Industry News

Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation announced that REVLIMID® (lenalidomide), a cancer medicine that is administered orally, has been granted full marketing authorization by Japan's Ministry of Health, Labour and Welfare (MHLW) for use in combination with dexamethasone as a treatment for patients newly diagnosed with multiple myeloma. This marketing authorization expands upon the approval of REVLIMID in 2010 for the treatment of patients with relapsed or refractory multiple myeloma.

Recipharm AB, a leading contract development and manufacturing organisation in the pharmaceutical industry, has entered into the previously announced strategic collaboration with Alcon, a Novartis company, and signed a long term supply agreement whereby Recipharm will manufacture a range of ophthalmic products using Blow Fill Seal technology.

Sanofi Pasteur, the vaccines division of Sanofi, announced  that the Philippines have granted marketing approval to Dengvaxia®, making it the first vaccine to be licensed for the prevention of dengue in Asia.

Boehringer Ingelheim will make a significant investment in biopharmaceutical production at its Vienna (Austria) site. There the research-driven pharmaceutical company will establish a new large-scale biopharmaceutical production facility for active ingredients manufactured using cell cultures. With the roughly half billion euro investment Boehringer Ingelheim will also create more than 400 new jobs in the Austrian capital. The exact investment and job numbers will be established as details are ironed out.

U.S. Food and Drug Administration approved Uptravi (selexipag) tablets to treat adults with pulmonary arterial hypertension (PAH), a chronic, progressive, and debilitating rare lung disease that can lead to death or the need for transplantation. Uptravi is marketed by San Francisco-based Actelion Pharmaceuticals US, Inc.

The U.S. Food and Drug Administration approved Zurampic (lesinurad) to treat high levels of uric acid in the blood (hyperuricemia) associated with gout, when used in combination with a xanthine oxidase inhibitor (XOI), a type of drug approved to reduce the production of uric acid in the body. Zurampic is manufactured by AstraZeneca Pharmaceuticals LP, based in Wilmington, Delaware.

Merck KGaA, Darmstadt, Germany and Pfizer announced the opening of trial sites for an international Phase III study of avelumab*, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, in patients with platinum-resistant/refractory ovarian cancer. The JAVELIN Ovarian 200 trial is the first Phase III study of a PD-L1 inhibitor investigated as a treatment for platinum-resistant/refractory ovarian cancer. The alliance also announced that the US Food and Drug Administration has provided approval to move forward with a Phase III study of avelumab as a maintenance treatment, in the first-line setting, in patients with locally advanced or metastatic urothelial cancer. The first trial sites are expected to open shortly.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of Astrazeneca's Brilique (ticagrelor) 60mg for the treatment of patients with a history of heart attack and at high risk of having a further atherothrombotic event. The opinion states that, treatment may be started as continuation therapy after an initial one-year treatment with dual anti platelet therapy.

[adsense:336x280:8701650588]