Industry News

Natco Pharma Limited has filed Abbreviated New Drug Applications (ANDAs) for Fingolimod, 0.5mg Capsules & Cabazitaxel, 60mg/1.5ml Injection, with the U.S. Federal Drug Administration (USFDA), through its respective marketing partners in the USA.

Cipla Ltd., a global pharmaceutical company which uses cutting edge technology and innovation to meet the everyday needs of all patients, today announced that it’s wholly owned subsidiary, Cipla (EU) Limited, U.K. has entered into a joint venture (JV) agreement with Cipla’s existing business partners in Morocco – Societe Marocaine De Cooperation Pharmaceutique (“Cooper Pharma”) and The Pharmaceutical Institute (PHI).

U. S. Food and Drug Administration granted accelerated approval to palbociclib (IBRANCE, Pfizer, Inc.) for use in combination with letrozole for the treatment of postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer as initial endocrine-based therapy for their metastatic disease.

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Sun Pharma and Ranbaxy Laboratories announced that the U.S. Federal Trade Commission (FTC) has completed its review of the proposed acquisition of Ranbaxy by Sun Pharma and has granted early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR Act).

Novartis announced results from the pivotal Phase III clinical trial demonstrating Jakavi® (ruxolitinib) significantly improved hematocrit control without the need for phlebotomy (a procedure to remove blood from the body to reduce the concentration of red blood cells) and reduced spleen size in patients with polycythemia vera (PV) who had an inadequate response to or unacceptable side effects from hydroxyurea as defined according to the modified European LeukemiaNet (ELN) criteria, which is published in The New England Journal of Medicine (NEJM). In PV, hematocrit control and spleen size reduction are key measures of a patient's response to therapy.

Piramal Enterprises Limited today announced that it is in final stages of discussion with the University of Kentucky for the potential acquisition of Coldstream Laboratories Inc. (‘Coldstream’) for a total consideration of USD 30.65 million.

Bristol-Myers Squibb (BMS) Company and the California Institute for Biomedical Research (Calibr) entered into a worldwide research collaboration to develop novel small molecule anti-fibrotic therapies, and an exclusive license agreement that allows BMS to develop, manufacture and commercialize Calibr’s preclinical compounds resulting from the collaboration.

Quintiles today announced that the company was awarded “Best Contract Research Organization” at the annual SCRIP Awards for the third year in-a-row. This is the company’s fourth award received in this category in the last five years. The SCRIP Awards acknowledge excellence in the biopharmaceutical industry, based on judging by an independent panel of 12 life sciences experts.

The skewed ratio of hazardous waste generated daily to innovations in hazardous waste management, points to a large unmet need for novel hazardous waste management technologies and processes. Apart from the rising volumes of hazardous waste, technology development in this space will also get a huge boost from the treaties signed by various countries for stopping transboundary waste shipping and public opposition to landfills.

Novartis announced today that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved Cosentyx(TM) (secukinumab, formerly known as AIN457), for the treatment of both psoriasis vulgaris and psoriatic arthritis (PsA) in adults who are not adequately responding to systemic therapies (except for biologics). This approval marks the first country approval for Cosentyx in the world and makes it the first interleukin-17A (IL-17A) inhibitor to receive regulatory approval in either of these indications in Japan.