Industry News

Hyderabad-based Aurobindo Pharma received the final approval from the US Food and Drug Administration to manufacture and market generic Aripiprazole tablets used for treatment of psychotic conditions in the American market. The approval is for the tablets in the strengths of 2mg, 5mg, 10mg, 15mg, 20mg and 30mg.

The U.S. Food and Drug Administration (FDA) has approved Opdivo (nivolumab) injection, for intravenous use, for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR mutation or ALK translocation should have disease progression on appropriate targeted therapy prior to receiving Opdivo. In a Phase 3 trial, CheckMate -057, Opdivo demonstrated superior overall survival (OS) in previously treated metastatic non-squamous NSCLC compared to chemotherapy, with a 27% reduction in the risk of death (hazard ratio: 0.73 [95% CI: 0.60, 0.89; p=0.0015]), based on a prespecified interim analysis.1 The median OS was 12.2 months in the Opdivo arm (95% CI: 9.7, 15.0) and 9.4 months in the docetaxel arm (95% CI: 8.0, 10.7). This approval expands Opdivo’s indication for previously treated metastatic squamous NSCLC to include the non-squamous patient population. Squamous and non-squamous NSCLC together represent approximately 85% to 90% of lung cancer cases.

Eli Lilly and Company plans to add 30,000 square feet and approximately 50 new jobs to its research and development presence at the Alexandria Center for Life Science in New York, New York.

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The US Food and Drug Administration approved Alkermes Inc's Aristada (aripiprazole lauroxil) extended release injection to treat adults with schizophrenia.  Schizophrenia is a chronic, severe and disabling brain disorder affecting about one percent of Americans. Typically, symptoms are first seen in adults younger than 30 years of age. Aristada is administered by a health care professional every four to six weeks using an injection in the arm or buttocks.

Cipla Medpro (Pty) Ltd., South African subsidiary of Cipla Ltd. has recently entered into an exclusive agreement with the world’s largest vaccine manufacturer, Serum Institute of India (SII) in South Africa. The partnership will not only enable affordable and accessible vaccines for South Africans, but will also facilitate a reliable supply stream to the South African Government.

Sun Pharmaceutical Industries announced that Ranbaxy Pharmaceuticals Inc. (Ranbaxy), a wholly-owned subsidiary, along with its partners, Cipher Pharmaceuticals Inc. (Cipher) and Galephar Pharmaceutical Research, Inc. (Galephar) have entered into a settlement agreement with Actavis Group (Actavis) that dismisses the patent litigation suit relating to Actavis’ Abbreviated New Drug Application (ANDA) for a generic version of Absorica (isotretinoin capsules). Absorica is the registered trademark of Ranbaxy Laboratories Inc.

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.