LONDON – Having bowed to the inevitability of Brexit, leading U.K. and EU research organizations are moving to influence the shape of the future relationship in science and innovation. Read More
Amgen Inc., of Thousand Oaks, Calif., came up short in its quest to force the FDA to grant it six months of pediatric exclusivity for Sensipar (cinacalcet), which is used to reduce calcium levels. A U.S. district court judge in the District of Columbia tossed Amgen's challenge, granting the FDA's request for summary judgment. The FDA denied the exclusivity, claiming that Amgen didn't "fairly respond" to the written request for pediatric trials because it didn't fully comply with the requirements of the request. For instance, the request required a trial to enroll a minimum of 15 patients ages 28 days to younger than 6 years, but only four patients completed the study. Read More
Glaxosmithkline plc, of London, presented data at the CDC's Advisory Committee on Immunization Practices meeting in Atlanta that Fluarix Quadrivalent demonstrated 63.2 percent efficacy against moderate to severe influenza and 49.8 percent efficacy against influenza of any severity in children 6 months through 35 months of age. Read More
Tetraphase Pharmaceuticals Inc., of Watertown, Mass., said it entered an exclusive licensing agreement with Everest Medicines Ltd., a C-Bridge Capital-backed company based in China, to develop and commercialize eravacycline in mainland China, Taiwan, Hong Kong, Macau, South Korea and Singapore. Read More
Dimerix Ltd., of Melbourne, Australia, said it raised an additional A$4.5 million (US$3.52 million through the issue of 37.5 million shares at A12 cents per share. Read More
DUBLIN – U.S. protectionism, the looming specter of Brexit and the European Union's increasingly vocal stance on Ireland's corporate tax regime should all be weighing on Ireland's export-oriented biopharma sector at present, but the mood during the opening plenary of the Biopharma Ambition Conference Wednesday was upbeat, if not buoyant. Read More
Scientists at Imperial College London are testing how the hepatitis B virus (HBV) interacts with the liver using new organ on a chip technology, which could lead to the future development of new treatments for HBV and other diseases. Read More
"People were surprised [by the deal] because we had been making a lot of progress and moving quickly [on our own]," Wave Life Sciences Ltd. CEO Paul Bolno told BioWorld, talking about the arrangement disclosed this week with Takeda Pharmaceutical Co. Ltd., a pact "very much aligned with our strategy, which is growth to becoming a fully integrated company." Read More
ORIC Pharmaceuticals Inc., a South San Francisco-based company going after treatment-resistant solid tumors with an oral glucocorticoid receptor inhibitor, ORIC-101, has completed a $50 million series C financing it said will support the clinical advancement of the asset and work targeting mechanisms of resistance in cancer. Read More
