Tag Archives: Food and Drug Administration

“Please Wait a Few Moments While Your Pill Prints”

Orphan Drugs

Since the late 1980’s, innovators have dreamed of living in a world where science could develop anything they want simply by pressing “print.” 3D printing has evolved to create an array of medical applications from prosthetics to printed bones and tissues, and now—3D printed pills. Three days ago, the Food and Drug Administration approved Spritam, the first 3D-printed drug expected to hit the market by early 2016. It was developed by Ohio based Aprecia Pharmaceuticals Read More >

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FDA Acts on Biosimilars

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The Biologics Price Competition and Innovation Act (BPCIA) deferred to the Food and Drug Administration with regard to implementing the particulars of how the biosimilar approval pathway would be implemented.  The U.S. Food and Drug Administration has issued a series of draft Guidances indicating how it was considering implementing the biosimilar approval pathway contained in the Act.  The Guidances were expressly “draft” in nature, and were the subject of public hearings with the Agency welcoming Read More >

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

BIO International Convention

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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New PhRMA report: Nearly 800 Cancer Medicines in Development

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A new report from the Pharmaceutical Research and Manufacturers of America (PhRMA) shows that biopharma companies are currently developing nearly 800 new medicines and vaccines for cancer. “In recent decades, we have seen great progress in developing effective cancer treatments that help extend lives, improve quality of life and increase productivity,” said PhRMA President and CEO John J. Castellani. “Continued research has expanded our knowledge of how cancer develops and how to target medicines for Read More >

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Tekmira Pharmaceuticals Ebola Drug Gets Nod From FDA

BIO Investor Forum

The U.S. Food and Drug Administration has authorized Canada’s Tekmira Pharmaceuticals to provide an experimental drug to people with confirmed or suspected Ebola virus infections, according to an article in The Wall Street Journal. “Our TKM-Ebola drug supplies are limited, but we will continue to help where we can,” Tekmira Chief Executive Mark J. Murray said in a press release. The drug is still in clinical testing to assess whether it is safe and effective. BIO Read More >

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