November 2015

Experts, including specialists and doctors, will brainstorm on innovations, research and new findings in haematology, haemato-oncology, laboratory medicine and blood banking at the 56th annual conference of Indian Society of Haematology & Blood Transfusion, beginning here.

The union cabinet on Thursday approved $750 million (Rs.4,944 crore) investment by Dutch drug major Mylan Group B.V. Netherlands into its Indian subsidiary Mylan Laboratories Ltd.

Taking Vitamin D supplements could prevent the development of heart disease in chronic kidney disease patients.

Adolescent exposre to organochlorine pesticides such as DDT may lead to defective sperm and consequently fertility problems later in life, says a study.

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.

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.

GlaxoSmithKline plc  received approval from the US Food and Drug Administration (FDA) for its Biologics License Application (BLA) for Nucala® (mepolizumab) as an add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype. Nucala is not approved for the treatment of other eosinophilic conditions or relief of acute bronchospasm or status asthmaticus.

The Indian Pharmacopoeia Commission (IPC) is set to become the first WHO Collaborating Centre for Safety of Medicines and Vaccines in the South-East Asia Region. This was stated by Shri J P Nadda, Union Minister of Health and Family Welfare while addressing the 38th Annual Meeting of Representatives of the National Pharmacovigilance Centres participating in the World Health Organization Programme for International Drug Monitoring, organized by the Indian Pharmacopoeia Commission (IPC) and World Health Organization (WHO).

Leading drugmaker Dr Reddy's Laboratories today acknowledged having received a warning letter from the US FDA relating to its three manufacturing plants in Andhra Pradesh and Telangana.