Tag Archive: Orphan Drug Designations

Oct 26

NORD Summit 2016 Highlights

By Kimberley Cummings, Ph.D., RAC (US), Vice President, Scientific & Regulatory Strategy and Operations Cato Research   The National Organization for Rare Disorders (NORD) held their annual Rare Diseases and Orphan Products Breakthrough Summit in Arlington, VA on October 17th and 18th.  If you have never been to this meeting before, it is the most …

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Nov 19

Health Canada Orphan Drug Policy – A Long Overdue Need

Canada is one of the only first world countries without an orphan drug policy. The United States, European Union, Australia, Singapore, and Japan recognized a long time ago the importance of having established policies around the development of orphan drugs. In a 1996 report from Health Canada’s Drugs Directorate that analyzed the need for an …

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Oct 12

Meningitis Tragedy Leads to Calls for Increased FDA Oversight

On 25 September 2012, three lots of steroid injections intended to treat pain were recalled by the pharmaceutical compounding company New England Compounding Center (NECC) in Framingham, MA, because of fungal contamination.  By Thursday, 11 October 2012, 12 people had died and there were 137 confirmed cases of fungal meningitis due to contaminated injections.  The …

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Aug 15

FDASIA, Part 4: Drug Supply Chain, Drug Shortages, and Other Provisions

On 09 July 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA, otherwise known as PDUFA V) was signed into law.  In a 4-part weekly series, we are covering the major changes in FDASIA as follows: Part 1: The “UFAs”: PDUFA, MDUFA, GDUFA, and BsUFA Part 2: Pediatric Drugs and Devices and Medical …

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Aug 07

FDASIA, Part 3: Generating Antibiotic Incentives Now (GAIN) and Drug Approval and Patient Access Changes

On 09 July 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA, otherwise known as PDUFA V) was signed into law.  In a 4-part weekly series, we are covering the major changes in FDASIA as follows: Part 1: The “UFAs”: PDUFA, MDUFA, GDUFA, and BsUFA Part 2: Pediatric Drugs and Devices and Medical …

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Jul 14

Recap of the DIA Annual Meeting 2011

The 47th Annual DIA Meeting was held on 19-23 June 2011 in Chicago and was a great success with thousands of attendees from the health care industry and regulators from around the world including representatives from the FDA, the EMA, and many other global agencies. This year’s keynote speaker was the renowned AIDS researcher and …

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Jun 28

Biotech Funding: Still Playing Hard-to-Get

After a few lean years, biotechs raised $25 billion in 2010.  For the majority of small companies however, funding remains difficult to find.  Ernst & Young’s annual report on the biotechnology industry, Beyond Borders, was recently released and it paints a less rosy picture than the $25 billion number would appear to. It turns out …

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May 11

Conference Recap – BayBio 2011

The BayBio Annual Conference 2011 was held on 20-21 April 2011 in Burlingame, CA.  The event was attended by more than 1,000 San Francisco Bay Area biotech and life sciences professionals from over 400 companies. This year’s conference focused on funding trends and emerging markets in the life sciences industry.  In keeping with BayBio’s spirit …

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Mar 10

Therapeutics for Rare and Neglected Diseases – How Rare is Rare?

The U.S. National Institutes of Health (NIH) classifies a rare disease as affecting less than 200,000 individuals in the United States.  As insignificant as this classification may sound, collectively there are more than 25 million people in the United States affected by approximately 6,800 rare diseases. These rare diseases are alarmingly overlooked and under researched. …

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Apr 19

Drug/Biologic/Device Highlights from the Health Care Reform Bill

Cautious, careful people, always casting about to preserve their reputations… can never effect a reform. – Susan B. Anthony Last month, the company behind the FDA Law Blog, Hyman, Phelps & McNamara, P.C., prepared a memo that outlines the provisions in the Patient Protection and Affordable Care Act (commonly known as the “Health Care Reform …

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