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Posted Yesterday in Daily MedNews
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: Former Head of Salmonella-Linked Peanut Firm Now a Consultant Even though he's under investigation for his role in a peanut-related salmonella outbreak that killed nine people and sickened hundreds in the United States, Stewart Parnell is working as a consultant to peanut companies, says the...
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Posted Yesterday in Daily MedNews
-- Here are the latest clinical trials, courtesy of ClinicalConnection.com: Pediatric GERD This study is for babies that seem to have a stomach ache, are fussy, or spit up frequently. If your baby has any of these symptoms, it is possible he or she may have gastroesophageal reflux disease (GERD). The research site is in Houston, Texas. More information Please see...
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Posted Yesterday in Daily MedNews.
WEDNESDAY, Sept. 8 -- Mutations in two genes may be associated with one of the most deadly types of ovarian cancer, U.S. researchers have found. In the study, researchers at the Johns Hopkins Kimmel Cancer Center looked for mutations in 18,000 protein-encoding genes in ovarian clear cell tumors from eight patients. The investigators found 268 mutations in 253 genes, with an average of 20...
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Posted Yesterday in Daily MedNews.
WEDNESDAY, Sept. 8 -- Out-of-shape men who work long hours more than double their risk of dying from heart disease compared to non-fit men working fewer hours, researchers report. The study also found that when men are fit, working long hours doesn't boost heart risk at all. The new study included 5,000 Danish men, aged 40 to 59 years, who worked at 14 different companies. Their fitness levels...
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Posted Yesterday in Daily MedNews.
WEDNESDAY, Sept. 8 -- Statins, lauded for their ability to lower cholesterol and prevent heart attacks and strokes, may also reduce the risk of developing rheumatoid arthritis, Israeli researchers report. "We found that statin users who purchased their medication persistently were less likely to develop rheumatoid arthritis over a long follow-up period," said lead researcher Gabriel Chodick,...
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Posted Yesterday in Clinical Trials.
Novel Therapeutic Approach Directly Regulates A Fundamental Immune Mechanism, Macrophage Differentiation   MALVERN, Pa.--(BUSINESS WIRE)--Sep 7, 2010 - Promedior, Inc., a clinical stage biotechnology company developing novel therapies to treat fibrotic and inflammatory diseases, announced today the publication of collaborative research in the Journal of Allergy and Clinical Immunology...
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Posted Yesterday in Clinical Trials.
    ROCKVILLE, Md., Sept. 7 /PRNewswire-FirstCall/ -- Neuralstem, Inc. (NYSE Amex: CUR) announced that Dr. Shinn-Zong Lin, Superintendent at China Medical University Hospital, will present results from a study entitled, "Intracerebral Implantation of Adherent Human Neural Stem Cells (or Neurals Progenitor Cells or "NPCs") to Reverse Motor Deficits in Chronic Stroke Rats," at the Stem...
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Posted Yesterday in Clinical Trials.
-Includes Oral Presentation and 12 posters- WATERTOWN, Mass.--(BUSINESS WIRE)--Sep 8, 2010 - Tetraphase Pharmaceuticals, Inc., today announced that 12 poster presentations and an oral summary presentation on preclinical and clinical data for its lead drug candidate, TP-434, will be presented at the 2010 Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Boston,...
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Posted Yesterday in New Drug Applications.
NEW YORK--(BUSINESS WIRE)--Sep 7, 2010 - Forest Laboratories, Inc. announced that the U.S. Food and Drug Administration's (FDA) Anti-Infective Drugs Advisory Committee voted 21 – 0 in favor of approval of ceftaroline fosamil for the treatment of community acquired bacterial pneumonia (CABP) and voted 18 – 0 in favor of approval for complicated skin and skin structure infections...
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Posted Yesterday in Clinical Trials.
Novel Cancer Vaccine Demonstrates Significantly Superior Two- and Three-Year Disease-Free Survival Rates Compared to Historical Controls LOS ANGELES--(BUSINESS WIRE)--Sep 8, 2010 - ImmunoCellular Therapeutics (OTCBB: IMUC), a biotechnology company focused on the development of novel immune-based cancer therapies, today announced long-term data from a Phase I clinical trial of ICT-107,...
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Posted Yesterday in Clinical Trials.
Renovo Group plc (LSE : RNVO), the biopharmaceutical company developing drugs to reduce scarring, improve wound healing and enhance tissue regeneration, today announces that its Phase I dose ranging clinical trials designed to establish the safety of Juvista® following the surgical excision of bilateral earlobe keloids met all primary safety objectives. As anticipated in the protocols, the...
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Posted 2 Days Ago in New Drug Applications.
AstraZeneca today announced that MedImmune, its biologics unit, has received a second complete response letter (CRL) on motavizumab from the U.S. Food and Drug Administration (FDA). Based on the preliminary assessment of the CRL, it contains the following requirements that the company should address to advance the motavizumab registration: The FDA has requested evidence from an additional...
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Posted 2 Days Ago in New Drug Applications.
