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Health Highlights: May 15, 2012
Posted yesterday in Daily MedNews
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: U.S. National Alzheimer's Plan has 2025 Deadline A deadline of 2025 has been set for the U.S. government's first National Alzheimer's Plan to find effective ways to treat, or at least slow, the disease. On Tuesday, the Obama administration is scheduled to outline measures the government and...
Read More...Genes Might Be Key to Parkinson's Spread
Posted yesterday in Daily MedNews.
TUESDAY, May 15 -- Researchers have identified gene variants that speed the progression of Parkinson's disease, and they say their findings could help identify patients who would benefit most from early treatment. The researchers, from the University of California-Los Angeles, say their findings also may help efforts to develop new therapies. Parkinson's disease is a progressive movement...
Read More...Asthma Cases Continue to Rise in U.S., Affecting Millions
Posted yesterday in Daily MedNews.
TUESDAY, May 15 -- Asthma continues to take its toll on Americans, with almost 19 million adults (8.2 percent) suffering from the disorder in 2010, according to a report released Tuesday by the U.S. Centers for Disease Control and Prevention. The CDC analysis also found that more than 29 million (almost 13 percent) of adults have been diagnosed with the illness at some point in their...
Read More...Trial Set to See if Drug Can Prevent Alzheimer's
Posted yesterday in Daily MedNews.
TUESDAY, May 15 -- Researchers are preparing to test an experimental drug in people genetically primed to develop Alzheimer's disease. The best-scenario hope is that the drug will lead to a way of preventing the progressive brain-wasting disease, and to a better understanding of its destructive processes, U.S. officials announced Tuesday. The study volunteers will include some Americans as well...
Read More...U.S. Assistance to Africa Cut AIDS-Related Deaths: Study
Posted yesterday in Daily MedNews.
TUESDAY, May 15 -- The lives of more than 740,000 people in nine African countries were saved between 2004 and 2008 by the U.S. President's Emergency Plan for AIDS Relief, a new study indicates. The program reduced adults' risk of death from all causes by 16 percent to 20 percent during those four years, Stanford University School of Medicine researchers found. The researchers said this is the...
Read More...Groundbreaking Alzheimer's Disease Prevention Trial Announced
Posted yesterday in Pharma Industry News.
Study of Novel Anti-Amyloid Therapy Will Help Launch New Research Era PHOENIX, May 15, 2012 /PRNewswire/ -- In collaboration with the National Institutes of Health (NIH), Banner Alzheimer's Institute (BAI), University of Antioquia in Colombia and Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announce the first-ever prevention trial in cognitively healthy individuals...
Read More...FDA Drug Safety Communication: Revised Recommendations for Cardiovascular Monitoring and Use of Multiple Sclerosis Drug Gilenya (Fingolimod)
Posted 2 days ago in Pharma Industry News.
This update is in follow-up to the FDA Drug Safety Communication: Safety review of a reported death after the first dose of multiple sclerosis drug Gilenya (fingolimod) 1on 12/20/2011. Safety Announcement The U.S. Food and Drug Administration (FDA) has completed its evaluation of a report of a patient who died after the first dose of multiple sclerosis drug Gilenya (fingolimod). The agency...
Read More...New Avonex Dosing Innovations for People with Multiple Sclerosis Now Available in US
Posted 2 days ago in Pharma Industry News.
- AVONEX PEN® Offers Multiple Sclerosis Patients Taking AVONEX Enhanced Administration and Dose Titration with AVOSTARTGRIP™ Allows More Tolerable Initiation - WESTON, Mass.--(BUSINESS WIRE)--May 14, 2012 - Biogen Idec (NASDAQ: BIIB) announced that two new dosing innovations designed to help patients receiving once-a-week AVONEX (interferon beta-1a) for relapsing forms of...
Read More...Stiefel Receives US FDA Approval of Fabior Foam, 0.1%
Posted 2 days ago in New Drug Approvals.
RESEARCH TRIANGLE PARK, N.C., May 11, 2012 /PRNewswire/ -- Stiefel, a GSK company, today announced that the US Food and Drug Administration has approved the New Drug Application for Fabior (tazarotene) Foam, 0.1%. It is the only retinoid in a topical foam formulation for the treatment of acne vulgaris in patients 12 years of age and older. "Stiefel is dedicated to meeting the needs of...
