Sanofi SA has announced regulatory filings in both the US and Europe for alemtuzumab (Lemtrada) to treat relapsing multiple sclerosis. The monoclonal antibody is already approved in the US for second-line CLL and trades as Campath.
Basilea Pharmaceutica Ltd is to receive £146 million upfront from Stiefel, a unit of GlaxoSmithKline Plc, for an eczema compound. It will use the proceeds to support the development and registration of its candidate antibiotic and antifungal drugs.
The US Food and Drug Administration has approved a new personalised medicine for HER2 positive breast cancer from Roche. But supplies of the drug will be limited pending the resolution of a manufacturing problem, according to the agency.
Zealand Pharma A/S and its partner, Sanofi SA, have presented further data supporting their candidate treatment for Type 2 diabetes, lixisenatide (Lyxumia). Lixisenatide is a glucagon-like peptide-1 agonist.
Eli Lilly and Company said that a Phase 2b study of baricitinib, a JAK inhibitor being developed for rheumatoid arthritis, reached its primary endpoint by showing a statistically significant response as measured by a scoring system.
GlaxoSmithKline Plc said that it has extended its $13 per share cash offer for Human Genome Sciences Inc until 17.00 Eastern Standard Time on 29 June. The tender offer was previously scheduled to expire at midnight on 7 June.
Affiris AG has started a Phase 1 study of a new vaccine for Parkinson’s disease which it says is aimed at modifying the disease rather than treating symptoms. The programme has received financial support from the Michael J Fox Foundation.
The US Food and Drug Administration has approved Horizant (gabapentin enacarbil) for the management of postherpetic neuralgia in adults. This follows the drug’s approval in the US in 2011 for restless legs syndrome.
Ridaforolimus, an investigational treatment for metastatic soft tissue or bone sarcoma, has been turned down by the US Food and Drug Administration. The sponsor, Merck & Co Inc, announced receipt of a complete response letter on 5 June 2012.
Addex Therapeutics Ltd said that its partner, Janssen Pharmaceuticals Inc (Johnson & Johnson), is to start a Phase 2 study of an allosteric modulator for major depressive disorder, with anxiety symptoms. The same drug is being studied in schizophrenia.