Industry News

- Read more about Astellas Pharma to acquire Ocata Therapeutics
Astellas Pharma Inc. and Ocata Therapeutics, Inc., a biotechnology company focused on the research and development of new therapies in the field of regenerative medicine, primarily cell therapy addressing unmet medical needs in ophthalmology patients, announced that they have entered into a definitive agreement. Under the agreement, Astellas will acquire Ocata through Laurel Acquisition Inc., a wholly-owned subsidiary of Astellas US Holding, Inc. ("Laurel").
- Read more about US FDA grants rare paediatric disease status to ArmaGen's AGT-181
The US Food and Drug Administration (FDA) has granted rare paediatric disease designation to ArmaGen Inc's AGT-181, a potential treatment for patients with Hurler syndrome, a disease that is also known as mucopolysaccharidosis type I (MPS I).
- Read more about US FDA accepts Espero Pharma's New Drug Application for GoNitro
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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- Read more about New two year data of Novartis Cosentyx showing no progression in joint damage in 84% of psoriatic arthritis patients
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.
- 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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