Article Listing - Orphan status for Adherex product
Questcor Pharma pays $60 million upfront to Novartis for rights to Synacthen
11 June 2013
USA-based Questcor Pharmaceuticals (Nasdaq: QCOR) says it has acquired rights to develop Synacthen (tetracosactide) and Synacthen Depot in the USA from Swiss drug major Novartis (NOVN: VX). Subject to certain closing conditions, Questcor has also acquired rights to Synacthen and Synacthen Depot in certain countries outside the USA.
PDL files for arbitration for alleged royalties underpayments by Genentech
11 June 2013
USA-based PDL BioPharma (Nasdaq: PDLI) revealed today (June 11) that it has filed a Notice of Arbitration against Genentech, the US biotech subsidiary of Swiss drug major Roche (ROG: SIX), with the American Arbitration Association in Voorhees, New Jersey, alleging, inter alia, that Genentech underpaid royalties going back to at least 2007 and impeded PDL's attempts to have Genentech's books and records inspected to determine whether Genentech's past payments to PDL were accurately calculated.
Immunomedics says that adding 90Y-epratuzumab following R-CHOP improves patients' response
11 June 2013
US biopharmaceutical company Immunomedics (Nasdaq: IMMU) reports that adding two doses of epratuzumab labeled with the radioisotope, yttrium-90 (90Y), to a combination of rituximab and CHOP chemotherapy (R-CHOP), the standard of care for patients with diffuse large B-cell lymphoma (DLBCL), appeared to improve elderly patients' responses to treatment.
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).
- US Supreme Court says patent settlement can "sometimes" be illegal
- InSite Vision joins Merck & Co and Pfizer in patent infringement law suit against
- Osteoporosis drug bazedoxifene stops growth of breast cancer cells, even in resistant tumors
- Additional indications in Japan for Roche's Avastin and Astellas' Prograf
- Highlights of EHA meeting: Novartis' Jakavi; Bristol-Myers and AbbVie's elotuzumab; Janssen's ibrutinib
