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Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D,a specialist with hiTech formulations and quality-by-design.  Shruti brings to you some highlights from current pharma and clinical research news, views and data. 


Oral Contraceptives May Reduce Risk Of Death From Any Cause In Women.
 "Women who have taken the Pill at any stage in their life are less likely to die from any cause -- including heart disease and all types of cancer -- than those who have never taken the oral contraceptive," according to research published online in the British Medical Journal. The study of "more than 46,000 women revealed ... 

FDA Proposes To Remove Orthostatic Hypotension Drug From Market.
The Wall Street Journalreported that the FDA proposed to remove brand and generic versions of low-blood pressure drug ProAmatine (midodrine hydrochloride) from the market because required post-marketing studies on the drug's effectiveness have yet to be conducted. The drug was approved under the FDA's accelerated approval program, and according to the Journal, this is the first time the agency is requesting a drug to be removed ...

Malaria sufferers might be able to protect themselves against life-threatening bouts of the disease by taking a single course of antibiotics, research in mice has shown.
Preventive treatment with 'needle-free' antibiotic vaccines could be used to control the infection in areas with high levels of transmission, a study published in Science Translational Medicine suggests. There are still no available vaccines against malaria. And although some antibiotics with anti-malarial properties, such as doxycycline, that kill the parasites directly are already ...

Hormonal Contraceptives May Not Be Effective In Overweight Or Obese Women.
Hormonal contraceptives may not be effective for contraception in overweight or obese women," according to a review published online in the Cochrane Database of Systematic Reviews. After performing a literature review encompassing "11 trials enrolling a total of 39,531 women...

Osteoporosis drug linked to irregular heart beat.
Women who take popular osteoporosis drug alendronate, known more commonly as Fosamax, are twice as likely to develop a common form of irregular heartbeat compared to those who have never taken it, suggests a new study published in the journal Archives of Internal Medicine.   

Researchers analyzed data from more than 700 women who had been diagnosed with atrial fibrillation, or irregular heartbeat, in a three-year period and compared them to a control group of more than 900 randomly selected women. They found a nearly two-fold increase in risk for developing atrial fibrillation among those women who had ever taken alendronate … 

More at http://www.pharm-education.com/2010/08/malaria-sufferers-might-be-able-to.html

References:

http://online.wsj.com/article/SB10001424052748704868604575433703888376436.html
http://www.google.com/hostednews/afp/article/ALeqM5gX0oxFR_ZpHn-RyPL8JkXqWD4PNg
http://www.usatoday.com/news/health/2010-08-16-fda-unproven-drug_N.htm
http://www.medpagetoday.com/ProductAlert/Prescriptions/21699
http://www.latimes.com/health/boostershots/la-heb-hypotension-drug-20100816,0,53066.story?track=rss
http://www.startribune.com/business/100813309.html?elr=KArks8c7PaP3E77K_3c::D3aDhUMEaPc:E7_ec7PaP3iUiD3aPc:_Yyc:aU7DYaGEP7vDEh7P:DiUs
http://www.bizjournals.com/philadelphia/stories/2010/08/16/daily8.html
http://www.theheart.org/article/1110411.do
http://www.medscape.com/viewarticle/725103

http://www.ncbi.nlm.nih.gov/pubmed/20614470?dopt=Abstract

http://stm.sciencemag.org/content/2/40/40ra49.full?ijkey=OAfu5Q9bUdH4Q&keytype=ref&siteid=scitransmed

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

Http://www.drshrutibhat.comExpert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.
YouTube Channel : Http://www.youtube.com/user/ShrutiBhat10


Introducing ! A new blog- Http://www.PharmaceuticalCareerDevelopment.blogspot.com  which contains articles on motivation, career counselling and coaching, job search strategies, personal branding etc. especially for pharma professionals. 

Do you have questions for the author?

 
 
Picture
Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D, a specialist with hiTech formulations and quality-by-design. 
Shruti brings to you some highlights from current pharma and clinical research news, views and data.
 

Calcium Supplements May Be Linked To Increased Risk Of Heart Attack.
Research data published in the online in the BMJ suggests that "Calcium supplements are a good way to keep your bones strong, but, they could lead to an increased risk for heart attack." Combined results from 11 randomized controlled trials of calcium supplements...involving more than 12,000 patients." The researchers "found a 31% increase in the risk of heart attack and smaller, non-significant increases in the risk of stroke and death." Although ... 

