FDA approves Climara Pro to treat menopause symptoms
...at the U.S. Food and Drug Administration (FDA) has granted marketing approval for Climara Pro®(estradiol/levonorgestrel) transdermal system. Climara Pro, a thin, translucent patch, is the first once-a-week, combined hormone therapy for the relief of moderate to severe vasomotor symptoms associated with ...NHS reforms have left no time to train surgeons
... of specialist consultant surgeon that we take for granted today," they conclude....Breakthrough cancer treatment Avastin receives first approval in the US
...erland and Canada priority review has already been granted and decisions are pending on requests for priority review in the European Union and Australia. We are dedicated to working closely with regulatory authorities to bring Avastin to patients as quickly as possible, particularly as this is the first trea...First global approval for FOSRENOL (lanthanum carbonate)
...gstoke, UK 24 March 2004 - Sweden's MPA has today granted the first regulatory approval in the world for FOSRENOL (lanthanum carbonate), a non-calcium, non-aluminium phosphate binding medicine developed to control phosphate levels in renal dialysis patients. Sweden will now become the Reference Member State...National Academies news: Clinical research involving children
...health policy advice under a congressional charter granted to the National Academy of Sciences. A committee roster follows....VELCADE (Bortezomib) receives European marketing authorisation
...loma and other cancers. A single licence has been granted to market VELCADE in the 15 member states of the EU, plus Norway and Iceland. In addition it will be available in the 10 accession countries. VELCADE is being co-developed by Millennium Pharmaceuticals, Inc. and Johnson & Johnson Pharmaceutical Res...On the edge: Are we at risk of an ESRD pandemic?
...nate), a new phosphate binding medication recently granted its first regulatory approval (in Sweden). Hyperphosphataemia (excessive levels of phosphate in the blood) develops in up to 80% of patients on dialysis 4 and can lead to bone pain, skeletal deformities and fractures if left untreated. It is also a...National Academies news: vaccines and autism
...health policy advice under a congressional charter granted to the National Academy of Sciences. A committee roster follows. Pre-publication copies of IMMUNIZATION SAFETY REVIEW: VACCINES AND AUTISM are available ...NIH awards Baylor, Texas Children's No. 1 spot in pediatric-research funding
... U.S. Department of Health and Human Services, has granted Baylor College of Medicine Department of Pediatric...s the hope of both institutions that the NIH funds granted will improve the lives of children across the globe," said Dr. Ralph D. Feigin, chairman of the Bayl...Two landmark studies show Taxotere (R) significantly improves survival in men with prostate cancer
...ay 19, 2004, the U.S. Food and Drug Administration granted approval of Taxotere® for use in combination with prednisone as a treatment for men with androgen-independent (hormone-refractory) metastatic prostate cancer. Among patients receiving Taxotere® the most common severe adverse events were low b...Tobacco sponsorship of Formula One must stop, say health experts
...ts, particularly in Asia. 'Several countries have granted advertising exemptions to Formula One. Others have effectively offered compensation for lost advertising opportunities in order to prevent the loss of coveted national races. These unfortunate practices reduce the financial incentives for teams to fi...Envisat Symposium report day 2: GMES turns science to services
...ns with an operational mandate. The wide-area view granted by Envisat and other Earth Observation satellites represents a crucial capability for GMES, but it relies on integrating data from many sources and multi-disciplinary fields. GMES is being enlarged on a modular basis, the session heard, and scientif...Stanford to test effects of drug widely used for pediatric hypertension
...fund the work. So far research contracts have been granted for just two drugs. Under the contract awarded to Stanford, Hammer and Drover will spend three years conducting clinical and laboratory tests to determine the safety and effectiveness of sodium nitroprusside. This drug works to control blood pressure...Hmong face high rates of some cancers
...in California. The U.S. State Department last year granted permission for another 15,000 Hmong to enter the country from Thailand. About half of these newest immigrants are also expected to settle in California. "The Hmong are a unique people with unique health challenges," says Moon S. Chen, Jr., professor ...FDA approves Fosrenol(R) in end-stage renal disease (ESRD) patients
...l follows Swedish regulatory approval for FOSRENOL granted in March this year. Shire is pursuing further European approvals for this product via the Mutual Recognition Process. "Effective reduction of phosphate levels in patients with kidney disease could make a real impact on their lives" said Dr Alastair H...Initiative yields effective methods for anthrax detection; RAMP and MIDI, Inc., methods approved
... Delaware. Previously, in February 2004, AOAC had granted Official Methods of AnalysisSM status to a confirmation procedure used by the Centers for Disease Control and Prevention (CDC) and the Laboratory Response Network (LRN). The RAMP test was one of five hand-held assays that underwent an exhaustive AOAC...Subanalysis finds patient-controlled, transdermal pain management system may be comparable
...by the Food and Drug Administration (FDA), and was granted approvable status in June, 2004. These data were presented at the American Society of Regional Anesthesia & Pain Medicine Annual Fall Pain Meeting. This research is a subanalysis of a broader, head-to-head study published earlier this year in the ...FDA grants accelerated approval of TYSABRI, formerly antegren, for the treatment of MS
...to reduce the frequency of clinical relapses. FDA granted Accelerated Approval for TYSABRI following Priority Review based on one-year data from two Phase III studies, the AFFIRM monotherapy trial and the SENTINEL add-on trial with AVONEX(Interferon beta-1a). TYSABRI, the first humanized monoclonal antibo...Testosterone patch will test FDA's decision making
The Food and Drug Administration (FDA) has granted a fast track review of testosterone patches for women with low sex drive, despite concerns about insufficient data and potentially misleading marketing by their manufacturer Proctor & Gamble, claim two articles in this week's BMJ. The patch is the ......LEX (darifenacin hydrobromide),7.5mg and 15mg, was granted approval by the European Commission for the treatment of overactive bladder (OAB) in all 25 European Member States as well as Norway and Iceland on 27th October 2004. Novartis is able to market EMSELEX throughout these countries. This product is kn...