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These 2 Healthcare Stocks Could Win Big With FDA's New 'Breakthrough' Status

By StreetAuthority: By Michael Vodicka The Food and Drug Administration (FDA) made a groundbreaking policy change last year that is having a large impact on the biotech industry and creating a big opportunity for investors.To create a faster path to commercialization for potentially life-saving drugs and medicine...

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Source: Seeking Alpha

Jun 14, 2013 - 9:02 AM

Browse Related Topics: The Food An... Healthcare ... Michael Vod...

FDA orders medical-device makers to detail cybersecurity efforts

WASHINGTON — The security analysts wanted to know how easy it would be to hack into medical devices used in hospitals, knowing the danger if outsiders could gain control.

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Source: Denver Post

Jun 14, 2013 - 7:53 AM

Browse Related Topics: Washington

Amgen's Xgeva gets new approval, just not one it wants most

Amgen has gotten an FDA approval for an expanded use of its drug Xgeva, just not the one it covets most. The drug was approved Thursday for treatment of the rare giant cell tumor of the bone (GCTB).

Comment

Source: FierceMarkets

Jun 14, 2013 - 5:49 AM

Browse Related Topics: Amgen Xgeva Xgeva

Consider Biotech Gilead Sciences Because Of Atripla, Sofosbuvir And Great R&D

By Bram de Haas:Gilead Sciences, Inc. (GILD) is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. This is a short article outlining 3 very attractive traits of this company and discussing the lofty valuation of the stock. Atr...

Comment

Source: Seeking Alpha

Jun 14, 2013 - 12:41 AM

Browse Related Topics: Viread Gild Atripla Sustiva More

FDA urges protection of medical devices from cyber threats

(Reuters) - The U.S. Food and Drug Administration on Thursday urged medical device makers and medical facilities to upgrade security protections to protect against potential cyber threats that could compromise the devices or patient privacy.

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Source: Reuters

Jun 13, 2013 - 6:05 PM

Browse Related Topics: U.S. Food A...

Zydus recalls warfarin after oversized tablets discovered

The FDA says that Zydus Pharmaceuticals is voluntarily recalling one lot of warfarin 2 mg tablets, after receiving one complaint that four oversized tablets had been discovered.

Comment

Source: FierceMarkets

Jun 13, 2013 - 5:51 AM

FDA comes down on another Indian drugmaker

Just weeks after the FDA issued a ban on products from a Wockhardt plant, another Indian company, RPG Life Sciences, has been issued a warning that accuses it of backdating worksheets, selectively reporting test results and destroying some records of out-of-spec test findings.

Comment

Source: FierceMarkets

Jun 12, 2013 - 2:42 PM

Browse Related Topics: Rpg Life Sc...

FDA warning letter nails 2 Baxter plants for repeat violations

Baxter's plant in Jayuya, Puerto Rico, has been cited again, along with a plant in Marion, NC, where inspectors noted mold in the filling area. The FDA said both facilities have yet to get on top of problems observed in earlier visits.

Comment

Source: FierceMarkets

Jun 12, 2013 - 12:19 PM

Browse Related Topics: Nc Puerto Rico Marion Baxter More

Sales upside for Sanofi's Fluzone Quadrivalent looks strong

The FDA two days ago gave its approval to Sanofi's Fluzone Quadrivalent, a 4-1 influenza vaccine, and now the estimates on the revenue upside are starting to roll in. GlobalData says they look very promising.

Comment

Source: FierceMarkets

Jun 12, 2013 - 8:52 AM

Browse Related Topics: Sanofi Sanofi Global Data Fluzone Qua...

Amgen Drug Delays Ovarian Cancer Re-Growth, Survival Benefit Unclear

THOUSAND OAKS, Calif. (TheStreet) -- An experimental drug from Amgen helped women with recurrent ovarian cancer extend the time before their disease worsened, according to results from a late-stage study announced Wednesday. The Amgen drug, known as trebananib or AMG 386, has not yet helped ovarian cancer patien...

Comment

Source: The Street

Jun 12, 2013 - 6:57 AM

Browse Related Topics: Amgen Europe Calif. Amgn More

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