Starting HIV Therapy Earlier May Help Reduce Mortality Risk, Thwart TB Infection.
The World Health Organization recommends patients start antiretroviral therapy when their CD4+ count drops to 350," as a "higher CD4+ count means greater infection-fighting ability because the immune system hasn't yet been depressed by the virus... 

More at  http://www.pharm-education.com/2010/08/calcium-supplements-are-good-way-to.html

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances. 

Http://www.drshrutibhat.com
Expert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.
YouTube Channel : Http://www.youtube.com/user/ShrutiBhat10

Do you have questions for the author?

 
 
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Dr.Shruti Bhat, Leader Pharmaceutical R&D and Expert in hiTech formulation development for over 35 different therapeutic class of drugs moeities, brings to you some highlights from current pharma and clinical research news, views and data. 

Presented below are updates in Pharmaceutical and clinical research-  

Researchers Develop Vaccine That Prevents Breast Cancer From Developing In Mice.
BBC News reported that "American scientists say they have developed a vaccine which has prevented breast cancer from developing in mice," according to a paper published ... 

Linaclotide Found To Relieve Chronic Constipation In Phase III Trials.
MedPage Today reported that linaclotide, an "investigational drug to relieve chronic constipation was effective and caused no unexpected ...

Pfizer Halts Late-Stage Clinical Study Of Sutent For Liver Cancer.
The AP reported that Pfizer, Inc. announced that it had "stopped a late-stage clinical study of its drug Sutent [sunitinib] as a treatment for" hepatocellular ...

Program May Help Physicians Improve Prescribing Practices For Patients With Hypertension.
HealthDay reported that, "after taking part in a face-to-face program designed to review current research and guidelines, doctors made small improvements in the way they prescribed medicine for patients with high blood pressure," according to a study ... 

Study Suggests Newly Approved Prostate Cancer Vaccine Is Safe, Has Few Side Effects.
The newly approved therapeutic prostate cancer vaccine, Provenge, is safe and has few side effects, according to a study scheduled to be presented at ... 

Blood-Sugar Meter That Connects With Gaming Systems May Help Children With Diabetes.
The Washington Post reported that the FDA "recently approved Bayer HealthCare's Didget, a blood-sugar meter that can connect with the Nintendo DS and ...  

Rosuvastatin May Reduce Blood Lipid Linked To Coronary Artery Disease.
MedPage Today reported, "In a study that specifically scrutinized the effects of statin therapy on triglycerides, researchers said that rosuvastatin (Crestor) significantly reduced ... 

Higher Lipitor Dose May Lower Heart Attack, Stroke Risk For Some Patients.
The AP reported, "A reanalysis of research data found a high dose of popular cholesterol pill Lipitor [atorvastatin calcium] lowers risk of heart attack and stroke in ....

References-

http://www.pharm-education.com/2010/06/researchers-develop-vaccine-that.html
http://news.bbc.co.uk/2/hi/health/8714085.stm
http://www.telegraph.co.uk/health/healthnews/7786916/Breast-cancer-vaccine-to-go-on-trial-within-a-year.html
http://healthday.com/Article.asp?AID=639554
http://www.timesonline.co.uk/tol/life_and_style/health/article7141155.ece
http://healthday.com/Article.asp?AID=639399
http://healthday.com/Article.asp?AID=639624http://healthday.com/Article.asp?AID=639624
http://www.washingtonpost.com/wp-dyn/content/article/2010/05/31/AR2010053101874.html  

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances. 

Http://www.drshrutibhat.com
Expert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.
YouTube Channel : Http://www.youtube.com/user/ShrutiBhat10 

Note : Shruti has initiated a new blog Http://www.PharmaceuticalCareerDevelopment.blogspot.com which contains articles on motivation, career counselling and coaching, job search strategies, personal branding etc. especially for pharma professionals.

Do you have questions for the author?

 
 
Picture
Dr.Shruti Bhat, Leader Pharmaceutical R&D and Expert in hiTech formulation development for over 35 different therapeutic class of drugs moeities, brings to you some highlights from current pharma and clinical research news, views and data. 

Presented below are updates in Pharmaceutical and clinical research-  

Significant Differences Found In US, UK Osteoporosis Treatment Guidelines.
MedWire reported that, according to a study published in the Journal of Clinical Endocrinology and Metabolism, "researchers from New Zealand have found striking differences ...

New Drug Combined With Diovan May Help Lower Blood Pressure.
WebMD reported that adding Novartis' AHU377, "a new kind of blood pressure drug called a vasopeptidase inhibitor," to Diovan (valsartan) "works better than either drug ... 

