SINGAPORE-- MerLion Pharmaceuticals announced Wednesday that the U.S. FDA has approved an otic suspension of finafloxacin to treat acute otitis externa, commonly known as "swimmer's ear."
SINGAPORE-- Cellular Biomedicine Group has bought chimeric antigen receptor T cell therapies from the Chinese PLA General Hospital in a deal valued at RMB12 million ($1.9 million) to be paid in three installments.
SINGAPORE-- Several Japan drugmakers are making strides toward being major pioneers in the new pharmaceuticals field of nucleic acid-based treartments. A few already have clinical trials in the works for such things as Duchenne muscular dystrophy.
Regulus Therapeutics upped the dosage of its microRNA hepatitis C therapy RG-101 in a small study and gathered evidence of a bigger impact on patients' viral loads. But investigators also added new evidence that the treatment was far less durable than the new therapies hitting the marketplace, sending a shiver through the market this morning.
London startup TrialReach hauled in $13.5 million in Series B cash, funds that will help expand its technology designed to connect patients with their ideal clinical trials.
SINGAPORE-- Fujifilm's Toyama Chemical is readying a study for a scientific journal stating that its Avigan (favipiravir) influenza drug has shown promise in treating ebolavirus so far in an early-phase clinical trial in the West African country of Guinea.
Phase II data from Genmab have ratcheted up expectations for a fast-track approval of its Johnson & Johnson-partnered treatment for double refractory multiple myeloma. Analysts see the data as strong enough to bring the CD38 monoclonal antibody to market in the first half of 2016.
Amgen wrapped up a second successful Phase III study of its Humira knockoff, ABP501, flagging its head-to-head success in a brief thumb's up announcing that the biosimilar hit its primary and key secondary endpoints. And barring any nasty surprises the positive readout on rheumatoid arthritis should give Amgen the ammunition needed to gun for an approval in a crowded field of late-stage contenders.
Fast-expanding CRO genae is buying into clinical trial technology, acquiring a company that focuses on electronic data capture.
Intercept Pharmaceuticals has nabbed the FDA's breakthrough therapy designation for obeticholic acid, a closely watched therapy in the pipeline for a blockbuster NASH indication.