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EMA COMP grants orphan medicinal product designation for Raptor's DR Cysteamine for cystinosis

Raptor Pharmaceutical Corp., announced that the European Medicines Agency's ("EMA") Committee for Orphan Medicinal Products ("COMP") has issued a positive opinion recommending orphan medicinal product designation for DR Cysteamine for the potential treatment of cystinosis.

15 Jun 2010

Orasi Medical signs agreement to study effect of Lundbeck CNS compounds on human brain

Orasi Medical today announced that it has entered an agreement with H. Lundbeck A/S to study the effect of Lundbeck central nervous system compounds on the human brain.

15 Jun 2010

Tips for correct application of sunscreen

You've gotten the message about the importance of sun protection, you're stocked up on sunscreen that's at least 15 SPF, and you're diligent about putting it on before you head outside. Once you've gotten this far, there's no reason to risk sunburns by applying it incorrectly. But, all too often, that's exactly what happens, says a Saint Louis University dermatologist.

15 Jun 2010

Comprehensive source for treatment information of atrial fibrillation in the European market

Arlington Medical Resources, a provider of premier market intelligence for the pharmaceutical and diagnostic imaging industries, finds that electrical cardioversion usage patterns in Europe differed dramatically by country in the fourth quarter of 2009. While ECV represented almost half of all cardioversion attempts in Germany, in Spain ECV accounted for only 13% of cardioversion attempts.

15 Jun 2010

ATA members raise concern about reduction in dietary iodine intake

Following publication of an article in the February 18 issue of the New England Journal of Medicine (Vol. 362 No. 7 pp 590-599) by Bibbins-Domingo, et al. that projected the effect of moderate dietary salt reductions on future cardiac disease rates, several members of the American Thyroid Association, concerned about the subsequent potential reduction in availability of iodine, have responded with a letter in the current issue of the NEJM (Vol. 362 No. 23 pp 2224-2226).

15 Jun 2010

Sulindac shuts down cancer cell growth, initiates cell death: Study

Without knowing exactly why, scientists have long observed that people who regularly take non-steroidal anti-inflammatory drugs like aspirin have lower incidences of certain types of cancer. Now, in a study appearing in Cancer Cell on June 15, investigators at Sanford-Burnham Medical Research Institute and their colleagues have figured out how one NSAID, called Sulindac, inhibits tumor growth.

15 Jun 2010

FDA grants Fast Track status for Genzyme's alemtuzumab development program for MS

Genzyme Corporation announced today that its alemtuzumab for multiple sclerosis development program has been granted Fast Track status by the U.S. Food and Drug Administration (FDA). This designation covers patients with relapsing-remitting forms of the disease.

15 Jun 2010

Cheap drug that prevents bleeding may save 100,000 lives each year: Study

Researchers have shown that a cheap and easy to use drug that stops bleeding may save up to 100,000 lives each year from injuries associated with road accidents and violence. The study was published this Tuesday in the acclaimed international journal The Lancet and was conducted by doctors at the London School of Hygiene and Tropical Medicine.

14 Jun 2010

UCB announces availability of Vimpat oral solution formulation

UCB today announced the availability of an oral solution formulation of Vimpat- (lacosamide) C-V, an antiepileptic drug (AED) for add-on treatment of partial-onset seizures in people with epilepsy age 17 years and older. Vimpat 10 mg/mL solution is now available in U.S. pharmacies.

14 Jun 2010

Medical marijuana advocates bypassing traditional approval, effectiveness regulations

NPR continues its examination of medical marijuana: "Fourteen states and the District of Columbia have launched a medical experiment that doesn't follow any of the rules of science. By approving the use of marijuana as a medicine — with varying kinds of restrictions — these jurisdictions are bypassing the federal government's elaborate processes for approving medicines."

14 Jun 2010

Patients beginning therapy on popular osteoporosis drugs discontinue treatment within 6 months: Report

According to a recent analysis by SDI, a leading healthcare market insight and analytics firm, about half of patients beginning therapy on popular osteoporosis drugs discontinue their treatment within 6 months. Amgen's Prolia, which was recently approved for postmenopausal women with osteoporosis at high risk of fracture, or patients who could not tolerate other osteoporosis therapies, is the newest product to enter the market. Prolia differs from existing therapies as it is given every 6 months via injection.

14 Jun 2010

Human Genome Sciences receives FDA feedback for ZALBIN BLA

Human Genome Sciences, Inc. today announced that it has received preliminary written feedback from the U.S. Food and Drug Administration (FDA) regarding the Company's Biologics License Application (BLA) seeking approval in the United States to market 900-mcg ZALBIN™ (albinterferon alfa-2b, known in Europe as JOULFERON®) dosed every two weeks for the treatment of chronic hepatitis C. FDA has expressed concerns regarding the risk benefit assessment of ZALBIN dosed at 900-mcg every two weeks.