Experimental Once-A-Day Malaria Drug May Be As Effective As Twice-Daily Pill.
Bloomberg News reported, "An experimental once-a-day malaria drug worked as well at treating the mosquito-borne illness as Novartis AG's twice-daily pill Coartem [artemether and lumefantrine]," according to a paper in The Lancet... 

Global Health Initiative To Fund Battle Against Malaria Among Children, Women In Africa.
Reuters reported that through the Global Health Initiative, the government plans to focus on battling malaria, especially in African populations of women and children. Over the next six years... 

Vaccine That Could Help People Stop Smoking Shows Promise In Clinical Trials.
CNN  reported that "a vaccine designed to stimulate the immune system to generate antibodies that would latch on to nicotine in a smoker's body and prevent it from ever entering the brain" has been "showing promise in early clinical trials... 

Radiolabeling Conjugated Trastuzumab May Help Physicians Track Its Cancer-Fighting Progress.
MedPage Today reported that "tagging a copper isotope to conjugated trastuzumab (Herceptin) might allow doctors to monitor the progress a drug is having in combating cancer," according to research presented ...  

Multi-Vitamins During Pregnancy May Reduce Risk Of Giving Birth To Underweight Babies.
The UK's Telegraph reported that "taking multi-vitamin pills during pregnancy could significantly reduce the risk of giving birth to underweight babies." Specifically, a study of 402 pregnant women "found cases of small-for-gestational age (SGA) births were less than half as common in ... 

More at http://www.pharm-education.com/2010/05/vaccine-that-could-help-people-stop.html 

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

Http://www.drshrutibhat.com
Expert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.
YouTube Channel : Http://www.youtube.com/user/ShrutiBhat10 

Shruti has initiated a new blog
Http://www.PharmaceuticalCareerDevelopment.blogspot.com which contains articles on motivation, career counselling and coaching, job search strategies, personal branding etc. especially for pharma professionals. 

Do you have questions for the author?

 
 
Picture
Dr.Shruti Bhat, Leader Pharmaceutical R&D and Expert in hiTech formulation development for over 35 different therapeutic class of drugs moeities, brings to you some highlights from current pharma and clinical research news, views and data. 

Presented below are updates in Pharmaceutical and clinical research-  

Pioglitazone May Slow, Stop Progression Of Insulin Resistance To Full-Blown Diabetes.
According to research presented at the World Congress on Controversies to Consensus in Diabetes, Obesity, and Hypertension, "in patients with insulin resistance but near-normal glycated hemoglobin levels... 

Biosimilar Development Said To Be More Difficult Than Generic Endeavors.
Merck & Co.'s decision to end its effort to copy Amgen Inc.'s Aranesp (darbepoetin alfa) anemia drug may highlight the difficulties drugmakers face when developing biosimilars. The FDA is ...

Biotech Industry Sees Profitable Year Following Research Cuts.
Bloomberg News reported "Biotechnology companies worldwide turned a profit last year for the first time since at least 1985 as those led by Celgene Corp. reduced ...

Gates Invests In Drug-Software Company To Aid Drug Development.
The Wall Street Journal reported Microsoft Corp. co-founder Bill Gates is investing $10 million in Schrodinger LLC, a pharmaceutical-software maker, as part of a bid to improve drug development. The investment will put Gates ...

Remission In RA Possible With Biologic Drugs.
MedPage Today reported that "more than half of rheumatoid arthritis patients who achieved remission during treatment with infliximab (Remicade) were able to discontinue the drug for more than a year without flaring," according to a study published online ...

Methadone Use During Pregnancy Associated With Risk Of Visual Problems In Babies.
MedPage Today reported that, according to a study published online in the British Journal of Ophthalmology, "infants whose ...

Liraglutide Added To Metformin May Benefit Patients With Type 2 Diabetes.

HealthDay reported that, according to a study published April 24 in The Lancet, "patients with type 2 diabetes who can't control their blood glucose levels with the drug metformin alone do better after adding injections of the drug liraglutide compared to oral doses of another drug called ... 

FDA Tightening Its Oversight Of Infusion Pumps.
Food and Drug Administration officials are "moving to tighten their oversight of medical devices, including one of the most ubiquitous and problematic pieces of medical equipment," the infusion pump. Approximately ...

More at ...http://www.pharm-education.com/2010/05/biosimilar-development-said-to-be-more.html

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances. 

