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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

The Partnership at Drugfree.org issues statement on FDA approval of VIVITROL for opioid dependence

The U.S. Food and Drug Administration's approval of Alkermes' opioid dependence medication (VIVITROL) for the prevention of relapse to opioid dependence following opioid detoxification is positive news for families of young adults and all those who are struggling to overcome opioid addiction. Addiction, a disease of the human brain, is a chronic illness while opioid dependence is frequently characterized by relapse.

13 Oct 2010

LifeWise improves access to common immunizations at pharmacies

LifeWise Health Plan of Oregon is announcing a new step to remove barriers to care by providing improved access to common immunizations at pharmacies. LifeWise members can now simply present their member card at a pharmacy just as they do at their doctor's office to receive immunizations.

13 Oct 2010

BioRx receives limited distribution rights from Baxter for AATD drug GLASSIA

BioRx, a specialty pharmacy company, has received limited distribution rights from Baxter International Inc. for a new drug, GLASSIA™ [Alpha 1-Proteinase Inhibitor (Human)], the first and only liquid, ready-to-use treatment for alpha-1 antitrypsin deficiency (AATD) in the United States. AATD is a genetic disorder that causes low levels of alpha 1-antitrypsin, resulting in emphysema. AATD is also referred to as "genetic" or "congenital" emphysema.

From Baxter International Inc. 13 Oct 2010

CyDex terminates joint development agreement on Captisol-enabled clopidogrel with Prism Pharmaceuticals

CyDex Pharmaceuticals, Inc. today announced a mutual decision with Prism Pharmaceuticals to terminate their existing joint development agreement on novel Captisol-enabled® intravenous formulations of clopidogrel. This provides CyDex with full development and commercialization rights to the product candidate - an injectable formulation of clopidogrel. Clopidogrel is the active ingredient in PLAVIX®, an orally available antiplatelet drug, which currently is marketed by Bristol-Myers Squibb Company and Sanofi-Aventis, Inc.

13 Oct 2010

B. Braun Medical announces availability of FDA-approved Cefepime in DUPLEX System

In an effort to meet industry demands for expanded Cephalosporin offerings delivered to patients through safe and accurate administration, B. Braun Medical Inc. (B. Braun) announced that FDA-approved 1g and 2g Cefepime for Injection USP and Dextrose Injection USP in B. Braun Medical Inc.'s DUPLEX Drug Delivery System will be available for purchase beginning today.

From B. Braun Melsungen AG 13 Oct 2010

Alkermes' VIVITROL medication for treatment of opioid dependence

Alkermes, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved VIVITROL(naltrexone for extended-release injectable suspension) for the prevention of relapse to opioid dependence, following opioid detoxification.

13 Oct 2010