Pharmaceutical industry
Johnson & Johnson's Janssen Research & Development, LLC (JRD) has submitted a supplemental New Drug Application (sNDA) to the FDA seeking approval for the use of XARELTO (rivaroxaban) to reduce the risk of thrombotic cardiovascular events in patients with Acute Coronary Syndrome (ACS). The sNDA is supported by
Pharmaceutical industry
Rheumatoid Arthritis (RA) is a debilitating disease affecting millions in the US, causing joint inflammation and progressive joint damage. Actemra, a humanized anti-human interleukin-6 (IL-6) receptor monoclonal antibody, has been extensively studied for its safety and efficacy in treating RA. On December 20, 2011, Chugai Pharmaceutical Co Ltd. and F.
Pharmaceutical industry
U.S. Senator Charles Schumer has announced a three-point plan to address the growing crisis of life-saving drug shortages. The plan aims to establish an early warning system to prevent shortages, make prescription drug price gouging a federal crime, and demand an investigation into "gray market" resellers that
Pharmaceutical industry
The US Department of Justice has announced that pharmaceutical company Merck will pay $950 million to resolve investigations into its marketing of the painkiller Vioxx. The settlement includes a $321.6 million criminal fine and a $628.4 million civil settlement agreement. Merck will also plead guilty to a misdemeanor
Pharmaceutical industry
Regeneron Pharmaceuticals Inc has made significant strides in the medical field by securing approval from the U.S. Food and Drug Administration (FDA) to treat a prevalent cause of blindness, Eylea. This breakthrough treatment is expected to challenge Roche Holding AG's Lucentis, a leading competitor in the market.
Pharmaceutical industry
Merck has announced that the U.S. Food and Drug Administration (FDA) has approved JUVISYNC, a new treatment for type 2 diabetes that combines two medications: sitagliptin, a glucose-lowering medication, and simvastatin, a cholesterol-lowering medication. This combination therapy is designed to help patients with type 2 diabetes who also need
Pharmaceutical industry
A genetically-modified salmon project on Prince Edward Island is facing opposition from environmentalists who fear it could harm the island's reputation as a green province. The AquaBounty Technologies facility in Bay Fortune produces salmon eggs with implanted genes that make the fish grow at twice the natural rate.
Pharmaceutical industry
BioSante Pharmaceuticals, Inc., a specialty pharmaceutical company focused on developing products for female sexual health and oncology, will present at three healthcare conferences in September 2011. The company will provide a company overview, update on LibiGel(R) Phase III clinical development program, and planned new drug application (NDA) submission at
Pharmaceutical industry
Keryx Biopharmaceuticals, Inc. (NASDAQ: KERX) announced that the independent Data Safety Monitoring Board (DSMB) for the Company's pivotal Phase 3 X-PECT study of KRX-0401 (perifosine) in patients with refractory advanced colorectal cancer has completed a pre-specified interim analysis for safety and futility. The study has been cleared to
Pharmaceutical industry
The US Food and Drug Administration (FDA) has approved Zelboraf (vemurafenib) for the treatment of inoperable or metastatic melanoma with a BRAF V600E mutation, as determined by an FDA-approved test. This approval marks a significant milestone in the treatment of metastatic melanoma, a devastating disease with limited approved treatment options
Pharmaceutical industry
Pfizer Inc's innovative medication, XALKORI (crizotinib) capsules, has made a groundbreaking achievement with its approval by the US Food and Drug Administration (FDA) for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK)-positive. This approval is
Pharmaceutical industry
Abbott has received approval from the US Food and Drug Administration (FDA) for a new molecular diagnostic test designed to detect rearrangements of the anaplastic lymphoma kinase (ALK) gene in non-small-cell lung cancer (NSCLC). The new Abbott Vysis ALK Break Apart FISH Probe test is designed to identify ALK-positive NSCLC
