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    Additional Data May Clarify Boston’s Watchman Mixed Results, Chances for Approval

    Compiled by Michael Manns, Senior Equity Analyst, Jason McGorman, Equity Analyst, Bloomberg Industries and Elizabeth Krutoholow Additional data on Boston Scientific’s Watchman device may provide clarity on mixed results from the Prevail trial. A preliminary analysis of how effective the device was after 18 months yielded varied results as the study met one of two [...]

    Biogen’s Recombinant Factors for Hemophilia May Provide Breakthrough for Patients

    by Elizabeth Krutoholow   Biogen’s hemophilia drugs may provide a breakthrough for patients by offering protection against bleeding with fewer infusions than standard agents, Dr. Jerry Powell, a hematologist with the UC Davis Comprehensive Cancer Center said in an interview.   These drugs will compete against currently marketed recombinant factors like Baxter’s Advate and Pfizer’s [...]

    Price Premium May Pose Hurdles for Arena, Eisai’s Belviq Similar to Vivus’ Qsymia

    Compiled by Andrew Berens, MD, Senior Healthcare Analyst, Bloomberg Industries and Elizabeth Krutoholow Arena and Eisai’s decision to price obesity drug Belviq at a premium to competitor Vivus may create a hurdle for the companies without broad coverage from insurers. Eisai disclosed that the wholesale acquisition cost of Belviq has been set at $199.50 for [...]

    Court Deals a Blow to Pharma by Excluding Off-Label Drugs From Part D Reimbursement

    by Jason M. Brocks , Legal Analyst, Bloomberg Law Pharmaceutical companies may begin to rethink their pipeline and marketing strategies in light of the U.S. District Court’s highly technical analysis of the language of the Medicare law. The court’s opinion resulted in a denial of reimbursement to a Medicare Part D beneficiary for a drug [...]

    Multinational Medical Device Manufacturers Face Stiff Local Competition in China

    by Michael Manns, Senior Equity Analyst & Jason McGorman, Equity Analyst, Bloomberg Industries China is now the world‘s second largest market for medical equipment, behind the U.S. Hospitals have purchased imaging and diagnostic equipment in compliance with the 2009 health reform that included a $124 billion stimulus package to build medical clinics in every village [...]

    Pfizer’s Xeljanz Has Strong Launch in Arthritis, May See Greater than Expected First-Line Use

    Pfizer’s novel rheumatoid arthritis drug (RA) Xeljanz has had a strong launch in the U.S. Initial analysis of prescription data from Symphony Health Solutions suggests that Xeljanz use will not be limited to patients who have an inadequate response to TNF inhibitors, which currently dominate the market. Additional data on a higher dose and use [...]

    Pharma’s Interest in Lexicon’s LX4211 May Grow After J&J’s Favorable Invokana FDA Panel

    Lexicon may be able to secure a partner for diabetes drug LX4211 following the favorable review of Johnson & Johnson’s Invokana by a panel that met to advise the FDA ahead of its decision on approval. The company has said it wants to seal a partnership for the drug before launching Phase III trials, which [...]

    Bar Raised for Off-Label Marketing False Claims Actions

    By Jason M. Brocks, Bloomberg Law A recent opinion issued by the United States Court of Appeals for the Fourth Circuit raises the pleading standard in cases alleging False Claims Act (FCA) violations by drug companies for off-label use of their drugs resulting from their own marketing practices. According to the court, a claim alleging [...]

    Nupathe Awaits FDA Decision for Migraine Patch

    NuPathe may gain approval for its first commercial product Zecuity, a transdermal migraine patch, this week. The company received a Prescription Drug User Fee Act (PDUFA) date of Jan.17 from the FDA. Click here to continue reading.

    Allergan May Add New Non-Cosmetic Use to Botox

    Allergan’s supplemental biologics license application (sBLA) for a Botox label expansion to idiopathic overactive bladder (OAB) may receive a final decision this month. The application has a PDUFA date in January, according to estimates by Bloomberg Industries, which are based on the company’s submission in both the U.S. Click here to continue reading.

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