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- Read more about Lupin receives FDA approval for generic loestrin®24 fe tablets
Pharma Major Lupin Limited (Lupin) announced that it has received final approval for its Blisovi 24 Fe Tablets (Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1 mg/0.02 mg and Ferrous Fumarate Tablets, 75 mg) from the United States Food and Drug Administration (FDA) to market a generic version of Warner Chilcott's Loestrin®24 Fe Tablets (Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1 mg/0.02 mg and Ferrous Fumarate Tablets, 75 mg). Lupin’s US subsidiary, Lupin Pharmaceuticals Inc. would commence promoting the product shortly in the US.
- Read more about U.S. Food and Drug Administration Approves Gilead’s Genvoya® for Treatment of HIV-1 Infection
The U.S. Food and Drug Administration approved Genvoya (a fixed-dose combination tablet containing elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older. Genvoya is marketed by Gilead Sciences Inc.
- Read more about FDA panel backs Merck & Co drug to reverse muscle relaxant effect
Merck & Co's drug to reverse the effects of muscle relaxants used in surgery is safe and effective enough to warrant approval, an independent panel to the U.S. Food and Drug Administration said. The drug, which goes by the chemical name of sugammadex, has repeatedly been rejected by the FDA due to concerns about potentially dangerous allergic reactions, even though it is approved in more than 75 countries.
- Read more about AstraZeneca acquire ZS Pharma
AstraZeneca, a global, innovation-driven biopharmaceutical business acquire ZS Pharma, a biopharmaceutical company based in San Mateo, California. ZS Pharma uses its proprietary ion¬-trap technology to develop novel treatments for hyperkalaemia (high potassium levels), a serious condition of elevated potassium in the bloodstream, typically associated with chronic kidney disease (CKD) and chronic heart failure (CHF).

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- Read more about Aurobindo Pharma net dips 13 percent in Q2
Pharmaceutical manufacturer Aurobindo Pharma it posted a standalone net profit of Rs.340.09 crore for the second quarter of 2015-16 against a net profit of Rs.391.66 crore in the same period last year, showing a 13.16 percent dip.

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- Read more about Merck's Glucophage(R) extended release (XR) can be used for more type 2 diabetes patients
Merck a leading science and technology company, announced that the British Medicines and Healthcare products Regulatory Agency (MHRA), has approved on November 2 an updated labeling for Glucophage® XR (extended release metformin) for the treatment of patients with type 2 diabetes. The label change removes moderate renal impairment stage 3a and stable chronic heart failure from the list of the contraindications of Glucophage® XR.

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- Read more about Merck KGaA, Darmstadt, Germany, and Pfizer Announce Initiation of Phase III First-Line Trial of Avelumab in Patients with Recurrent or Stage IV Non-Small Cell Lung Cancer(NSCLC)
Merck KGaA, Darmstadt, Germany, and Pfizer announced the initiation of an international Phase III study of the investigational cancer immunotherapy avelumab* in a treatment naïve advanced NSCLC setting. The study, JAVELIN Lung 100, is designed to assess the safety and efficacy of avelumab compared with platinum-based doublet chemotherapy, in patients with late-stage NSCLC who have not previously received any treatment for their systemic lung cancer. Avelumab (previously known as MSB0010718C) is an investigational fully human anti-PD-L1 IgG1 monoclonal antibody that potentially uses the body’s own immune system to fight cancer.
- Read more about Johnson & Johnson announces agreement to acquire Novira Therapeutics, inc.
Johnson & Johnson announced a definitive agreement to acquire Novira Therapeutics, Inc., a privately held, clinical-stage biopharmaceutical company developing novel therapies for curative treatment of chronic hepatitis B virus (HBV) infection. The acquisition includes Novira’s portfolio of novel antivirals, including its lead candidate, NVR 3-778. Financial terms of the transaction have not been disclosed.
- Read more about GSK’s Nucala® (mepolizumab) receives approval from US FDA
GlaxoSmithKline plc received approval from the US Food and Drug Administration (FDA) for its Biologics License Application (BLA) for Nucala® (mepolizumab) as an add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype. Nucala is not approved for the treatment of other eosinophilic conditions or relief of acute bronchospasm or status asthmaticus.
- Read more about Dr Reddy's Lab receives FDA warning over three facilities
Leading drugmaker Dr Reddy's Laboratories today acknowledged having received a warning letter from the US FDA relating to its three manufacturing plants in Andhra Pradesh and Telangana.