Aridis Pharmaceuticals Inc., a San Jose-based company focused on the discovery and development of targeted immunotherapies to treat life-threatening infections, launched an IPO of 2 million shares of its common stock that would raise $28 million at the midpoint of the company's proposed offering price range. Read More
With a House and Human Services rule in the works to anchor manufacturer drug rebates to pharmacy benefit managers (PBMs) outside the anti-kickback safe harbor, CVS Health is launching its own plan to reduce prescription drug costs and shore up the case for PBM rebates. In a new paper, CVS foghorned the power of PBMs to hold down drug costs, putting the blame for high prescription drug prices on manufacturers. Read More
Synlogic Inc., of Cambridge, Mass., said preclinical data published in Nature Biotechnology show that SYNB-1618, its Synthetic Biotic program targeting phenylketonuria (PKU), significantly reduced blood phenylalanine levels, the key metabolite associated with PKU, in mouse models, and resulted in dose-dependent pharmacodynamics in healthy nonhuman primates. SYNB-1618 currently is in phase I/IIa testing. Read More
Magnolia Neurosciences Corp., a startup developing a drug with the mission of making neurons harder to kill, launched with a $31 million series A financing backed by a roster heavy with corporate and regional venture funds. Though headquartered in New York, where it will be managed by Accelerator Life Science Partners, Magnolia is expected to develop medicines based primarily on discoveries made by researchers in Houston-based MD Anderson's Therapeutics Discovery division, a unit that has already sparked the formation of at least two new cancer-focused companies, Navire Pharma Inc. and Vescor LLC. Read More
PERTH, Australia – Drug development is a risky business, and no one knows that better than U.S. Rep. Chris Collins (R-N.Y.), who likely won't forget how a failed clinical trial at Aussie biotech Innate Immunotherapeutics Ltd. last June ultimately ended his political career. But the thrifty little biotech isn't losing any sleep over Collins. It had already acquired some new assets and was readying them for the clinic when news broke that Collins was indicted for insider trading as a fallout from that failed trial. Read More
LONDON – Almost a third of the EMA's 890 staff will not be relocating from London to Amsterdam, and are starting to move to new jobs, forcing the agency to further scale back and suspend operations in order to safeguard core activities. Read More
LONDON – Orchard Therapeutics Ltd. announced the closing of an oversubscribed $150 million series C round, providing funding to take three ex-vivo gene therapy programs through to regulatory submission over the next three years. Read More
Regeneron Pharmaceuticals Inc.'s bid to get ahead of competitor Novartis AG in wet age-related macular degeneration (AMD) hit a blip as the FDA delivered a complete response letter (CRL) with regard to the supplemental BLA seeking a modified, 12-week dosing schedule for Eylea (aflibercept). Read More
One business day earlier than expected, rare disease specialist Amicus Therapeutics Inc. secured a long-sought FDA approval for its oral Fabry disease therapy, Galafold (migalastat), on Friday, the company's first U.S.-approved medicine. The initial U.S. list price will be $315,000 per year. Read More
The team responsible for leveraging a preclinical nonalcoholic steatohepatitis (NASH) asset into the acquisition of developer Akarna Therapeutics Ltd. by Allergan plc now is spearheading a psoriasis program at Escalier Biosciences BV, where lead program ESR-114, a topical gel, has moved into a phase I/IIa study. ESR-114 targets the retinoid acid receptor gamma t (RORyt), which Escalier co-founder and CEO Raju Mohan described as the master regulator of Th17 cell differentiation and the production of pro-inflammatory cytokines, including IL-17A and IL-17F, which are linked to the pathophysiology of psoriasis. Read More
