Industry news

  • 25 July 2017

    BioPhorum Launches Biomanufacturing Technology Roadmap

    BioPharm International

    On July 20, 2017, the BioPhorum Operations Group (BPOG), a cross-industry collaboration, announced it published The Technology Roadmap for the Biopharmaceutical Manufacturing Industry, to address the pressure biomanufacturers face to innovate biomanufacturing platforms. Biomanufacturers are facing pressure from current biopharmaceutical industry trends, including continued market growth, the arrival of new product groups, cost pressure, and the trend toward localized manufacture. BPOG’s technology roadmap identifies common biomanufacturer needs and shares those needs with supply partners, academics, regional innovation hubs, regulators, and government agencies, to align directions and enable pre-competitive collaboration.

  • 25 July 2017

    Drug spending in U.S. tops the world. Translation: No pricing-headache relief soon

    Beth Snyder Bulik / FiercePharmaMarketing

    What will it take for pharma to get the drug-pricing monkey off its back? A research report this month laid out the pricing landscape, tensions and problems pharma companies face. At the top of the list? The unrivaled access U.S. patients enjoy comes at a cost.

  • 24 July 2017

    FDA assigns orphan status to a Russian drug

    GMP News

    The US Food and Drug Administration (FDA) assigned an orphan status to a drug for the treatment of myeloid leukemia, which is being developed by Fusion Pharma, a resident of Skolkovo Foundation’s biomed cluster. This means that the regulator recognized the uniqueness of the drug and importance of its trials, which guarantees increased attention and assistance in the process of further development from FDA. This is the first time when a drug fully developed in Russia received such status in the United States.

  • 24 July 2017

    Pharma's U.S. reputation is badand Trump may be to blame: survey

    Beth Snyder Bulik / FiercePharmaMarketing

    The pharma industry’s reputation among patient groups in the U.S. has sunk to a recent low, and some are pointing to the country's leader as the reason.

  • 21 July 2017

    FDAs Scott Gottlieb is fielding a new team of recruiters to start scouting top talent

    John Carroll / Endpoints News

    Biotech execs have been bullish supporters of the FDA in recent years, offering their appreciation of faster review times with new programs like the breakthrough therapy designation. But if there’s one recurrent gripe you hear frequently, it’s that the regulators biopharma companies and patient advocates deal with don’t have the right kind of scientific experience for the drugs under review — especially as you stray outside of oncology.

  • 21 July 2017

    EU watchdog asks if drugmakers influence EMA decisions

    Nick Paul Taylor / Fierce Biotech

    The European Union is investigating whether presubmission meetings with the EMA enable drug companies to influence marketing authorization approval decisions. Officials at the EMA must now allay concerns their meetings with sponsors introduce a source of bias into their decision-making.

  • 20 July 2017

    Russian pharmaceutical products included in the priority export list

    GMP News

    Dmitry Medvedev signed the Order No. 1473-r of July 12, 2017, approving a list of products (goods, works, services), the export of which will be supported by federal executive authorities as being a priority.

  • 20 July 2017

    Pharmas best digital embracers? Theyve got these 4 traits in common: expert

    Carly Helfand / FiercePharma

    Pharma still lags behind other sectors when it comes to adopting digital technology. But some companies are doing better than others—and those companies have a few things in common, one consultant says.

  • 19 July 2017

    Talking cents in pharma? PhRMA finally launches campaign to discuss drug costs

    Beth Snyder Bulik / FiercePharmaMarketing

    Probably one of the last things the pharma industry wants to talk about today is the cost of drugs. Or does it? Industry trade group PhRMA has launched new advertising meant to tackle the issue head-on.

  • 19 July 2017

    King cancer: The top 10 therapeutic areas in biopharma R&D

    John Carroll / Endpoints News

    It’s not going to come as a surprise to anyone who’s been paying attention to drug R&D trends that cancer is the number 1 disease in terms of new drug development projects. But it is amazing to see exactly how much oncology dominates the industry as never before.

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  • 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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