Tag Archives: FDA approved drugs

“When Genetic Engineering Came Of Age”

insulin

October 29 was the 30th anniversary of the approval by the Food and Drug Administration (FDA) of human insulin synthesized in genetically engineered bacteria. In an article for Forbes, Henry Miller, the founding director of the FDA’s Office of Biotechnology, marked the anniversary and commented on today’s regulatory environment: “Regulators have adopted a highly risk-averse and even adversarial mindset, few new drugs are approved without convening extramural advisory committees, and decisions are sometimes hijacked by Read More >

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Indices, IPOs, Approvals – YTD Update Aug 14th, 2012

We are now more than eight months into the year and biotech indices have maintained their outperformance, squeezed out a modest size IPO class, and delivered double digit novel FDA approvals. 1. Indices. The Nasdaq Biotech Index (NBI) is up 27% Year to Date (YTD) as of last Friday. It was up nearly 20% by the end of the 1st quarter, consolidated during the 2nd quarter, and has participated in the summer rally to tack on another 7%. Here Read More >

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Repositioning Drugs for Parkinson’s Disease

Parkinson's Research

Last month, The Michael J. Fox Foundation (MJFF) announced the launch of its Repositioning Drugs for PD 2012 program. The program follows a successful 2011 during which the Foundation funded nine awards totaling $3.4 million repositioning existing drugs that could benefit Parkinson’s disease patients. The program seeks projects that will test drugs that are either already FDA-approved or that have been proven safe in a clinical trial for a certain indication, to determine whether the Read More >

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Role of Public-Sector Research in the Discovery of Drugs and Vaccines

Interesting article out of the New England Journal of Medicine entitled The Role of Public-Sector Research in the Discovery of Drugs and Vaccines. Findings: We found that during the past 40 years, 153 new FDA-approved drugs, vaccines, or new indications for existing drugs were discovered through research carried out in PSRIs [public-sector research institutions]. These drugs included 93 small-molecule drugs, 36 biologic agents, 15 vaccines, 8 in vivo diagnostic materials, and 1 over-the-counter drug. More Read More >

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