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Sep28
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In a report to be released today, the FDA was found to do very little to ensure the safety of people who help test drugs in clinical trials.  An article in the New York Times quotes Daniel Levison, Inspector General for the Department of Health and Human Services as saying that FDA officials are not aware of how many clinical trials are being conducted and have audited fewer than 1 percent of trials.
The New York Times reports that the FDA has 200 inspectors that are required to monitor over 350,000 testing sites and that top drug officials downgraded negative findings their reports 68% of the time. Levinson recommended that the FDA create a registry of all clinical trials so that these trials may be better monitored.
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Sep28
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The FDA issue approval on Ethicon Endo-Surgery Inc. Realize™ Gastric Band. Realize™ Adjustable Gastric Band is a surgical implant for weight reduction in obesity related health conditions. In a 3 year study of 276 patients, those using the Realize(TM) Band saw...
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BusinessWeek published an interesting article on the newest efforts to hold pharmaceutical companies accountable for the money handed out to doctors in giveaways.It is estimated that pharma companies hand out over $19 billion worth of gifts to doctors every year....
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The FDA announced that it will take enforcement action against companies who manfucture unapproved prescription drug products that contain hydrocodone.Hydrocodone, one of the strongest pain relief and cough suppressants, can result in breathing problems or cardiac arrest when used improperly....
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Results of a study of Herceptin have shown that, when combined with chemotherapy, the drug has let to complete disappearance of tumor in the breast or lymph nodes in three times as many women as with chemotherapy alone. Prof. Dr. med. Wolfgang Eiermann,...
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Sep27
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The Food and Drug Administration got more power today as President George W. Bush signed a measure that gives them more authority to police dangerous side effects from prescription drugs after they are marketed.The measure is largely a response to the...
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Daiichi Sankyo Co. (TYO:4568) announced today that it has received FDA approval for AZOR.AZOR, amlodipine and olmesartan medoxomil, is used in the treatment of hypertension also referred to as high blood pressure. A once daily pill that is a combination...
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Major pharmaceutical companies, regulators and academics have joined in an effort to study the genetics of patients who develop serious side effects from prescription drugs. The hope is to develop information that will help doctors determine which people are at...
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WalMart Store Inc. (NADSAQ: WMT) announced the launch of the second phase of their $4 prescription drug program. Phase 2 offers more medicines in more categories like attention deficit disorder, glaucoma, fungal infections and acne. Fertility and prescription birth control...
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CollaGenex Pharmaceuticals Inc (NASDAQ: CGPI) announced that the results of a Phase 2 clinical trial of the therapeutical benefits of incyclinide for the treatment of rosacea did not meet expectations and further trials would be stopped.Expectations were that the incyclinide...
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Sep26
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Nastech Pharmaceuticals Company Inc announced that it starting a Phase 2 clinical trial to evaluate its fast-acting Insulin Nasal Spray for patients with diabetes.The trial will be conducted with 20 Type 2 diabetic patients and will evaluate different dosages as...
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At a meeting of the European Cancer Organization in Barcelon, Spain Synta Pharmaceuticals announced promising new research in the area of skin cancer treatments. The drug, STA-4783, may be able to overload cancer cells with oxygen containing chemicals causing the...
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Pfizer Inc. reported that clinical trials of its kidney cancer drug, Stutent, has shown potential as a treatment for advanced gastric cancer. Early clinical data from trials of Stutent, sunutinib, showed anti-tumor activity in patients previously treated with chemotherapy that...
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Sanofi-Aventis SA is suing Teva Pharmaceuticals and Barr Laboratories, generic drug manufactures, over Uroxatral. Uroxatral is a drug used for treating prostrate grand enlargement.Sanofi argues that Teva and Barr are infringing two U.S patents according to two complaints filed in...
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Watson Pharmaceuticals announced that it has received final FDA approval for its generic drug, Accuneb. Accuneb is an alubterol sulfate inhalation solution, the generic equivalent of Dey, L.P.’s AccuNeb Inhalation Solution, is used for relief of bronchospam in patients between...
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Sep25
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A review of patients at the Mayo Clinic suggests that the warning for the anti vomiting drug, droperidol, may not be needed."We found no change in bad heart rhythms with the commonly used low-dose droperidol versus no droperidol use in...
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A new book out today might be the extra help that those suffering from Multiple Sclerosis are looking for. The MS Recovery Diet published by Penguin Books claims to be able to halt and even reverse the effects of MS...
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I ran across a great web site called Radiation Therapy Answers. The site offers brochures with the intent on helping patients gain information about the different treamtent options that are available to them.The brochures include:Radiation Therapy for Bladder CancerRadiation Therapy...
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In what could easily be perceived as a marketing ploy Pfizer released a study 2 weeks ago showing that people who switched from Pfizer's Lipitor to Merck's Zocor increased their risk of heart attack or stroke.[Source CNN Money]The study tracked...
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You can now chew gum with your dentist's approval but only if it's Wrigley's. The American Dental Association has awarded Wrigley sugar free gums, Orbit, Extra and Eclipse its seal of approval.ADA approval was based on studies, partially funded and...
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Sep24
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It was announced today that Bristol-Meyer Squibb and Adnexus Therapeutics have an agreement where Bristol-Meyers will acquire Adnexus. Adnexus Therapeutics, a privately held company, is the developer of a new therapeutic class of biologics called Adnectins."Bringing Adnexus into the Bristol-Myers...
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Scientists in Singapore have developed a hand held device capable of detecting bird flu quicker and cheaper than existing technology.The device is being sold by Roche Holding AG, Veredus Laboratories and Qiagen NV and Applied Biosystems at a cost of...
