Pharma News

Lannett Company, Inc. announced that it received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Buprenorphine and Naloxone Sublingual Tablets, 2 mg/0.5 mg and 8 mg/2 mg, the therapeutic equivalent to the reference listed drug, Suboxone Sublingual Tablets, 2 mg/0.5 mg and 8 mg/2 mg.  According to IMS, total U.S. sales in 2015 of Buprenorphine and Naloxone Sublingual Tablets, 2 mg/0.5 mg and 8 mg/2 mg, at Average Wholesale Price (AWP) were approximately $270 million.

Discovery of a novel, advanced technique to identify the rare cells where human immunodeficiency virus (HIV) hides in patients taking antiretroviral therapy (ART). This is an important step forward in the search for a HIV/AIDS cure.

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.

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for the Phase III CONCERTO clinical trial evaluating laquinimod in relapsing remitting multiple sclerosis (RRMS) was rescinded.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).