Ablynx NV and Merck Serono have expanded a partnership dating from 2008 to focus on early discovery across a range of therapeutic areas with the goal of identifying antibody-derived therapeutic proteins for later stage development.
Merck Serono has changed course and decided to continue development of its MUC1 antigen-specific immunotherapy against non-small lung cancer focusing on a patient subgroup. The Phase 3 trial is being conducted under a Special Protocol Assessment with the FDA.
Galapagos NV and AbbVie Inc have reached an agreement to co-develop small molecule drugs to treat cystic fibrosis. The goal is to identify compounds that can correct defects and/or restore the activity to the cystic fibrosis transmembrane regulator protein.
Inovio Pharmaceuticals Inc has described a new modality for generating monoclonal antibodies that involves the use of DNA plasmid technology to produce specific antibody molecules in the bloodstream of mice.
The US Food and Drug Administration has expanded the indication for an artificial heart valve manufactured by Edwards Lifesciences Corp to include the treatment of patients who have inoperable aortic valve stenosis.
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.