NEW YORK, NY -- (Marketwire) -- 09/12/12 -- A recent $6.4 billion dollar deal between medical companies and U.S. regulators to help speed reviews of new drugs and medical devices could be in jeopardy due to funding. FDA spokeswoman Karen Riley stated that the agency would require certain funding from Congress before they could spend any industry money. Five Star Equities examines the outlook for companies in the Medical Appliances & Equipment Industry and provides equity research on Antares Pharma Inc. (NASDAQ: ATRS) and Sunshine Heart Inc. (NASDAQ: SSH).
Riley has stated that the current standstill "could result in the loss of whole user fee programs, programs that have become essential to public health and medical product innovation."
The FDA Safety and Innovation Act, which allows the FDA to collect fees from companies to help fund reviews of innovative drugs and medical devices, became law in July 2012. The new legislation was applauded by industry officials as it would help speed up the lengthy review process of innovative drugs and medical devices.
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Antares Pharma is a revenue-generating product focused specialty pharmaceutical company that has developed three proprietary platforms, two of which now include FDA approved products. According to their latest financials the company increased total revenues to $4.5 million and $11.4 million in the three and six month periods ended June 30, 2012, an increase of 28 percent and 60 percent, respectively.
Sunshine Heart is an early-stage global medical device company committed to the commercialization of the C-Pulse Heart Assist System, an implantable, non-blood contacting, heart assist therapy for the treatment of moderate to severe heart failure. Canaccord Genuity last Friday initiated coverage on the company with a "buy" rating. Shares of the company soared over 23 percent Monday.
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