Http://www.drshrutibhat.com
Expert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.
YouTube Channel : Http://www.youtube.com/user/ShrutiBhat10
Do you have questions for the author?  

 
 
Picture
Dr.Shruti Bhat, Leader Pharmaceutical R&D and Expert in hiTech formulation development for over 35 different therapeutic class of drugs moeities, brings to you some highlights from current pharma and clinical research news, views and data. 

She has initiated a new blog Http://www.PharmaceuticalCareerDevelopment.blogspot.com that would contain articles on motivation, career counselling and coaching, job search strategies, personal branding etc. 

Presented below are updates in Pharmaceutical and clinical research-  

Spanish Translations Of Prescription Information May Often Be Inaccurate Or Confusing.  

The Chicago Tribune reported that, "Pharmacies that print prescription labels translated in Spanish often issue inaccurate or confusing instructions that could be potentially hazardous to a patient's health, according to ... 

Merck To Seek FDA Approval For Five New Drugs In 2010.  

Bloomberg News reported that, "Merck & Co. said it will seek US regulatory approval for five new medicines this year, including new treatments for hepatitis C and diabetes." The company also ...

Majority Of US' Best-Selling Drugs Are Generics.  

Forbes reported,, "The most popular medicine in the US," Vicodin (acetaminophen/hydrocodone), "was prescribed 128 million times last year, even as ... 

Abbott To License Products From Zydus Cadila To Sell In Emerging Markets.  

The AP reported that, Abbott Laboratories will license at least 24 products in emerging markets through a new unit created to boost sales outside of the US. Specifically, "Abbott said it will ...

Basic Science May Not Be Translating Into Drug Approvals.  

Newsweek reported that "frustration is growing with how few seemingly promising discoveries in basic biomedical science lead to something that helps patients, especially ... 

Extended-Release Carvedilol May Not Increase Triglyceride Levels In Hypertensive Patients Without Dyslipidemia.  

MedWire reported, "Extended-release carvedilol differs to extended-release metoprolol in its effect on triglyceride levels, but has a similar impact on high-density lipoprotein (HDL) cholesterol in hypertensive patients without dyslipidemia, trial findings suggest." The study ... 

Newly Developed Vaccine May Reverse, Cure Malignant Melanoma.  
Researchers have developed a vaccine, "which will be tested on British patients over the next few months" that "can reverse and even cure malignant melanoma." The "vaccine... 

More at...http://www.pharm-education.com/2010/05/pharmaceutical-r-updates-newly.html  

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances. 

Http://www.drshrutibhat.com
Expert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.
YouTube Channel : Http://www.youtube.com/user/ShrutiBhat10

Do you have questions for the author?

 
 
Picture
Dr.Shruti Bhat, Leader Pharmaceutical R&D and Expert in hiTech formulation development for over 35 different therapeutic class of drugs moeities, brings to you some highlights from current pharma and clinical research news, views and data.

FDA To Decide On Therapeutic Cancer Vaccine.
Prostate cancer strikes more American men than any other cancer. In fact, "just last year there were nearly 200,000 new cases" and "more than 27,000 deaths." But ...

Concurrent Use Of PPIs, Clopidogrel In Heart Disease Linked To Fewer Gastroduodenal Bleeding Hospitalizations.
Concurrent use of proton pump inhibitors (PPIs) in patients with serious coronary heart disease treated with clopidogrel is associated with fewer hospitalizations for gastroduodenal bleeding," Vanderbilt researchers found after reviewing data on "20,596 patients (including 7,593 concurrent users of clopidogrel and PPIs) who received clopidogrel between 1999 and 2005...

Metformin May Improve Ability Of Bicalutamide To Slow Proliferation In Hormone-Resistant Prostate Cancer Cell Lines.
The commonly prescribed anti-diabetes drug metformin appears to improve the ability of bicalutamide (Casodex), an androgen ablation drug, to slow proliferation in hormone-resistant prostate cancer cell lines," according to a study presented ...

NSAID Use May Not Reduce Risk Of Ovarian Cancer.
Regular use of anti-inflammatory drugs did not reduce the risk of ovarian cancer," according to a study presented at the American Association for Cancer Research meeting. Researchers found that "neither weekly nor daily use of aspirin...  

References- http://www.pharm-education.com/2010/04/pharmaceutical-research-updates.html

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

Http://www.drshrutibhat.com
Expert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.
YouTube Channel : Http://www.youtube.com/user/ShrutiBhat10
Do you have questions for the author?

