Quantcast
Last updated on April 17, 2014 at 10:34 EDT

Latest Clinical pharmacology Stories

2014-02-10 12:22:10

DUBLIN, Feb. 10, 2014 /PRNewswire/ -- Research and Markets ( http://www.researchandmarkets.com/research/wjn6lr/companion ) has announced the addition of the "Companion Diagnostics: Market Size, Segmentation, Growth, Competition and Trends" report to their offering. (Logo: http://photos.prnewswire.com/prnh/20130307/600769) Companion diagnostics (CDx) is an emerging (+$200M) segment of the -$50B in vitro diagnostics (IVD) industry, which is growing at double digit rates through...

2014-02-10 08:27:44

SMC advice follows positive NICE final guidance issued in November 2013 ATLANTA, Feb. 10, 2014 /PRNewswire/ -- Alimera Sciences, Inc. (NASDAQ: ALIM) (Alimera), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that the Scottish Medicines Consortium (SMC), after completing its assessment and review of a simple patient access scheme, has accepted ILUVIEN® for restricted use within...

2014-02-06 16:27:42

NEW YORK, Feb. 6, 2014 /PRNewswire/ -- The nationwide law firm of Bernstein Liebhard LLP is now investigating Anatabloc lawsuit (http://www.consumerinjurylawyers.com/consumer-products/anatabloc-lawsuit/) claims against Star Scientific Inc. (NASDAQ: STSI), Rock Creek Pharmaceuticals, Inc. and GNC Holdings, Inc. (NYSE: GNC), the manufacturers and sellers of Anatabloc dietary supplements. Anatabloc was recently the subject of a warning letter issued by the U.S. Food & Drug...

2014-02-05 08:30:51

BUFFALO, N.Y., Feb. 5, 2014 /PRNewswire/ -- Kinex Pharmaceuticals, (Kinex), a leading specialty biotech focused on the development and commercialization of next generation oral therapies for cancer diseases has appointed Dr. Rudolf Kwan, as Chief Medical Officer and Dr. Wing-Kai Chan as Head of Clinical Operations- Asia/Pacific. Kinex currently has four oral oncology drug candidates allowed in the clinic and the appointments of Dr. Kwan and Dr. Chan adds significant expertise in...

2014-02-05 08:28:36

-- Enrollment in Huntington's Phase 2 Trial Expected Soon -- SEATTLE, Feb. 5, 2014 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to OMS824, the company's phosphodiesterase 10 (PDE10) inhibitor, for the treatment of cognitive impairment in patients with Huntington's disease. OMS824 selectively inhibits PDE10, an enzyme expressed in areas of the brain linked to a wide range of diseases...

2014-02-04 08:33:16

Urges Reinstatement of SPA for Heart Drug Vascepa NEW YORK, Feb. 4, 2014 /PRNewswire-USNewswire/ -- The EPA Drug Initiative (EPADI) asserts that the FDA did not live up to its own scientific integrity standards in rescinding the Special Protocol Assessment (SPA) related to the "ANCHOR" sNDA for the triglyceride (TG) lowering drug, Vascepa, and urges that the Agency adhere to its own policies in the appeal of the SPA rescission decision. (Photo:...

2014-02-03 12:28:15

ROCKVILLE, Md. and WHITE PLAINS, N.Y., Feb. 3, 2014 /PRNewswire/ -- RRD International, LLC (RRD), a product development company that provides expert-level support to biopharmaceutical companies and investors, announced today a partnership with Dipexium Pharmaceuticals, LLC (Dipexium) to develop Locilex(TM) (pexiganan acetate cream 1%), a broad spectrum, small peptide topical antibiotic for the treatment of mild to moderate skin infections in superficial wounds. Working closely with...

2014-01-31 23:33:57

The ICH's pending Q3D guideline sets tighter limits on the amounts of metals that can be in finished drug products, representing a drastic departure from the status quo. The guideline clearly means that facilities will be facing daunting new compliance requirements and Falls Church, VA (PRWEB) January 31, 2014 Metal Impurities in Drug Products: Charting a Course in an Uncertain Regulatory Landscape **FDAnews Management Report** http://www.fdanews.com/MetalImpurities Regardless of how...

2014-01-28 23:30:23

Jill Anderson advises startup healthcare companies on best practices at the Bio and Health Tech Entrepreneurship Lab NYC. New York, NY (PRWEB) January 28, 2014 Moses & Singer LLP attorney Jill Anderson, a Partner in the firm’s Healthcare practice, addressed the Bio and Health Tech Entrepreneurship Lab NYC on Jan. 23rd on regulations affecting startup companies in healthcare and the life sciences. ELab is a prestigious training and mentorship program for aspiring entrepreneurs in...

2014-01-27 23:27:30

The FDA’s focus on drug and devicemakers promotional activities is no longer limited to magazine and TV ads. They're looking at websites, Twitter, journal articles, TV appearances, Facebook and more. Falls Church, VA (PRWEB) January 27, 2014 The FDA is Watching: What Twitter, Tradeshows and TV Have in Common **FDAnews Webinar** Feb. 11, 2014 — 12:00 p.m. – 1:30 p.m. EST http://www.fdanews.com/FDAisWatching There’s more: FDA officials have been seen walking the floors at...