DUBLIN – Shares in GW Pharmaceuticals plc rose as much as 28 percent Monday on news that Epidiolex, its liquid formulation of plant-derived cannabidiol, hit the primary endpoint of a phase III trial in patients with Lennox-Gastaut syndrome (LGS), a rare and difficult-to-treat form of childhood-onset epilepsy. Read More
A potential new tool in the war on gram-negative pathogens, The Medicines Co.’s Carbavance (meropenem-vaborbactam) met both FDA and EMA primary endpoints in a pivotal phase III trial testing the therapy in patients with complicated urinary tract infections (cUTIs). Read More
The Supreme Court of the United States on June 27 declined to hear the case of Sequenom v. Ariosa, which invokes the problematic law-of-nature discussion that proved decisive in a landmark case at the court. The decision leaves the outcome in Mayo v. Prometheus in place despite the filing of nearly two dozen amicus briefs, including a brief in support from a coalition of circuit court judges. Read More
With the specter of antimicrobial resistance (AMR) posing a serious threat to global health systems, discovery of new antibiotics has become paramount in order to replenish the sparse medicine chest caused by a slowing of research and development in the field that began in the 1970s and persisted for almost 30 years. Read More
Since the mcr-1 gene was found in people and pigs in China last year and then last month the first U.S. case of a patient with an infection resistant to a last-resort antibiotic was reported, tensions are mounting. Read More
Antibiotics development underwent “a bad period, and probably the low point was around 2009,” Melinta Therapeutics Inc. Chief Scientific Officer Erin Duffy told BioWorld Today. Read More
TOKYO – Takeda Pharmaceutical Co. Ltd. said its TAK-214 vaccine, the world’s first to tackle the Norovirus, is now in phase IIb field efficacy trials. Read More
Everything about Sean Parker’s first-in-human cancer trial of CRISPR gene editing technology is monumental, including ethical concerns about the safety of the first patients who will serve as true pioneers to test the potentially breakthrough cancer immunotherapy. Read More
The FDA is extending the comment period for two draft guidances because of next week’s scheduled maintenance on the Federal Erulemaking portal. The extensions apply to draft guidances on special protocol assessments and the development of direct-acting antiviral drugs to treat hepatitis C infections. Both drafts were published in the Federal Register May 4. Comments are now due by July 19. Read More
Noxopharm Ltd., of Sydney, said is seeking to raise A$6 million (US$4.4 million) in an IPO and to list on the ASX. In its offering 30 million shares will be sold at $0.20 each under a prospectus, which will remains open until July 18 unless closed earlier. The company’s first anti-cancer drug candidate, NOX66, is poised to enter a phase I study later this year. It is a new dosage form of the drug candidate, idronoxil. Read More
Agilis Biotherapeutics LLC, of Cambridge, Mass., said it has been selected by the National Center for Accelerating Translational Sciences (NCATS) as an awardee of a cooperative research and development agreement (CRADA) under the National Institutes of Health’s (NIH) Therapeutics for Rare and Neglected Diseases (TRND) program. Read More
Twi Biotechnology Inc., of Taipei, Taiwan, completed patient enrollment in its phase II trial with AC-201CR for the treatment of gout. The company expects to report top-line results from this study in the fourth quarter of 2016. The positive interim results of the proof-of-concept study were made public late last year. AC-201 is described as a first-in-class, orally available small molecule which has shown the dual abilities to inhibit URAT1 as well as the production and activity of caspase-1 and the cytokine interleukin-1 beta through the inhibition of the assembly of the NLRP3 inflammasome. Read More
