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$FDA warns of risk of atypical thigh bone fracture in patients taking bisphosphonates$

FDA warns of risk of atypical thigh bone fracture in patients taking bisphosphonates

The U.S. Food and Drug Administration today warned patients and health care providers about the possible risk of atypical thigh bone (femoral) fracture in patients who take bisphosphonates, a class of drugs used to prevent and treat osteoporosis. A labeling change and Medication Guide will reflect this risk. Bisphosphonates inhibit the loss of bone mass in people with osteoporosis.

14 Oct 2010

Study finds hemostatic powder effective in treating 95% of patients with bleeding peptic ulcers

A new material similar to that used by the U.S. Military to treat traumatic injuries is showing promise as the next novel treatment for bleeding ulcers, a condition that commonly affects up to 15 per cent of adults, according to Hong Kong physician Dr. James Lau.

14 Oct 2010

Risingsun signs consent decree to stop selling unapproved drugs

The U.S. Food and Drug Administration today announced that Toby McAdam and Greta Armstrong, doing business as Risingsun Health and The Center for Complimentary and Alternative Health of Livingston, Montana, have signed a consent decree that prohibits them from manufacturing and selling unapproved new drugs and adulterated or misbranded dietary supplements in violation of the law.

14 Oct 2010

World's third rectal microbicide trial launched in Pittsburgh

The world's third rectal microbicide trial launched in Pittsburgh, Pennsylvania today, with sites preparing to open in Boston, Massachusetts, and Birmingham, Alabama soon. Scientists will test the rectal safety and acceptability of tenofovir gel, a microbicide developed for vaginal use that has shown promise for preventing HIV through vaginal intercourse. Depending on the outcome of this new study, tenofovir gel could be further evaluated to determine if it can reduce the risk of HIV among both men and women who engage in receptive anal intercourse.

14 Oct 2010

GSK to expand donation of albendazole medicine to treat children with STH risk

At the launch of the World Health Organization's (WHO) first report on Neglected Tropical Diseases today, GSK announced a new five year commitment to expand the donation of its medicine albendazole to treat children at risk of intestinal worms, known as soil-transmitted helminths (STH).

14 Oct 2010

Workshop to focus on FDA process that grants orphan drug designation

The U.S. Food and Drug Administration has scheduled the third in a series of workshops on orphan drug designation for academics, biotechnology companies, and those unfamiliar with the process for Nov. 4-5, 2010, in Lansdowne, Va.

14 Oct 2010

Justices wrestle with issue of protecting vaccine makers

The Supreme Court is grappling with the question of how much protection the 1986 National Childhood Vaccine Injury Act was meant to provide vaccine manufacturers against lawsuits. The case involves Hannah Bruesewitz, whose parents claim that a Wyeth-manufactured D.T.P. vaccine she received as an infant in 1992 led to developmental problems.

14 Oct 2010

Labopharm announces European approval of twice-daily tramadol-acetaminophen

Labopharm Inc. today announced its twice-daily tramadol-acetaminophen has received a positive opinion under the European Union Decentralized Procedure in eight countries (Czech Republic, Iceland, Ireland, Poland, Portugal, Slovakia, Slovenia and Spain). Marketing Authorization will be granted in each country subject to the approval of translations of the Summary of Product Characteristics (SPC) and other labeling documents.

14 Oct 2010

Stop TB Partnership launches Global Plan to Stop TB 2011-2015

The WHO's Stop TB Partnership "laid out a new plan on Wednesday to combat tuberculosis and the nearly 2 million deaths it causes each year," Reuters reports.

14 Oct 2010

Scientists suggest lemon-lime soft drink can improve effectiveness of oral anticancer drug

Experiments with an artificial stomach suggest that a popular lemon-lime soft drink could play an unexpected role in improving the effectiveness of an oral anticancer drug. The experiments produced evidence that patients will absorb more of the unnamed drug, tested in Phase I in clinical trials, when taken with "flat" or degassed Sprite. The study appears in ACS' Molecular Pharmaceutics, a bi-monthly journal.