14 Jun 2010

M&A issues in bio-pharma mega-mergers

The bio-pharma mega-mergers that grabbed headlines last year - Roche + Genentech, Pfizer + Wyeth, and Merck + Schering-Plough - are now in the critical post-integration period and the acquiring companies are finding out how well they planned and executed their integration plans.

14 Jun 2010

Intellipharmaceutics International files Protonix ANDA with FDA

Intellipharmaceutics International Inc. today announced that is has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration for a generic of Protonix® (delayed release pantoprazole sodium). Protonix inhibits gastric acid secretion and is prescribed for the short-term treatment of conditions such as stomach ulcers associated with gastroesophageal reflux disease as well as the long term treatment of pathological hypersecretory conditions including Zollinger-Ellison syndrome.

14 Jun 2010

ARBs increase risk of cancer: Study

University Hospitals Case Medical Center cardiologists have uncovered new research showing an increased risk of cancer with a group of blood pressure medications known as angiotensin-receptor blockers (ARBs).

14 Jun 2010

CTI announces AIFA approval for manufacture of pixantrone at NerPharMa facility

Cell Therapeutics, Inc. today announced that the Italian Medicines Agency ("AIFA"), the national authority responsible for drug regulation in Italy, has approved the facility at NerPharMa DS (a pharmaceutical manufacturing company belonging to Nerviano Medical Sciences Srl, in Nerviano, Italy) for the production of CTI's drug candidate pixantrone.

14 Jun 2010

Australian rainforests may provide potential cancer cure

Queensland scientists have discovered a drug to cure cancer that has effectively worked in animals and is to be tried on humans in the next phase of trials. This drug is plant-derived and is called EBC-46 for trial purposes. The plant from which it is obtained is found in the Australian tropical rainforest. The drug has shown to reduce inoperable tumors in 150 dogs, cats and horses and a ferret to a significant extent. The drug was developed over the past six years from the seed of a rainforest plant found in the Atherton Tablelands. Scientists had cultivated their own plantation of the plant since forming the company QBiotics Limited in 2004.

14 Jun 2010

Telmisartan reduces hypertension, cardiovascular risk in ACE-intolerant patients: Boehringer Ingelheim

Telmisartan, an angiotensin receptor blocker, is one of the best researched drugs worldwide. It has been studied in clinical trials in more than 50,000 patients. Its positive safety profile has been confirmed also in a market exposure of 34.5 million patient years. Convincing safety data for patients with a high cardiovascular risk were collected in the three long-term outcome trials ONTARGET, PRoFESS and TRANSCEND which followed some of the patients for up to five years.

14 Jun 2010

Effective antimicrobial products can reduce hospital-acquired infections

The Centers for Disease Control estimate that more than two million people in the United States are affected annually by hospital-acquired infections. Meanwhile, a report released in April by the Agency for Healthcare Research and Quality concluded that this problem, which is worsening, requires urgent attention.

14 Jun 2010

3M Health Care launches new foam adhesive dressings for acute and chronic wounds

3M Health Care today announced the introduction of a full line of new, innovative Tegaderm™ High Performance Foam Adhesive Dressings. In clinical and laboratory tests, these new adhesive foam wound dressings outperform other leading foam adhesive dressings in managing the full range of low- to high-moisture conditions that can be present in chronic and acute wounds.

14 Jun 2010

Pharmaceutical News

EMA COMP grants orphan medicinal product designation for Raptor's DR Cysteamine for cystinosis

Orasi Medical signs agreement to study effect of Lundbeck CNS compounds on human brain

Tips for correct application of sunscreen

Comprehensive source for treatment information of atrial fibrillation in the European market

ATA members raise concern about reduction in dietary iodine intake

Sulindac shuts down cancer cell growth, initiates cell death: Study

FDA grants Fast Track status for Genzyme's alemtuzumab development program for MS

Cheap drug that prevents bleeding may save 100,000 lives each year: Study

UCB announces availability of Vimpat oral solution formulation

Medical marijuana advocates bypassing traditional approval, effectiveness regulations

Patients beginning therapy on popular osteoporosis drugs discontinue treatment within 6 months: Report

Human Genome Sciences receives FDA feedback for ZALBIN BLA

M&A issues in bio-pharma mega-mergers

Intellipharmaceutics International files Protonix ANDA with FDA

ARBs increase risk of cancer: Study

CTI announces AIFA approval for manufacture of pixantrone at NerPharMa facility

Australian rainforests may provide potential cancer cure

Telmisartan reduces hypertension, cardiovascular risk in ACE-intolerant patients: Boehringer Ingelheim

Effective antimicrobial products can reduce hospital-acquired infections

3M Health Care launches new foam adhesive dressings for acute and chronic wounds

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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