AV Therapeutics Inc. decloaked in late December by merging with a public shell company. It is developing a chemotherapy candidate, capridine, that has been shown in preclinical models to have activity against prostate and colon cancer, with plans to launch Phase I trials in the second quarter of 2014.
Neurocrine Biosciences Inc.’s tardive dyskinesia candidate, NBI-98854, nailed its endpoints in a Phase IIb (Kinect 2) study by causing a significant change from baseline in the abnormal involuntary movement scale (AIMS) after six weeks of treatment. Tardive dyskinesia is a syndrome characterized by involuntary, repetitive movements of the extremities. It has no approved treatment and is rarely reversible.
Linda Marban, CEO of Capricor Therapeutics Inc. called a new collaboration between Capricor and Janssen Biotech Inc. a “potentially game-changing validation” of the company’s technology – an allogeneic adult stem cell therapy for heart disease.
A startling report in The New England Journal of Medicine shows U.S. industry investment in biomedical research and development falling off a cliff over the past five years – and reappearing in Asia.
Two biotech companies, Argos Therapeutics Inc. and Eleven Biotherapeutics Inc., slid initial public offering (IPO) filings under the wire for 2013 to raise $60 million and $69 million, respectively. The filings cap a spectacular year for IPOs. Thirty-seven biotechs successfully completed IPOs in 2013, raising about $3 billion. Argos and Eleven will join 15 other companies filed and pending for 2014.
As promised, Peregrine Pharmaceuticals Inc. has launched a Phase III trial (SUNRISE) of its lung cancer immunotherapy, bavituximab, in spite of a discouraging Phase II failure.
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.
Tesaro Inc.’s stock took a hit Monday when it released results of two Phase III studies showing that while its chemotherapy-induced nausea (CINV) drug rolapitant was effective for treating the condition in the 24-hour to 120-hour period after chemotherapy, it did not improve symptoms in the first 24 hours, and also did not demonstrate sustained improvement after 120 hours.
Biocryst Pharmaceuticals Inc. has snatched victory from the jaws of defeat with a new drug application (NDA) filing for intravenous perimavir, a drug that failed a Phase III influenza trial just over a year ago.
