In yet another hint of policy changes that are afoot to address drug prices, the U.S. Department of Health and Human Services (HHS) wants to delay implementation of a final rule that calculates ceiling prices for the 340B Drug Pricing Program and clarifies the civil money penalties drug companies will face for overcharging safety net health care providers for covered outpatient drugs. Read More
Melinta Therapeutics Inc., of New Haven, Conn., said it entered a partnership with CARB-X, under which the firm will be awarded up to $6.2 million to develop its pyrrolocytosine compounds. Under the terms, Melinta will receive an initial award of up to $2.3 million, with the possibility of $3.9 million in additional awards based on the achievement of certain project milestones. Read More
Genprex Inc., of Austin, Texas, said it entered into purchase agreements with institutional investors for a private placement of $10 million of shares of its common stock and warrants. The price of the common stock is $12.07 each, and the initial exercise price for the warrants is equal to $15.62 per share. The company's gene therapy platform includes product candidate, Oncoprex immunogene therapy for non-small-cell lung cancer. Read More
Cortexyme Inc., a stealthy South San Francisco-based biotech exploring developing therapies for Alzheimer's disease (AD) and other degenerative disorders, is moving ahead with development of a bacterial protease inhibitor. The candidate, COR-388, targets a pathogen identified in the brain tissue and cerebral spinal fluid of patients with AD. It started the first of two phase I studies in January. Both trials, a single ascending dose and a multiple ascending dose in healthy elderly participants, will finish by May. Meanwhile, it's moving toward publication of a manuscript detailing its approach. Read More
AUSTIN, Texas – In Jeffrey Rathmell's reckoning, the modern era of immunometabolism began 25 years ago, with the demonstration that in obese individuals, fat cells will make inflammatory cytokines – an ability that was previously thought to be limited to bona fide immune cells. Read More
The possibility of offering the first treatment in the U.S. for neurological muscle spasms that bears no warning of sedative side effects in the label attracted the interest of Sofinnova Ventures, which led to a $60 million series A round for Neurana Pharmaceuticals Inc. Funds will be used to support an upcoming phase II study testing a highly purified version of muscle relaxant tolperisone in neuromuscular spasms of the neck and back. Read More
The recent deal between OSE Immunotherapeutics SA and Boehringer Ingelheim GmbH may have brought renewed interest in CD47, a controversial target in immuno-oncology (I-O), but plenty of biotech outfits started before word of the tie-up. Nantes, France-based OSE licensed the preclinical SIRP-alpha antibody OSE-172, to Boehringer, of Ingelheim, Germany, for €15 million (US$18.5 million) up front, with the potential for another €15 million when the phase I study starts. Down the road, OSE could collect more than €1.1 billion if undisclosed development, commercialization and sales milestones are met, plus royalties on worldwide net sales. (See BioWorld Today, April 5, 2018.) Read More
With the integration of Impax Laboratories Inc. now complete, one of the first orders of business for Amneal Pharmaceuticals Inc. was to initiate a phase III trial of IPX-203, an oral sustained-release version of carbidopa-levodopa (CD-LD) in individuals with advanced Parkinson's disease (PD). The move, combined with Amneal's disclosure of a biosimilars partnership with Mabxience SL, on the day Amneal's shares began to trade on the New York Stock Exchange as AMRX, signaled the Bridgewater, N.J.-based company's intention to move beyond generics and build a pipeline that is at once profitable and "more affordable and accessible" for patients. Read More
