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An FDA reform agenda: What would Commissioner Scott Gottlieb do in his first six months?
9 years ago
Pharma
After steering through a controversy over soaring price of naloxone, FDA rejects Amphastar’s intranasal version
9 years ago
Pharma
Arix IPO raises £100M for new biotech investments; Santhera sets up shop in Massachusetts
9 years ago
News Briefing
Another price-gouging CEO proves the system is broken, underscoring need for principled reform at the FDA
9 years ago
Bioregnum
Opinion
Gilead offloads a PhII-ready addiction therapy to an upstart which knows this drug well
9 years ago
Pharma
In the hunt for a megablockbuster, Celgene plans FDA filing in wake of PhIII win for ozanimod in MS
9 years ago
R&D
Pharma
AstraZeneca throws down the gauntlet with a PhIII victory in head-to-head PARP war with Tesaro
9 years ago
R&D
ArQule’s lead drug tivantinib flops again in PhIII liver cancer study
9 years ago
R&D
Sage CEO’s M&A chatter sparks a spike, and an awkward correction
9 years ago
Deals
Looking to an IPO? Rhythm raises $41M to pay for pivotal trials
9 years ago
Financing
Alkermes CEO Pops stays focused on 5461 filing plans; Shkreli gets booed at Harvard
9 years ago
News Briefing
With an extra $25M in hand, Dauntless maps the next stage of growth for the pipeline
9 years ago
Startups
Alexion shelves an early-stage Sanfilippo B drug, writes off $85M
9 years ago
Pharma
Behind the scenes of J&J’s $30B Actelion buyout: Walkouts, Sanofi’s blunder and a $230M sweetener
9 years ago
Deals
PhRMA disses Marathon CEO—and PhRMA board member—Jeff Aronin after latest price gouging controversy
9 years ago
People
Pharma
Valeant gets an FDA OK for new psoriasis drug brodalumab — but there’s a big catch
9 years ago
Pharma
Patent board tells CRISPR scientists to back off from a nasty fight over gene editing tech
9 years ago
Pharma
Ionis bags a $75M milestone from Bayer; Inventiva garners $51M from IPO
9 years ago
News Briefing
No, President Trump, biopharma does not want you to deregulate drug development
9 years ago
Bioregnum
Opinion
Versant gambles $20 million on a UCSD spinout focused on NASH and fibrosis
9 years ago
Startups
Surrozen grabs $33M, joins startups looking to spark a comeback in regenerative med
9 years ago
Startups
Ardelyx touts a PhIII hyperphosphatemia success for tenapanor, looking to calm fears over diarrhea
9 years ago
R&D
Merck’s HIV drug doravirine looks solid — though far less stellar than rivals — in 1st PhIII
9 years ago
R&D
Merck’s leading PhIII BACE drug implodes in latest Alzheimer’s disaster
9 years ago
R&D
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