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.

In keeping with its commitments in the 2012 user fee agreements, the FDA released draft information technology (IT) plans for prescription and generic drugs.

Amarin Corp. plc, of Dublin, named John F. Thero president and CEO, and Lars Ekman chairman of the board, effective Jan. 1, 2014.

Takeda Pharmaceutical Co., of Deerfield, Ill., said the FDA extended its PDUFA date for vedolizumab in ulcerative colitis.

BioWorld’s offices were closed Wednesday, Dec. 25, in observance of the Christmas holiday in the U.S.

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.