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Latest US Food and Drug Administration Stories

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2011-03-10 11:15:00

A drug for high-risk pregnant women that once cost between $10 to $20 per injection will next week cost $1,500 a dose, meaning the total cost during a pregnancy could be as much as $30,000. Makena, a form of progesterone given as a weekly shot, has been mixed inexpensively for years in special pharmacies that mix custom-compounds that are not federally approved, according to an Associated Press (AP) report. Doctors predict the price hike may deter low-income women from getting the treatment...

2011-03-09 06:30:00

MONMOUTH JUNCTION, N.J., March 9, 2011 /PRNewswire/ -- Tris Pharma, a specialty pharmaceutical company that develops innovative drug delivery technologies, announced today that the US Food and Drug Administration (FDA) has accepted its Extended Release Carbinoxamine Oral Suspension NDA for the treatment of allergies in kids two years and older. If approved, Tris Pharma's Extended Release Suspension will provide an alternative to the currently available immediate release formulations....

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2011-02-28 06:30:00

Reynolds and Lorillard, the second- and third-biggest US cigarette makers, filed suit to block the US Food and Drug Administration (FDA) from receiving recommendations from an advisory committee that the cigarette makers claim have conflicts of interest, Reuters is reporting. Reynolds, a unit of Winston-Salem, North Carolina-based Reynolds American Inc., makes Camel and Winston cigarettes in addition to its Kool and Salem menthol brands. Lorillard Tobacco is a unit of Lorillard Inc., based...

2011-02-09 16:10:00

EAST HANOVER, N.J., Feb. 9, 2011 /PRNewswire/ -- The New England Journal of Medicine (NEJM) published a study today that shows Afinitor® (everolimus) tablets plus best supportive care (BSC) more than doubled progression-free survival (PFS), or time without tumor growth, versus placebo plus BSC in patients with advanced pancreatic neuroendocrine tumors (NET)(1). Data from the study, RADIANT-3 (RAD001 In Advanced Neuroendocrine Tumors), were first presented last year at...

2011-02-02 15:49:00

Contrave Disallowed Pending Further Large-Scale Testing SILVER SPRING, Md., Feb. 2, 2011 /PRNewswire-USNewswire/ -- In its latest blow to obesity medication development efforts, the US Food and Drug Administration (FDA) yesterday notified Orexigen Therapeutics that it would need to conduct an extremely large-scale study of the long-term cardiovascular effects of its drug, Contrave, before approval could be considered. The economics of such a trial make it extremely unlikely that it can be...

2011-01-27 15:05:00

SAN DIEGO, Jan. 27, 2011 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) announced today a reduction of its US workforce of approximately 25%, or 66 employees. As a result of the workforce reduction, which Arena plans to complete around March 28, 2011, the company expects to incur restructuring charges, primarily in the first quarter of 2011, of approximately $3.8 million in connection with one-time employee termination costs. Arena expects the reduction to decrease annualized...

2011-01-20 06:00:00

PRINCETON, N.J., Jan. 20, 2011 /PRNewswire/ -- Soligenix, Inc. (OTC Bulletin Board: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company, announced today that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation to RiVax(TM) for the prevention of ricin intoxication. RiVax(TM) is a proprietary vaccine that contains a recombinant subunit of the A chain of ricin toxin which induces ricin neutralizing antibodies in humans and animals. The US Orphan...

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2010-12-31 06:30:00

Two American companies broke new ground this year by gaining regulatory approval to begin the first experiments using embryonic stem cells on people suffering from spinal cord injuries and blindness. The use of the cells, which have been hotly debated for years, can transform into nearly any cell in the human body, which could lead to finding ways to eliminate such ailments as Parkinson's disease, diabetes, heart disease, paralysis, and may even help fight aging. As scientists find ways to...

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2010-12-29 06:15:00

A US food safety agency warned consumers on Monday against eating alfalfa sprouts and spicy sprouts (a mixture of three types of sprouts) from Tiny Greens Organic Farm in Urbana, Illinois, after reports surfaced that the foods were tainted with salmonella, possibly behind the 89 cases found throughout the Midwest. USA Today received a call from Tiny Greens Organic Farm owner Bill Bagby on Monday evening. Bagby, who was stranded at a family reunion in North Carolina, told USA Today that the...

2010-12-22 06:30:00

SAN DIEGO and WOODCLIFF LAKE, N.J., Dec. 22, 2010 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) and Eisai Inc. announced today the completion of an end-of-review meeting with the US Food and Drug Administration (FDA) for the lorcaserin New Drug Application (NDA). "The meeting discussions reinforce our position that we have a path forward to seek FDA approval of lorcaserin," said Jack Lief, Arena's President and Chief Executive Officer. "Based on guidance we have received...


Word of the Day
jument
  • A beast of burden; also, a beast in general.
'Jument' ultimately comes from the Latin 'jugum,' yoke.
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