BOGOTA, Colombia – A visit by Agustin Laje to Beijing earlier this month has helped cement ties between Cuba and China, particularly in terms of exploring biotech opportunities.
New FDA fast track status for Medicinova Inc.'s phase II nonalcoholic steatohepatitis (NASH) drug MN-001 (tipelukast) invigorated the company's U.S.-listed shares (NASDAQ:MNOV), pushing them 41.3 percent higher to $4.96 in heavy trading Thursday as investors warmed to the company's chances for gaining FDA approval to treat the chronic liver condition, for which no drug is currently approved.
Daiichi Sankyo Co. Ltd., of Tokyo, said Swissmedic, the regulatory authority of Switzerland, approved Lixiana (edoxaban), an oral, once-daily selective factor Xa inhibitor, to prevent stroke and systemic embolism in adults with nonvalvular atrial fibrillation.
HONG KONG – Opening the door wide to a broad range of investments, a European biotech investment firm is working with a diversified Chinese biotech company to invest in and introduce mature and innovative technologies to Greater China.
Dr. Reddy's Laboratories Ltd., of Hyderabad, India, said it filed three 505(b)(2) new drug applications to the FDA, seeking approval of DFD-01, a corticosteroid delivered in a non-irritating spray platform, intended for the treatment of patients suffering from psoriasis; DFD-09, a modified-release oral tetracycline intended for the treatment of rosacea; and DFN-11, a drug-device combination product intended to treat acute migraine.
SHANGHAI – Shanghai-based Ark Biosciences Inc. has received financial backing, the amount undisclosed, to usher its lead candidate through phase II trials in Australia and possibly other sites. Ark is developing AK0529, an asset licensed from Roche AG to treat respiratory syncytial virus (RSV), a significant cause of death for children younger than 5 and the elderly.
HONG KONG – Japanese scientists have used an advanced high-energy radiation particle accelerator to elucidate the structure of two receptors of the adipocyte-derived hormone, adiponectin, which could lead to the development of new treatments for obesity-related diseases, in particular type 2 diabetes.
Taxus Cardium Pharmaceuticals Group Inc. inked a new deal with its Chinese investor to help fund a recently launched subsidiary aimed at advancing Generx (alferminogene tadenovec [Ad5FGF-4]), an angiogenic gene therapy candidate that has been in development for nearly 20 years, but may be finally reaching the finish line just as interest is reigniting the overall space.
As health care across the globe shifts to a more patient-focused model, one of the challenges is getting patients to be more accountable for their own health.
TOKYO – Japan is taking further steps to speed up reviews of innovative new drug and medical device applications through a new Sakigake designation. Sakigake roughly translates into "leading the way."
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