 
 
Picture
Dr.Shruti Bhat, an Leader,Pharmaceutical R&D and expert in oncology product development, brings to you some highlights from current pharma and clinical research news, views and data. 

Many Oncologists Say Drugs Aimed At Disabling Proteins Are The Future Of Cancer Therapies. The New York Times reported that "drugs aimed at disabling proteins that spur cancer are, many oncologists say, the future of cancer therapies." ... 

Diabetes Drug May Help Reduce Lung Tumors.
The Los Angeles Times "Booster Shots" blog reported, "Metformin, a safe and inexpensive drug widely used to lower blood glucose in type 2 diabetics, may have a variety of other uses, researchers are finding." For example, "at an American Society of Clinical Oncology meeting on genitourinary cancers last month, Dr. Cristiano Ferrario, of McGill University in Montreal, Canada, reported that metformin could inhibit the growth of prostate cancer cells in the laboratory... 

Statins May Not Lower Risk Of Colorectal Cancer.
HealthDay reported that "statins don't lower the risk of colorectal cancer, and may even increase the chances of developing precancerous polyps," according to a study published in the journal Cancer Prevention Research...

Tailored Treatment Based On Tumor's Molecular Traits May Improve Lung Cancer Survival.
The Wall Street Journal reports that tailoring treatment based on a tumor's molecular features may improve survival in lung cancer patients, according to a study called Biomarker-Integrated Approaches of Targeted Therapy for Lung Cancer Elimination (BATTLE) presented at the annual meeting of the American Association for Cancer Research...

FDA Okays Tarceva As Initial Maintenance Treatment For Most Common Form Of Lung Cancer.
OSI Pharmaceuticals Inc. won approval from US regulators to expand the use of its Tarceva [erlotinib] drug as an initial maintenance treatment for the most common form of lung cancer. In 2004, the drug "was approved...  

Other Gene Mutations May Inhibit Colon Cancer Drug's Effectiveness.
Amgen Inc.'s Vectibix [panitumumab], a drug for colon cancer, may be useful to even fewer patients who suffer from that illness than scientists previously found," according to a new study. "Previous research showed that Vectibix doesn't work in about 40 percent of colon cancer patients... 

More at http://www.pharm-education.com/2010/04/many-oncologists-say-drugs-aimed-at.html  

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances. 

Http://www.drshrutibhat.com
Expert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.
TouTube Channel : Http://www.youtube.com/user/ShrutiBhat10

Do you have questions for the author?

 
 
FDA does not approve Ofirmev due to manufacturing site issues.

Reuter’s reported, "A pain and fever drug," called Ofirmev (intravenous acetaminophen), "being developed by Cadence Pharmaceuticals was not approved by federal regulators because of manufacturing problems at a facility where the drug is made, the company said Thursday." The FDA said it will not approve the drug until the issues are resolved. "Cadence said the FDA inspected a third party manufacturing facility on Friday," and the company "plans to meet with the FDA to make sure the problems have been addressed."  It is stated further that, the FDA did not cite any safety or efficacy issues for the drug or require any additional studies to be conducted prior to approval.  

FDA approves heat-stable version of Norvir.

Abbott Laboratories reported that it received Food and Drug Administration approval for a heat-stable version of the HIV treatment Norvir [ritonavir]." The approval is for a new formulation of the drug that "allows it to be stored at room temperature rather than in a refrigerator."  

Taspoglutide may reduce sugar levels when compared with or added to other treatments.

Roche Holding AG declared  results from five late-stage clinical trials show that its experimental diabetes drug taspoglutide reduced blood sugar levels when compared with or added to widely prescribed treatments." Roche said in a statement that the drug met the main goal of studies comparing it to Lantus (insulin glargine injection), Byetta (exenatide injection) and Januvia (sitagliptin), as well as trials where it was combined with metformin and against placebo. Additionally, taspoglutide was found to be generally well tolerated in all five trials, and the most frequently reported side effects were nausea and vomiting.  

Few women taking tamoxifen for breast cancer prevention.

A study, appearing in the February 2010 edition of Cancer Epidemiology, Biomarkers & Prevention,Gardner) reported that, "despite the fact that experts have known since 1998 that tamoxifen can cut the risk of developing breast cancer by almost 50 percent," a recent study found that "only a tiny fraction of women at high risk of developing breast cancer take tamoxifen to prevent the disease." Looking at data on about 10,000 women from 2000 and 2005,. Researchers found that "only about 0.2 percent of US women aged 40 to 79 took tamoxifen to prevent breast cancer" in 2000. "In 2005, the prevalence was even lower -- only 0.08 percent." Researchers "did not say specifically how many of the women taking tamoxifen were at high risk for breast tumors."  

