Article Listing - Low-dose Ampyra fails in multiple sclerosis study, says Acorda
UK's NICE gives thumbs up for GSK's Revolade as NHS blood disorder treatment
12 June 2013
UK drugs watch dog the National Institute for Health and Care Excellence (NICE) has published final draft guidance recommending pharma major GlaxoSmithKline's (LSE: GSK) Revolade (eltrombopag) as an option for treating some adults with the bleeding disorder, chronic immune (idiopathic) thrombocytopenic purpura.
ThromboGenics' Jetrea gets initial NICE recommendation for VMT
12 June 2013
Belgium-based biopharma company ThromboGenics (Euronext Brussels: THR) said this morning (June 12) that the UK's drugs watch dog the National Institute for Health and Care Excellence (NICE) has provisionally recommended its ophthalmic agent Jetrea (ocriplasmin) for reimbursement within the National Health Service (NHS).
US FDA considering making "masked" trial data available to outside experts
12 June 2013
According to a Federal Register posting, the US Food and Drug Administration is seeking public comments from interested persons on the proposed availability of "deidentified" and "masked" data derived from medical product applications.
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.
- US Supreme Court says patent settlement can "sometimes" be illegal
- InSite Vision joins Merck & Co and Pfizer in patent infringement law suit against
- Highlights of EHA meeting: Novartis' Jakavi; Bristol-Myers and AbbVie's elotuzumab; Janssen's ibrutinib
- Daiichi Sankyo files for Japanese approval of Prasugrel
- Osteoporosis drug bazedoxifene stops growth of breast cancer cells, even in resistant tumors
