Table of Contents Office of the Federal Register Agency for Healthcare Research and Quality NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 11203-11206 Agricultural Marketing Service RULES Honey Packers and Importers Research, Promotion, Consumer Education and Industry Information Order: Change in Producer..
FDA is publishing this order in accordance with the section of the Federal Food, Drug, and Cosmetic Act permitting the exemption of a device from the requirement to submit a 510. FOR FURTHER INFORMATION CONTACT: Rebecca Nipper, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1540, Si
You come down with a minor cold, and to seek relief from your symptoms, you stop by your local pharmacy. Within minutes you're out of the store, medicine in hand and on your way to feeling better- all without the need to call your doctor or get a prescription. Most OTC medicines are regulated by the U.S. Food and Drug Administration under what's ca
Johnson and Johnson issued the following news release:. The Janssen Pharmaceutical Companies of Johnson& Johnson today announced results of a new analysis showing that INVOKANA (R) significantly reduced the risk of cardiovascular death or hospitalization for heart failure in patients with type 2 diabetes at high CV risk. "This new analysis from th
Deep clinical pipeline of novel small molecule tyrosine kinase inhibitors: Eight clinical drug candidates now in active or completing clinical trials in 36 target patient populations around the world; over 3,500 subjects dosed in trials to date, over 700 in 2017; Stream of second-generation immunotherapy compounds advancing through pre-clinical...
Pfizer, a pharmaceutical company, issued the following news release:. Bristol-Myers Squibb Company and Pfizer Inc. will present findings today from a real-world data analysis titled, Comparison of Effectiveness, Safety, and the Net Clinical Outcome between Different Direct Oral Anticoagulants in 162,707 Non-Valvular Atrial Fibrillation Patients...
Sarasota, FL 03/12/2018 Active pharmaceutical ingredient is used in the manufacturing of a pharmaceutical drug as a biologically active compound. API is an organic compound which has unique chemical structure and stereochemistry. Any medication is made up of two portions.
By a News Reporter-Staff News Editor at Pharma Business Week First paragraph, second sentence should read: The new website can be found at innovuspharma.com. The corrected release reads: INNOVUS PHARMA LAUNCHES ITS NEW BRAND, LOGO AND ITS LATEST E-COMMERCE-ENHANCED CONTENT WEBSITE New Website Features its Robust Beyond Human Sales& Marketing P
Orexigen Therapeutics, Inc., a biopharmaceutical company focused on the treatment of obesity, announced today that it has elected to file a voluntary petition under Chapter 11 of the Bankruptcy Code in the U.S. Bankruptcy Court for the District of Delaware. Orexigen also intends to file a motion seeking authorization to pursue an auction and sale
DUBLIN- Perrigo Company plc today announced that it has received final approval from the U.S. Food& Drug administration for the store brand OTC equivalent of Mucinex DM Maximum Strength. Perrigo Company plc, a leading global healthcare company, delivers value to its customers and consumers by providing Quality Affordable Healthcare Products.
Eliquis use was associated with lower rates of stroke or systemic embolism and major bleeding than matched patients receiving rivaroxaban or dabigatran This oral presentation is one of nine Bristol-Myers Squibb-Pfizer Alliance abstracts being presented at the American College of Cardiology's 67th Annual Scientific Session& Expo.
Traphaco, the second-largest publicly-traded drug maker in Vietnam, aims to make a net consolidated profit of VND300 billion, and consolidated revenues of VND2.4 trillion this year, up 15.28 per cent and 28.47 per cent on-year, respectively. TRA, which has Vietnam Azalea Fund Ltd. as a major foreign shareholder with a 24.99 per cent stake, also aim
TARRYTOWN, N.Y. and PARIS, March 10, 2018/ PRNewswire/ Regeneron Pharmaceuticals, Inc. and Sanofi today announced that the ODYSSEY OUTCOMES trial met its primary endpoint, showing Praluent Injection significantly reduced the risk of major adverse cardiovascular events in patients who had suffered a recent acute coronary syndrome event, such as
TARRYTOWN, N.Y. and PARIS, March 10, 2018/ PRNewswire/ To help ensure more affordable and timely access to patients most in need, Regeneron Pharmaceuticals and Sanofi will offer payers that agree to reduce burdensome access barriers for high-risk patients a further reduced net price for Praluent Injection, in alignment with a new value assessm
By a News Reporter-Staff News Editor at Investment Weekly News Wize Pharma, Inc., a clinical-stage biopharmaceutical company currently focused on the treatment of ophthalmic disorders, announced it has received Institutional Review Board approval for the protocol of its planned Phase IV study. The study will take place in Israel and will evaluate
Innovus Pharmaceuticals, Inc., an emerging commercial-stage pharmaceutical company that delivers safe, innovative and effective over-the-counter medicine and consumer care products to improve men s and women's health and respiratory diseases, today announced that Dr. Bassam Damaj, President and Chief Executive Officer and Rauly Gutierrez, Vice..
Dear Editor, A new trend has caught on across America. This has resulted in the Food and Drug Administration or FDA to release warnings over the last several weeks. One Doctor at Bay care Clinic in Wisconsin detailed the dangerous effects of the drug in an interview with ABC 2 WBAY.
-via OTC PR WIRE Nutra Pharma Corporation, a biotechnology company developing drugs for the treatment of Multiple Sclerosis and HIV and that also markets the over-the-counter pain drugs; Nyloxin and Pet Pain-Away, announced today that they are in the process of restructuring their Board of Directors as well as their corporate debt to pave the way
PUNE, INDIA, March 9, 2018/ EINPresswire.com/ WiseGuyRerports.com Presents Latin America Over The Counter Drugs Market: Global Market Estimation, Dynamics, Regional Share, Trends, Competitor Analysis 2012 to 2016 and Forecast 2017 to 2023 New Document to its Studies Database. Over-the-counter drugs Market, also known as the non-prescription
Both letters, sent by the US Food and Drug Administration on February 23, highlight violations of current good manufacturing practice regulations for finished pharmaceuticals observed during inspections of their respective plants. Nan San Pharmaceutical Factory Limited had its facility in Kowloon, Hong Kong inspected in September 2017 and was scold
Much of America, however, takes an opposing view, although happily Congress just included $6 billion in its recently passed budget for dealing with what is generally viewed as America's most pressing public health problem after cigarette smoking and alcohol, "The Opioids Crisis." Fortunately, the federal government is finally following the lead of.
via OTC PR WIRE Nutra Pharma Corporation, a biotechnology company developing drugs for the treatment of Multiple Sclerosis and HIV and that also markets the over-the-counter pain drugs; Nyloxin and Pet Pain-Away?, announced today that they are in the process of restructuring their Board of Directors as well as their corporate debt to pave
Today we are offering reports on ABBV, BSPM, BMY, and LLY which can be accessed for free by signing up to www.wallstequities.com/registration. WallStEquities.com has selected four major players in the Drug Manufacturers space for review today: AbbVie Inc., Biostar Pharmaceuticals Inc., Bristol-Myers Squibb Co., and Eli Lilly and Co.. On Wednesday,
The FDA is expected to provide a decision on or around December 21, 2018, the designated Prescription Drug User Fee Act action date with FDA noting that timelines are flexible and subject to change based on workload and identification of potential review issues. 'Today's acceptance of the NDA reinforces the breadth and depth of Shire' s capabilitie
-Ultragenyx Pharmaceutical Inc., a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, today announced positive longer-term safety and efficacy data from the first dose cohort of the Phase 1/ 2 study of DTX301, an investigational adeno-associated virus gene therapy for the treatment of ornithine.