Tag Archives: FDA approval

“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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BIO Investor Forum – Raring to Go: The Race to Treat Ultra-Rare Diseases

BIO Investor Forum

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. In anticipation of an even more compelling opportunity, many companies are taking a step beyond and focusing on ultra rare diseases. Last week’s 11th Annual BIO Investor Forum in San Francisco hosted a panel, Raring 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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Indices, IPOs, and New Drug Approvals – Update July 6th 2012

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1. Stock Performance. The Nasdaq Biotech Index (NBI) continued on its path of outperforming the market, up 24.6 percent and increasing its Year-to-Date (YTD) lead over the S&P 500 which is up 8.3 percent. The Amex Biotech Index (BTK) closed out June up a hefty 34.6 percent YTD: 2. IPOs: Tesaro, Inc. (TSRO) was June’s sole U.S. IPO, raising $81M.  The company was formed just two years ago and has aggressively in-licensed cancer treatments from Read More >

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Indices, IPOs, and New Drug Approvals – Update April 3rd 2012

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1. Stock Performance. The Nasdaq Biotech Index (NBI) continued to outperform in March, maintaining its Year-to-Date (YTD) lead of 18% vs. 12% for the S&P 500. Concentrated portfolios holding Amlyin, Regeneron, and Illumina came out even higher. For example, the Amex Biotech Index (BTK) is up 29% this year mainly because it held concentrated positions in these names. Amylin (ALMN) has doubled on the FDA approval for Bydureon and post-approval buy-out rumors. Illumina (ILMN) is up 72% Read More >

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