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2014-09-15 08:29:16

PHILADELPHIA, September 15, 2014 /PRNewswire/ -- Shire plc (LSE: SHP, NASDAQ: SHPG), the global specialty biopharmaceutical company, announced today that the US Food and Drug Administration (FDA) has accepted for filing with priority review a supplemental New Drug Application (sNDA) for Vyvanse(R) (lisdexamfetamine dimesylate) Capsules (CII) as a treatment for adults with binge eating disorder (BED). The FDA is expected to provide a decision in February 2015, based on the...

2014-09-15 08:28:36

MONMOUTH JUNCTION, N.J., Sept. 15, 2014 /PRNewswire/ -- Vernalis plc (LSE: VER) and Tris Pharma, Inc. ("Tris") are pleased to announce that the U.S. Food and Drug Administration ("FDA") has confirmed that the New Drug Application ("NDA") for Tuzistra(TM) XR ("CCP-01") has been accepted for full review. This triggers a milestone payment from Vernalis to Tris. The FDA has set a Prescription Drug User Fee Act (PDUFA) target date for conclusion of its review of 30 April 2015. Under...

2014-09-12 23:06:24

On August 25, Tjs Place announced the recall of approx. 20 containers of Basil Pesto Pasta packed in 8 oz plastic tubs due to potential health risk. In light of this news, AttorneyOne, a recognized authority on law, updated the website providing detailed information to consumers. San Diego, CA (PRWEB) September 12, 2014 AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from the FDA on Basil Pesto Pasta. Tjs Place announced on...

2014-09-12 23:00:22

Testosterone Lawsuit Claims Continue As The FDA Seeks Answers From Its Advisory Panel Over Cardiovascular Risks Associated With Testosterone Replacement Therapy. Columbus, OH (PRWEB) September 13, 2014 As low testosterone lawsuit claims continue to increase, Wright & Schulte LLC notes two of the U.S. Food & Drug Administration (FDA) advisory committees will meet on September 17 and 18 to discuss controversial public health issues surrounding testosterone replacement therapy. The...

2014-09-12 12:25:25

FALLS CHURCH, Va., Sept. 12, 2014 /PRNewswire-iReach/ -- 9(th) Annual FDA Inspections Summit **Presented by FDAnews** Oct. 22-24, 2014 - Bethesda, MD Early Bird Registration discount ends on Friday, Sept. 19. http://www.fdanews.com/9thInspectionsSummitEarlyBird Photo - http://photos.prnewswire.com/prnh/20140912/145652 What better way to prepare for the next inspection than to get a glimpse into the inner workings of an investigator's mindset before, during and after an inspection. Come to...

2014-09-12 08:25:15

Accomplished regulatory leader to advance Epic's circulating tumor cell (CTC) technology for 510(k) and PMA approvals SAN DIEGO, Sept. 12, 2014 /PRNewswire/ -- Epic Sciences announced today the appointment of Glen Paul Freiberg, RAC as vice president of regulatory affairs and quality assurance. Mr. Freiberg has more than 35 years of FDA-related experience and is recognized as a key leader in successful regulatory and compliance strategies for diagnostic products. Epic's circulating...

2014-09-12 08:24:55

From 1969 to September 5, 2014, 1,413 artificial hearts of 13 different designs have been implanted in heart failure patients. Here's an update on the state of this life-saving technology. TUCSON, Ariz., Sept. 12, 2014 /PRNewswire/ -- Cardiovascular disease, which includes heart failure, is the number one cause of death, killing more people worldwide than all cancers combined. http://photos.prnewswire.com/prnvar/20140911/145568 The need for donor hearts is growing as heart disease continues...

contrave
2014-09-12 05:31:01

John Hopton for redOrbit.com - Your Universe Online The Food and Drug Administration (FDA) has approved the weight loss pill Contrave, a medication that will be used to treat obese adults in conjunction with a controlled diet and exercise. It is the third such drug to be approved since 2012, although its predecessors have not sold well and all have considerable potential side effects. An FDA statement advises that Contrave, which works by decreasing appetite, is approved for use in...

2014-09-11 23:12:12

All manufacturers of combination products need to conduct a comprehensive gap analysis and determine where to make changes to their manufacturing operations, SOPs, training programs and quality assurance. Mark the calendar for Wednesday, Oct. 1, for On-Demand access to Suzanne O’Shea’s immensely popular webinar on combination products. Falls Church, VA (PRWEB) September 11, 2014 All manufacturers of combination products need to conduct a comprehensive gap analysis and determine where...

2014-09-11 23:11:26

On September 8, Tullia's announced the recall of Italian Meatless Pasta Sauce code 530140 due to possible health risk. In light of this news, AttorneyOne, a recognized authority on law, updated the website providing detailed information to consumers. San Diego, CA (PRWEB) September 11, 2014 AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from the FDA on Italian Meatless Pasta Sauce. Tullia's announced on September 8,...


Word of the Day
cacodemon
  • An evil spirit; a devil.
  • A nightmare.
  • In astrology, the twelfth house of a scheme or figure of the heavens: so called from its signifying dreadful things, such as secret enemies, great losses, imprisonment, etc.
'Cacodemon' comes from a Greek term meaning 'evil genius.'
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