Tag Archives: FDASIA

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

FDA115x76

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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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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Prosensa’s IPO and the Value of the BIO Investor Forum

Hans Schikan

Prosensa (NASDAQ: RNA) is a Dutch biotechnology company engaged in the discovery and development of RNA-modulating therapeutics for the treatment of genetic disorders. Our primary focus is on rare neuromuscular and neurodegenerative disorders with a large unmet medical need, including Duchenne muscular dystrophy, myotonic dystrophy and Huntington’s disease. We completed an IPO onto NASDAQ in June of this year. Prior to last year’s BIO Investor Forum in San Francisco, we were still in the very Read More >

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Orphan Drugs: Making Rare Diseases Rarer

Panel

A panel at the BIO CEO & Investor Conference provided an analysis of the thriving orphan drug market opportunity featuring industry, clinical and regulatory experts specializing in rare diseases. The signing of FDASIA by President Obama in July reinforces the country’s commitment to fostering innovation for rare diseases. With a record 460 medicines in late-stage clinical trials, biopharmaceutical companies have embraced rare disease medicine and are rapidly developing the pipeline with hopes of achieving the Read More >

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FDASIA: A Step Forward for Patients

fdasia-panel

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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