Industry news

  • 17 November 2017

    FDA Overhauls Inspection Process and Field Operations

    Jill Wechsler / BioPharm Inertnational

    To ensure the quality and safety of drugs, biologics, and medical products more efficiently and effectively, FDA is making significant changes in its plant inspection program, including more attention to imports and to foreign producers of drugs for American consumers. An aim is to target manufacturing oversight to more high-risk operations and free up resources for greater scrutiny of foreign facilities in the process.

  • 16 November 2017

    EMA and EUnetHTA published a new joint work plan

    GMP News

    The European Medicines Agency (EMA) and the European Network for Health Technology Assessment (EUnetHTA) have published a joint work plan outlining key areas of collaboration for the next three years.

  • 16 November 2017

    U.S. approves digital pill that tracks when patients take it

    Reuters

    U.S. regulators have approved the first digital pill with an embedded sensor to track if patients are taking their medication properly, marking a significant step forward in the convergence of healthcare and technology.

  • 15 November 2017

    MIT scientists propose a safer way to edit genes with CRISPR

    Arlene Weintraub / FiercwBiotech

    The gene editing system CRISPR-Cas9 has generated excitement for its potential use in eliminating disease-causing irregularities in DNA. But most CRISPR systems rely on viruses to carry Cas9 components into cells, where they then go to work cutting DNA.

  • 15 November 2017

    NANOLEK will cover the needs for inactivated polio vaccine in Russia

    GMP News

    Polymilex®, an inactivated polio vaccine, is the first IPV fully manufactured in Russia. Nanolek is implementing the project to manufacture this vaccine since 2012.

  • 15 November 2017

    Drug sales in Russia steadily grow this year

    Remedium

    Drug sales in Russia are steadily growing this year, according to latest data of the Russian Ministry of Health, reports The Pharma Letter’s local correspondent. For the 9 months of the current year drug sales in Russia grew by 13.7% on year-on-year basis to 3.3 billion packs in value terms.

  • 14 November 2017

    Russian State Duma approves the drug labeling bill in the first reading

    GMP News

    Russia introduces total control over the quality of drugs. This is the goal of the bill submitted by the Ministry of Health and approved by the State Duma in the first reading. The amendments include the introduction of a federal state information system for monitoring the circulation of medicines in Russia. The system will track the circulation of drugs from the manufacturers to the end consumers. To ensure this, the bill proposes to use special labeling.

  • 13 November 2017

    Clearside Biomedicals Phase 1/2 Open Label Clinical Trial of CLS-TA With and Without Eylea in Diabetic Macular Edema Presented at the American Academy of Ophthalmology 2017 Annual Meeting

    Clearside Biomedicals Phase 1/2 Open Label Clinical Trial of CLS-TA With and Without Eylea in Diabetic Macular Edema Presented at the American Academy of Ophthalmology 2017 Annual Meeting

    Clearside Biomedical, Inc. (NASDAQ:CLSD), a late-stage clinical biopharmaceutical company developing first-in-class drug therapies to treat back-of-the-eye diseases, announced that, on Friday, November 10, 2017, during the Retina Subspecialty Day of the American Academy of Ophthalmology  2017 Annual Meeting in New Orleans Charles C. Wykoff presented preliminary results from an exploratory clinical trial of CLS-TA, Clearside’s proprietary suspension formulation of the corticosteroid triamcinolone acetonide for suprachoroidal administration with and without intravitreally injected EYLEA® (aflibercept) for the treatment of diabetic macular edema.

  • 13 November 2017

    Gottlieb: Dont take away FDAs drug/device approval remit for soldiers

    Ben Adams / FierceBiotech

    FDA Commissioner Scott Gottlieb, M.D., has hit back at plans that could see the Pentagon take control over the approval of some experimental drugs and devices for soldiers. A new policy from the Senate’s National Defense Authorization Act, which is going through committee, would allow the Pentagon to approve devices and drugs not green-lit by FDA to be used on military personnel “for emergency use.” The plans were first published this week by Politico.

  • 13 November 2017

    Russian government proposed to increase funding for pharmaceutical industry

    GMP News

    The government has proposed to increase funding for the state program “Development of Pharmaceutical and Medical Industry” by 6.38 million rubles in 2018-2020. This results from the amendments to the draft budget prepared for the second reading in the State Duma.

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MEDIA CENTER

  • NovaMedica began construction of a pharmaceutical plant in the Kaluga region

    NovaMedica began construction of a pharmaceutical plant in the Kaluga region

    Russian pharmaceutical company NovaMedica, a portfolio company of RUSNANO, announces the start of construction of a plant for the production of sterile injectable drugs as part of its long-term strategy to localize innovative medicines and technologies of their development and production in Russia. The plant will be built in the industrial park “Vorsino” in the Kaluga region.

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