Tag Archives: FDA

Expanding the Role of Patients in Drug Development

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Working alongside scientists, universities, and biotech companies, patients and patient organizations have the ability to play a critical role in the search for treatments and cures for chronic and deadly diseases.  As part of the 5th authorization of the Prescription Drug User Fee Act (PDUFA V), the Food and Drug Administration made a commitment to more systematically gather patients’ perspectives on their condition and the available therapies in order to incorporate these findings into their Read More >

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BIO Is Almost Here – What To Consider Before Entering New Therapeutic Areas

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Over the past decade, the biopharmaceutical industry has witnessed a shift towards specialty care. From 2008 to 2014, FDA specialty drug approvals jumped from 33 percent to over 50 percent of all approvals. In 2014, the FDA approved a record 19 specialty care medicines. Given this new reality, companies are expanding the focus of their R&D into new therapeutic areas to address difficult-to-treat, specialty care conditions. Building successful franchises requires a strategic approach to determine the Read More >

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Biosimilars at the Federal Circuit – Can the Parties Be Compelled to Dance?

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In 2009, Congress passed the Biologics Price Competition and Innovation Act (“BPCIA”), which for the first time provided for biosimilar or interchangeable biological drug products.  But it was not until March 6, 2015, that the FDA approved the first biosimilar application – an application by Sandoz to market a version of Amgen’s NEUPOGEN® (filgrastrim) biologic drug product.  Nevertheless, there is still a question as to when Sandoz will be able to begin selling its drug product, Read More >

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New PhRMA Report: A Decade of Innovation in Rare Diseases

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Today, the Pharmaceutical Research and Manufacturers of America (PhRMA) released “A Decade of Innovation in Rare Diseases,” which highlights 10 years of progress in understanding rare diseases and drug development resulting in groundbreaking therapies. According to the report, more than 230 new medicines to treat rare or “orphan” diseases were approved by the U.S. Food and Drug Administration (FDA) in the last decade, and there are currently more than 450 orphan drugs in development. The Read More >

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The Administration Focuses on Improving Food Safety

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The Obama administration wants to establish a new agency that would be housed within the Department of Health and Human Services and serve as the primary voice on food safety standards and compliance with those standards. The Agency would be named the Food Safety Administration, the Obama administration said in its new budget request. The New York Times covered the story here: …At least 15 government agencies — from the Environmental Protection Agency to the National Oceanic and Atmospheric Administration — have Read More >

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