The US Food and Drug Administration has issued its second ‘complete response letter’ to the AstraZeneca unit, MedImmune, rejecting its application to market motavizumab, a new monoclonal antibody for respiratory syncytial virus disease.
The US Food and Drug Administration has approved a new treatment for high blood pressure from Novartis which combines the renin inhibitor, aliskiren, with the calcium channel blocker, amlodipine, in a single pill.
The US Food and Drug Administration has granted priority review status to belimumab, a potential treatment for systemic lupus erythematosus, according to the drug’s co-developers, GlaxoSmithKline Plc and Human Genome Sciences Inc.
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.