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This Week in Medicine February 23–March 1, 2013
Public health officials are urging the US Food and Drug Administration (FDA) to set a safe limit on the amount of sugars in soft drinks. The FDA pledged in 1982 and 1988 to reassess the safety of “caloric sweeteners” if they became a public health hazard. Soft drinks are now the biggest source of sugars in the American diet.
Source: LANCET - February 22, 2013 Category: Journals (General) Authors: The Lancet Tags: This Week in Medicine Source Type: research
Keck Medical Center of USC offers new treatment for chronic reflux disease
(University of Southern California - Health Sciences) Clinical trial results published in the New England Journal of Medicine offer additional evidence that a new device may help relieve chronic heartburn symptoms that standard treatment cannot. The Keck Medical Center of USC was one of 14 US and European medical centers to test the device prior to its March 2012 approval by the US Food and Drug Administration.
Source: EurekAlert! - Medicine and Health - February 22, 2013 Category: Global & Universal Source Type: news
Vismodegib: The first drug approved for advanced and metastatic basal cell carcinoma
AK Dubey, S Dubey, SS Handu, MA QaziJournal of Postgraduate Medicine 2013 59(1):48-50Treatment of basal cell carcinoma (BCC) usually involves surgical interventions and laser ablation, but in locally advanced BCC, which arise either from earlier untreated lesions or from recurrence of aggressive BCC, surgery and radiotherapy are not helpful. Vismodegib, the first oral-targeted therapy for locally advanced and metastatic BCC, unsuitable for surgery or radiotherapy, was recently approved by US Food and Drug Administration (FDA). The drug was under the priority review program of FDA and was approved on the basis of promising ...
Source: Journal of Postgraduate Medicine - March 22, 2013 Category: Internal Medicine Authors: AK DubeyS DubeySS HanduMA Qazi Source Type: research
Do vein filters help or harm?
In 2010, the Food and Drug Administration issued a medical alert warning consumers that inferior vena cava vein filters could potentially move or break, causing medical emergencies. Matt Johnson, M.D., is co-chairing a study to measure the safety and efficacy of vein filters over a five-year period. The IVC is the biggest vein in the body and transports the blood supply from the legs and abdomen ....
Source: Sound Medicine - April 28, 2013 Category: Global & Universal Authors: Sound Medicine Source Type: news
Preventing Skin Cancer Through Reduction of Indoor Tanning: Current Evidence
Abstract: Exposure to ultraviolet radiation from indoor tanning devices (tanning beds, booths, and sun lamps) or from the sun contributes to the risk of skin cancer, including melanoma, which is the type of skin cancer responsible for most deaths. Indoor tanning is common among certain groups, especially among older adolescents and young adults, adolescent girls and young women, and non-Hispanic whites. Increased understanding of the health risks associated with indoor tanning has led to many efforts to reduce use. Most environmental and systems efforts in the U.S. (e.g., age limits or requiring parental consent/accompanim...
Source: American Journal of Preventive Medicine - May 21, 2013 Category: Global & Universal Authors: Meg Watson, Dawn M. Holman, Kathleen A. Fox, Gery P. Guy, Andrew B. Seidenberg, Blake P. Sampson, Craig Sinclair, DeAnn Lazovich Tags: Theme: Strategies to Prevent Skin Cancer Source Type: research
Is controversial morning sickness medication safe?
In 1983, a morning sickness medication called Bendectin was taken off the market after hundreds of lawsuits claimed the drug caused birth defects. According to Men-Jean Lee, M.D., there was no scientific evidence linking Bendectin to birth defects, but distributor Merrell Dow bowed to pressure and pulled it from the market. After rigorous re-testing, the Food and Drug Administration re-approved th....
Source: Sound Medicine - June 15, 2013 Category: Global & Universal Authors: Sound Medicine Source Type: news
Retapamulin: A newer topical antibiotic
D Dhingra, A Parakh, S RamachandranJournal of Postgraduate Medicine 2013 59(2):127-130Impetigo is a common childhood skin infection. There are reports of increasing drug resistance to the currently used topical antibiotics including fusidic acid and mupirocin. Retapamulin is a newer topical agent of pleuromutilin class approved by the Food and Drug Administration for treatment of impetigo in children and has been recently made available in the Indian market. It has been demonstrated to have low potential for the development of antibacterial resistance and a high degree of potency against poly drug resistant Gram-positive b...
Source: Journal of Postgraduate Medicine - June 21, 2013 Category: Internal Medicine Authors: D DhingraA ParakhS Ramachandran Source Type: research
Who will be able to buy Plan B over the counter?
Plan B, commonly referred to as "the morning after pill," is emergency contraception that can prevent pregnancy if taken within 72 hours of unprotected sex. Last week, the Food and Drug Administration approved Plan B Onestep for over-the-counter sale with no age restrictions. Plan B Onestep previously required a prescription or parental consent for those younger than 17; research by the FDA proved....
