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  • In a press conference in Mumbai today, the Indian Internet Pharmacy Association (IPA) called for the regulators and the government to help ensure there is an end to the harassment faced by the new entrepreneurs in this space. The IPA has explained its business model in detail and is demanding a level field for all players in the pharmacy space, without favour or bias. They seek clarity on guidelines to enable legitimate players to develop their business in this space and bring in the much needed innovation and technology driven transparency in this sector, leveraging best practices from across the world.

  • The competition is fierce and only the strongest survive the obstacle course within the female reproductive tract. Of the millions of sperm that enter the vagina, only about 10 or so make it to the oocyte or egg, demonstrating how rigorous the natural sperm selection process really is. So how is it possible to select only the best sperm for assisted reproductive technologies such as in vitro fertilization? That's what a researcher at Florida Atlantic University is aiming to do with his microfluidic technology for reproductive medicine.

  • People with diabetes often suffer from wounds that are slow to heal and can lead to ulcers, gangrene and amputation. New research from an international group led by Min Zhao, professor of ophthalmology and of dermatology at the University of California, Davis, shows that, in animal models of diabetes, slow healing is associated with weaker electrical currents in wounds. The results could ultimately open up new approaches for managing diabetic patients.

  • Allergan plc announced that the 510(k) Premarket Notification Application for the XEN Glaucoma Treatment System (consisting of the XEN45 Gel Stent and the XEN Injector) has been accepted for filing by the U.S. Food and Drug Administration (FDA). XEN45 is a minimally invasive implantable crosslinked gelatin shunt used to reduce intraocular pressure (IOP) associated with refractory glaucoma.

    XEN45 is CE marked in the European Union, where it is indicated for the reduction of intraocular pressure in patients with primary open angle glaucoma where previous medical treatments have failed. It is also licensed for use in Canada, Switzerland, and Turkey.

    "We are pleased that the FDA has accepted the 510(k) filing for the XEN Glaucoma Treatment System, an excellent complement to Allergan's ongoing portfolio and development programs in this critical treatment area. We look forward to working together with the FDA to bring this treatment to market and, in doing so, offer a potential new option to millions of Americans who suffer from glaucoma," said David Nicholson, Chief R&D Officer, at Allergan.

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  • Endo Pharmaceuticals Inc., a subsidiary of Endo International plc announced that, based on discussions with the U.S. Food and Drug Administration (FDA), the Company has been notified that an Advisory Committee of the FDA will be convened in the fall of 2016 to review the Company's Supplemental New Drug Application (sNDA) for OPANA® ER. As a result of the Advisory Committee meeting, the current Prescription Drug User Fee Act (PDUFA) date of July 29, 2016 for the OPANA® ER sNDA will not be met and the action on the supplement is expected to be taken by the FDA as soon as possible following the Advisory Committee meeting.

  • Roche  announced that the European Commission has approved Gazyvaro® (obinutuzumab) in combination with bendamustine chemotherapy followed by Gazyvaro maintenance in people with follicular lymphoma who did not respond or who progressed during or up to six months after treatment with MabThera® (rituximab) or a MabThera-containing regimen.

  • Zydus Cadila, a global healthcare provider and Eczacibasi Ilac Pazarlama AS, a leading healthcare company of Turkey, have signed a strategic collaboration agreement to market biotech products in the Turkish market. The agreement involves the import of biosimilars which are currently unavailable in the country especially for the treatment of cancer and also paves the way for a long term strategic collaboration to produce and launch new products in the market.

  • Aegerion Pharmaceuticals, Inc. and QLT Inc. have entered into a definitive merger agreement under which Aegerion will be merged with a wholly owned indirect subsidiary of QLT. Upon completion of the proposed merger, each outstanding share of Aegerion common stock will be exchanged for 1.0256 shares of QLT common stock. QLT plans to change its name upon the closing of the proposed transaction to Novelion Therapeutics Inc. (Novelion) and its common shares will trade on the NASDAQ Global Select Market and the Toronto Stock Exchange.

    A broad-based investor syndicate comprised of both new investors and existing shareholders of both companies (collectively, the "Investors") has committed to invest approximately USD 22 million in QLT and to vote in favour of the proposed transaction. Assuming completion of the proposed merger by the end of the third quarter of 2016, Novelion is expected to have an unrestricted cash balance of over USD 100 million.

    The proposed merger is expected to create a strong, rare disease-focused global biopharmaceutical company with a diversified portfolio consisting of Aegerion's two commercially branded products, Juxtapid (lomitapide) capsules and Myalept (metreleptin), and QLT's QLT091001 ("Zuretinol Acetate" or "Zuretinol"), a phase 3-ready Ultra-Orphan Fast Track and Orphan Drug designated asset being developed for the treatment of Inherited Retinal Disease caused by underlying mutations in RPE65 or LRAT genes ("IRD"), which indication comprises Leber Congenital Amaurosis ("LCA") and Retinitis Pigmentosa ("RP").

    Zuretinol acetate is expected to advance to Phase 3 clinical trials in the third quarter of 2016 and has Orphan Drug designation from both FDA and EMA, as well as FDA Fast Track designation.


    In combination with the proposed merger transaction, a broad-based investor syndicate will subscribe to purchase approximately USD 22 million in shares of QLT common stock for a purchase price of USD 1.76 per share is subject to the satisfaction or waiver of the conditions to closing the merger. The investor syndicate includes new investors, including Deerfield, and a broad group of existing Aegerion and QLT shareholders, including Armistice Capital, Broadfin Capital, Healthcare Value Capital, JW Asset Management, K2 & Associates Investment Management, Sarissa Capital, Tiger Legatus Capital Management, and others.

    The Board of Directors of Novelion will be comprised of ten members, including four QLT designees, four Aegerion designees and two shareholder representatives, one from Broadfin Capital and the other from Sarissa Capital. For a period of time that expires shortly after Novelion's 2017 annual shareholder meeting, Sarissa Capital also has the right to designate an additional director to the Novelion Board.


    Under the terms of the merger agreement, Aegerion will become a wholly-owned indirect subsidiary of QLT, and each existing share of Aegerion common stock will be converted into the right to receive 1.0256 common shares of Novelion. As a result of the structure of this transaction, a repayment obligation with respect to Aegerion's outstanding convertible notes will not be triggered.

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