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Pfizer Inc. has announced that it has received European Commission approval for its AIDS drug Celsentri. The drug, generically known as Maraviroc is the first in a class of oral HIV medicine in more than 10 years.Celsentri, discovered and developed by...
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TWC Global LLC Inc. has issued an nationwide recall of its products Axcil and Desirin, which are marketed as dietary supplements, as they contain potentially harmful ingredients.The FDA found that the products contained sildenafil, the active ingredient of an FDA approved...
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Health blogs and health watchdogs have been saying that the fluoride in our drinking water is unhealthy for a long time and studies have been conducted as to the validity of their claims now there is a report that give...
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Sep23
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Clinical trials results have found that patients receiving a starting dose of Takeda Pharmaceutical's diabetes drug, Actos gain better control of blood sugar and lipid levels than those using GlaxoSmithKline's Avandia.This finding comes on the heels of recent fears that Avandia...
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I previously wrote about the benefits of screening our children for mental health issues. That all stemmed from a comment made to another article I'd written that sent me off on a bit of a rant.Now the downside. Firstly, I have...
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Sep22
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Merck & Co announced that it was ending enrollment and vaccination of volunteers in what was previously hailed as a promising experimental AIDS vaccine.The trial, called STEP, was an international phase II trial in unaffected volunteers at high risk for getting...
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Previously I had posted in response to a comment that had been posted after one of my articles. The comment contained a link to a petition to stop TeenScreen which is the testing of children for depression and suicidal tendencies....
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Sep21
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Amy Gemoules posted a comment on another article about something called TeenScreen. Having never heard of it I decided to do some research. I started with the link to an online petition she left and read through their complaints. I found...
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An article today in The New York Times, by Stephanie Saul, debates different reasons for the slowing of inflation in drugs cost.One of the aspects she discusses is "the WalMart effect" which is the initiative that was launched last fall where...
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Novo Nordisk A/S announced that it has received approval for its drug, Norditropin, from the FDA. Norditropin is for use on children with Turner's Sydrome. Turner's Syndrome is a rare chromosomal condition that is caused by a complete or partial lack...
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ReBuilder Medical Technologies is taking their ReStore Energy drink to the next level of trials. They are currently looking for physicians and subjects to begin clinical trials of the nutritional supplement.ReStore is an all-natural, sugar-free energy drink that has been...
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Early next week a group of Atlantic Canadians are expected to file a class-action suit against Perdue Pharma, the maker of OxyContin in the Supreme Court of Nova Scotia. The suit alleges that the pharmaceutical company misrepresented the drug as...
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Sep20
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Family Medical Associates, servicing families in the Ridgefield, Ct. area offers family oriented medical care. A well-rounded staff provides care in Pediatrics, Family Medicine and Internal Medicine. Serving the community since 1989, Primary Care Doctors David Pazer, MD, Wendy Maki,...
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I was buzzing through one of our sister blogs, BizToolBelt, and came across and article Alex wrote about Nanotechnology. Seems researchers at the University of Missouri-Columbia have developed nanotechnology. A nanodevice that researchers claim will act as a drug delivery...
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I ran across this great marketing site that was discussing the problems that pharmaceutical companies seem to be encountering when advertising on the web. Seems that an estimated $2.2 billion USD will be spent on online advertising by the pharma and...
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Germany based pharmaceuticals company, Evotec AG, announced Wednesday that it will be buying the American company Renovis Inc. The deal, worth $151.8M USD will increase Evotec's research ability into treatments for inflammatory illnesses.With an insomnia drug ready to begin human...
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Applied Biosystems has released the new SQL*LIMS Plug and Play Package which is a laboratory information management system (LIMS) to aid pharma companies with regulatory compliance and to help decrease the cost of managing manufacturing operations.Claiming to save 85% in...
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MedImmune Inc. announced that the FDA has now approved FluMist™ for use in children as young as 24 months. The expansion in age now allows for FluMist™ to be used on people from ages 2 - 59. FluMIst(TM) is an...
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Sep19
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In a recent interview with The New York Time, Novartis Pharmaceuticals CWO Daniel L. Vasella stated that though Americans have made progress in curing some diseases, the U.S is still facing a serious increase in obesity and aging-related diseases.Vasella criticized the...
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TraumaCure Inc. received news that the FDA has cleared its product, WoundStat™, after only six weeks of review.WoundStat™, a lightweight, pre-mixed dressing compound, has been scientifically proven to control high pressure bleeding in moderate to severe wounds. "The FDA's speedy approval of...
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Australia’s Therapeutic Goods Administration (TGA) has ordered the recall of the anti-inflammatory drug Novartis AG’s Prexige. TGA decided on the recall after the medication was linked to two deaths. Claiming to be the first country to issue the recall, the...
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Accentia Biopharmaceuticals has reported that results from its trials for SinuNase supports theories that most, if not all, chronic sinusitis is as a result of fungal infection.In support of the theory advanced by Mayo Clinic researchers that the cause of chronic...
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Users of the following Abbott Laboratories manufactured glucose meters: Precision Xtra™, Optium™, ReliOn® Ultima, Rite Aid® and Kroger® are being warned that dropping the units on a hard surface could cause improper function of the display screens. Units manufactured after January...
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Hi Everyone!My name is Lynn and I have the honor and pleasure of writing for PharmaGazette. I know that you have all been missing new articles and starting today you will get a regular dose. I look forward to sharing...
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An article in the New York Times quotes Daniel Levison, Inspector General for the Department of Health and Human Services as saying that FDA officials are not aware of how many clinical trials are being conducted and have audited fewer than 1 percent of trials.
