Newly minted FDA Commissioner Margaret Hamburg says she will toughen up the agency’s enforcement practices. She wants to take the sprawling bureaucracy and remake it into the key federal agency that protects public health.
The agency—responsible to ensure drugs, medical devices and products, some human and animal food products, cosmetics, and other consumer goods are safe to Americans—has been widely faulted for all manner of problems, including that had no permanent commissioner for the majority of former President Bush’s eight-year term.
After the Obama administration unveiled its plans for a major regulatory revamp, stocks settled in to a mixed finish for the day. The plan, which gives increased power to the Federal Reserve and creates a new national regulator for financial firms was met with skepticism from traders, who doubt whether the effort will strike the right balance between curbing the excesses and boosting profits.
In the health care sector, stocks were definitely more animated than they were yesterday.
President Obama today proposed the most sweeping overhaul of the U.S. financial regulatory system in 75 years, seeking to correct a “cascade of mistakes” that toppled major securities firms, froze credit markets and destroyed $26.4 trillion in stock market value around the world.
The proposal, much of which will be subject to approval by Congress, sets out the biggest overhaul of market rules in more than seven decades, adding an additional layer of regulation for the biggest firms. It would create an agency for monitoring consumer financial products, make the Federal Reserve the overseer of companies deemed too big to fail, and bring hedge and private equity funds under federal scrutiny.
Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of over 200 entries. 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 response letter (CRL) re-submissions to the FDA, and pending late-stage pivotal Phase 3 clinical trial results which are designed to support a filing for FDA approval.
Nuvo Research Inc. (TSE:NRI) (PINK:NRIFF) has been red hot this past month and is expected to continue. StocksHaven Investments has identified Nuvo Research as its top candidate for undervalued biotech pre-PDUFA. With a current PPS below $1.00 CAD, and their product Pennsaid, a new and innovative treatment for osteoarthritis having expected net sales of $200-400 million in the U.S., Nuvo Research (TSE:NRI) could see extensive gains leading prior to their expected FDA decision on 8/5/09 as investors gain confidence in the company once again.
Below is a sample of entries from the BioMedReports.com FDA Calendar, which includes a database of over 200 entries. The companies outlined below have expected FDA new drug product decisions or clinical trial results expected over the next three months of summer. The list also includes some Extreme Trades of companies with market caps below $250 million that have pending clinical trial results or FDA decisions that could have a major stock price impact.
Is the three month rally on Wall Street really over?
Stocks declined for a second straight day after some factory data yesterday pointed to a very weak economic recovery. Even one Wall Street banker suggested the three-month rally in stocks may be over. Morgan Stanley's Jason Todd told the Wall Street Journal that after the S&P 500 breached the 950 level last week, "the [stock] rally may now be over."
In Healthcare, equities were very sluggish but a couple of late session run-ups did present some nice profits for traders.
Mammography has long been the standard for detecting breast cancer in its early stages, however dense breast tissue can make tumors difficult to find. According to the New England Journal of Medicine, women with dense breast tissue are five times more likely to develop breast cancer.