The European regulatory review of a ground-breaking gene therapy for the treatment of a protein deficiency linked to pancreatitis is on schedule with a decision expected by mid-2011, according to the developer, Amsterdam Molecular Therapeutics (AMT).
NicOx SA will be seeking a meeting with the Food and Drug Administration to discuss the agency’s refusal to approve its lead product, naproxcinod, for marketing, the company’s chief executive, Michele Garufi, told analysts in a conference call on 30 July.
Merck Serono said that its new small molecule drug for relapsing-remitting multiple sclerosis, which is an oral formulation of cladribine, has been granted priority review by the FDA, which means a decision can be expected in about six months.
A cannabis medicine developed by GW Pharmaceuticals Plc for the treatment of spasticity due to multiple sclerosis has been approved by the Spanish regulator. This follows its approval in June, 2010, by the UK regulator, the MHRA.
The European Medicines Agency’s main scientific committee has recommended that Boehringer Ingelheim’s new combination pill for hypertension, Twynsta, be approved for marketing.
The European Medicines Agency said it expects to complete its review of the safety of rosiglitazone-containing medicines, including Avandia, by September 2010. The review is looking at the risk of cardiovascular problems with the drugs.
At the request of the FDA, Pfizer Inc has suspended its clinical programme for tanezumab in chronic lower back pain and diabetic peripheral neuropathy. But studies will continue in areas of unmet medical need such as cancer pain.
A majority of members of a joint US Food and Drug Administration advisory panel voted on 14 July 2010 to recommend that GlaxoSmithKline’s diabetes drug, Avandia (rosiglitazone), be kept on the market but they expressed concerns about cardiovascular risk.
Merck Serono’s new small molecule drug for relapsing-remitting multiple sclerosis, which is an oral formulation of cladribine, has been approved for marketing in Russia, the first government agency to approve the oral disease-modifying therapy.
The European Medicines Agency has announced a review of rosiglitazone-containing medicines for diabetes following new safety data. The review will decide whether or not the marketing authorisations of the drugs should be revoked, suspended or changed.