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Carrier screening reduces CF birth rates in northeast Italy

An increase in the number of screened carriers for cystic fibrosis (CF) was associated with a decrease in the number of children born with CF in northeast Italy, according to a study in the December 16 issue of JAMA.

16 Dec 2009

DSMB approves advancement of PLX-PAD to intermediate dose level in Phase I clinical trial for CLI treatment

Pluristem Therapeutics Inc. today announced that the independent DSMB approved the advancement to the intermediate dose level of the company’s placenta derived cell therapy, PLX-PAD, in the Phase I clinical trial in Europe for the treatment of critical limb ischemia (CLI), the end stage of peripheral artery disease (PAD).

15 Dec 2009

BioAlliance Pharma SA to enter Phase II clinical trial for clonidine Lauriad and Phase I clinical trial for AMEP

BioAlliance Pharma SA, a company dedicated to the treatment and supportive care of cancer and AIDS patients, today announces the approval from the French Drug Agency (AFFSSaPS) to enter Phase II clinical trial for clonidine Lauriad® in radiotherapy and chemotherapy-induced oral mucositis and the approval from Danish and Slovene Agencies to enter Phase I clinical trial for AMEPTM in invasive melanoma.

15 Dec 2009

CHUM neurosurgeon raises funds for epilepsy research

On January 8, 2010, CHUM neurosurgeon Dr. Alain Bouthillier will leave for Argentina, where he will brave the 6,962-metre heights (over 22,840 feet) of Mount Aconcagua. Dr. Bouthillier's climb is intended to raise public awareness about epilepsy and raise funds for further research on the illness.

15 Dec 2009

Tarenflurbil drug does not appear to benefit Alzheimer’s patients

Although there were promising results in a phase 2 trial, patients with mild Alzheimer disease who received the drug tarenflurbil as part of a phase 3 trial did not have better outcomes on measures of cognitive decline or loss of activities of daily living compared to patients who received placebo, according to a study in the December 16 issue of JAMA.

15 Dec 2009

Tips to prevent noise-induced hearing loss in children

Parents and children giving or receiving an electronic device with music this holiday season should give their ears a gift as well by pre-setting the maximum decibel level to somewhere between one-half and two-thirds maximum volume.

15 Dec 2009

AstraZeneca, UVa announce collaboration in development of new treatments for CAD and PAD

AstraZeneca and the University of Virginia (UVa) in Charlottesville, today announced that they have entered into a strategic research collaboration to enhance development of new treatments primarily for coronary artery disease (CAD) with a secondary focus on peripheral vascular disease (PAD).

15 Dec 2009

Positive results from study comparing exenatide once weekly to BYETTA

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced positive results from a head-to-head study comparing exenatide once weekly, an investigational diabetes therapy, to BYETTA® (exenatide) injection taken twice daily, in patients with type 2 diabetes.

15 Dec 2009

Femta Pharmaceuticals, Lonza Group collaborate in cGMP production of FM101 antibody

Femta Pharmaceuticals and Lonza Group Ltd jointly announce the execution of a manufacturing services agreement to facilitate the development and cGMP manufacturing of FM101. FM101 is a high affinity monoclonal antibody in late pre-clinical development for the treatment of Rheumatoid Arthritis.

15 Dec 2009

Pfizer to co-promote Actos with Tianjin Takeda Pharmaceuticals in China

Takeda Pharmaceutical Company Limited (“Takeda”) and Pfizer Inc. (“Pfizer”) announced that they have entered into an agreement under which Pfizer in China will co-promote Takeda’s Actos® (pioglitazone HCl) with Tianjin Takeda Pharmaceuticals in China.

15 Dec 2009

Spinal Restoration receives FDA SPA concurrence letter for its Phase 3 Biostat System study

Spinal Restoration, Inc. announced today it has received a Special Protocol Assessment concurrence letter from the U.S. Food and Drug Administration (FDA) for the design of its Phase 3 study of the Biostat System for the treatment of chronic discogenic low back pain.

15 Dec 2009

Almac Discovery initiates Phase I clinical trial of intranasal Granisetron for CINV

Almac Discovery today announced the start of Phase I clinical trial of the novel intranasal Granisetron product. This product, which uses Archimedes' proprietary ChiSys® delivery technology, is being developed as a rapidly acting, well tolerated and convenient treatment for chemotherapy-induced nausea and vomiting (CINV).

