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EMA CHMP adopts positive opinion for Pfizer’s axitinib to treat advanced renal cell carcinoma

Pfizer announced today that the Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion regarding the marketing authorization of axitinib in the European Union (EU), for the treatment of adult patients with advanced renal cell carcinoma (RCC), a type of advanced kidney cancer, after failure of prior treatment with sunitinib or a cytokine.

25 May 2012

Merck welcomes launch of ROTATEQ in Rwanda of Africa’s rotavirus vaccination program

Merck, known as MSD outside the United States and Canada, welcomes today's launch in Rwanda of Africa's first national rotavirus vaccination program with ROTATEQ (rotavirus vaccine, live, oral, pentavalent), Merck's vaccine for the prevention of rotavirus disease.

25 May 2012

European CHMP issues positive opinion to Vertex's KALYDECO for treatment of CF

Vertex Pharmaceuticals Incorporated announced today that the European Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion by consensus recommending the approval of KALYDECO (ivacaftor) for people with cystic fibrosis (CF) ages 6 and older who have at least one copy of the G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

25 May 2012

MIT researchers engineer new jet-injection system

MIT researchers have engineered a device that delivers a tiny, high-pressure jet of medicine through the skin without the use of a hypodermic needle. The device can be programmed to deliver a range of doses to various depths - an improvement over similar jet-injection systems that are now commercially available.

25 May 2012

Thioridazine drug successfully kills human cancer stem cells

A team of scientists at McMaster University has discovered a drug, thioridazine, successfully kills cancer stem cells in the human while avoiding the toxic side-effects of conventional cancer treatments.

25 May 2012

Cyanobacterium produces compounds that could treat chronic inflammatory conditions

A seaweed considered a threat to the healthy growth of coral reefs in Hawaii may possess the ability to produce substances that could one day treat human diseases, a new study led by scientists at Scripps Institution of Oceanography at UC San Diego has revealed.

25 May 2012

IUDs, implants far more effective at preventing pregnancy than the pill

A large study of birth control methods in the U.S. found that women using pills, skin patches or vaginal rings were 20 times more likely to have an unplanned pregnancy than women who used intrauterine devices (IUDs) or implants placed under the skin of the upper arm.

25 May 2012

New compound can enhance apoptosis in cancer cells

The BCL-2 protein family plays a large role in determining whether cancer cells survive in response to therapy or undergo a form of cell death known as apoptosis.

25 May 2012

FDA advisory committee votes in favor of Pfizer's tafamidis meglumine

Pfizer Inc. announced today that the United States Food and Drug Administration's (FDA) Peripheral and Central Nervous System Drugs Advisory Committee voted on Pfizer's clinical data package for tafamidis meglumine.

25 May 2012

Alpha-2 agonists decrease postoperative consumption of opioid drugs

A study from researchers at Geneva University Hospital, Geneva, Switzerland, provides evidence that use of alpha-2 agonists alongside opioids in surgical patients decreased opioid use by 25-30 percent. Even though opioid use was less, these patients reported slightly less pain after surgery.

25 May 2012

Auxilium, FCB I file suit against Watson over generic Testim

Watson Pharmaceuticals, Inc. today confirmed that its subsidiary, Watson Laboratories, Inc., filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Testosterone Gel, 1%. Watson's 1% testosterone gel product is a generic version of Auxilium Pharmaceuticals, Inc.'s Testim 1%.

25 May 2012

IUDs and implants effectively reduce risk of unintended pregnancy

A study to evaluate birth control methods has found dramatic differences in their effectiveness. Women who used birth control pills, the patch or vaginal ring were 20 times more likely to have an unintended pregnancy than those who used longer-acting forms such as an intrauterine device (IUD) or implant.

24 May 2012

USP announces two new standards related to elemental impurities

As part of its ongoing efforts to help ensure the quality of medicines, the U.S. Pharmacopeial Convention (USP) has announced two new standards related to elemental impurities: General Chapters <232> Elemental Impurities-Limits and <233> Elemental Impurities-Procedures. The new standards provide procedures for the detection of selected impurities in drug products based on modern analytical methods, as well as acceptable limits for their presence based on toxicity data and exposure levels.

24 May 2012

Experts, advocates urge continued funding for research into HIV, TB vaccines

"[P]articipants at a symposium held last week by the U.K. Consortium on AIDS and International Development warned that progress on HIV and tuberculosis (TB) vaccines could be jeopardized by the recent downturn in global health funding," BMJ reports.

24 May 2012

Omega-3 fatty acids may provide more benefits for elderly people with Alzheimer's

According to a recent study published online in Neurology, Omega-3 fatty acids, like those found in Omega XL fish oil extract containing DHA and EPA from the New Zealand green-lipped mussel, may provide more benefits for elderly people suffering from Alzheimer's.

24 May 2012

Is access problem preventing generic drug makers' progress?

Some drugmakers assert they are unable to create cheaper generic versions of drugs because their rivals are exploiting a legal loophole. It all comes down to process: To get a generic drug approved for sale, a company has to test a sample of the brand-name version and show regulators that the generic version is essentially identical and as effective.

24 May 2012

APP expands portfolio of injectable critical care products

APP Pharmaceuticals, LLC, a Fresenius Kabi Company, today announced it has acquired three products from Nexus Pharmaceuticals, Inc.

24 May 2012

Chronic diseases, bloodstream infections on the rise among HIV+ ICU patients

The expanded use of antiretrovirals, potent drugs used to treat retroviral infections such as human immunodeficiency virus (HIV), has been linked to significant decreases in hospital mortality rates among severely ill HIV-positive (HIV+) patients nationwide, primarily due to a decrease in opportunistic infections, according to a new study by researchers at Stanford University.

24 May 2012

New DHA and ARA source suitable for supplementation of infant formulas

Scientists are reporting development of a healthy "designer fat" that, when added to infant formula, provides a key nutrient that premature babies need in high quantities, but isn't available in large enough amounts in their mothers' milk.

24 May 2012

Study shows prevalence of drug-resistant HIV strains in Uganda rising, among highest in sub-Saharan Africa

"The prevalence of drug-resistant HIV strains in Uganda has risen from 8.6 percent to 12 percent in the last five years, one of the highest rates in sub-Saharan Africa, according to a recent study," PlusNews reports.

24 May 2012