Pharmaceutical industry
The US Food and Drug Administration has approved Synjardy, a combination medication of empagliflozin and metformin, for the treatment of adults with type 2 diabetes. This approval marks the third product containing empagliflozin to be approved by the FDA, following Jardiance and Glyxambi. Synjardy combines two medicines with complementary mechanisms
Pharmaceutical industry
Omeros Corporation announced plans to file a patent infringement lawsuit against Par Pharmaceutical in response to the Abbreviated New Drug Application (ANDA) filed by Par seeking FDA approval to market a generic version of Omeros' commercial drug Omidria. Omidria, approved by the FDA for use during cataract surgery or
Pharmaceutical industry
Researchers at Roche announced that their investigational immunotherapy atezolizumab (MPDL3280A; anti-PDL1) has met its primary endpoint in a large pivotal Phase II study, known as BIRCH, demonstrating the medicine's ability to shrink tumors in people with a specific type of lung cancer. The study showed that the amount
Pharmaceutical industry
Allergan plc has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Posaconazole Delayed-Release Tablets, 100mg, a generic version of Merck's antifungal agent Noxafil(r). The filing marks a significant step in Allergan's efforts to
Pharmaceutical industry
Sanofi and Regeneron Pharmaceuticals have announced the approval of Praluent (alirocumab) Injection by the U.S. Food and Drug Administration (FDA) for the treatment of adults with high levels of low-density lipoprotein (LDL) cholesterol. Praluent is the first FDA-approved treatment in a new class of drugs known as PCSK9 (proprotein
Pharmaceutical industry
Dr Reddy's Laboratories Ltd, a leading pharmaceutical company, has collaborated with US-based biotechnology giant Amgen Inc to market and distribute three of Amgen's innovative medicines in India. These medicines, Kyprolis, Blincyto, and Repatha, cater to the areas of oncology and cardiology, addressing significant unmet needs of
Pharmaceutical industry
Allergan, a multinational pharmaceutical company, has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market a generic version of Tyvaso(r), a treatment for pulmonary arterial hypertension (PAH). The move comes as United Therapeutics, the manufacturer of Tyvaso(r)
Pharmaceutical industry
Japanese patients with hypercholesterolemia at high cardiovascular risk, or with an inherited form of high cholesterol, benefited significantly from the investigational therapy Praluent, as part of its standard of care, including statins. The trial, ODYSSEY JAPAN, demonstrated a substantial reduction in low-density lipoprotein cholesterol (LDL-C) levels in the patients. Praluent,
Pharmaceutical industry
At the Japanese Atherosclerosis Society (JAS) Annual Scientific Meeting, Regeneron Pharmaceuticals and Sanofi announced that the Phase 3 ODYSSEY JAPAN trial of the investigational therapy Praluent (alirocumab) met its primary endpoint. The trial evaluated the efficacy and safety of Praluent in Japanese patients with hypercholesterolemia at high cardiovascular (CV) risk
Pharmaceutical industry
Eisai Co., Ltd. has announced that its U.S. subsidiary, Eisai Inc., has received approval from the U.S. Food and Drug Administration (FDA) for an indication expansion of its antiepileptic agent Fycompa (perampanel hydrate) as an adjunctive treatment of primary generalized tonic-clonic (PGTC) seizures in patients with epilepsy 12
Pharmaceutical industry
The US FDA has approved the Ventana ALK (D5F3) CDx Assay as a companion diagnostic to aid in the identification of patients for Pfizer's targeted therapy, XALKORI (crizotinib). This approval makes ALK IHC testing widely accessible on VENTANA BenchMark(1) immunohistochemistry instruments globally, and the assay provides fast
Pharmaceutical industry
Immunomedics, a clinical-stage biopharmaceutical company, has announced that it has received notice from the U.S. Food and Drug Administration (FDA) designating sacituzumab govitecan, the Company's lead antibody-drug conjugate (ADC), as a Fast Track development program for the treatment of patients with metastatic non-small cell lung cancer (NSCLC)
