Novartis has agreed to pay privately-owned Enanta Pharmaceuticals Inc $34 million upfront, plus potential milestones of $406 million, for exclusive rights to a compound to treat hepatitis C. The compound is poised to enter clinical development.
From 1 March, the European Medicines Agency will begin publishing information on new drug applications that it receives from companies. The measure is part of an ongoing policy to make the European regulatory procedures more transparent.
GlaxoSmithKline PLC has decided to exercise an option giving it the right to exclusively license from Galápagos NV two compounds against immuno-inflammatory diseases. The compounds are part of an alliance dating from 2006.
Algeta ASA of Norway has successfully raised more than $45 million in a private share placement which will support the registration and commercialisation of its lead product, Alpharadin, for the treatment of cancer patients with bone metastases.
A meningococcal vaccine and a new treatment for non-Hodgkin’s B-cell lymphoma were among four new medicines to receive positive opinions from the European Medicines Agency’s Committee for Medicinal Products for Human Use on 17 February.
The management of Amsterdam Molecular Therapeutics NV is proposing to de-list the company and transfer its gene therapy assets to a new private concern following a regulatory rejection of its lead product Glybera. Shareholders will vote on the proposal on 30 March.
The European Medicines agency has issued contraindications and warnings for aliskiren medicines which include the Novartis drug Rasilez. The drug shouldn’t be used in patients with diabetes or renal impairment who take ACE inhibitors.
The US Food and Drug Administration has approved the synthetic steroid, mifepristone (Korlym), as a treatment for adults with endogenous Cushing’s syndrome, a rare disease caused by the overproduction of cortisol. It is the first approved treatment for this condition.
GlaxoSmithKline Plc has withdrawn an application from the European Medicines Agency to expand the use of its breast cancer drug, Tyverb (lapatinib), in combination with paclitaxel. Separately, it has applied to have the drug used with trastuzumab.
EOS imaging SA, which has developed a three-dimensional imaging system for orthopaedic investigations, has raised €38 million in an initial public offering on the Paris NYSE Euronext Exchange. The French company said its offering was 3.8 times oversubscribed at €6.87 per share.