The US Food and Drug Administration has announced the approval of a new drug for Type 2 diabetes, Tradjenta (linagliptin). The drug was developed by Boehringer Ingelheim which has a commercialisation deal for the drug with Eli Lilly.
Four multinational pharmaceutical companies are among 10 new members of a consortium that has been formed to reach consensus on standards and tools for developing new drugs to treat tuberculosis that might then be adopted by drug regulators.
The US Food and Drug Administration has approved Zytiga (abiraterone acetate), in combination with prednisone, for the treatment of patients with late-stage castration-resistant prostate cancer. The developer is the J&J company, Centocor Ortho Biotech.
The US Food and Drug Administration has approved Menactra, a vaccine to prevent invasive meningococcal disease, for use in children as young as nine months old. The vaccine was developed by Sanofi Pasteur.
The Japanese Ministry of Health, Labour and Welfare has approved escitalopram (Lexapro) to treat patients with depression, according to the drug’s developer, H. Lundbeck A/S. The Danish company’s partner in Japan is Mochida Pharmaceutical.
The US Food and Drug Administration has approved Rituxan (rituximab), in combination with glucocorticoids, to treat patients with Wegener’s granulomatosis and microscopic polyangiitis, two rare disorders that cause blood vessel inflammation.
NicOx SA has decided to withdraw its European marketing authorisation application for naproxcinod, a candidate drug for osteoarthritis, following feedback from the CHMP that more data would be required in order to get a positive opinion.
Novartis has decided to withdraw its marketing authorisation application for Joicela (lumiracoxib) from the European Medicines Agency, the EMA announced. Joicela was intended to be used for symptomatic relief of osteoarthritis.
The US Food and Drug Administration has approved Actemra (tocilizumab), given alone or in combination with methotrexate, for the treatment of active systemic juvenile idiopathic arthritis in children aged two or over. Roche is the developer
In another twist to the long-running Avastin saga, the European Medicines Agency has reversed an earlier opinion and its now recommending that Avastin (bevacizumab), plus capecitabine, be approved for first-line metastatic breast cancer.