Ix Biopharma Ltd., of Singapore, reported results of a pivotal bioequivalence study comparing its sildenafil wafer (Pheonix) with the reference drug (Viagra, Pfizer Inc.), approved to treat erectile dysfunction. The study achieved its primary objective by demonstrating that the sublingual wafer formulation of Pheonix had a similar rate and extent of drug absorption as the reference drug. Pheonix was well-tolerated and there were no serious adverse events reported. The company plans to apply for registration of Pheonix in Australia. Read More

Aptinyx Inc., of Evanston, Ill., said the FDA granted fast track designation to NYX-2925, its lead compound, to treat neuropathic pain associated with diabetic peripheral neuropathy, or DPN. The company said preclinical data on the drug will be featured in two poster presentations at the 16th World Congress on Pain in Yokohama, Japan, at the end of September. The data show NYX-2925 has potential as an oral therapeutic in DPN without sedative side effects, the company said. Read More

Matinas Biopharma Holdings Inc., of Bedminster, N.J., announced the final closing of an $8 million private placement of 1.6 million series A preferred shares at $5 each. Net proceeds were approximately $6.9 million and will be used for research and development activities, a new manufacturing facility and for working capital and general corporate purposes. Sternaegis Ventures acted as the exclusive placement agent. Participants in the offering included members of the company's board and management, as well as affiliates of the placement agent. Read More

NEW DELHI – India's drug regulator has made it mandatory for employees of drug manufacturing companies to be certified by a government body over the next 15 months. Read More

It looks like tenacity is paying off for Ferring Pharmaceuticals Inc. in its pursuit of a longer exclusivity for its Prepopik, a fixed-dose combination (FDC) used in colonoscopies. Read More

BOSTON – Tweaks were made this year to the format of Biopharm America, which featured shorter, snappier sessions intended to stimulate exactly the kind of early partnering talks that the event is designed to foster. Read More

LONDON – After a summer of concerted effort to scope out and reach a unified view, the life sciences sector had its first meeting with the government's new Department for Exiting the EU, to put forward the industry's wish list and requirements once negotiations on U.K. withdrawal from the EU get underway. Read More

Interim CEO Alexis Borisy told BioWorld Today that, thanks to "all these really cool technologies that have just matured or just emerged," Relay Therapeutics Inc. is ready to advance beyond inhibitors that do their jobs in conventional ways and aim its further research in such a way as to detect and characterize dynamic interactions anywhere on a protein. New methods together will do more than any of the static, snapshot approaches can accomplish alone. Read More

Shares of Applied Genetic Technologies Corp. opened sharply lower Tuesday and fell to a historic trough of $8.77 after the company reported slower than expected enrollment in phase I/II studies of its gene therapy candidates to treat the rare visual conditions X-linked retinoschisis (XLRS) – a program partnered with Biogen Inc. – and achromatopsia (ACHM). Read More