EMA recommends BI's Pradaxa bleeding agent and Amgen's Kyprolis; Endo moves forward with Par buyout;

@FiercePharma: Investors trounce Aratana on dashed hopes for canine lymphoma drugs. FierceAnimalHealth article | Follow @FiercePharma

@EricPFierce: Sun Pharma unit Mutual Pharma recalls 216,766 bottles that may have chemical leaching labels. FiercePharmaManufacturing story | Follow @EricPFierce

@CarlyHFierce: Proud to say my home state is like, basically, the champion of pumpkin-growing. Where America's pumpkins come from. More | Follow @CarlyHFierce

> The European Medicines Agency (EMA) has recommended accelerated approval of Praxbind, which can be used to control bleeding in patients taking Boehringer Ingelheim's blood thinner Pradaxa. Release

> The EMA has also recommended approval for Amgen's ($AMGN) Kyprolis to treat patients with relapsed multiple myeloma. Release

> The EMA also recommended approval of Vertex Pharmaceuticals' ($VRTX) orphan drug Orkambi for the treatment of cystic fibrosis. Release

> Endo ($ENDP) says it will promptly proceed with its buyout of Par Pharmaceutical after receiving notice of termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act in the U.S. Release

> Teva ($TEVA) says it has a deal to buy Gecko Health Innovations, a software company working with ways to help tired people with respiratory disease adhere to meds and manage their diseases. Release

Medical Device News

@FierceMedDev: ICYMI: Study: 3-D tissue marker helps improve breast cancer monitoring, aids recovery. Article | Follow @FierceMedDev

@VarunSaxena2: Four key medical device recalls of 2015. Feature | Follow @VarunSaxena2

@EmilyWFierce: ICYMI: EU regulators crack down on Brazilian devicemaker for implant safety scare. Article | Follow @EmilyWFierce

> Pathway Genomics' direct-to-consumer cancer diagnostic earns FDA warning letter. Report

> Sientra off by more than 50% after it discloses CE mark suspension for its contract manufacturer. More

> FDA panel grills Bayer over Essure safety. Story

Biotech News

@FierceBiotech: ICYMI: Aduro adds checkpoint inhibitors to a 'breakthrough' mix in $32M buyout. Article | Follow @FierceBiotech

@JohnCFierce: Think the drug pricing issue is going away? Washington Post: The secret truth. Report | Follow @JohnCFierce

@DamianFierce: As a longtime appreciator of dumb corporate M&A codenames, "Project Potsticker" is a solid addition. Bloomberg story | Follow @DamianFierce

> Troubled GlaxoSmithKline to shutter R&D facility in France. Story

> Roche, Boehringer and Gilead line up for EU drug approvals. News

> AbbVie dumps Galapagos' arthritis drug and presses on with its own. Article

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