LONDON – Cell therapy specialist Reneuron Group plc has sealed a Chinese commercialization and marketing deal, agreeing to an exclusive license for both its CTX treatment for disability caused by stroke and hRPC for treating retinitis pigmentosa, with Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. Read More
DUBLIN – Poxel SA and development partner Sumitomo Dainippon Pharma Co. Ltd. are on track for a regulatory submission of their type 2 diabetes drug, imeglimin, in Japan next year, after the first of three phase III trials delivered a positive result. Two other phase III studies are also due to read out this year, and the partners aim to have the drug on the market by 2021. Read More
The FDA has approved Amgen Inc.'s UCB SA-licensed sclerostin-neutralizing antibody Evenity (romosozumab) for the treatment of osteoporosis in postmenopausal women at high risk of breaking a bone. The drug is already approved in Japan and awaits further review in Europe. Read More
Three biotechs – Turning Point Therapeutics Inc., Hookipa Pharma Inc. and Trevi Therapeutics Inc. – are gearing up to join the public sector. Turning Point and Hookipa both set terms, aiming to raise $125.8 million and $100.5 million at the midpoint of their respective ranges, while Trevi filed for an IPO, aiming to raise as much as $86.25 million. Read More
Zogenix Inc. CEO Stephen Farr said the refusal to file (RTF) letter from left field for Fintepla (ZX-008, fenfluramine hydrochloride) for seizures associated with Dravet syndrome (DS) could set the compound back "12 to 15 months, would be our best guess" if the FDA insists that the Emeryville, Calif.-based firm do further nonclinical toxicology studies. "We had constructive interactions with the FDA on our program, which started in 2015," Fuller said during a conference call with investors. "This requirement is definitely unexpected for us." Read More
With pharmacy benefit managers (PBMs) guarding the secrecy of their price negotiations more than HBO is guarding the ending of its Game of Thrones, PBMs have become one of the "most confounding, gnarled riddles in health care," U.S. Sen Ron Wyden (D-Ore.) said in his opening remarks Tuesday at the third in a series of Senate Finance Committee hearings on prescription drug prices. Read More
Tricida Inc., of South San Francisco, said it closed its public offering of 6.44 million shares at $36 per share, which includes the exercise in full by the underwriters of their option to purchase an additional 840,000 shares for total gross proceeds of approximately $231.8 million. (See BioWorld, March 29, 2019.) Read More
Enesi Pharma Ltd., of Oxford, U.K., said it inked an agreement with scientists at the Oxford Vaccine Group (OVG) at the University of Oxford to create and test a solid dose vaccine against plague. The collaboration will leverage Enesi's Implavax needle-free technology and a vaccine based on a ChAdOx adenovirus vector that was developed by OVG against the bacteria-causing plague Yersinia pestis. Read More
