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Posted Today in Daily MedNews
-- Here are the latest clinical trials, courtesy of ClinicalConnection.com: Smoking Cessation This year-long study will evaluate an investigational vaccine to aid in smoking cessation. To qualify, you must be aged 18 to 65, and have smoked more then 10 cigarettes a day for the past year. The research site is in Boise, Idaho. More information Please see...
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Posted Today in Daily MedNews
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: New Guidelines Coming on Use of Newborn Blood Samples U.S. government advisers say new national recommendations that will give parents more information and more say on the use of blood samples taken from newborns should be available by spring. The heel-prick blood spots taken from all newborns...
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Posted Today in Daily MedNews.
TUESDAY, Feb. 9 -- The lifestyle habits you bring into pregnancy can have lasting effects on your baby's health, new research shows. A Dutch study found that women who smoked, had high blood pressure or low folic acid levels in early pregnancy had babies that were smaller in the first trimester of pregnancy and had a higher risk of complications later. "Our study demonstrates that several...
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Posted Today in Daily MedNews.
TUESDAY, Feb. 9 -- Children born to mothers who drink lots of milk and have a high dietary intake of vitamin D during pregnancy have a much lower risk of developing multiple sclerosis later in life, researchers say. The new study included 35,794 U.S. nurses whose mothers provided information about their experiences and diet during pregnancy. The nurses were followed for 16 years, and 199 of them...
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Posted Today in Daily MedNews.
TUESDAY, Feb. 9 -- Severely obese teens who received gastric banding surgery lost significantly more weight than those who made lifestyle changes such as dieting and exercise, Australian researchers report. Their study included 50 teens, aged 14 to 18, with a body-mass index (BMI) higher than 35 (statistical obesity begins at a BMI of 30). Half underwent laparoscopic adjustable gastric banding...
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Posted Today in Clinical Trials.
Data Supports Advancement of Product Development   CONCORD, Calif.--(BUSINESS WIRE)--Feb 9, 2010 - Cerus Corporation (NASDAQ:CERS) announced today that its Phase 1 trial of red blood cells treated with the INTERCEPT Blood System met its primary endpoint, with preliminary analysis demonstrating that greater than 75 percent of treated cells continued to circulate 24 hours following...
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Posted Today in Pharma Industry News.
From Associated Press (February 9, 2010) WASHINGTON -- Federal regulators have granted Anglo-Swedish drug maker AstraZeneca approval to market its cholesterol pill Crestor as a preventive measure against heart attack and stroke in patients with healthy cholesterol levels. The Food and Drug Administration decision will allow the company to promote Crestor to millions of U.S. patients who...
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Posted Today in Clinical Trials.
Denosumab Trial Met Primary and All Secondary Endpoints by Significantly Delaying Time to First Skeletal Related Event and Significantly Reducing First-and-Subsequent Skeletal Related Events Compared to Zometa Second Phase 3 Advanced Cancer Trial to Demonstrate Denosumab Superiority Versus Zometa THOUSAND OAKS, Calif., Feb. 8 /PRNewswire-FirstCall/ -- Amgen (NASDAQ: AMGN) today announced that a...
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Posted Today in Clinical Trials.
- Paper Examines the Potential of Microplasmin to Improve the Treatment of a Range of Back of the Eye Diseases LEUVEN, Belgium, February 9/PRNewswire-FirstCall/ -- ThromboGenics NV (Euronext Brussels: THR), a biopharmaceutical company focused on the discovery and development of innovative treatments for eye disease, vascular disease and cancer, announces today that the positive microplasmin Phase...
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Posted Today in Pharma Industry News.
New Report: The Internet Has More Influence Over Consumer Health Actions than Traditional DTC Channels Manhattan Research’s Health Influence Mapping Research Module Helps Marketers Understand the Relative Influence of Various Communication Channels on Consumer Health Behavior New York, February 9, 2010 – The Internet has considerably more influence over consumer health decisions and...
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Posted Yesterday in Clinical Trials.
~ Conference call will be held today at 4:45 p.m. Eastern time ~ LEXINGTON, Mass.--(BUSINESS WIRE)--Feb 5, 2010 - AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG), a biopharmaceutical company focused on the development and commercialization of a therapeutic iron compound to treat anemia and novel imaging agents to aid in the diagnosis of cancer and cardiovascular disease, today provided a safety...
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Posted Yesterday in Clinical Trials.
Tβ4 – Potential New Therapeutic Agent for Liver Failure BETHESDA, Md.--(BUSINESS WIRE)--Feb 8, 2010 - REGENERX BIOPHARMACEUTICALS, INC. (NYSE Amex:RGN) announced today that researchers have correlated Tβ4 levels with the clinical course of patients with hepatitis B virus-related liver failure. It was reported that serum thymosin β4 levels were...
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Posted Yesterday in Pharma Industry News.
Getting Shingles Vaccine Easier [The Columbus Dispatch, Ohio] From Columbus Dispatch (OH) (February 8, 2010) Feb. 8--In theory, people should have scrambled to get the shingles vaccine. The disease is notoriously painful and quite common, especially in those 80 or older. But long after Zostavax was approved in 2006 for people 60 or older, vaccination rates remained low. For a...
