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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...
Read More... 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...
Read More... 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...
Read More... 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...
Read More... 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...
Read More... 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...
Read More... 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...
Read More... 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...
Read More... 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...
Read More... 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...
Read More... 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...
Read More... 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...
Read More... 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...
Read More... 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...
Read More... 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...
Read More... 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...
Read More... 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...
Read More... 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...
Read More... 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...
Read More... 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)...
Read More... 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...
Read More...Protalix Announces NDA Submission Update for taliglucerase alfa for the Treatment of Gaucher Disease
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...
Read More... 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...
Read More... 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:...
Read More... 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...
Read More...
