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Docs to FDA: Biosimilars should have different names than branded drugs

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Yesterday, Fierce Biotech highlighted a letter written by more than 10 medical associations and 20 individual specialists to FDA Commissioner Margaret Hamburg saying that biosimilars “must have distinguishable nonproprietary names. The FDA drafted a set of rules for biosimilars in 2012, sparking a debate on whether those drugs should carry the same generic names as the originator products. Now, some doctors are weighing in on the issue, urging the FDA to require biosimilars to have distinguishable names. The physicians argued that using different Read More >

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National Immunization Awareness Month

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August is National Immunization Awareness Month, providing a reminder of the importance of proper vaccination just as kids are heading back to school. Schools are a prime venue for transmitting vaccine-preventable diseases, and school-age children can further spread disease to their families and others with whom they come in contact. As children get older, they are at an increased risk for some infections, and the protection from some childhood vaccines begins to fade, requiring a Read More >

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Seattle Times Commentary: New Approaches Needed to Fight Ebola

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In the Seattle Times this week, BIO Ventures for Global Health President Jennifer Dent offered commentary on the need for new drug development models to develop treatments for Ebola, arguing that conventional approaches are not working for neglected tropical diseases. Partnerships involving drug companies as well as academic, non-profit, and government stakeholders are needed. Dent offers the WIPO Re:Search consortium as an example: In 2011, BIO Ventures for Global Health established a partnership with the Read More >

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BIO Presents at 2014 Biological Weapons Convention Meeting of Experts

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Last week marked the annual Biological Weapons Convention (BWC) Meeting of Experts in Geneva. The BWC is a multi-national treaty prohibiting the manufacture of biological weapons, and also contains provisions related to national implementation and multi-national coordination for preparedness and assistance. Each year a Meeting of Experts takes place to discuss ongoing issues related to the implementation of the treaty. This year, for the first time ever, BIO was invited to present on novel technologies Read More >

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Forbes: Faster FDA Approvals Have Not Caused More Drug Safety Problems

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In 1992, Congress, industry, and the FDA worked together to create the Prescription Drug User Fee Act (PDUFA). This program ensures that FDA has the ability to hire additional reviewers to expedite the drug review process by having industry pay “user fees.” Recently, attention has been given to a flawed study in the August 2014 issue of Health Affairs, which has some critics claiming that PDUFA fees are biasing FDA review decisions. The study looked at Read More >

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