Living in Stockholm, where the length of daylight ranges from about six hours at winter solstice to 18.5 hours at midsummer, pretty much guarantees a curiosity about how internal circadian rhythms are maintained. Read More

The FDA is seeking comment on the design of its REMS Platform Standards Initiative, as well as the methods and best practices for its construction. Read More

Innovation Pharmaceuticals Inc., of Beverly, Mass., said the last patient completed study treatment in its phase II trial of brilacidin for the prevention and treatment of severe oral mucositis (OM) in patients undergoing chemoradiation for head and neck cancer. Read More

Arbutus Biopharma Corp., of Vancouver, British Columbia, said it signed a share purchase agreement with Roivant Sciences Inc., of New York, for the sale of convertible preferred shares for gross proceeds of $116.4 million, which the company intends to use to further develop and advance its clinical and preclinical hepatitis B virus (HBV) pipeline programs. Read More

DUBLIN – A flurry of deals in late September added a burst of energy to what was otherwise a pretty sleepy third quarter for European biotech firms engaged in drug development. The last week of the month – and of the quarter – was a particularly busy one. European firms raised $472 million during that time, more than half of the total third-quarter raise, which came to $837 million. Read More

LONDON – Shares in Ablynx NV rose by 25.8 percent on Monday to €15.50 (US$18.20) when the company announced positive results from the phase III study of caplacizumab in the treatment of rare blood coagulation disorder acquired thrombotic thrombocytopenic purpura (aTTP). Read More

Biohaven Pharmaceutical Holding Co. Ltd.'s trigriluzole, the most advanced candidate from its glutamate modulation platform, failed to outperform a placebo in the treatment of spinocerebellar ataxia (SCA) during a phase II/III study, the largest trial conducted in the rare disorder to date. Read More

Looking to one-up early stage entries in harnessing CRISPR technology, 2-year-old KSQ Therapeutics burst onto the biopharma scene with $76 million across two financing rounds and an aspiration to pioneer what it called "high-confidence" drug development. Read More

Making good on Commissioner Scott Gottlieb's promise to tackle high drug prices by streamlining the path for generics, the FDA issued new guidance on developing generics of complex drugs and opened a two-day workshop Monday on ways to modernize the development and review of generic drugs. Read More

PERTH, Australia – Australia's Therapeutic Goods Administration (TGA) reported a mixed review for its annual performance for drugs and devices covering the period from July 2016 to June 2017 compared to the previous year. Read More

Opiant Pharmaceuticals Inc., of Santa Monica, Calif., and Titan Pharmaceuticals Inc., of South San Francisco, are collaborating to develop a product for the prevention of opioid relapse and overdose in individuals with opioid use disorder using Titan's Proneura sustained-release technology. Read More