Tamoxifen use linked to lower cognitive test scores.

 According to a study appearing in the February Journal of Clinical Oncology, tamoxifen appears to affect cognitive abilities, including some types of memory. After a year of taking tamoxifen (Nolvadex), women in the study scored lower on tests of verbal memory functioning and other cognitive skills than did women taking another breast cancer drug, exemestane (Aromasin). Still, researchers "emphasized that it's important to keep the study results in perspective, noting the life-saving benefits of tamoxifen. 

Statin users may continue to suffer muscle pains long after stopping the drugs.

According to a study published in the New England Journal of Medicine. Researchers found that  patients experiencing muscle pain and weakness as a result of statin treatment may continue to suffer symptoms long after stopping the drugs. Nearly a third of patients who stopped statin treatment because of neuromuscular symptoms still showed myalgia six months later, and creatine kinase levels above 200 units/L persisted in 17%. The researchers suggested that creatine kinase measurements at the start of statin therapy could help identify patients with underlying neuromuscular diseases." 

Twice weekly etanercept may provide benefits for skin but not joints.

According to a study published Feb. 2 in the BMJ, "twice weekly treatment with 50 mg of etanercept appears to be superior to once weekly treatment for the clearance of skin lesions in patients with psoriasis and psoriatic arthritis," but "there was no significant difference between the two etanercept regimens in the treatment of joint symptoms." Researchers arrived at those conclusions after studying "752 patients with both psoriasis and psoriatic arthritis who were randomly assigned to receive etanercept 50 mg twice weekly (n=379) or 50 mg once weekly (n=373) for 12 weeks by subcutaneous injection." 

Also at http://www.pharm-education.com/2010/02/clinical-research-updates-on-new-drugs.html

Disclaimer- The information posted here is for knowledge purpose only and should not be considered as medical advise. Expert opinion should be sought for individual case matter.
 
 
 
February 10, 2010 news room bring Bad news for GSK and generics manufacturers of Paxil !  

A report appeared of a new study published in BMJ (the British Medical Journal) linking antidepressant paroxetine (marketed by GSK as Paxil) with increased mortality rates in breast cancer patients over the age of 66. 

The observational study, conducted by a team at the Sunnybrook Health Sciences Centre in Toronto, looked at data on 2,430 patients treated with tamoxifen for breast cancer along with a single SSRI (selective serotonin reuptake inhibitor) for depression. The women were all 66 or older, and all were from the province of Ontario. Those taking paroxetine for 25 percent of the duration of their tamoxifen treatment had a 24 percent increase in risk of death from breast cancer. Patients taking paroxetine for 75 percent of the duration saw their risk jump to 91 percent.  

The researchers report that these percentages were confined to paroxetine; other SSRIs, like fluoxetine (Prozac) and sertraline (Zoloft) had no effect on mortality rate. 

David Juurlink, a member of the research team, explained that the discrepancy comes from paroxetine’s method of reuptake inhibition. While the other SSRIs settle for temporarily inhibiting a particular enzyme (CYP2D6), paroxetine’s effect is not reversible. Unfortunately, CYP2D6 is essential for metabolizing tamoxifen, so with paroxetine permanently inactivating this enzyme, the cancer-fighting drug is essentially neutralized. 

“There’s been a suspicion for years about possible negative effects of paroxetine on drugs like these,” Juurlink said. “This is the first study to actually quantify it.” 

The data excluded women younger than 66 for the simple reason that data sets are much less complete—or nonexistent—for those populations in Canada. However, Juurlink believes physicians will (and should) discontinue using paroxetine for all patients being treated with tamoxifen, and is confident that further studies on younger populations will yield similar results.  

“You’ll soon see warnings from the FDA and Health Canada, which have already been sniffing around this for a while,” he predicted.  

Also at http://www.pharm-education.com/2010/02/study-links-paxil-to-breast-cancer.html 

Disclaimer – This information is for knowledge purposes only and should not be considered as medical or legal advise. Expert consultation should be sought for your individual query related to this topic.
 

     

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    Dr.Shruti Bhat, an Expert in Pharmaceutical industry, brings to you some highlights from current pharma and clinical research news, views and data.

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