organon chief com­mu­ni­ca­tions of­fi­cer Wendy Lund for new health and well­ness client role

3 years ago
People
Pharma

In­ven­ti­va signs over Chi­na NASH rights to Sino Bio­pharm in pos­si­ble $300M+ deal

3 years ago
Deals
R&D

CD­MO makes an AI and drug dis­cov­ery play in lat­est, small-time ac­qui­si­tion

3 years ago
R&D
Manufacturing

Up­dat­ed: Eli Lil­ly's RET drug notch­es tu­mor-ag­nos­tic ac­cel­er­at­ed ap­proval, full FDA OK in NSCLC

3 years ago
Pharma
FDA+

The End­points 11: The top pri­vate biotechs in pur­suit of new drugs. Push­ing the en­ve­lope with pow­er­ful new ...

3 years ago
Special
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