Read More...FDA Concept Would Mean Fewer Prescriptions, More Over-the-Counter Drugs
Posted 2 days ago in Pharma Industry News.
FDA Concept Would Mean Fewer Prescriptions, More Over-the-Counter Drugs [Ventura County Star, Calif.] From Ventura County Star (CA) (May 12, 2012) May 12--In the paradigm pitched by the Food and Drug Administration, people who won’t see doctors for high blood pressure or diabetes may have another way to get their meds: Go straight to a pharmacy and buy them. Officials of the federal...
Read More...FDA Advisory Committee Supports Approval of Gilead's Once-Daily Quad Single Tablet Regimen for HIV
Posted 5 days ago in New Drug Applications.
FOSTER CITY, Calif.--(BUSINESS WIRE)--May 11, 2012 - Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) has voted 13 to 1 in support of approval of the Quad, a complete single tablet regimen of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate, for the treatment of HIV-1...
Read More...FDA Panel Backs First Pill to Block HIV Infection
Posted 5 days ago in Pharma Industry News.
From Associated Press (May 11, 2012) SILVER SPRING, Maryland -- The first drug shown to prevent HIV infection won the endorsement of a panel of U.S. federal advisers, clearing the way for a landmark approval in the 30-year fight against the virus that causes AIDS. In a series of votes on Thursday, a Food and Drug Administration advisory panel recommended approval of the daily pill Truvada...
Read More...Lorcaserin Receives Positive Vote From FDA Advisory Committee
Posted 6 days ago in New Drug Applications.
SAN DIEGO and WOODCLIFF LAKE, N.J., May 10, 2012 /PRNewswire/ -- Arena Pharmaceuticals, Inc. and Eisai Inc. announced today that the US Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee voted 18 to 4, with one abstention, that the available data demonstrate that the potential benefits of lorcaserin outweigh the potential risks when used long-term in a...
Read More...FDA Arthritis Advisory Committee Recommends Approval of Tofacitinib for Adult Patients with Moderately to Severely Active Rheumatoid Arthritis
Posted 1 weeks ago in New Drug Applications.
NEW YORK--(BUSINESS WIRE)--May 9, 2012 - Pfizer Inc. announced today that the Arthritis Advisory Committee to the U.S. Food and Drug Administration (FDA) voted 8-2 to recommend approval of the investigational agent tofacitinib for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA). The Committee's recommendation will be considered by the FDA in its...
Read More...Shionogi Files a New Drug Application for Ospemifene Oral Tablets 60mg for the Treatment of Vulvar and Vaginal Atrophy
Posted 1 weeks ago in New Drug Applications.
Osaka, Japan, May 9, 2012 - Shionogi & Co., Ltd. (Head Office: Osaka; President & CEO: Isao Teshirogi, Ph.D.; hereafter “Shionogi”) today announced that the U.S. subsidiary Shionogi Inc. submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ospemifene oral tablets 60 mg for the treatment of vulvar and vaginal atrophy (VVA) due to...
Read More...Talon Therapeutics Receives Notification of Three Month PDUFA Date Extension for Marqibo
Posted 1 weeks ago in New Drug Applications.
SAN MATEO, Calif., May 7, 2012 -- Talon Therapeutics Inc. today announced that it has been informed by the U.S. Food and Drug Administration (FDA) that its New Drug Application (NDA) seeking accelerated approval of Marqibo(R) has been given a three-month Prescription Drug User Fee Act (PDUFA) date extension to August 12, 2012. On March 21, 2012, the Oncologic Drugs Advisory Committee...
Read More...MEDA Announces Dymista Approved by the FDA
Posted 2 weeks ago in New Drug Approvals.
Göteborg, Sweden--(BUSINESS WIRE)--May 2, 2012 -- The U.S. Food and Drug Administration (FDA) has approved Dymista, a new patented product for treatment of seasonal allergic rhinitis (SAR). In several clinical studies, Dymista has consistently showed a rapid and more complete symptom relief than standard treatment. "Allergic rhinitis is an increasing problem. Many patients have severe...
Read More...FDA Approves New Orphan Drug Elelyso to Treat a Form of Gaucher Disease
Posted 2 weeks ago in New Drug Approvals.
May 1, 2012 -- The U.S. Food and Drug Administration today approved Elelyso (taliglucerase alfa) for long-term enzyme replacement therapy to treat a form of Gaucher disease, a rare genetic disorder. Gaucher disease occurs in people who do not produce enough of an enzyme called glucocerebrosidase. The enzyme deficiency causes fatty materials (lipids) to collect in the spleen, liver, kidneys,...
