Boston Biomedical Inc. unblinded a global phase III study of its cancer stem cell pathway inhibitor, napabucasin, in advanced gastric and gastroesophageal junction cancer after the trial's data and safety monitoring board (DSMB) determined that combining napabucasin with paclitaxel is unlikely to yield better overall survival (OS) at 36 months than paclitaxel alone. Read More
AOP Orphan Pharmaceuticals AG, of Vienna, and Pharmaessentia Corp., of Taipei, Taiwan, reported data from three clinical trial of Ropeginterferon alfa-2b in patients with polycythemia vera. Read More
The draft of a pending executive order suggests a give-and-take effort to lower U.S. drug prices, with a lot of give to biopharma companies and a bit of take. Read More
With two phase III studies of lead compound, KPI-121 1.0 percent, in the books to treat inflammation and pain following cataract surgery, Kala Pharmaceuticals Inc. looked to the public markets to fund pre-commercialization activities for the nanoparticle-based therapy by filing for an IPO of $86.25 million. Read More
The FDA has approved the Oncomine Dx Target Test from Thermo Fisher Scientific Inc., the first test of its kind to screen tumor samples for biomarkers associated with multiple cancer therapies, in this case for non-small-cell lung cancer (NSCLC). Read More
HONG KONG – Tessa Therapeutics Pte. Ltd. stumbled on to a biomarker, which it contended could make a huge difference in predicting patient reaction to treatment and survival rates. Read More
Selecta Biosciences Inc., of Watertown Mass., said it entered definitive agreements to sell securities in a private placement that is expected to result in gross proceeds of $50 million. Certain new and existing institutional investors agreed to purchase an aggregate of 2.75 million shares of common stock at $16 each. Read More
Conatus Pharmaceuticals Inc., of San Diego, said the FDA granted orphan drug designation to IDN-7314 for the treatment of primary sclerosing cholangitis, a disease affecting bile ducts in the liver which can lead to cirrhosis and liver failure. Read More
TG Therapeutics Inc., of New York, recapped data from two triple-combo therapy trials using TGR-1202 (umbralisib), its oral, next-generation PI3K delta inhibitor, and TG-1101 (ublituximab), its glycoengineered anti-CD20 monoclonal antibody, as the backbone of the combinations at the European Hematology Association meeting in Madrid, Spain. Read More