Abon Pharmaceuticals' clofarabine injection was approved by the FDA for the treatment of acute lymphoblastic leukemia in previously treated pediatric patients ages 21 and younger.
Corbin Therapeutics will use Proteorex Therapeutics' in vitro and in vivo drug-discovery platform to research and develop potential treatments for neuroinflammatory diseases. Financial details of the agreement, which aims to identify small-molecule inhibitors of ubiquitin-specific protease 15, were undisclosed.
Health Canada has approved Allergan's Viberzi, or eluxadoline, as a treatment for adults with irritable bowel syndrome with diarrhea. The drug showed significant reduction in abdominal pain and diarrhea in as early as the first four weeks with sustained relief during two late-stage studies.
A Series B funding round led by Arix Bioscience has raised $65 million for Iterum Therapeutics. The firm intends to begin late-stage trials of sulopenem in first half of 2018 evaluating the drug candidate for complicated urinary tract infections, uncomplicated UTIs, and complicated intra-abdominal infections.
In a 216-67 vote, the Canadian Parliament rejected a bill that would require mandatory labeling of biotech food. Opponents of the bill, which was introduced by New Democratic Party MP Pierre-Luc Dusseault, said the legislation was too vaguely worded, while supporters argued that the wording offered important "latitude."
Cinfa Biotech said its drug candidate B12019, a biosimilar to Amgen's Neulasta, or pegfilgrastim, has met the primary and secondary endpoints of an early-stage trial, in which it was compared with its reference drug. The company intends to advance the candidate to European regulators in the second half of the year.
An orphan drug designation has been granted by the FDA to Octapharma's Octagam immune globulin intravenous (human) 10% liquid as a treatment for patients with dermatomyositis.
A higher rate of serious side effects related to heart problems was observed in a late-stage trial of Amgen and UCB's Evenity, or romosozumab, which is intended for treatment of patients with osteoporosis. Serious heart-related problems were reported in 2.5% of patients who received Evenity compared with 1.9% who were given Merck's Fosamax treatment.
XBiotech's Xilonix, a human interleukin-1α monoclonal antibody for debilitating symptoms of advanced colorectal cancer, has not been recommended for European marketing authorization application approval by the European Medicines Agency's Committee for Medicinal Products for Human Use. A negative trend vote was registered by the EMA in April after meeting with the company to review its day 180 List of Outstanding Issues, but XBiotech says late-stage study results give the drug a "strong position for re-examination," which it said it planned to ask for "promptly."
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