Viamet Pharmaceuticals, Inc. announced that the US Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) designation to VT-1598, a novel candidate for the oral treatment of coccidioidomycosis, or valley fever. Valley fever is an invasive fungal infection found primarily in the southwest United States that affects an estimated 150,000 people annually.
The U.S. Food and Drug Administration (FDA) has approved Bayer AG’s new low dose levonorgestrel-releasing intrauterine system (LNG-IUS) which will be marketed in the US under the brand name Kyleena™. Kyleena releases the lowest daily dose of the hormone levonorgestrel in an intrauterine system for up to five years of effective protection against pregnancy, using the smallest T-shaped body in an IUS available today. Long-acting contraception is one of the most effective methods of birth control as it does not require user interventions such as daily dosing or monthly re-fills. An LNG-IUS can be removed at any time and offers rapid return to a woman’s natural level of fertility after removal.
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BioInvent International has been granted additional patent protection in Japan, Russia and China for BI-505, its lead immune-oncology programme currently in phase II for the treatment of multiple myeloma. These patents cover the use of BI-505 in the treatment of patients previously treated for cancer that have either not responded or subsequently relapsed. The patents now granted, add to patents previously granted in these countries, as well as in the US, Europe and other countries for BI-505 and its use in the treatment of cancer. BI-505 has received Orphan Drug designation for multiple myeloma by both the US Federal Drug Administration (FDA) and European Medicines Agency (EMA).
Active Biotech provided an update on laquinimod which is being developed in multiple sclerosis (MS) and Huntington's disease (HD) by Teva Pharmaceutical Industries, Ltd. The U.S. Food and Drug Administration (FDA) has informed Teva that the Special Protocol Assessment (SPA) for the Phase III CONCERTO clinical trial evaluating laquinimod in relapsing remitting multiple sclerosis (RRMS) was rescinded.
Zydus Cadila, an innovation driven global healthcare provider and Takeda Pharmaceutical Company Limited announced a partnership to tackle chikungunya, an emerging infectious disease. The chikungunya virus is most often spread to people by Aedes aegypti and Aedes albopictus mosquitoes, the same vectors that spread dengue and zika. The broad-based agreement includes early stage development to the final commercialisation of the vaccine. There is currently no vaccine to prevent or medicine to treat chikungunya virus infection.
Syngene International, one of Asia’s largest R&D focused contract research organization, today announced the establishment in Bangalore, India, of an integrated, multi-disciplinary drug discovery and development center for Amgen, Inc. This center, named Syngene Amgen Research and Development Center (SARC), will be Syngene’s fourth such exclusive R&D center. Syngene already operates dedicated R&D centers for Bristol-Myers Squibb, Abbott Nutrition and Baxter Inc.
Varian Medical Systems announced it has received 510(k) clearance from the US Food and Drug Administration (FDA) to market the Nexus DR, a high resolution imaging system for X-ray imaging using a digital X-ray detector. The Nexus DR is designed to replace conventional film techniques, or existing digital systems, in multipurpose or dedicated applications. The system is a single common imaging platform intended for general radiographic procedures (excluding fluoroscopy, angiography, and mammography).
Aralez Pharmaceuticals Inc., a global specialty pharmaceutical company, announced that the US Food and Drug Administration (FDA) has approved once-daily Yosprala, the only prescription fixed-dose combination of aspirin, an anti-platelet agent, and omeprazole, a proton pump inhibitor (PPI) in the US. Yosprala is indicated for patients who require aspirin for secondary prevention of cardiovascular (CV) and cerebrovascular events and who are at risk of developing aspirin associated gastric ulcers. The company is expanding its US sales force by 85 representatives in September to a total of 110 high quality sales representatives and plans to begin the US promotional launch of Yosprala the first week in October.
Sanofi announced that it filed a patent infringement suit against Merck Sharp & Dohme Corp. (“Merck”) on September 16, 2016 in the United States District Court for the District of Delaware. In its suit Sanofi alleges infringement of ten patents.
Neurocrine Biosciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has conditionally accepted the proprietary name "INGREZZA™" for the Company's once-daily vesicular monoamine transporter 2 (VMAT2) inhibitor valbenazine.
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