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.
Trials of potential treatments for both early and late-onset Alzheimer’s diseases are among seven projects to receive $45 million in new funding from the National Institutes of Health as part of a US effort to accelerate research into the disease.
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.
The boundaries of stem-cell technology have once again pushed back with a finding by Spanish researchers that adult mouse cells can be reprogrammed in vivo to generate induced pluripotent stem (iPS) cells. The finding was reported on 11 September, 2013 in Nature.
For more than a decade, the European Medicines Agency has maintained a policy for handling problems that arise if the judgement of one of its scientific experts is clouded by an association with the pharmaceutical industry. The policy started out as a code of conduct. It was later strengthened to become a formal policy on conflicts-of interest, together with a requirement that experts publicly declare their interests and submit to a breach-of-trust procedure if they failed to tell the truth.
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.