Invokana Gets Positive CHMP Opinion

barbara.lempert INVOKANA® (canagliflozin) Receives Positive Opinion Recommending Approval in the European Union for the Treatment of Adults with Type 2 Diabetes Mellitus1 September ...

GSK gets double dose of good news for Breo Ellipta

Eric Palmer GlaxoSmithKline got a double dose of good news today about its respiratory drug Breo Ellipta, known as Relvar Ellipta in other markets. Regulators in Europe recommended ...

Takeda’s Colitis Drug Gets Priority Review

barbara.lempert Takeda’s New Investigational Drug Vedolizumab is Granted Priority Review Status by U.S. Food and Drug Administration for Ulcerative Colitis DEERFIELD, Ill. and ...

Pharma M&A gets soft in second quarter

Eric Palmer According to a new report from consultant PwC, there was a decline in the two Vs–volume and value–after some big deals in the first quarter pushed both of those ...

Biotech accelerator BioMotiv gets a $20M commitment from new investor

John Carroll A week after Cleveland's nascent biotech accelerator BioMotiv bumped its financial reserves to $ 46 million, Torrey Pines Investment has stepped in to offer a $ 20 ...

Bavarian Nordic Gets EU OK for Imvanex Smallpox Vaccine

barbara.lempert Bavarian Nordic Receives European Marketing Authorization for IMVANEX Smallpox Vaccine First product approved using MVA-BN® vaccine platform technology In Phase ...

Bayer hypertension drug riociguat gets unanimous backing from FDA panel

John Carroll An FDA panel of outside experts has contributed a round of thumbs-up for Bayer's new drug for pulmonary arterial hypertension, to be sold as Adempas, sending the pharma ...

Sanofi’s Nasacort OTC bid gets nod from FDA advisers

Carly Helfand FiercePharma News

Sanofi’s bid for more OTC meds gets FDA boost

Tracy Staton Sanofi may soon have a another allergy drug to add to its over-the-counter stable. FDA reviewers backed Nasacort AQ as safe for use without a prescription Reuters reports, ...

Teva gets exclusive rights for OTC morning-after pill

barbara.lempert Teva gets exclusive rights for OTC morning-after pill PHILADELPHIA, July 26, 2013 (PHILADELPHIA INQUIRER)–The morning-after pill debate began anew this week when ...

Novartis COPD drug gets European backing

Emily Mullin Swiss pharma giant Novartis has earned an endorsement from the European Committee for Medicinal Products for Human Use for it once-daily Ultibro Breezhaler to treat chronic ...

Gilead earnings firm, but company gets shot in arm from Vertex setback

Eric Palmer Gilead Sciences turned in second-quarter earnings that were pretty much in line with analysts' projections Thursday, then caught a break in the same day that pushed ...
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