Stock to watch: Human Genome Sciences The U.S. Food and Drug Administration is expected to post briefing documents for next week's advisory panel set up to review Human Genome's lupus drug Benlysta. These FDA documents will include the agency's review of the drug and the voting questions that will be posed to the panel's independent experts. The FDA typically posts advisory panel briefing documents in the morning. You'll want to check frequently the FDA's Arthritis Drugs Advisory Committee web site starting around 7:30 am. Traders will be keying on what the FDA says about Benlysta in its review, which will, of course, impact Human Genome Science's stock price. Tuesday, Nov. 16
Stocks to watch: Human Genome Sciences and MELA Sciences The FDA convenes an advisory panel to review Human Genome Science's lupus drug Benlysta, beginning at 8 am. Expect a trading halt in Human Genome all day, which may or may not extend into the after-hours trading session depending on the length of the panel meeting. I will be live-blogging the Benlysta panel all day, including a real-time, play-by-play of the panel's votes on whether to recommend the drug's approval, which will likely come towards the mid-afternoon. A live link to my blog will be available on Tuesday morning, starting around 7:45 am ET, but you can register now for an email reminder below. I previewed the Benlysta FDA panel on Monday, which outlines the issues and questions that will likely be raised about the drug's efficacy and safety. Also on Tuesday, the FDA is expected to post briefing documents for the advisory panel set up to review MELA Sciences' skin cancer detection device MELAFind. Like above, these briefing documents will include the FDA's review of MELAFind and will clearly have a big impact on MELA Sciences trading. Check the FDA's General and Plastic Surgery Devices Panel web site early Tuesday morning for the MELAFind briefing documents. Wednesday Nov. 17
Stock to watch: Dendreon Investor focus will shift from FDA to the Center for Medicare and Medicaid Services (CMS), which is conducting a "national coverage analysis" to determine reimbursement coverage for on-label and off-label use of Dendreon's prostate cancer vaccine Provenge.
Stock to watch: MELA Sciences The FDA advisory panel meeting for MELAFind kicks off at 8 am ET. I will be live-blogging the panel all day, so check back for a live link or register below for an email reminder: I've been critical of MELAFInd in the past so in full disclosure, I expect Thursday's panel to be tough on the skin cancer detection device. You can read my analysis of the MELAFind clinical data and a statistical issue that has hung over the stock. I also commented on MELA in a recent Biotech Stock Mailbag. --Written by Adam Feuerstein in Boston. >To contact the writer of this article, click here: Adam Feuerstein. >To follow the writer on Twitter, go to http://twitter.com/adamfeuerstein. >To submit a news tip, send an email to: firstname.lastname@example.org.