Article Listing - Oscient completes Ph IV enrollment in Factive trial early
Boehringer Ingelheim to build biopharma facility in China
7 June 2013
German family-owned drug major Boehringer Ingelheim has signed a strategic alliance agreement and contract to build a current Good Manufacturing Practices (cGMP) biopharmaceuticals facility with China's Zhangjiang Biotech & Pharmaceutical Base Development Company (ZJ Base) in Pudong, Shanghai.
European Medicines Agency and EUnetHTA review progress of their cooperation
7 June 2013
The European Medicines Agency and EUnetHTA, the European network for Health Technology Assessment (HTA), met to review the progress of their cooperation in London on May 14, it was reported today (June 7). This was the sixth meeting since the start of their collaboration in 2010.
Majority vote from FDA advisory panel to ease restrictions on GSK's Avandia
7 June 2013
A joint advisory committee to the US Food and Drug Administration (FDA) voted to continue to make UK pharma giant GlaxoSmithKline's (LSE: GSK) diabetes drug Avandia (rosiglitazone) available to appropriate patients with the majority of the 26 panel members voting to either modify (13) or remove (7) the Risk Evaluation and Mitigation Strategy (REMS) program in place. Remaining members voted to continue the REMS (5) or withdraw (1) Avandia from the US market.
Novavax makes public offer to acquire Sweden's Isconova for $29.6 million
7 June 2013
In what seems to be confirmation that adjuvants are fast becoming a serious element in vaccine development, USA-based Novavax (Nasdaq: NVAX) revealed that it has made a public tender offer to acquire Sweden-based Isconova (OMX: ISCO) directly from shareholders and intends to make a private offer for all outstanding stock options.
FDA warns Novartis on Austrian generic manufacturing plant cGMP failures
7 June 2013
The US Food and Drug Administration has written to Joseph Jimenez, chief executive of Swiss drug major Novartis (NOVN: VX), relating to its investigation of the pharmaceutical manufacturing plant at Ebewe Pharma's Unterach am Attersee, Austria, production facility, which identified significant violations of current good manufacturing practice (cGMP) regulations for finished pharmaceuticals. Ebewe was acquired by Novartis' generics subsidiary Sandoz in 2009.
Positive Ph III results for Regeneron/Bayer's Eylea in mCNV
6 June 2013
US biotech firm Regeneron Pharmaceuticals (Nasdaq: REGN) and partner Germany's Bayer (BAYN: DE) have reported positive top-line results for Eylea (aflibercept) Injection from the Phase III MYRROR study in myopic choroidal neovascularization (mCNV).
New Florida law takes a major step in promoting access to biologic medicines
6 June 2013
Legislation amending the US state of Florida's existing prescription drug substitution law has the potential to create a pathway for biosimilar product substitution at the pharmacy. The bill, House Bill 365, passed both houses of the state's legislature in late April with nearly unanimous support, and has now must be signed by Governor Rick Scott.
Santhera gets exclusive rights from NIH for novel approach to pp multiple sclerosis treatment
6 June 2013
Swiss Santhera Pharmaceuticals (SIX: SANN) says that it has obtained an exclusive license from the USA's National Institutes of Health (NIH) to its rights on a patent granted in the USA for the use of idebenone for the treatment of primary progressive multiple sclerosis (ppMS), a currently untreatable disease affecting about 40,000 patients in the USA.
Amendments to EMA pharmacovigilance legislation: new notification requirements
6 June 2013
The European Medicines Agency has announced that marketing-authorization holders of human medicines will now have to declare the reasons that lead them to take any of the actions below to the Agency, in accordance with the amendments to the 2010 pharmacovigilance legislation of the European Union:
France Biotech reports on dynamism of nation's life sciences industry
6 June 2013
France Biotech, the association of French entrepreneurs in the Life Sciences, published the 11th edition of its annual study, titled Panorama of the Life Sciences Industry, which reports on the international and domestic industry trends in 2012/2013. This year, 186 French companies took part in the study.
- 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
