Latest US Food and Drug Administration Stories
Agreement opens clear path to NDA for early diagnosis of Parkinsonian Syndromes HOPKINTON, Mass., April 6 /PRNewswire-FirstCall/ -- Alseres Pharmaceuticals, Inc. (Nasdaq: ALSE) announced today that it has reached agreement with the US Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) process for the Phase III protocol of Alseres' Altropane(R) Molecular Imaging Agent to aid in the early diagnosis of Parkinsonian syndromes including Parkinson's disease. A SPA...
- Lorcaserin Very Well Tolerated Throughout Two-Year Study - Conference Call Scheduled for Today at 8:30 a.m. EDT SAN DIEGO, March 30, 2009 /PRNewswire-FirstCall/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) announced today positive top-line results from BLOOM (Behavioral modification and Lorcaserin for Overweight and Obesity Management), the first of two pivotal trials evaluating the safety and efficacy of lorcaserin for weight management. Statistical significance (p<0.0001) was...
About Regulatory Issues in Telemedicine, Regenerative Medicine, More ROCKVILLE, Md., March 19 /PRNewswire-USNewswire/ --Six expert representatives from the US Food and Drug Administration (FDA) will be among the speakers to address several hundred healthcare product regulatory professionals who will gather in San Francisco next month. The Regulatory Affairs Professionals Society (RAPS) will convene its 2009 RAPS Horizons Conference & Exhibition, 1-3 April at The Fairmont San Francisco....
On Friday, US lawmakers introduced a bill that would ban the toxic chemical Bisphenol-A from food and beverage containers.The chemical, commonly referred to as BPA, is suspected of harming human development and has been blamed for many health problems in infants.The move comes on the heels of an announcement made by state officials that the top six baby bottle makers in the US were agreeing to stop using BPA in their products."The scientific evidence is mounting that BPA poses serious...
MINNEAPOLIS, Feb. 28 /PRNewswire/ -- In its ongoing contribution to science and the innovation of industry leading nutraceuticals, Eniva Nutraceutics announces the introduction of its new Eniva(R) Cholesterol Reducer(TM) formula. This advanced, liquid nutritional supplement is Eniva's newest heart health product, designed to support healthy cholesterol and homocysteine levels in the body.* The potent cholesterol lowering plant sterol formulation in the Eniva Cholesterol Reducer meets the...
SOPHIA ANTIPOLIS, France, February 26 /PRNewswire-FirstCall/ -- NicOx S.A. (NYSE Euronext Paris: COX) today announced its financial results for full year 2008 and provided an overview of the development and pre-commercialization activities for naproxcinod, its lead investigational drug for the treatment of the signs and symptoms of osteoarthritis (OA). Michele Garufi, Chief Executive Officer of NicOx, commented: "We believe NicOx has entered 2009 in its strongest strategic position...
PHILADELPHIA, Pennsylvania and DUBLIN, Ireland, February 19 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY) the global specialty biopharmaceutical company announces results for the year to December 31, 2008 - a year which has seen significant growth in Shire's new product portfolio. Financial Highlights Full Year 2008 (1) Q4 2008 (1) Product sales $2.75bn + 27% $0.70 bn + 7%(3) Product...
Reports of the most recent salmonella outbreak have raised a number of concerns among US consumers. In light of the recent outbreak that has killed 8 people and sickened at least 550 nationwide, consumers are becoming exceedingly cautious."You just don't want to take a chance," Louie Paine, manager of Penny's Noodle Shop in Oak Park, Illinois, told Reuters. Penny's is among a number of businesses that have decided to stop using peanuts in their menu items altogether.In fact, the...
As more peanut items continue to be added to the list of foods linked to the latest salmonella outbreak, US lawmakers are vowing to create a system of tighter food safety laws and conduct more frequent inspections. Sen. Tom Harkin, D-Iowa, chairman of the Senate Agriculture Committee, on Thursday referred to the US food safety system as "a hit or miss gamble."The committee held a hearing on the outbreak on Thursday."To say that food safety in this country is a patchwork system is giving...
It appears that the plant allegedly responsible for the latest massive salmonella outbreak owned and operated a Texas plant that had never been inspected by the US Food and Drug Administration until the company came under recent speculation. Although no salmonella was discovered at the Peanut Corp. of America plant in Plainview, news of its under-advised facility have sparked new questions about government's ability to regulate the nation's food supply. In Texas health records obtained by the...
