Michael Krychman, a renowned physician and sex therapist who has been a leading champion of FDA action on a treatment for HSDD, includes 62 signees consisting of gynecologists, psychiatrists, psychologists, nurses and others on the front lines of treating women with the condition. The signees represent a multitude of well-known and influential medi
Aetna and NYUPN Clinically Integrated Network, LLC today announced an accountable care collaboration that is designed to improve patient care and lower health care costs. Effective July 1, NYUPN and its more than 1,800 clinical faculty and health care professionals affiliated with NYU Langone Medical Center and University Physicians Network began..
Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications. Submit written comments on the collection of information to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 2085
Anacor Pharmaceuticals, Inc. will release its financial results for the second quarter ended June 30, 2014, on Thursday, August 7, 2014 at approximately 4:00 p.m. ET/ 1:00 p.m. PT. Anacor s first approved drug, KERYDIN TM topical solution, 5%, is an oxaborole antifungal approved by the U.S. Food and Drug Administration for the topical treatment
By a News Reporter-Staff News Editor at Insurance Weekly News Anesthesia Business Consultants, a leading provider in billing and practice management for the anesthesia and pain management specialties, shares important developments regarding CMS' publishing the Proposed and Final Medicare Fee Schedule Rules payment updates. Instead, the current...
ANI Pharmaceuticals, Inc. today announced that it has acquired the US rights for Vancocin 125 mg and 250 mg capsules from Shire plc, a global biopharmaceutical company. Year to date we have invested $23 million in two mature brand acquisitions that will contribute a combined $9.4 million in annual revenues and $8 million in annual non-GAAP EBI
SUMMARY: The Food and Drug Administration is announcing the fee rates and payment procedures for fiscal year 2015 generic new animal drug user fees. FOR FURTHER INFORMATION CONTACT: Visit FDA's Web site at http://www.fda.gov/ForIndustry/UserFees/AnimalGenericDrugUserFeeActAGDUFA/default. htm, or contact Lisa Kable, Center for Veterinary Medicine,..
The American Telemedicine Association lauds Reps. Mike Thompson, Gregg Harper, and Peter Welch, for their latest actions to introduce H.R. 5380, the Medicare Telehealth Parity Act of 2014, which improves telemedicine coverage in Medicare. About the American Telemedicine Association The American Telemedicine Association is the leading international.
SUMMARY: The Food and Drug Administration is announcing the rates for biosimilar user fees for fiscal year 2015. The Federal Food, Drug, and Cosmetic Act, as amended by the Biosimilar User Fee Act of 2012, authorizes FDA to assess and collect user fees for certain activities in connection with biosimilar biological product development, certain appl
'We are proud to be the first national pharmacy to earn URAC Community Pharmacy Accreditation,' said Josh Flum, Senior Vice President of Retail Pharmacy at CVS Caremark.' Having a widely recognized and respected accreditation organization such as URAC independently scrutinize our operation and attest to the quality of the pharmacy care and services
Cynosure reported that PicoSure is the first and only picosecond laser now FDA- cleared to treat acne scars. "We are thrilled to announce that PicoSure, the world's most advanced laser technology for tattoo removal and benign pigmented lesions, has now received FDA- clearance to treat acne scars," says Cynosure President and CEO Michael Davin "Our
Data on Urology Reported by Researchers at Research Institute. According to news reporting out of Tampa, Florida, by NewsRx editors, research stated, "The limitations of traditional ureteral stents in patients with deficiencies in ureteral drainage have resulted in frequent stent exchanges. Our news journalists obtained a quote from the research fr
These statements involve substantial known and unknown risks and uncertainties that could cause our actual results to differ materially from those described in the forward-looking statements, including but not limited to, risks resulting from the concentration of profits generated by higher-paying commercial payor plans for which there is continued
Dublin- Research and Markets has announced the addition of the "Effective Complaint Handling, Medical Device Reporting and Recalls and Avoiding Costly Errors: One and a Half-day In-Person Seminar" conference to their offering. This interactive one and a half day course lead by FDA's recently retired CDRH Recall Branch Chief Rita Hoffman who has mor
ENP Newswire- 01 August 2014. Release date- 31072014- The European Medicines Agency has published the first summaries for the public of the Paediatric Committee's evaluations of paediatric investigation plan and waiver applications. This new type of document increases the amount of public-friendly information published by the EMA on its assessments
WASHINGTON, Aug. 1 The U.S. Food& Drug Administration published the following rule in the Federal Register:. A Rule by the Food and Drug Administration on 07/31/2014. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
Boehringer Ingelheim today announced that the U.S. Food and Drug Administration has approved Striverdi Respimat Inhalation Spray 5 mcg as a long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, including chronic bronchitis and/or emphysema.
Findings from University of Alberta in Medical Economics Provides New Insights. By a News Reporter-Staff News Editor at Health& Medicine Week Research findings on Health and Medicine are discussed in a new report. The news correspondents obtained a quote from the research from the University of Alberta, "A third-party perspective of direct cost w
SUMMARY: The Food and Drug Administration is announcing the rates for abbreviated new drug applications, prior approval supplements to an approved ANDA, drug master files, generic drug active pharmaceutical ingredient facilities, and finished dosage form facilities user fees related to the Generic Drug User Fee Program for fiscal year 2015. The Fed
Genzyme, a Sanofi company, today announced that the U.S. Food and Drug Administration approved a supplement to expand the indication for Lumizyme . Previously, in the United States, Lumizyme had been approved only for patients with late onset Pompe disease. Based on the biochemical and clinical data provided as part of the submission, FDA conclud
Management commentary Half Yearly Report August 1, 2014- Shire plc, in accordance with the Financial Conduct Authority' s Disclosure Rules and Transparency Rules, is publishing today its Half Yearly Report for the six months ended June 30, 2014. It should be noted that on July 18, 2014 the Company previously announced its results in respect of the
By a News Reporter-Staff News Editor at Insurance Weekly News Cigna and Harbin Clinic, the largest privately owned multispecialty medical clinic in Georgia, have launched a collaborative care initiative to improve patient access to health care, enhance care coordination, and achieve the goal of improved health, affordability and patient experienc
By a News Reporter-Staff News Editor at Insurance Weekly News HealthPlanOne, one of the nation's leading Medicare and under-65 health insurance sales and customer acquisition companies, has announced plans to open a new location in Phoenix. The center will be led by Cyndi West, who previously managed HealthPlanOne's telesales centers in Tampa and
Market Publishers Ltd announces that in-demand Kelly Scientific Publications research reports have been added to its catalogue. Pharmaceutical Market India 2014-2020, Formulations, Active Pharmaceutical Ingredients, Contract Research and Manufacturing Services, Biosimilars, Generics& Vaccines. Global& USA Cancer Biomarker Market to 2018.
ESRX may look to exclude Gilead's Sovaldi or other competing products in Hepatitis C once new drugs reach the market later this year. Shares of Insys Therapeutics closed at $27.03, down 10.14 percent.======================== Halozyme Therapeutics received notice Thursday that the Blood Products Advisory Committee of the U.S. Food and Drug Administr