Read More...FDA Approves Levaquin as an Antibacterial Treatment for Plague
Posted 2 weeks ago in New Drug Approvals.
April 27, 2012 -- The U.S. Food and Drug Administration today approved Levaquin (levofloxacin) to treat patients with plague, a rare and potentially deadly bacterial infection. The agency also approved the drug to reduce the risk of getting plague after exposure to Yersinia pestis, the bacterium that causes the disease. Plague is extremely rare in most parts of the world, including the United...
Read More...FDA Approves Stendra for Erectile Dysfunction
Posted 2 weeks ago in New Drug Approvals.
April 27, 2012 -- The U.S. Food and Drug Administration today approved Stendra (avanafil), a new drug to treat erectile dysfunction. Erectile dysfunction is when a man has trouble getting or keeping an erection. An estimated 30 million men in the United States are affected by erectile dysfunction. Stendra is a pill that patients take on an as-needed basis 30 minutes before sexual activity....
Read More...Alnylam Presents Final Results from a Phase I Clinical Trial of ALN-TTR01, an RNAi Therapeutic Targeting Transthyretin (TTR) for the Treatment of Transthyretin-Mediated Amyloidosis (ATTR)
Posted yesterday in Clinical Trials.
– Results Demonstrate Rapid, Dose-Dependent, and Durable Lowering of Both Wild-Type and Mutant TTR Protein Levels, and Show Human Proof of Concept for RNAi Therapeutics using First-Generation Lipid Nanoparticle (LNP) Delivery – – Alnylam On Track for Presenting Phase I Clinical Trial Data for ALN-TTR02, using Second-Generation LNP Delivery, in the Third Quarter of 2012...
Read More...Telik Announces the Publication of Two Reports in the Journal Of Hematology & Oncology Describing the Results of a Clinical Study of Telintra(R) in Combination With Revlimid and a Genomic Study Designed to Identify Genes That Predict Response to Telintra in Patients With Myelodysplastic Syndrome
Posted yesterday in Clinical Trials.
PALO ALTO, Calif., May 15, 2012 /PRNewswire/ -- Telik, Inc. (Nasdaq: TELK) today announced two publications in the Journal of Hematology & Oncology. The first is "Phase 1 dose-ranging study of ezatiostat hydrochloride in combination with lenalidomide in patients with non-deletion (5q) low to intermediate-1 risk myelodysplastic syndrome (MDS)," Raza, A., et al., Journal of Hematology...
Read More...AXIOS Stent and Delivery System Study Demonstrates Successful Treatment of Pancreatic Pseudocysts and Acute Cholecystitis
Posted yesterday in Clinical Trials.
Peer-Reviewed Paper Validates Promise of New Transenteric Therapy MOUNTAIN VIEW, Calif., May 15, 2012 /PRNewswire/ -- Xlumena, Inc. announces the publication of a scientific paper describing the first human study of the AXIOS™ Stent and Delivery System. The article, entitled "Clinical evaluation of a novel lumen-apposing metal stent for endosonography-guided pancreatic pseudocyst and...
Read More...One-Year EVOLVE Trial Clinical Results Confirm Comparable Safety And Effectiveness Data Of The Boston Scientific SYNERGY Stent Versus PROMUS Element Platinum Chromium Stent
Posted yesterday in Clinical Trials.
Follow-up Data from EVOLVE Trial Presented at EuroPCR; Trial is Evaluating Next-Generation Everolimus-Eluting Platinum Chromium Coronary Stent with Ultra-Thin Bioabsorbable Abluminal Polymer NATICK, Mass., May 15, 2012 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) announces that the SYNERGY™ Everolimus-Eluting Bioabsorbable Polymer-Coated Platinum Chromium Coronary Stent...
Read More...Achaogen Announces All Objectives Met in Phase 2 Plazomicin Complicated Urinary Tract Infections Study and Start of First-in-Human Study with ACHN-975
Posted yesterday in Clinical Trials.
Key milestones achieved with two internally-discovered clinical candidates being developed to treat multi-drug resistant Gram-negative infections SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--May 15, 2012 - Achaogen, Inc. announced today that all objectives were met in the company's multi-national Phase 2 study of plazomicin compared to levofloxacin for the treatment of complicated urinary...
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