Here is a list of 7 stocks which broke out during Friday's trade on big volume. I will be keeping my eye on all of these stocks this week, but chose only one to write a detailed option trade about this week. All of these stocks demonstrated tremendous strength during Friday's trade breaking out to the upside on huge volume.[More...]
Earlier this week, King Pharmaceuticals, Inc. (KG) announced the launch of Embeda, which recently received U.S. Food and Drug Administration (FDA) approval for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.
Embeda, which is the first FDA-approved long-acting opioid designed to reduce drug [...]
King Pharmaceuticals, Inc. (KG) and Acura Pharmaceuticals, Inc. (ACUR) recently met with the U.S. Food and Drug Administration (FDA) to discuss the agency’s response to the New Drug Application (NDA) for Acurox (oxycodone HCl and niacin).
The companies and the agency agreed that the NDA should be reviewed by an FDA advisory committee. The agency has [...]
King Pharmaceuticals Inc. (KG) and Pain Therapeutics Inc. (PTIE) Tuesday said that they would resubmit a new drug application for pain drug Remoxy with the FDA in mid 2010.
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Remoxy is a long acting oral formulation of oxycodone intended to treat moderate-to-severe pain, and designed to reduce risks of unintended use. The drug is being developed by Pain Therapeutics under license from Durect Corp. (DRRX), and Pain Therapeutics in turn has sublicensed the commercialization rights of Remoxy to King Pharma.
According to King Pharma, Remoxy is designed to resist common methods of prescription drug misuse and abuse. The company believes the rate-limiting step is the generation of six-month stability data, and no new clinical trials are required. King remains committed to the development and commercialization of Remoxy, and said it would work closely with the FDA toward approval of the product.
The new drug application for Remoxy was submitted in June 2008. An FDA panel, which reviewed Remoxy last November, had a mixed view about the drug - with some members concluding that Remoxy is less susceptible to abuse than other pain killers and some members ruling that the drug may be not so tamper resistant.
The FDA, however, issued a complete response letter for Remoxy last December and requested additional non-clinical data to support the drug's approval.
KG is currently trading at $9.40, down 10 cents or 1.05%. PTIE is currently trading at $4.55, down 93 cents or 16.97%.
Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of 243 entries as of 7/7/09. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of BioMedReports.com, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete respon (...)[More...]
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