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In an effort to help pharma manufacturers evaluate test results, the FDA is issuing a new guidance on investigating out-of-specification (OOS) results that fall outside the acceptance criteria established in drug applications, drug master files, official compendia or by the manufacturer.
Swiss drugmaker Novartis has announced the start of the GALIANT trial, which will involve more than 7,500 people, to compare the company's investigational oral Type 2 diabetes medication Galvus (vildagliptin) with commonly prescribed antidiabetic oral medicines called thiazolidinediones (TZDs).
Torrent Pharma, an India-based drugmaker, announced that it has entered into an agreement with Tasly, one of China's largest pharma companies, to exclusively market its Cardiotonic pill in India.
India and Australian Government have established an Indo-Australian Fund for Scientific and Technological Cooperation in Biotechnology (Indo-Australian Biotechnology Fund).
Daiichi Sankyo Co., Ltd. has announced that its subsidiary Daiichi Pharmaceutical Co., Ltd. has signed an agreement to acquire 100% of the shares of Seoul-based Daiichi Pharmaceutical Korea Co., Ltd. ('KDP'), a joint venture with Jeil Pharmaceutical Co., Ltd. The acquisition will take effect on October 13, when KDP becomes a wholly owned subsidiary of Daiichi Pharmaceutical.
GlaxoSmithKline PLC said it is seeking regulatory approval to sell its breast cancer drug Tykerb -- one of the most promising high earners in its pipeline of new medicines -- in Europe.
Novartis Pharmaceuticals Canada announced the Health Canada approval of Femara, or letrozole, as adjuvant (post-surgery) treatment for postmenopausal women with hormone receptor-positive early breast
cancer.
U.S.-based Barr Pharmaceuticals Inc. has managed to acquire more than 70 percent of drug company Pliva d.d., Croatian authorities said Wednesday, making its (euro2 billion; US$2.6 billion) takeover
seem certain.
Israeli drugmaker Teva has presented new data on its drug Azilect
(rasagiline tablets) as initial monotherapy for Parkinson's disease, as first adjunctive therapy in moderate Parkinson's and in combination with other adjunct agents in moderate to advanced Parkinson's.