Editing the myocilin gene, the most frequently mutated gene in primary open-angle glaucoma, reduced glaucoma symptoms in an animal model. Primary open-angle glaucoma is the most frequent form of glaucoma in the U.S., affecting roughly 3 million people. Read More
Aveo Oncology Inc., of Cambridge, Mass., completed a pre-planned futility analysis of its phase III TIVO-3 trial comparing Fotivda (tivozanib) to Nexavar (sorafenib, Bayer AG) in patients with refractory advanced renal cell carcinoma after 128 progression events and decided to continue the trial as planned without modification. Read More
Beximco Pharmaceuticals Ltd., of Dhaka, Bangladesh, said that it has entered into a non-binding memorandum of understanding under which in may acquire 85.22 percent of Nuvista Pharma, another Bangladeshi drugmaker specializing in hormones and steroid drugs. Read More
Panoptica Inc., of Bernardsville, N.J., said it secured $11 million in a series B financing. The additional financing, provided by Third Rock Ventures and SV Health Investors (formerly SV Life Sciences), will enable clinical advancement of PAN-90806, a small-molecule anti-vascular endothelial growth factor (anti-VEGF) eye drop for the treatment of neovascular eye diseases. Read More
One of the challenges for weight loss is that the body is evolutionarily programmed to worry about famines, not feasts. As a result, losing weight, if not exactly easy, is achievable for many individuals. Keeping that weight off, though, is a formidable challenge, because weight loss sets off powerful compensatory mechanisms in the body. Read More
HONG KONG Abbvie Inc. has added a biologics manufacturing unit in its Singapore plant, to ensure sufficient supply of biomedicines and perfect the ecosystem of biologics innovation in the region. Read More
LONDON – The EMA is trying and plug an expected gap in the staff roster when it leaves London, publishing a £31.8 million (US$41.5 million) tender for the provision of temporary workers over the next four years. Read More
LONDON – Only half of the cancer drugs approved by the EMA from 2009 to 2013 are increasing overall survival or improving quality of life, according to a study in the British Medical Journal. Read More
Harmony Biosciences LLC, a new company created by entrepreneur Jeff Aronin's Paragon Biosciences, has acquired exclusive U.S. rights to a drug already EMA-approved for adults with narcolepsy, from France's Bioprojet Societe Civile de Recherche. Harmony is fueling the deal with a $270 million equity financing that it said will also help accelerate its ability to advance other treatments for central nervous system disorders. Meanwhile, it intends to establish an expanded access program for the medicine, called pitolisant, in the U.S. in early 2018 and to submit an FDA new drug application for it during the first half of 2018. Read More
Backed by strong data and boasting a mechanism of action that avoids the opioid route, Zilretta (FX006, triamcinolone acetonide with a poly lactic-co-glycolic acid matrix) – the pain drug for osteoarthritis of the knee from Flexion Therapeutics Inc. – won FDA approval smack on its PDUFA date. Read More