14 Oct 2010

NIH awards grant to Bavarian to advance early research in filoviruses

Bavarian Nordic A/S announced today that the company has received funding from the U.S. National Institutes of Health (NIH) to advance its early research in filoviruses (Ebola and Marburg virus).

14 Oct 2010

Ligand launches Viviant in Japan and Spain for postmenopausal osteoporosis

Ligand Pharmaceuticals Incorporated today announced that its partner Pfizer, Inc. launched Viviant® (Bazedoxifene) in Japan for the treatment of postmenopausal osteoporosis. Under the brand name Conbriza®, the drug is also marketed in Spain through a co-promotion with Almirall, an international pharmaceutical company based in Spain.

14 Oct 2010

Antidepressant Reboxetine ineffective: Review

According to a new study, an antidepressant prescribed over the last 13 years is ineffective and potentially harmful. The drug in question is called Reboxetine and is available under the name of Edronax. The study showed that it works no better than a placebo.

13 Oct 2010

AusBiotech 2010 set to demystify the impact of US Healthcare Reforms on Australian biotech

Australian biotechnology and pharmaceutical companies are seeking to understand the implications of the US Healthcare Reform Bill, says Australia’s biotechnology industry organisation, AusBiotech. In order to remain compliant and globally competitive, biotechs need to identify and work within a gamut of new requirements, complications and hurdles imposed by this new regulatory environment.

13 Oct 2010

Mesoblast broadens cancer indications for bone marrow transplant product

Australian regenerative medicine company Mesoblast Limited (ASX: MSB, USOTC: MBLTY) today announced that it is broadening the oncology applications of its "off-the-shelf" cell product for expansion of haematopoietic stem cells in patients with blood cancers. Building on the recent clinical success of Mesoblast’s proprietary cell product for expansion of cord blood, the Company will now address new markets where expansion of haematopoietic stem cells can make a meaningful impact on clinical outcomes, including diseases such as multiple myeloma.

13 Oct 2010

ImmunoCellular develops ICT-107 cell-based vaccine for GBM treatment

ImmunoCellular Therapeutics, a biotechnology company focused on the development of novel immune-based cancer therapies, today announced that it has developed an innovative method for manufacturing the company's lead product candidate, ICT-107, a dendritic cell-based vaccine for the treatment of glioblastoma multiforme (GBM).

13 Oct 2010

Researchers investigate statin drugs to treat lung disease

Researchers at Queen's University Belfast are investigating a potential new treatment for lung disease that could save many lives each year. The research team is studying how statins, drugs which are commonly used to treat high cholesterol, can be used to treat lung disease.

13 Oct 2010

Physicians anticipate new oral therapies for multiple sclerosis patients

Physicians are anticipating the arrival of new oral therapies for multiple sclerosis patients, with initial research showing very high awareness of oral candidates, particularly Novartis' Gilenya, which received FDA approval for relapsing forms of the disease in late September. The majority of neurologists expect Gilenya to be very useful as a therapy and trial of the drug is predicted to be strong, according to new research by GfK HealthCare.

13 Oct 2010

Pharmalink's Nefecon for IgA nephropathy receives FDA orphan drug designation

Pharmalink AB, a privately held Swedish pharmaceutical company, has received orphan drug designation by the US Food and Drug Administration (FDA) for its product candidate Nefecon (PL-56) for patients with IgA nephropathy, also referred to as Berger's Disease. This program is presently in clinical development phase II.

13 Oct 2010

Buprenorphine implant decreases opioid usage in persons with opioid dependence

Helping to address the issue of medication adherence, persons with opioid dependence who had the medication buprenorphine implanted had less opioid use over 16 weeks, according to a study in the October 13 issue of JAMA.

13 Oct 2010