Ablynx NV has secured a licensing deal with AbbVie Inc for its antibody-derived therapeutic protein ALX-0061 to treat inflammatory diseases. The product targets the interleukin-6 receptor and is in Phase 2 for rheumatoid arthritis and systemic lupus erythematosus (SLE).
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.
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.