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Specialty: Pharmaceuticals
Management: Food and Drug Administration (FDA)
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Total 38 results found since Jan 2013.
Cynthia A. Bens
Vice President, Public PolicyCynthia Bens is the Vice President of Public Policy at the not-for-profit Alliance for Aging Research in Washington, D.C. In this capacity, Ms. Bens is responsible for guiding the organization’s federal policy work, representing the Alliance in multiple national coalitions, and directing all aspects of the Accelerate Cure/Treatments for Alzheimer’s Disease (ACT-AD) and Aging in Motion (AIM) coalitions. Ms. Bens sits on the Alliance for a Stronger FDA Board of Directors and is a Founding Executive Committee Member of Friends of the National Institute on Aging (FoNIA). She has served on the...
Source: PHRMA - June 17, 2014 Category: Pharmaceuticals Authors: Sabrina Source Type: news
FDA Finds Pradaxa Linked to Lower Stroke, Brain Hemorrhage Risk
A Food and Drug Administration analysis found the blood thinner Pradaxa was better at avoiding strokes and brain hemorrhage, though it was linked to more stomach bleeding.
Source: WSJ.com: Health - May 14, 2014 Category: Pharmaceuticals Tags: PAID Source Type: news
Merck's Zontivity gets FDA approval to reduce heart attacks and stroke risk in patients
Merck has received approval from the US Food and Drug Administration (FDA) for Zontivity (vorapaxar) for people at high-risk of heart attack or stroke.
Source: Pharmaceutical Technology - May 13, 2014 Category: Pharmaceuticals Source Type: news
Amy Comstock Rick - PARKINSONS
By far, the greatest challenge facing the Parkinson’s community today is the lack of disease modifying therapies to slow or stop the progression of the disease.
Parkinson’s disease is one of the most complicated diseases we know of. No two people with Parkinson’s have the same symptoms, and there is no one-size-fits-all approach to treating the disease. People affected are often forced to stop working and manage their disease full time. If Parkinson’s itself isn’t disrupting enough, often the medications used to treat the disease cause a host of side effects that impact the quality of life and sometimes stop bein...
Source: PHRMA - March 27, 2014 Category: Pharmaceuticals Authors: Julie Source Type: news
FDA lifts clinical ban on Morrisville pharma's lead candidate
Morrisville drug developer Oxygen Biotherapeutics received good news from federal regulators when it heard that the FDA lifted a clinical ban on Oxygen’s leading product candidate.
The U.S. Food and Drug Administration had put a clinical hold on Oxycyte, the leading product developed by Oxygen Biotherapeutics (Nasdaq: OBXT) that would carry oxygen throughout the body, potentially reducing negative effects from a stroke or traumatic brain injury.
The clinical hold essentially stopped further development…
Source: bizjournals.com Health Care:Pharmaceuticals headlines - March 5, 2014 Category: Pharmaceuticals Authors: Jason deBruyn Source Type: research
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
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
FDA: Drug to Prevent Blood Clots Approved
From UPI Health News (Business) (December 30, 2012)
The U.S. Food and Drug Administration approved the use of the
anti-clotting drug Eliquis to reduce the risk of stroke and blood
clots, officials say.
The FDA said Eliquis, or apixaban, can be...
Source: Drugs.com - Pharma News - January 2, 2013 Category: Pharmaceuticals Source Type: news