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Posted Yesterday in Pharma Industry News.
  Safety Announcement Additional Information for Patients Additional Information for Healthcare Professionals Data Summary   Safety Announcement [02-05-2010] The U.S. Food and Drug Administration (FDA) is alerting the public that the risk of developing progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection associated with the use of...
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Posted Yesterday in Pharma Industry News.
From Associated Press (February 5, 2010) WASHINGTON -- Federal health officials warned doctors Friday that the risk of a deadly brain inflammation linked to the multiple sclerosis treatment Tysabri increases with use of the drug. Tysabri has been plagued for years by rare cases of progressive multifocal leukoencephalopathy, or PML, which can cause swelling of the brain that is usually...
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Posted 5 Days Ago in New Drug Applications.
SANTA CLARA, Calif.--(BUSINESS WIRE)--Feb 4, 2010 - XenoPort, Inc. announced today that, subject to the approval of the U.S. Food and Drug Administration (FDA), the brand name for GSK1838262/XP13512 (gabapentin enacarbil) in the United States will be Horizant. The Prescription Drug User Fee Act (PDUFA) goal date for the New Drug Application (NDA) for Horizant for the treatment of...
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Posted 5 Days Ago in New Drug Applications.
JERSEY CITY, N.J.--(BUSINESS WIRE)--Feb 4, 2010 - Lux Biosciences, Inc. today announced its submission of simultaneous regulatory filings to both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) seeking marketing approval for its investigational drug Luveniq (LX211; oral voclosporin) for the treatment of noninfectious uveitis involving the intermediate or...
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Posted 6 Days Ago in New Drug Approvals.
LAVAL, QC and PRINCETON, NJ, Feb. 3 /PRNewswire-FirstCall/ -- Labopharm Inc. today announced the U.S. Food and Drug Administration (FDA) has approved Oleptro (trazodone hydrochloride) Extended Release Tablets, a novel once-daily formulation of the antidepressant trazodone, for the treatment of major depressive disorder (MDD) in adults. Oleptro utilizes Contramid(R), Labopharm's clinically...
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Posted 6 Days Ago in New Drug Approvals.
MALVERN, Pa., Feb. 3 /PRNewswire/ -- Auxilium Pharmaceuticals, Inc., a specialty biopharmaceutical company, just announced that it has received marketing approval from the U.S. Food and Drug Administration (FDA) for Xiaflex (collagenase clostridium histolyticum), a novel, first-in-class, orphan-designated, biologic, for the treatment of adult Dupuytren's contracture patients with a palpable...
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Posted 1 Weeks Ago in New Drug Applications.
NDA for Management of Acute Moderate-to-Severe Pain Includes Data from 16 Clinical Studies CAMBRIDGE, Mass.--(BUSINESS WIRE)--Feb 2, 2010 - Javelin Pharmaceuticals, Inc., a leading developer and marketer of specialty pharmaceutical products for pain management, today announced that its New Drug Application (NDA) submitted on December 2, 2009 to the US Food and Drug Administration (FDA)...
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Posted 1 Weeks Ago in New Drug Applications.
JERUSALEM--(BUSINESS WIRE)--Feb 2, 2010 - Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing Teva's Biologics License Application (BLA) for XM02, a granulocyte colony-stimulating factor (G-CSF) for the reduction in the duration of severe neutropenia and the incidence of febrile neutropenia in patients treated with...
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Posted 1 Weeks Ago in New Drug Applications.
CARMIEL, Israel, Feb. 2 /PRNewswire-FirstCall/ -- Protalix BioTherapeutics, Inc. (NYSE Amex: PLX) announced today that, in connection with the New Drug Application (NDA) filed by the Company in December 2009 for taliglucerase alfa for the treatment of Gaucher disease, the U.S. Food and Drug Administration (FDA) has requested additional data regarding the Chemistry, Manufacturing and...
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Posted 1 Weeks Ago in New Drug Approvals.
PHILADELPHIA, Jan. 29 /PRNewswire/ -- GlaxoSmithKline announced today that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for a new combination regimen using Tykerb (lapatinib) as a first-line, all-oral treatment for women with metastatic breast cancer. Tykerb is now indicated in combination with letrozole for the treatment of postmenopausal women with hormone...
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Posted 1 Weeks Ago in New Drug Approvals.
Approval is part of Agency's unapproved drugs initiative SILVER SPRING, Md., Jan. 26 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Morphine Sulfate Oral Solution for the relief of moderate to severe, acute and chronic pain in opioid-tolerant patients. This medicine will be available in 100 milligrams per 5 mL or 20 milligrams per 1 mL.   (Logo:...
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Posted 1 Weeks Ago in New Drug Approvals.
BRIDGEWATER, N.J., Jan. 27 /PRNewswire/ -- Tibotec Therapeutics announced today that the U.S. Food and Drug Administration (FDA) has approved a labeling update for Prezista (darunavir) tablets to include 96-week data from the ARTEMIS and TITAN studies. Both ARTEMIS and TITAN evaluated the efficacy and safety of Prezista with ritonavir (r) vs. lopinavir/r in combination with other...
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