Skip to main content

Industry News

Join WhatsApp Channel 

Regulatory Affairs Courses
  • 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.

  • 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.

  • Sun Pharmaceutical Industries Ltd. and Ranbaxy Laboratories Ltd announced on 9th December that they have received the order of the Competition Commission of India (“CCI”) dated December 5, 2014(“Order”) by which CCI has approved the acquisition of Ranbaxy by Sun Pharma, subject to compliance with certain conditions.

  • AstraZeneca announced that MOVENTIG® (naloxegol) has been granted Marketing Authorisation by the European Commission (EC) for the treatment of opioid-induced constipation (OIC) in adult patients who have had an inadequate response to laxative(s). MOVENTIG is the first once-daily oral peripherally-acting mu-opioid receptor antagonist (PAMORA) to be approved in the European Union (EU).

  • (26th November, 2014); Kerala based natural drug company, Arjuna Natural Extracts Ltd, got US patent of turmeric extract for treatment of Alzheimers disease. BCM-95, has received a US patent (US Patent No. 8859020) for a composition for the treatment of Alzheimers disease comprising curcuminoid mixture and added essential oil of turmeric. The patent also covers method of making the composition.

Subscribe to Industry News