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Mylan receives final FDA approval for Morphine Sulfate ER Tablets ANDA

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Morphine Sulfate Extended-release (ER) Tablets, 15 mg, 30 mg, 60 mg, 100 mg and 200 mg, the generic version of Purdue Pharma's MS Contin, an opioid analgesic for moderate to severe pain management.

27 Oct 2011

Nanoparticles could help increase retention of osteoarthritis drugs in knee cavity

A novel study demonstrates that using nanoparticles to deliver osteoarthritis drugs to the knee joint could help increase the retention of the drug in the knee cavity, and therefore reduce the frequency of injections patients must receive.

27 Oct 2011

EC approves Pfizer's pneumococcal conjugate vaccine, Prevenar 13

Pfizer Inc. announced today that the European Commission has approved the Company's pneumococcal conjugate vaccine, Prevenar 13 (pneumococcal polysaccharide conjugate vaccine, for active immunization for the prevention of vaccine-type invasive disease caused by Streptococcus pneumoniae in adults aged 50 years and older.

27 Oct 2011

E. coli asparaginase linked to relapses in ALL patients with special form of ATF5 gene

One of the causes of resistance to cancer treatment in children is now beginning to be elucidated. Acute lymphoblastic leukemia patients with a particular form of the ATF5 gene are at higher risk of having a relapse when treated with E. coli asparaginase, a key chemotherapy drug for this type of leukemia.

27 Oct 2011

Gilead, Bristol-Myers Squibb to develop and commercialize fixed-dose combination for HIV

Bristol-Myers Squibb Company and Gilead Sciences, Inc. today announced a licensing agreement for Bristol-Myers Squibb to develop and commercialize a fixed-dose combination containing Bristol-Myers Squibb's protease inhibitor REYATAZ (atazanavir sulfate) and Gilead's cobicistat, a pharmacoenhancing or "boosting" agent that increases blood levels of certain HIV medicines to potentially allow for one pill once daily dosing.

27 Oct 2011

New potential leukemia therapy targets and kills cancer cells

A new potential leukemia therapy targets only cancer cells, while leaving healthy cells alone. Many current chemotherapy treatments affect cancer cells and healthy cells, causing significant side effects, such as fatigue, hair loss, nausea, anxiety and depression.

27 Oct 2011

Clinical and genetic risk factors associated with early stent thrombosis

Patients with certain genes or specific factors related to use of the anti-clotting drug clopidogrel are more likely to experience a blood clot within a coronary stent shortly after placement, according to a study in the October 26 issue of JAMA.

27 Oct 2011

Study: pGJA-P/VAX vaccine shows promise against dental caries

In a report on a preclinical investigation titled "Flagellin Enhances Saliva IgA Response and Protection of Anti-caries DNA Vaccine," lead author Wei Shi, Wuhan Institute of Virology, Chinese Academy of Sciences, and his team of researchers demonstrate that anti-caries DNA vaccines, including pGJA-P/VAX, are promising for preventing dental caries. However, challenges remain because of the low immunogenicity of DNA vaccines.

27 Oct 2011

FDA responds to Delcath's request for pre-NDA meeting

Delcath Systems, Inc. announced today that the U.S. Food and Drug Administration (FDA) has responded to the Company's request made in September for a pre-New Drug Application (NDA) meeting and has scheduled a date in mid-January 2012.

27 Oct 2011

WSU researcher to learn more about links between stress and drug use

A Wayne State University researcher is using a three-year, $1.55 million grant from the National Institute on Drug Abuse of the National Institutes of Health to learn more about the links between stress and drug use by applying behavioral economics.

27 Oct 2011

Medco, Pfizer and UBC collaborate to enhance precision medicine approach

Pfizer Inc. announced today that it has established a research collaboration with Medco Health Solutions, Inc. and its wholly owned subsidiary, United BioSource Corporation (UBC), aimed at more effectively matching patients with treatments that will benefit them the most, thereby improving patient outcomes.

27 Oct 2011

Taking the Pill for 10 years can reduce risk of ovarian cancer by almost half

Taking the Pill for 10 years can reduce the risk of ovarian cancer by almost half (45 per cent), new research part-funded by Cancer Research UK shows today.

27 Oct 2011

No link between Chantix and mental health problems says FDA

According to federal health officials this Monday Pfizer's anti-smoking drug Chantix – known as Varenicline, did not increase psychiatric problems like depression and suicidal thoughts in two studies, though the findings are not definitive.

25 Oct 2011

Viewpoints: Health law curbs savings from OTC meds; Calif. wrestles with managing medical marijuana

[Over-the-counter] medicines play an important role in our nation's health care system, with almost 90 percent of physicians recommending patients try to address many ailments with self-care interventions, including the use of OTC medication, before seeking professional care.

24 Oct 2011

Scientists, WHO warn of public health implications of proposed mercury ban due to its use in vaccines

"Scientists are warning officials negotiating a global treaty on mercury that banning the deadly chemical completely would be dangerous for public health because of the chemical's use in vaccines," the Associated Press reports.

24 Oct 2011

Macular degeneration drug may cause increased IOP

Two major drug trials conclude there was little risk from a drug aimed at age-related macular degeneration. Yet a Mayo Clinic ophthalmologist began to note something concerning in some of her patients: an increase in pressure inside the eye. It led to a retrospective study and findings that will be presented at the American Academy of Ophthalmology in Orlando.

24 Oct 2011

FDA's ODAC to review Affymax peginesatide NDA for treatment of CKD-associated anemia

Affymax, Inc. today announced that the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) will review the New Drug Application (NDA) for peginesatide proposed for the treatment of anemia associated with chronic kidney disease (CKD) in adult patients on dialysis on December 7, 2011 during the afternoon session.

24 Oct 2011

SafeMinds praises UNEP's draft treaty ban on use of mercury in pharma products

SafeMinds applauds UNEP's draft treaty language which does not exempt the use of mercury in pharmaceutical products, including vaccines, from the global ban. Governmental regulators, public health officials and pharmaceutical companies have recognized that the toxicity of mercury in pharmaceutical and personal care products, to which people are directly exposed, justifies a preventive approach to minimize all exposures.

24 Oct 2011

Bioject receives FDA communication on use of jet injectors with flu vaccines

Bioject Medical Technologies Inc., a leading developer of needle-free drug delivery systems, today announced that the Food and Drug Administration (FDA) has issued a communication on the use of jet injectors with influenza vaccines.

24 Oct 2011

Arrowhead acquires RNA therapeutics assets from Roche

Arrowhead Research Corporation, today announced that it has acquired RNA therapeutics assets from Roche including the state-of-the-art research site in Madison, WI.

24 Oct 2011