Uppsala, September 7, 2010 - Orexo AB (STO: ORX) announces that the US Food and Drug Administration ("FDA") has informed Orexo's partner, ProStrakan Group plc (LSE: PSK), the international specialty pharmaceutical company, that it will not yet be making a decision under the Prescription Drug User Fee Act ("PDUFA") for Abstral. Discussions between ProStrakan and the FDA on the review...
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Posted 2 Days Ago in Pharma Industry News.
From Canadian Press DataFile (September 6, 2010)   LONDON -- GlaxoSmithKline’s controversial diabetes pill Avandia should be pulled from the U.K. market because of concerns that the drug can increase the risk of heart attacks, British drug regulators said Monday. The Medicines and Healthcare products Regulatory Agency (MHRA) said an independent panel of experts had advised it that the...
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Posted 2 Days Ago in Pharma Industry News.
From Guardian Web (September 7, 2010) What are we to do about the diminishing power of antibiotics - once the miracle drugs that looked set to end infectious diseases? We know the problem is becoming very serious - here is a piece I wrote about the alarming prospects for a future without antibiotics. But we don’t hear much in the way of imaginative answers. So it’s refreshing to read...
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Posted 6 Days Ago in Pharma Industry News.
New antimalarial drug candidate with novel mechanism of action has the potential to rapidly clear a Plasmodium infection upon administration of a single oral dose, as published in Science Novartis led collaboration includes The Scripps Research Institute, the Swiss Tropical and Public Health Institute, with major support from the Wellcome Trust, Medicines for Malaria Venture, the...
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Posted 6 Days Ago in Pharma Industry News.
-Research: Oral bisphosphonates and risk of cancer of the esophagus, stomach and colorectum: Case-control analysis within a UK primary care cohort   LONDON, Sept. 2, 2010-People who take oral bisphosphonates for bone disease over five years may be doubling their risk of developing oesophageal cancer (cancer of the gullet), according to a new study published on bmj.com today. Oral...
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Posted 6 Days Ago in Pharma Industry News.
Qiuping Gu, M.D., Ph.D.; Charles F. Dillon, M.D., Ph.D.; and Vicki L. Burt, Sc.M., R.N. Key findings Over the last 10 years, the percentage of Americans who took at least one prescription drug in the past month increased from 44% to 48%. The use of two or more drugs increased from 25% to 31%. The use of five or more drugs increased from 6% to 11%. In 2007-2008, 1 out of every 5 children and 9 out...
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Posted 1 Weeks Ago in New Drug Approvals.
IRVINE, Calif.--(BUSINESS WIRE)--Aug 31, 2010 - Allergan, Inc. today announced the United States Food and Drug Administration (FDA) has approved Lumigan (bimatoprost ophthalmic solution) 0.01% as a first-line therapy indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Lumigan 0.01% is an optimized reformulation...
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Posted 1 Weeks Ago in New Drug Approvals.
Richmond, VA (31st August 2010) – Reckitt Benckiser Pharmaceuticals Inc. today announces that it has received approval from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) to manufacture and market Suboxone sublingual film. Suboxone sublingual film has been developed through an exclusive agreement with MonoSol Rx, utilising its proprietary PharmFilm technology, to...
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Posted 1 Weeks Ago in New Drug Applications.
WATERTOWN, Mass.--(BUSINESS WIRE)--Aug 31, 2010 - pSivida Corp., a leader in the development of sustained release back of the eye drug delivery systems for difficult-to-treat conditions, today announced that its licensee, Alimera Sciences has been notified that the U.S. Food and Drug Administration (FDA) has granted Priority Review status for the New Drug Application (NDA) filed for Iluvien...
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Posted 1 Weeks Ago in New Drug Applications.
WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)--Aug 30, 2010 - Eisai Inc. announced today that it has received notification from the U.S. Food and Drug Administration (FDA) that the agency expects to complete priority review of the eribulin mesylate New Drug Application (NDA) for locally advanced or metastatic breast cancer on or before December 30, 2010, which is a three month extension from the...
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Posted 1 Weeks Ago in New Drug Approvals.
EAST HANOVER, N.J., Aug. 27 /PRNewswire/ -- The US Food and Drug Administration (FDA) approved Tekamlo (aliskiren and amlodipine) tablets, a single-pill for the treatment of high blood pressure combining the only approved direct renin inhibitor, Tekturna (aliskiren), with the widely used calcium channel blocker amlodipine. Tekamlo is approved as initial therapy for patients who are likely...
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Posted 3 Weeks Ago in New Drug Approvals.
ROCKVILLE, Md., Aug. 13, 2010--The U.S. Food and Drug Administration today approved ella (ulipristal acetate) tablets for emergency contraception. The prescription-only product prevents pregnancy when taken orally within 120 hours (five days) after a contraceptive failure or unprotected intercourse. It is not intended for routine use as a contraceptive. ella is a progesterone...
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Posted 4 Weeks Ago in New Drug Approvals.
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Aug 10, 2010 - Genentech, Inc., a member of the Roche Group, announced today that the U.S. Food and Drug Administration (FDA) approved increasing the length of therapy with Valcyte (valganciclovir hydrochloride) in adult kidney transplant patients at high risk for cytomegalovirus (CMV) disease. The supplemental approval is based on data that...
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