Checkpoint Therapeutics Inc., a subsidiary of Fortress Biotech Inc., has big plans. During September the company will launch a phase I/II trial of its third-generation EGFR inhibitor CK-101 in non-small-cell lung cancer and, around the same time, a public market listing.
Chasing improved safety and decreased brain damage for stroke sufferers, Nuvox Pharma LLC is preparing for a fourth quarter start to a phase Ib study of NVX-208 (dodecafluoropentane emulsion), one of multiple oxygen therapeutics the company is advancing.
Authors of a draft report published by the Institute for Clinical and Economic Review evaluating the health outcomes and economic effects of certain tyrosine kinase inhibitors (TKIs) and programmed death 1 (PD-1) immunotherapies in the treatment of advanced non-small-cell lung cancer (NSCLC) expressed "high certainty" that TKIs provide at least a small net health benefit relative to platinum-based chemotherapy.
An FDA complete response letter (CRL) for Portola Pharmaceuticals Inc.'s factor Xa inhibitor antidote, Andexxa (andexanet alfa), left the company "significantly surprised," said CEO Bill Lis.
Avelas Biosciences Inc. raised $20 million in a series C financing that the company will use to carry its cancer imaging agent, AVB-620, into late-stage trials while also developing new targeted cancer therapies that leverage its Activatable Cell Penetrating Peptide platform.
Vertex Pharmaceuticals Inc. is ending a phase III study testing VX-661 with the company's already-approved Kalydeco (ivacaftor) in a hard-to-treat subgroup of cystic fibrosis patients (CF) after learning that the combination failed to deliver a pre-specified improvement in lung function.
Acelrx Pharmaceuticals Inc. moved its sublingual sufentanil candidate ARX-04 (sufentanil sublingual tablet, 30 mcg) closer to an anticipated FDA new drug application (NDA) filing this year, announcing top-line results of a small phase III results that showed emergency room (ER) patients realizing an average 35 percent drop in pain intensity one hour after treatment. The trial bolstered safety data for inclusion in the NDA while also ruling out any cognitive impairment issues, chief medical officer and co-founder Pamela Palmer told BioWorld Today.
A pivotal phase III study launched by Ascendis Pharma A/S to test its long-acting Transcon growth hormone (GH) in children with GH deficiency moves the Danish company one step closer to entering the $3 billion daily human GH market. The trial will measure annualized height velocity at 52 weeks for the company’s weekly prodrug treatment and compare it to Pfizer Inc.’s daily human GH treatment, Genotropin (somatropin).
Eli Lilly and Co. said that a phase III study combining its cyclin-dependent kinase (CDK) inhibitor abemaciclib with the chemotherapy fulvestrant to treat metastatic breast cancer will continue without modification despite failing to meet "stringent" interim efficacy criteria.
