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Tag Archives: Orphan Drug Designations
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, … Continue reading
Posted in Uncategorized
Tagged AIDS, biologics, biosimilar, Cato Research, CBER, CDER, clinical trials, DIA, EMA, EU, FDA, follow-on biologics, generic drugs, geriatric, GMP, guidance, HIV, marketing application, oncology, Orphan Drug Designations, pediatric, pharmacovigilance, pre-IND
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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 … Continue reading
Posted in Clinical Trials, Industry News, Venture Capital
Tagged biotech, Cato BioVentures, clinical research, clinical trials, drug development, funding, nonclinical research, Orphan Drug Designations, R&D
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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 … Continue reading
Posted in Conferences and Meetings, Venture Capital
Tagged BayBio, biotech, Cato BioVentures, clinical development, CROs, drug candidate, drug development, funding, marketing, nonprofits, Northern California, Orphan Drug Designations, Phase 1, Phase 2, regulatory strategy, risk, safety, venture capital
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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 … Continue reading
Posted in Clinical Trials, Regulatory Strategy
Tagged analytical testing, biomarker, clinical trials, dos, exclusivity, FDA, IND, NIH, novel therapeutic, Orphan Drug Designations, tax credit, toxicology
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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 … Continue reading