15 Dec 2009

University of Wisconsin IRB approves GenSpera's G-202 Phase I study for cancer

GenSpera, Inc. announced today that the Institutional Review Board (IRB) at the University of Wisconsin, in Madison, WI, has approved a Phase I study of its target activated pro-drug, G-202, for the treatment of cancer. The FDA (US Food and Drug Administration) approved the study in September. GenSpera expects to enroll the first study patient early in the first quarter of 2010.

15 Dec 2009

Encouraging results from DAVANAT in combination with chemotherapies and biologics

Pro-Pharmaceuticals, Inc. today announced that the Brussels Branch of the Ludwig Institute of Cancer Research is testing the ability of DAVANAT® to stop Galectin-3 from blocking the immune system’s action on cancer cells. Peer reviewed studies have demonstrated that Galectin-1 and Galectin-3 induce apoptosis (cell death) in immune system T cells (“Galectins,” Chapter 7, Wiley, 2008).

15 Dec 2009

Celgene announces positive data from its apremilast Phase IIb study for plaque-type psoriasis

Celgene Corporation announced clinical data from an investigational Phase IIb, double-blind, placebo-controlled study of apremilast (CC-10004) in patients with moderate-to-severe plaque-type psoriasis (PSOR-005). This was a 352-patient, multi-center study in which patients received either 10mg, 20mg or 30mg of apremilast twice per day (BID), or placebo.

15 Dec 2009

Novartis submits JOULFERON MAA to the EMEA

Human Genome Sciences, Inc. today announced that Novartis has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) for approval to market JOULFERON® (albinterferon alfa-2b, known in the United States as ZALBIN™) for the treatment of chronic hepatitis C. In November 2009, HGS submitted a Biologics License Application (BLA) for ZALBIN to the FDA in the United States.

15 Dec 2009

Lytix Biopharma AS receives approval to commence Phase I clinical trials of Oncopore

The Norwegian pharmaceutical company Lytix Biopharma AS today announced approvals from the Norwegian Medicines Agency (”Statens legemiddelverk”) and the Swedish Medical Products Agency (”Läkemedelverket”) to commence Phase I clinical trials of OncoporeTM (LTX-315) for the treatment of cancer.

15 Dec 2009

Jazz Pharmaceuticals announces submission of JZP-6 NDA for treatment of fibromyalgia

Jazz Pharmaceuticals, Inc. announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for JZP-6 (sodium oxybate oral solution) for the treatment of fibromyalgia.

15 Dec 2009

New technique may help diagnose treatments for Alzheimer's, diabetes and cancer

Chemists and biologists from the University of Bath have developed a new technique that could be used to diagnose and develop treatments for age-related conditions like Alzheimer's disease, diabetes and cancer.

15 Dec 2009

Cerebrospinal fluid signature and PiB imaging help predict Alzheimer's disease

Early Alzheimer's disease detected by a compound that binds to brain plaques appears likely to progress into symptomatic Alzheimer's disease with dementia, according to a report in the December issue of Archives of Neurology, one of the JAMA/Archives journals.

15 Dec 2009

Medical Condition News

Carrier screening reduces CF birth rates in northeast Italy

DSMB approves advancement of PLX-PAD to intermediate dose level in Phase I clinical trial for CLI treatment

BioAlliance Pharma SA to enter Phase II clinical trial for clonidine Lauriad and Phase I clinical trial for AMEP

CHUM neurosurgeon raises funds for epilepsy research

Tarenflurbil drug does not appear to benefit Alzheimer’s patients

Tips to prevent noise-induced hearing loss in children

AstraZeneca, UVa announce collaboration in development of new treatments for CAD and PAD

Positive results from study comparing exenatide once weekly to BYETTA

Femta Pharmaceuticals, Lonza Group collaborate in cGMP production of FM101 antibody

Pfizer to co-promote Actos with Tianjin Takeda Pharmaceuticals in China

Spinal Restoration receives FDA SPA concurrence letter for its Phase 3 Biostat System study

Almac Discovery initiates Phase I clinical trial of intranasal Granisetron for CINV

University of Wisconsin IRB approves GenSpera's G-202 Phase I study for cancer

Encouraging results from DAVANAT in combination with chemotherapies and biologics

Celgene announces positive data from its apremilast Phase IIb study for plaque-type psoriasis

Novartis submits JOULFERON MAA to the EMEA

Lytix Biopharma AS receives approval to commence Phase I clinical trials of Oncopore

Jazz Pharmaceuticals announces submission of JZP-6 NDA for treatment of fibromyalgia

New technique may help diagnose treatments for Alzheimer's, diabetes and cancer

Cerebrospinal fluid signature and PiB imaging help predict Alzheimer's disease

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