Author Archive: Tracy Cooley

Tracy Cooley

Tracy serves as the Director of Events Communications and handles all communications for BIO’s events and emerging company policy issues. She loves blogging and podcasting on all things biotech and believes in the great potential of the industry, looking for every opportunity to spread the message far and wide. Nearly everyone in her family is a golfer, and as such, she has what many people have called a “natural” swing. Sometimes she even hits the ball. Tracy just finished her ninth marathon, and has nearly mastered the skill of one-foot-in-front-of-the-other (usually, sometimes the laces get in the way). The joy of her life is her five-year-old daughter Josephine.

Latest Posts

Pitts Sounds off on Biosimilar Naming

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This week, the Food and Drug Law Institute published a white paper – Biosimilar Nomenclature: Can we achieve the truth, the whole truth, & nothing but the truth? – outlining key considerations around the naming of biosimilars. Peter J. Pitts, President, Center for Medicine in the Public Interest and Former Associate Commissioner, US Food and Drug Administration, asserts that ‘those who view distinctive biosimilar nomenclature naming as either contrary to safety or anti-competitive are addressing Read More >

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4 Benefits of Plant-Made Pharmaceuticals

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For centuries, plants have served as a natural source of treatments and therapies. New advances in biotechnology make it possible to turn plants into “factories” that produce therapeutic proteins for use in the manufacture of biologics. The potential of plant-made pharmaceuticals to combat life-threatening diseases has been in the news recently as they may be helpful in treating Ebola. Developing therapeutic proteins in plants can be a safer, more efficient and cost-effective method of protein Read More >

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Promising vaccine companies set to take the stage at BIO Investor Forum

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It is no secret that vaccines are a hot space in biotech right now, and the 13th Annual BIO Investor Forum will feature several companies working on promising vaccine R&D. The event, scheduled for October 7-8 in San Francisco, Calif., will feature 120 late-stage private and emerging public company presentations. Attendees at the BIO Investor Forum will hear from Immunovaccine, a clinical-stage vaccine development company focused on product candidates for cancer therapy, infectious disease and Read More >

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AP: Groups Claim Insurance Discrimination

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In this August 18 article, Ricardo Alonso-Zaldivar highlights assertions by patient groups that new insurance barriers are discriminatory against sick people, particularly patients with chronic conditions. More than 300 patient advocacy groups – including the AIDS Institute, the American Lung Association, Easter Seals, the Epilepsy Foundation, the Leukemia & Lymphoma Society, the National Alliance on Mental Illness, the National Kidney Foundation and United Cerebral Palsy – recently wrote to Health and Human Services Secretary Sylvia Read More >

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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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