The FDA's accelerated go-ahead Monday for Venclexta, the first BCL-2 inhibitor to win market clearance, gave hope not only to patients with CLL with the 17p deletion but also to those with other cancers and to more companies that are developing drugs that target BCL-2. Read More
Aduro Biotech Inc., of Berkeley, Calif., said that during the upcoming American Association for Cancer Research meeting in New Orleans, its chief scientific officer, Thomas Dubensky will present an overview of a planned phase I trial to evaluate the safety, tolerability and possible anti-tumor activity of ADU-S100 given by intratumoral injection to patients with advanced cutaneously accessible solid tumors or lymphomas. Read More
Valeant Pharmaceuticals International Inc., of Laval, Quebec, issued a statement Monday that its board has requested CEO J. Michael Pearson to cooperate in connection with a subpoena for deposition from the Senate Committee on Aging prior to the schedule April 27 hearing. Read More
Insys Therapeutics Inc., of Phoenix, is estimating its preliminary revenues from Subsys (fentanyl sublingual spray) for the first quarter will be in the range of $61 million to $62 million, which reflects a decline in demand. Read More
Despite a reduction in force two weeks ago at Ariad Pharmaceuticals Inc. that slashed 90 positions in the U.S. and Europe, the Cambridge, Mass.-based company moved brigatinib into its first phase III trial. Read More
NEW DELHI – Taking another step toward international expansion, Indian pharma major Biocon Ltd. has secured its first approval in Japan for its biosimilar insulin glargine. Read More
Following a positive readout last month for a phase III trial in Dravet syndrome, GW Pharmaceuticals plc is keeping the momentum going, launching late-stage testing of Epidiolex in another rare epilepsy indication and looking ahead to what could be an exciting 2016 for the London-based firm as cannabinoid-based platforms appear finally to be catching on. Read More
Big changes are afoot in how Medicare reimburses for Part B drugs, and the reaction to the potential changes has stakeholders scurrying in every direction. Read More
HONG KONG – Taking another step to strengthen its presence in the promising Chinese market, South Korea-based Hanmi Science Co. Ltd. (KS:008930) will pour about $200 million into a new plant in the fast growing neighboring market. Read More
Viamet Pharmaceuticals Holdings LLC, of Durham, N.C., which filed for a $75 million IPO in 2014 but withdrew the registration a few months later, is making a second attempt to join the public ranks. Read More
