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.
Dapagliflozin, a treatment for Type 2 diabetes that has been co-developed by AstraZeneca Plc and Bristol-Myers Squibb Company, has been recommended for approval in Europe. In January, the same drug was turned down by the FDA.
SkyePharma Plc’s asthma treatment, Flutiform, has been given a positive opinion by the European Medicines Agency’s Committee for Medicinal Products for Human Use. This brings the drug one step closer to a marketing authorisation in Europe.
Eric Abadie, the chair of the European Medicines Agency’s Committee for Medicinal Products for Human Use, has resigned and the agency’s executive director, Guido Rasi, has accepted the resignation with immediate effect, the EMA said.
Drug regulators in the European Union have reached an agreement on what kinds of data submitted to them from companies can be made public, effectively making the pharmaceutical sector more responsive to public demands for information.
Alkermes Pharma Ireland Ltd has withdrawn its marketing authorisation application from the European Medicines Agency for the drug, megestrol, which was intended to be used to treat unexplained weight loss in patients with AIDS and cancer.
AstraZeneca Plc has filed a lawsuit against the US Food and Drug Administration seeking to overturn the agency’s decision to deny the company’s petition to withhold approval of generic versions of its antipsychotic, Seroquel (quetiapine).
The US Food and Drug Administration has approved an allogeneic cell therapy- the first of its kind – to treat vascular wounds caused by surgery to treat mucogingival conditions in adults. The product, Gintuit, was developed by Organogenesis Inc of Massachusetts, US.