Roche’s antibody-drug conjugate for HER2-positive breast cancer, Kadcyla, has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), paving the way for marketing authorisation by the end of the year.
Drisapersen, an antisense oligonucleotide being developed by GlaxoSmithKline Plc for Duchenne muscular dystrophy (DMD), has failed to meet its primary endpoint in a Phase 3 study – intended to lead to registration in the US.
Skyepharma Plc has received a double endorsement of its technology with the approval by the Japanese health authority of the company’s proprietary asthma treatment flutiform, as well as the approval of a GSK product using Skyepharma technology.
GlaxoSmithKline Plc has entered into a four-year contract with an arm of the US government to supply the monoclonal anti-toxin, raxibacumab, for stockpiling against a potential bioterrorist attack. The contract has a value of about $196 million.
MorphoSys AG has raised €84 million in a private placement of shares that received strong support from international investors. The company said the issue, which was priced at €55.76 per share, was heavily oversubscribed. The new shares will be listed on the Frankfurt Stock Exchange.
Affimed Therapeutics AG has announced plans to advance a bispecific antibody into a Phase 2 trial in patients with Hodgkin lymphoma with co-funding from the US Leukemia & Lymphoma Society. The society will invest up to $4.4 million over two years in the project.
The Food and Drug Administration has granted ‘breakthrough therapy’ designation to the Genmab A/S-developed therapeutic antibody ofatumumab and to Boehringer Ingelheim’s (BI) kinase inhibitor volasertib for indications in oncology.
Sanofi SA has taken the unusual step of withdrawing its new drug application (NDA) for the Type 2 diabetes drug, lixisenatide, from the US Food and Drug Administration in order to allow a cardiovascular outcomes study of the drug to finish. The French company said the decision is not related to any safety issues or deficiencies with the application.
Evotec AG, the Hamburg-based drug discovery and development company, has once again joined forces with scientists at Harvard University – this time to identify compounds that could prevent or slow down the loss of motor neurons in disease.
AstraZeneca Plc has moved to further strengthen its position in ovarian cancer with an agreement to in-license a kinase inhibitor from Merck & Co Inc that is currently being evaluated as a combination therapy in patients with certain types of the disease.