-
Featured Authors
-
Archives
- May 2013
- April 2013
- March 2013
- February 2013
- January 2013
- December 2012
- November 2012
- October 2012
- September 2012
- August 2012
- July 2012
- June 2012
- May 2012
- April 2012
- March 2012
- February 2012
- January 2012
- December 2011
- November 2011
- October 2011
- September 2011
- August 2011
- July 2011
- June 2011
- May 2011
- April 2011
- March 2011
- February 2011
- January 2011
- December 2010
- November 2010
- October 2010
- September 2010
- August 2010
- July 2010
- June 2010
- May 2010
- April 2010
- March 2010
- February 2010
- January 2010
- December 2009
- November 2009
- October 2009
- September 2009
- August 2009
- July 2009
- June 2009
- May 2009
- April 2009
- March 2009
- February 2009
- January 2009
- December 2008
- November 2008
- October 2008
- September 2008
- August 2008
- July 2008
- June 2008
- May 2008
- April 2008
- March 2008
- February 2008
-
Meta
Tag Archives: FDA approval
BIO Investor Forum – Raring to Go: The Race to Treat Ultra-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. 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 >
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 >
Indices, IPOs, and New Drug Approvals – Update July 6th 2012
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 >
Indices, IPOs, and New Drug Approvals – Update April 3rd 2012
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 >
Dealing with Rejection, the Regulatory Kind
The ubiquitous CRL in biotech has made its way into the news headlines again. But is the Complete Response Letter a game-changing hurdle for a biotech, or is it par for the course these days? It turns out that almost half of NDA/BLA filings get rejected by the FDA on the 1st round. However, most companies resubmit their application, and by the 2nd review 75% of drugs gain FDA approval. After heading for a 3rd Read More >
