GlaxoSmithKline picks up FDA approval for its latest COPD contender

Damian Garde Adding to its string of respiratory victories, GlaxoSmithKline won an FDA nod for Incruse Ellipta, a once-daily COPD inhaler. FierceBiotech News

Biogen brings Quintiles to the R&D table in 5-year pact

Damian Garde Biogen Idec has struck up a far-reaching agreement with CRO giant Quintiles, tapping the contractor to help design, plan and run its Phase II-IV studies. FierceBiotech ...

Allergan poison pill presages a battle against Valeant’s $47B takeover

Carly Helfand Valeant may think Allergan is a great buyout fit, as evidenced by the $ 47 billion bid it made for the California company Tuesday. But Allergan may feel differently–at ...

Should Amgen join the biopharma breakup party? Analyst says maybe

Tracy Staton Now that the Big Pharma breakup craze has moved down the drugmaker food chain to Baxter International, should Big Biotech jump on the trend? Maybe one of that group, an ...

Gilead’s Sovaldi turns in outsize Q1 sales

Eric Palmer Powered by sales that averaged more than $ 25 million a day for brand-new hep C drug Sovaldi, Gilead Sciences beat all expectations, with quarterly sales that nearly doubled ...

Aastrom surges after acquiring Sanofi’s cell therapies

John Carroll A little more than a year after reorganizing the company and slashing staff in the wake of a Phase III failure, Ann Arbor, MI-based Aastrom Biosciences has acquired Sanofi's ...

GlaxoSmithKline wins an FDA nod for its GLP-1 diabetes drug albiglutide

Damian Garde After a three-month delay pushed pause on its commercial plans, GlaxoSmithKline has secured FDA approval for albiglutide, a new diabetes treatment that will contend for ...

ThromboGenics is picking between billion-dollar bids, report says

Damian Garde Just over a month into its search for "strategic options," ThromboGenics has rounded up a bevy of high-dollar offers that could value the company at as much as ...

AbbVie angles for hep C spotlight as Merck shoulders to the front

Damian Garde While AbbVie is widely expected to be the second entrant to the soon-to-explode market for hepatitis C cocktail drugs after standard-bearer Gilead Sciences, promising data ...

Biogen wins FDA OK for long-acting hemophilia drug Alprolix

John Carroll FierceBiotech News

Galapagos ships out its CRO biz for $179M to focus on R&D

Damian Garde Belgian biotech Galapagos is getting out of the CRO business, selling off its two contract units to preclinical giant Charles River Laboratories for $ 179 million and ...

Drugmakers, FDA need a SWAT team approach on shortages, group says

Eric Palmer The FDA has reduced the number of new drug shortages considerably, and hospitals have gotten much better at responding when they occur. But the total number of drug shortages ...
© 2018 Global Regulatory Science. All rights reserved. Site Admin · Entries RSS · Comments RSS