In an unusual public rebuke, the European Medicines Agency has cited Roche for deficiencies in its medicine-safety reporting system. It has given the company until 27 June to submit a comprehensive plan for dealing with outstanding cases.
The US Food and Drug Administration has approved a new combination vaccine for infants and children aged six weeks through 18 months for the prevention of two types of meningococcal disease and Haemophilus influenzae type b (Hib disease).
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.
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.
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.
The European Medicines Agency (EMA) has launched a new public website that contains information about suspected adverse events relating to medicines that have been authorised for sale in the European Economic Area (EEA).
An advisory panel of the US Food and Drug Administration has recommended that the agency approve tofacitinib, a JAK inhibitor which has been developed to treat rheumatoid arthritis. A formal decision is expected in August, according to Pfizer.
The US Food and Drug Administration has approved the antibacterial medicine, Levaquin (levofloxacin), for the treatment of patients with plague, a rare disease that is estimated to affect up to 2,000 people per year.
The US Food and Drug Administration is asking farmers and veterinarians to restrict their use of antibiotics in food-producing animals in a further step towards protecting the effectiveness of currently marketed antibiotic medicines.