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Combination of metformin and exercise can prevent Type 2 diabetes

Kinesiology researcher Barry Braun of the University of Massachusetts Amherst and colleagues recently reported unexpected results of a study suggests that exercise and one of the most commonly prescribed drugs for diabetes, metformin, each improves insulin resistance when used alone, but when used together, metformin blunted the full effect of a 12-week exercise program in pre-diabetic men and women.

6 Dec 2011

FDA assigns CTIs' pixantrone NDA new PDUFA action date

Cell Therapeutics, Inc. today announced that the U.S. Food and Drug Administration's Division of Oncology Products 1 has notified CTI that CTI's October 2011 resubmitted New Drug Application is considered a complete, Class 2 response to the FDA's April 2010 complete response letter.

6 Dec 2011

Prenatal exposure to valproate may increase risk of autism in children

Investigators in a population-based study in Denmark reporting today at the American Epilepsy Society's 65th annual meeting have found there is an increased risk of autism spectrum disorder and childhood autism in children born of mothers who are exposed to the anticonvulsant valproate during pregnancy.

6 Dec 2011

Fetal exposure to valproate impairs IQ till age six

Researchers in the U.S. and U.K. are conducting an ongoing investigation of the cognitive effect of fetal exposure across four commonly used antiepileptic drugs (AEDs) as part of an NIH-funded Neurodevelopmental Effects of Antiepileptic Drugs (NEAD) Study. An early NEAD analysis found that fetal exposure to valproate impairs IQ at age three.

6 Dec 2011

MorphoSys unveils next-generation antibody technology Ylanthia

MorphoSys AG today unveiled its next-generation antibody technology Ylanthia®. The technology was presented to an audience of specialists at the 2011 Antibody Engineering and Antibody Therapeutics Conference in San Diego. MorphoSys expects Ylanthia to set new standards for therapeutic antibody generation in the pharmaceutical industry over the next decade and beyond. Commercial application will commence in 2012.

6 Dec 2011

Bold move by Astra Zeneca to share 22 early stage potential drugs with MRC

Drug maker AstraZeneca will be sharing 22 of its early-stage research compounds with the Medical Research Council as part of a make over of life sciences research. This would speed up patients’ access to breakthrough drugs and arrest the decline of research and development in the UK.

6 Dec 2011

Aspirin decreases risk of major complications from cardiac surgery

Aspirin taken within five days of cardiac surgery is associated with a significant decrease in the risk of major postoperative complications, including renal failure, a lengthy intensive care unit stay and even early death (30-day mortality), according to a study by researchers at Thomas Jefferson University and UC Davis Medical Center set to appear in the journal Annals of Surgery.

6 Dec 2011

Biogen, Samsung partner to develop and market biosimilars

Samsung and Biogen Idec today announced that they have entered into an agreement to invest $300 million to establish a joint venture to develop, manufacture and market biosimilars. Samsung will take a leading role in the joint venture, with Biogen Idec contributing its expertise in protein engineering and biologics manufacturing.

5 Dec 2011

Converting patients to lamotrigine extended-release for epilepsy treatment found effective and safe

Epilepsy drug-switching study shows that using more ethical control groups could be the way forward for testing both drug efficacy and safety

5 Dec 2011

Spectrum seeks FDA IND approval for SPI-014 to treat hyperphosphatemia

Spectrum Pharmaceuticals today announced that it has submitted an investigational new drug (IND) application to the U.S. Food & Drug Administration for SPI-014 (previously referred to as RENAZORB), a second-generation lanthanum-based nanoparticle phosphate binding agent, that has the potential to treat hyperphosphatemia in patients with Stage 5 chronic kidney disease, or end-stage renal disease (ESRD).

5 Dec 2011

CTI seeks license to market Pixuvri in the E.U. for treatment of NHL

Cell Therapeutics, Inc. announced today an update on the status and progress of its European marketing authorization application for Pixuvri.

5 Dec 2011

Bromide shows promise against SCN1A-associated Dravet syndrome with intractable seizures

In the mid-nineteenth century Charles Locock, physician to Queen Victoria, introduced bromide as the first effective treatment for epilepsy. The drug was little used in treating the disorder until 1868, however, when its efficacy against seizures was first demonstrated in a clinical trial. Bromide was the sole anticonvulsant available until 1912 and the introduction of phenobarbital.

5 Dec 2011

Latin American, Caribbean national rotavirus immunization campaigns show success, CDC report says

"Fourteen of the 32 countries in Latin America and the Caribbean make the rotavirus vaccine available for all infants via national programs," according to a report published Friday in the CDC's "Morbidity and Mortality Weekly Report," United Press International reports.

3 Dec 2011

FDA approves Mylan's Tranexamic Acid Injection ANDA

Mylan Inc. today announced that its business Mylan Institutional has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for Tranexamic Acid Injection, 100 mg/mL, packaged in 1,000 mg/10 mL Single-dose Vials.

3 Dec 2011

MK 1775 shows promise against sarcomas

MK 1775, a small, selective inhibitor molecule, has been found to be active against many sarcomas when tested by researchers at Moffitt Cancer Center in Tampa, Fla.

3 Dec 2011

Mylan's NDA for Atazanavir Sulfate and Ritonavir Tablets receives tentative FDA approval through PEPFAR

Mylan Inc. today announced that its subsidiary Mylan Laboratories Limited has received tentative approval from the U.S. Food and Drug Administration through the President's Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application for Atazanavir Sulfate and Ritonavir Tablets, 300 mg/100 mg.

2 Dec 2011

Assembly Bill 5502-B would raise cost of many prescriptions in NY by 10%

Assembly Bill 5502-B—transmitted to Governor Andrew Cuomo yesterday—would needlessly raise the cost of many prescriptions in New York by 10 percent, according to the Pharmaceutical Care Management Association. If enacted, the Bill would prohibit consumers from getting discounted prescriptions through mail-service pharmacies.

2 Dec 2011

New insight into why aminoglycoside antibiotics cause deafness

Peter Steyger's research on hearing is very personal. That's because Steyger - a research scientist with the Oregon Hearing Research Center at Oregon Health & Science University - is deaf. Now Steyger has published groundbreaking research that is as personal as it gets. The study gives scientists new insight into why a specific class of antibiotics causes deafness - the same class of antibiotics that caused Steyger's deafness as a child in England 48 years ago. The study was published this month in Scientific Reports, part of the Nature Publishing Group.

2 Dec 2011

U.S. Marshals seize all Syntec's dietary supplements for false claims

U.S. Marshals, at the request of the FDA, today seized all dietary supplements by a Wisconsin maker for false claims made about their safety and effectiveness in treating a number of diseases.

2 Dec 2011

The Lipitor story: Drug companies brace for losses as patents expire on this and other popular medications

News outlets analyze the impact that generic Lipitor could have on costs and the "era of 'blockbuster drugs'" as well as the strategies from Lipitor's maker to block its generic competitors. Meanwhile, some of these generics are already reaching the marketplace.

2 Dec 2011