Industry News

- 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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- Read more about Merck KGaA, Darmstadt, Germany, and Pfizer Announce Initiation of Phase III First-Line Trial of Avelumab in Patients with Recurrent or Stage IV Non-Small Cell Lung Cancer(NSCLC)
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.
- Read more about Johnson & Johnson announces agreement to acquire Novira Therapeutics, inc.
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.
- Read more about GSK’s Nucala® (mepolizumab) receives approval from US FDA
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.
- Read more about Dr Reddy's Lab receives FDA warning over three facilities
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.
- Read more about NIPERs and Pharma Industries bridged to fulfill academic and industry gap
National Institutes for Pharmaceutical Education and Research (NIPERs) and Pharma Industries signed 17 MoU to bridge gap betwwen academic education and industrial needs. One of the critical factors in building innovation ecosystem and for Drug Discovery is Academia-Industry linkage. Department of Pharmaceuticals (DoP) for the last one year has actively engaged both the NIPERs and the Pharma Industry to build partnership in areas of education, research and development.
- Read more about ViiV Healthcare declare positive headline results from a study of two drug injectable regimen for HIV maintenance therapy
ViiV Healthcare, a global specialist HIV company with GSK, Pfizer Inc. and Shionogi Limited as shareholders, announced that the Phase IIb study LATTE 2 (NCT02120352) met its primary endpoint at 32 weeks. These results show that the investigational, long acting, injectable formulations of cabotegravir (ViiV Healthcare) and rilpivirine (Janssen) were comparable in maintaining viral suppression rates to a three drug oral regimen of investigational cabotegravir and two nucleoside reverse transcriptase inhibitors (NRTIs). The 32 week results of LATTE 2 will be presented at a forthcoming scientific conference. ViiV Healthcare and Janssen Sciences Ireland UC (Janssen) are collaborating to conduct LATTE 2.
- Read more about Merck Serono and Selvita to discover new drugs for cancer metabolism
Merck Serono has signed a collaboration with Polish biotechnology firm Selvita to jointly discover small molecule based drugs targeting proteins involved in cancer cell metabolism.
- Read more about GSK, Merck to study immunotherapy combination as potential cancer treatment
GSK and Merck, known as MSD outside the US and Canada, announced the initiation of a phase I clinical trial designed to evaluate GSK’s investigational immunotherapy GSK3174998 as monotherapy and in combination with Merck’s anti-PD-1 therapy, Keytruda® (pembrolizumab) in patients with locally advanced, recurrent or metastatic solid tumour(s) that have progressed after standard treatment.