Source: Sound Medicine - June 29, 2013 Category: Global & Universal Authors: Sound Medicine Source Type: news
Merck Receives Complete Response Letter for Suvorexant, Merck’s Investigational Medicine for Insomnia
Dateline City:
WHITEHOUSE STATION, N.J.
WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada,
announced today that the company has received a Complete Response Letter
from the U.S. Food and Drug Administration (FDA) regarding the New Drug
Application for suvorexant, Merck’s investigational medicine for the
treatment of insomnia.
In the Complete Response Letter, the FDA advised Merck that:
Language:
English
Contact:
Merc...
Source: Merck.com - Research and Development News - July 1, 2013 Category: Pharmaceuticals Authors: hq_site_admin Tags: Research and Development News Corporate News Latest News Source Type: news
Merck Announces FDA Acceptance of New Drug Application for Vorapaxar, Investigational Anti-Thrombotic Medicine
Dateline City:
WHITEHOUSE STATION, N.J.
WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada,
today announced that the New Drug Application (NDA) for its
investigational anti-thrombotic medicine, vorapaxar, has been accepted
for standard review by the U.S. Food and Drug Administration (FDA).
Merck is seeking FDA approval of vorapaxar for the secondary prevention
of cardiovascular events in patients with a history of heart attack and
no history of stroke or transient ischemic attack (TIA).
About Mer...
Source: Merck.com - Research and Development News - July 24, 2013 Category: Pharmaceuticals Authors: hq_site_admin Tags: Research and Development News Corporate News Latest News Source Type: news
Merck Receives Complete Response Letter for Investigational Medicine Sugammadex Sodium Injection
Dateline City:
WHITEHOUSE STATION, N.J.
WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada,
announced today that the company has received a Complete Response Letter
from the U.S. Food and Drug Administration (FDA) for the resubmission of
the New Drug Application for sugammadex sodium injection, Merck’s
investigational medicine for the reversal of neuromuscular blockade
induced by rocuronium or vecuronium.
Language:
English
Contact:
Media:Pam...
Source: Merck.com - Research and Development News - September 23, 2013 Category: Pharmaceuticals Authors: hq_site_admin Tags: Research and Development News Corporate News Latest News Source Type: news
INTRODUCTION: Institutional Corruption and the Pharmaceutical Policy
Today, the goals of pharmaceutical policy and medical practice are often undermined due to institutional corruption — that is, widespread or systemic practices, usually legal, that undermine an institution's objectives or integrity. In this symposium, 16 articles investigate the corruption of pharmaceutical policy, each taking a different look at the sources of corruption, how it occurs, and what is corrupted. We will see that the pharmaceutical industry's own purposes are often undermined. Furthermore, pharmaceutical industry funding of election campaigns and lobbying skews the legislative process that sets pharmaceutic...
Source: The Journal of Law, Medicine and Ethics - September 1, 2013 Category: Medical Law Authors: Marc A. Rodwin Source Type: research
Specialty Medicine Compounding Pharmacy Issues Voluntary Recall of Certain Unexpired Compounded Sterile Products
Specialty Medicine Compounding Pharmacy is voluntarily recalling all lots of certain unexpired human and veterinary sterile products to the consumer level due to particulate matter found in vials of a compounded dextrose injection product dispensed to a local hospital. Further testing and analysis of the medication is being conducted.
Source: Food and Drug Administration - October 20, 2013 Category: Food Science Source Type: news
FDA announces voluntary recall of certain sterile products from Specialty Medicine Compounding Pharmacy
The U.S. Food and Drug Administration is alerting hospitals, health care providers, veterinarians, and patients of a voluntary recall of certain human and veterinary products produced and distributed for sterile use by Specialty Medicine Compounding Pharmacy of South Lyon, Mich.
Source: Food and Drug Administration - October 22, 2013 Category: American Health Source Type: news
Merck Statement on FDA Advisory Committee for Vorapaxar, Merck’s Investigational Antiplatelet Medicine
Dateline City:
WHITEHOUSE STATION, N.J.
WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK),
known as MSD outside the United States and Canada, today said it was
pleased with the U.S. Food and Drug Administration (FDA)’s
Cardiovascular and Renal Drugs Advisory Committee’s recommendation for
approval of vorapaxar. Vorapaxar is the company’s investigational
antiplatelet medicine for the reduction of atherothrombotic events, when
added to standard of care, in patients with a history of heart attack
and no history of stroke or transient ischemic attack.
...
Source: Merck.com - Research and Development News - January 15, 2014 Category: Pharmaceuticals Tags: Research and Development News Corporate News Latest News Source Type: news
