Tag Archives: FDA approval

FDA Check-Up: Drug Development and Manufacturing Challenges

Paul Hastings

I have over 27 years of experience in the biotechnology and pharmaceutical industry. My current company, OncoMed Pharmaceuticals, is working at the cutting edge of oncology research, focused on antibodies that target a specific set of cells within tumors, known as tumor initiating cells, that drive the growth of the tumor and can differentiate into various cell types within the tumor. Currently, we have five products in clinical development in over 13 completed or ongoing Read More >

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Approving Drugs for Alzheimer’s Disease

Russ Katz

BIOtechNOW delves into the current state of Alzheimer’s disease research with today’s feature on regulatory challenges. Tomorrow, we cover the first Alzheimer’s prevention trial, and on Wednesday, we will explore the societal and economic impact of this devastating disease. The therapies currently approved for Alzheimer’s disease work by treating the patients’ symptoms, improving their cognitive and overall functions. Increasingly, however, experts are intent on slowing or halting the disease process—before it has ravaged patients’ brains. In February, the U.S. Food Read More >

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A Bright Future for Orphan Disease Indications

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In celebration of National Rare Disease Day BIO’s Industry Analysis team took a look at recently-approved drugs in the BioMedTracker database with an orphan indication designation. Our research found that 2012 saw the greatest number of approvals of therapies for orphan indications going back all the way to 2000 (This count includes previously approved drugs with new, orphan indication approvals).   Overall, 24 therapies were approved in orphan indications last year, including drugs for Anthrax, Gaucher’s Read More >

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Celgene CEO on New Multiple Myeloma Drug Approvals

BIO CEO

Following on the heels of two big announcements in February, Celgene CEO Robert Hugin (one of FierceBiotech’s most influential people in biopharma) participated in a fireside chat with Joel Sendek, managing director and biotechnology analyst at Stifel Nicolaus & Company, at the 15th Annual BIO CEO & Investor Conference in New York. First, on Friday, February 8, the Food and Drug Administration (FDA) approved Celgene’s drug Pomalyst for patients with multiple myeloma whose disease has Read More >

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FDASIA: A Step Forward for Patients

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Earlier this year, Congress passed and President Obama signed the FDA Safety and Innovation Act (FDASIA) which included a re-authorization of the Prescription Drug User Fee Act (PDUFA). PDUFA provides essential funding to the FDA by authorizing the agency to charge user fees to companies seeking to have products reviewed. Originally enacted in 1992, it must be reauthorized every 5 years. Sara Radcliffe, executive vice president of health at BIO, moderated a panel of experts and advocates Read More >

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