Industry News

Espero Pharmaceuticals, Inc., a privately held specialty pharmaceutical company, announced that the US Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for GoNitro for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease.

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Novartis announced  new results for Cosentyx® (secukinumab) showing no further progression in joint damage in 84% of patients with psoriatic arthritis (PsA). In addition, Cosentyx maintained a treatment response in joint and skin disease, physical function and quality of life in patients over two years of treatment. These results from the extension phase of the FUTURE 1 study were presented at the 2015 Annual Meeting of the American College of Rheumatology (ACR) in San Francisco, United States.

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.

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.

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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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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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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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.

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.