1) Astellas Pharma has submitted marketing authorization application to Japan MOH for approval of Degarelix for treating prostate cancer
Degarelix is Gonadtropin releasing hormone (GnRH) blocker. Degarelix was approved for the treatment of prostate cancer by the U.S. Food and Drug Administration (FDA) in December 2008, and by the European Medicines Agency (EMA) in February 2009, and is commercialized in twenty-one countries* including U.S., Canada, U.K., Germany, and France.
2) Hanmi Pharmaceuticals has submitted NDA for marketing Esomeprazole strontium salt instead of magnesium salt. This NDA is submitted through 505 (b)(2) pathway. This formulation is already approved in Korea and some other countries. (Link)
3) WIPO Patentscope search now includes national collections of Brazil also (Link). In Sep 2009, WIPO has launched search tool for searching National collections in addition to PCT applications (Link). This search tool, as of now, includes ARIPO, Cuba, Israel, Korea, Mexico, Singapore, South Africa, Vietnam and Brazil.
4) GlaxoSmithKline (GSK) announced that it has received approval in Japan from the Ministry of Health, Labour and Welfare for Revolade (eltrombopag) for the treatment of the blood disorder, chronic idiopathic thrombocytopenic purpura (ITP), and for Xyzal (levocetirizine dihydrochloride), the first new anti-histamine to be made available in Japan for eight years (Link). GSK is licensee for levocetrizine in Japan.
5) Pharmacapsules @ Gowlings Volume 9 – Number 8 (Link)
6) Zydus Fights For Right To Make Generic Strattera (Law360)
7) Forest & COPD: Forest and Almirall Report Preliminary Topline Results from the ACCORD COPD II Phase III Study of aclidinium bromide in Chronic Obstructive Pulmonary Disease (COPD). Note: Forest has already licensed Roflumilast from Altana to market in USA territory for COPD.
8) Baxter International Inc announced today that it has entered into a definitive agreement to divest its U.S. generic injectables business to Hikma Pharmaceuticals PLC (Link).
9) GlaxoSmithKline PLC and Amicus Therapeutics today announced a definitive agreement to develop and commercialize Amigal , currently in Phase 3 for the treatment of Fabry disease, a rare inherited disorder. Under the terms of the agreement, GSK will receive an exclusive worldwide license to develop, manufacture and commercialize migalastat HCl. Additionally, as part of the agreement GSK and Amicus also intend to advance clinical studies exploring the co-administration of migalastat HCl with enzyme replacement therapy for the treatment of Fabry disease (Link).
10) Pfizer’s Lyrica® (Pregabalin) Capsules CV Receives Approval for Treatment of Peripheral Neuropathic Pain In Japan (Link).
11) Forest Announces FDA Approval of Teflaro™ (ceftaroline fosamil) for the Treatment of Community-Acquired Bacterial Pneumonia and Acute Bacterial Skin and Skin Structure Infection (Link).
12) FDA approves new schizophrenia treatment from Japanese drugmaker Sunovion Pharmaceuticals (Latuda)
13) Valeant Pharmaceuticals to Acquire #2 Suncare Brand in Australia (Link)