Skip to main content

Pharma News

 

Clinical courses

 

Clinical research courses

Get the latest news from world and India’s leading pharmaceutical companies Pharma Industry, pharmaceutical marketing, generic drugs, and Complete news for Pharmacy and Life Sciences professionals.

  • 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.

  • Novartis announced that it will further expand its long-standing partnership with Medicines for Malaria Venture (MMV). Novartis will lead the development of antimalarial compound KAF156 with scientific and financial support from MMV in collaboration with the Bill & Melinda Gates Foundation. This agreement sets out the terms and conditions for the development of KAF156 and its future availability to patients.

  • Swedish Orphan Biovitrum AB (Sobi) announced that the Food and Drug Administration (FDA) has approved a higher strength 20 mg capsule of Orfadin® (nitisinone) for the treatment of Hereditary Tyrosinaemia type-1 (HT-1). HT-1 is a rare genetic disease that affects infants and children. It is progressive and may result in liver and kidney complications and can be fatal if untreated.

  • Today leading experts on infectious disease and urinary tract infections (UTIs) will gather in London to discuss the alarming state of antibiotic resistance, and present findings from a landmark study that conclusively shows that cranberries can be a nutritional approach to reducing symptomatic UTIs, and as a result, may be a useful strategy to decrease worldwide use of antibiotics.

  •  Dioxins are environmental pollutants that stay in the body for long periods of time because they can accumulate in fat tissue. They are mainly by-products of combustion and industrial processes. Long-term exposure to dioxins has been suspected to have a host of toxicities, causing health issues such as cancer and impairment of the immune system and the developing nervous system.

    (adsbygoogle = window.adsbygoogle || []).push({});
  • The dangers of arterial thrombosis - the formation of blood clots that can block arteries and cause illness or death - can escalate through a vicious cycle of coagulation and inflammation. But microRNAs - single-stranded, non-coding small RNAs that can tamp down signaling from specific genes - may be able to break this cycle. In previous studies, researchers from Brigham and Women's Hospital found that microRNA-181b (miR-181b) could regulate acute and chronic vascular inflammation. In a new study published online this week in The FASEB Journal, the research team investigated the role of miR-181b in blocking the development of arterial thrombosis. The new findings have implications for heart attacks, stroke and peripheral artery disease.

  • Blood safety researchers say it is highly likely that the mosquito-borne Zika virus can be transmitted through blood transfusions and are calling for an evidence-based approach to protecting the blood supply from the threat of Zika virus according to a commentary in the journal Transfusion.

Subscribe to Pharma News