In keeping with its commitments in the 2012 user fee agreements, the FDA released draft information technology (IT) plans for prescription and generic drugs. Read More
Immunocellular Therapeutics Ltd., of Los Angeles, said the first patient has been treated in the Phase I trial of ICT-121, a cancer vaccine targeting recurrent glioblastoma multforme (GBM). Read More
Veloxis Pharmaceuticals A/S, of Horsholm, Denmark, said Envarsus, a once-daily formulation of immunosuppressive drug tacrolimus using the company’s Meltdose technology, was granted orphan status by the FDA for the prevention of organ rejection in patients receiving allogenic kidney transplants. Read More
LONDON – A new generation of therapies for malaria, which target a molecule that has a crucial role in the parasite’s life cycle, could enter clinical trials within just a few years, researchers said. Read More
HONG KONG – A Chinese pharmaceutical company best known for its work on traditional Chinese medicine saw its stock drop significantly after it issued disappointing results from a Phase IIb trial on a new hepatitis vaccine. Read More
TAIPEI, Taiwan – Taiwan Liposome Co. Ltd. (TLC), of Taipei, recently signed a distribution agreement giving Sandoz AG, the generics drug affiliate of Novartis AG, of Basel, Switzerland, distribution rights in the European Union (EU) and U.S. for TLC’s generic version of Gilead Sciences Inc.’s Ambisome, a liposomal rendering of antifungal drug amphotericin B. Read More
Patients with congenital Factor XIII A-subunit deficiency will have access to a new recombinant treatment for the disorder beginning early in 2014, following the FDA’s approval of Novo Nordisk A/S’s Tretten (coagulation Factor XIII A-subunit [recombinant]) for routine prophylaxis of bleeding. Read More
