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  • Lonza announced  that it recently acquired Triangle Research Labs (TRL) from PBM Capital Group. TRL is a fast-growing hepatocyte provider with products supporting in vitro evaluation of metabolism, drug-drug interactions, drug transporter activity, toxicity of drug candidates and other applications. Triangle Research Labs has facilities based in Research Triangle Park, North Carolina (USA).

  • Novartis announced that The New England Journal of Medicine (NEJM) published data for PKC412 (midostaurin) demonstrating an overall response rate, defined as a major or partial response, of 60% (95% confidence interval [CI], 49-70%; P<0.001) in patients with advanced systemic mastocytosis (SM). The median duration of response for all responders in the primary efficacy population was 24.1 months (95% CI, 10.8-not estimated [NE].

  • Ahmedabad-based Torrent Pharmaceuticals Ltd entered a  binding agreement to acquire a manufacturing unit of Hyderabad-based Glochem Industries Ltd. The Visakhapatnam unit, approved by the US Federal Drug Administration (FDA) and European regulatory authorities, is a multi-product facility which can manufacture advance intermediates and active pharmaceutical ingredients (APIs). With the latest acquisition, Torrent Pharma, which currently has five formulation manufacturing units, will have three API units for the regulated markets. The acquisition will help the firm in vertically integrating its abbreviated new drug application (ANDA) filings in the future, it said in a statement.

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  • 30 June 2016
    ICMR-CEEW launch the ‘solar for healthcare’ initiative

    The Indian Council of Medical Research (ICMR) has signed an MoU with the Council on Energy, Environment and Water (CEEW), a policy research institution, to launch a new ‘Initiative on Solar for Healthcare’. The collaboration will focus on providing effective health care delivery at the last mile by reducing uncertainty in critical infrastructure, particularly electricity supply via cost effective solar-based solutions.

  • Genentech, a member of the Roche Group announced that the U.S. Food and Drug Administration (FDA) accepted for review the company’s Biologics License Application (BLA) for OCREVUS™ (ocrelizumab) for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS), and granted the application Priority Review Designation with a targeted action date of December 28, 2016.

  • Pfizer Inc. announced two additional phase 3 bococizumab trials, SPIRE-HR (HighRisk) and SPIRE-FH (Familial Hypercholesterolemia), met their primary endpoint, demonstrating a significant reduction in the percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at 12 weeks compared to placebo among adults at high and very high risk for cardiovascular events who were receiving a maximally tolerated dose of a highly effective statin.

  • Lipocine Inc., a specialty pharmaceutical company, announced that it has received a Complete Response Letter ("CRL") from the United States Food and Drug Administration ("FDA") regarding its New Drug Application ("NDA") for LPCN 1021, an oral testosterone product candidate for testosterone replacement therapy ("TRT") in adult males for conditions associated with a deficiency or absence of endogenous testosterone, also known as hypogonadism.

  •  A single dose of either of two experimental Zika vaccines fully protected mice challenged with Zika virus four or eight weeks after receiving the inoculations. The research, conducted by investigators supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, suggests that similar vaccines for people could be similarly protective.

  • High triglycerides a type of fat, or lipid, in the blood  increase the risk of heart disease and perhaps type 2 diabetes. For the first time, it has been shown that profoundly lowering triglycerides in diabetics improves their insulin sensitivity over time, which helps them maintain healthy glucose - blood sugar levels. Volanesorsen, an experimental lipid-lowering medication, improved insulin sensitivity and glucose control by significantly decreasing patients' overall hemoglobin A1c the standard clinical measurement of blood glucose levels for diabetics in a new study reported by researchers from the Perelman School of Medicine at the University of Pennsylvania. The results are published online this month in Diabetes Care.

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