New study raises new questions about Merck cholesterol drug

Tracy Staton A new study finds that the drug lingers in the bodies of patients long after they've stopped using it, sometimes even for years. FiercePharma News

FDA Panel Backs Janssen’s Simeprevir

barbara.lempert FDA Advisory Committee Recommends Approval of Simeprevir for Combination Treatment of Genotype 1 Chronic Hepatitis C in Adult Patients   RARITAN, N.J. (October ...

Alexion bags another FDA ‘breakthrough’ for rare-disease drug

Damian Garde Alexion Pharmaceuticals has racked up its second breakthrough therapy designation from the FDA, securing a faster track for an early-phase enzyme-replacement treatment ...

Celgene raises earnings forecast third time

Eric Palmer Celgene CFO Jacqualyn Fouse recently noted the markets have been rewarding the biotech for plainly explaining how its pieces fit together to reward investors. That comfort ...

FDA Recommends Tighter Restrictions On Certain Painkillers

esilverman In a major change of policy, the FDA has recommended reclassifying commonly used prescription painkillers that contain hydrocodone, such as Vicodin, to a more restrictive ...

J&J wins FDA panel blessing for hep C blockbuster hopeful

Damian Garde Johnson & Johnson's much-hyped simeprevir picked up the unanimous support of FDA advisers on Thursday, moving the potential hepatitis C blockbuster one step closer ...

Versant Ventures amassing $200M fund for biotech upstarts

Damian Garde California VC Versant Ventures is putting together another $ 200 million fund, according to a regulatory filing, building up its chest as biotech investments maintain ...

Ex-Bristol-Myers exec faces 1 year in prison for insider trading

Tracy Staton A former Bristol-Myers Squibb executive could have walked out of a courtroom yesterday facing more than three years in prison for insider trading. But he was sentenced ...

Are Federal Call Centers Up To The Task Of Enrolling Millions In Health Plans?

barbara.lempert Are Federal Call Centers Up To The Task Of Enrolling Millions In Health Plans? By Phil Galewitz KHN Staff Writer HARTFORD, Conn., Oct 24, 2013 — An elderly man ...

Repros plummets as FDA questions testosterone drug data

Damian Garde Repros has again swung southward in its up-and-down development of the testosterone drug Androxal, pushing back its proposed NDA filing and revealing that the FDA is taking ...

Bristol-Myers scores with cancer, diabetes sales hikes

Tracy Staton Bristol-Myers Squibb's third-quarter results amount to a good-news, bad-news report. On the positive side, international sales were up 18%, driving an overall increase ...

Tweets of the day, 10/23/2013

chris.truelove by Christiane Truelove (chris.truelove@ubm.com) Another business trip to prepare for, but another Twitter roundup has to get done. Last night I was at the Prix Galien ...
Page 5 of 22« First...34567...1020...Last »
© 2018 Global Regulatory Science. All rights reserved. Site Admin · Entries RSS · Comments RSS