The Committee for Medicinal Products for Human Use has given a positive opinion to Benlysta (belimumab), GlaxoSmithKline’s new medicine for patients with systemic lupus erythematosus. The drug was approved by the FDA on 9 March 2011.
The US Food and Drug Administration has approved the first test for establishing whether a pregnant woman or a person with swollen lymph nodes who tests positive for toxoplasmosis has developed the infection within the past four months.
Evotec AG and the Roche group said they have voluntarily ended a Phase 2 proof-of-concept study in a candidate molecule for treatment-resistant depression. The decision was triggered by difficulties recruiting patients under the study protocol.
Takeda Pharmaceutical Company Ltd is set to significantly increase its commercial presence in Europe with the planned acquisition of privately-owned Nycomed A/S of Switzerland. Under the agreed takeover, Takeda will pay €9.6 billion in cash to Nycomed’s shareholders who are members of a consortium of private equity funds led by Nordic Capital Private Equity Funds.
Curetis AG, a molecular diagnostics company specialising in the development of in-vitro diagnostic products for infectious diseases, has raised €4.5 million in an extension of a Series A financing, bringing the total for the round to €24.5 million.
A French company that specialises in biomarkers for cancer, Median Technologies, has raised €10 million in a private placement of its shares with institutional investors. The company is also planning an initial public offering on NYSE Euronext Paris.
Shire Plc has announced an agreement to acquire the privately-held US regenerative medicines company, Advanced BioHealing Inc, for $750 million in cash. The US company has a marketed product for diabetic foot ulcers.
The Roche group and Merck & Co have announced a number of non-exclusive agreements under which they will explore new combinations of investigational and marketed medicines for hepatitis C. This follows FDA approval of the Merck HCV drug, Victrelis.
ArGEN-X NV, a young Dutch antibody company whose technology is based on the llama, has progressed a candidate antibody into preclinical development, its second therapeutic candidate. The compound targets an undisclosed cancer cell receptor.
A monoclonal antibody that targets placental growth factor (PIGF) has been taken to the next stage of clinical development with the start of a Phase 1b/2 study in patients with glioblastoma multiforme, the most aggressive type of brain cancer.