Impax Laboratories, Inc., a specialty pharmaceutical company, announced that the US Food and Drug Administration (FDA) has approved its generic version of glyburide tablets 1.25 mg, 2.5 mg, and 5 mg. The company is preparing for commercialisation of this product through Impax's generic division.
Nestle India on asked the apex consumer court why fresh tests were being ordered on Maggi noodles on food safety when a similar exercise has already been conducted as per directions of the Bombay High Court.
Allergan plc,, a leading global pharmaceutical company, has received approval from the US Food and Drug Administration (FDA) to market Juvederm Ultra XC for injection into the lips and perioral area for lip augmentation in adults over the age of 21.
The Delhi High Court on Wednesday restrained Mumbai-based Glenmark Pharmaceuticals Ltd from making or selling its generic anti-diabetes drugs Zita and Zita-Met while holding it infringing patent of a US drug maker Merck, Sharp and Dohme Corporation. (MSD)
International medical aid agency Medecins Sans Frontieres (MSF/Doctors Without Borders) on Wednesday called for a cautious approach from Indian negotiators on the reinstatement of talks for the EU-India free trade agreement which was discussed during German Chancellor Angela Merkel's visit.
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Sandoz, a Novartis company and the global leader in biosimilars, announced that US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) under the 351 (k) pathway for its proposed biosimilar to Amgen's US-licensed Enbrel (etanercept) - a tumour necrosis factor alpha (TNF-alpha) inhibitor. This is the second BLA submission by Sandoz using the 351(k) biosimilar pathway.
Biocon acquired a manufacturing unit of Vishakapatnam based Acacia Life Sciences for an undisclosed amount. The company has acquired business assets of the pharmaceutical manufacturing unit of Acacia Life Sciences with effect from October 1, on a going concern basis, Biocon said in a regulatory filing.
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Dr. Reddy’s Laboratories has launched ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES USP, 20 mg and 40 mg, a therapeutic equivalent generic version of NEXIUM® (esomeprazole magnesium) Delayed-Release Capsules in the US market.
Merck, known as MSD outside the United States and Canada announce the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA® (pembrolizumab) monotherapy, the company’s anti-PD-1 (programmed death receptor-1) therapy, at a dose of 2 mg/kg every three weeks, for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 as determined by an FDA-approved test and who have disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA. Under FDA’s accelerated approval regulations, this indication for KEYTRUDA is approved based on tumor response rate and durability of response. An improvement in survival or disease-related symptoms has not yet been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
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Astellas Pharma Inc. and Chromocell Corporation collaborate for the development and commercialisation of therapeutics to treat neuropathic and other pain conditions.
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