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).
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.
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.
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.
With vaccines in the works for herpes simplex virus 2 (HSV-2) and pneumonia, Genocea Biosciences Inc. added to a banner year for initial public offerings (IPOs) in biotech, filing to go public and raise $75 million by way of selling an unspecified number of shares at an also-undisclosed price range.
Caught off guard by the FDA’s approval – and ahead of schedule, to boot – of Orenitram (treprostinil) extended-release tablets for pulmonary arterial hypertension (PAH), United Therapeutics Corp. plans to launch the product within the next six months.