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China forms global alliance with Germany's blue inspection for drug quality

11 June 2013

Effective June 1, 2013, the China Chamber of Commerce for Import & Export of Medicines & Health Products (CCCMHPIE) and the German Good Manufacturing Practices (GMP) third party auditor blue inspection body GmbH have established a strategic cooperation. Its primary goal is to support Chinese manufacturers of drug products and active ingredients (APIs) in the framework of their quality management system (QMS) to comply with European GMP regulations.

BioLineRx collaborates with Chinese firm on hep C drug BL-8030

11 June 2013

Israeli drug developer BioLineRx (TASE: BLRX) has signed an out-licensing agreement with Jiangsu Chia-tai Tianqing Pharmaceutical Co (CTTQ), a leading Chinese pharmaceutical company in the liver disease therapeutic area, for the development and commercialization of BL-8030, an orally available treatment for the hepatitis C virus (HCV).

SOBI gets FDA approval to manufacture substance for Kineret with partner Boehringer Ingelheim

11 June 2013

Swedish Orphan Biovitrum (STO: SOBI) said today (June 11) that it has received approval from the US Food and Drug Administration for the manufacture of drug substance for Kineret (anakinra) at German family-owned drug major Boehringer Ingelheim's microbial site in Vienna, Austria.

Japanese launches of subcutaneous injection forms of Pralia and Enbrel, and of Acofide

11 June 2013

Among a bunch of Japanese drug launches in the past couple of days, Daiichi Sankyo (TYO: 4568) announced the debut of the osteoporosis treatment Pralia (denosumab, genetic recombinant) subcutaneous injection 60mg syringe, which was approved in Japan for manufacture and marketing on March 25, 2013, and placed on National Health Insurance drug price list, May 24.

Canada announces new medical marijuana regulations

11 June 2013

Canada's Health Minister Leona Aglukkaq has announced new regulations that will change the way Canadians access marijuana for medical purposes. The new Marijuana for Medical Purposes Regulations (MMPR) will be published in the Canada Gazette on June 19, 2013.

Negative FDA news for AVEO's tivozanib and Dynavax' hep B vaccine

11 June 2013

US biotech firm AVEO Oncology (Nasdaq: AVEO) says that it has received a complete response letter from the US Food and Drug Administration saying that the FDA will not approve in its present form the New Drug Application for the company's investigational agent tivozanib for the treatment of patients with advanced renal cell carcinoma (RCC).

Elan board unreservedly rejects Royalty's increased tender offer

11 June 2013

Ireland-based drugmaker Elan Corp (NYSE: ELN) says that its board of directors, after careful review and consideration and with the assistance of its executive management team as well as outside financial and legal advisors, has rejected the revised bid from privately held investment firm Royalty Pharma to acquire all of the shares of Elan for $13.00 plus up to an additional $2.50 per share in contingent value rights (CVR; The Pharma Letter June 10).

Emerging targeted therapies offer advantages over currently-used platinum-resistant ovarian cancer drugs

11 June 2013

The effect of an emerging therapy on key efficacy endpoints, including time to disease progression and overall survival, has the most influence over surveyed US and European oncologists' prescribing decisions for platinum-resistant advanced ovarian cancer, according to a new report from health care advisory firm Decision Resources.

Zambon to acquire UK respiratory specialist Profile Pharma

10 June 2013

Family-owned Italian drugmaker Zambon has taken a significant step to grow in the respiratory therapy area, with the planned acquisition of UK-based Profile Pharma from present owner the Philips Group. Financial details of this transaction will not be disclosed.

Licensing deals between Xenon and Isis for XEN701, and Access and AMAG for MuGard

10 June 2013

USA-based Isis Pharmaceuticals (Nasdaq: ISIS) revealed that privately-held Canadian firm Xenon Pharmaceuticals has exercised its option to an exclusive worldwide license to XEN701, an antisense drug discovered in a collaboration between Isis and Xenon.

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