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Apricus Biosciences announces reformulation of Rituxan enables rectal delivery of biologics

Apricus Biosciences, backed by a revenue generating CRO business and seeking to leverage its multi-route NexACT drug delivery technology and internal pipeline through out-licensing arrangements and partnerships, today announced results from a pre-clinical pharmacokinetic study showing the ability of NexACT to enable rectal delivery of biologics, such as human antibodies.

15 Sep 2010

CytoGenix reports positive results of CYDBA507 avian influenza vaccine candidate

CytoGenix reports positive results of an animal study where mice were immunized with CYDBA507, CytoGenix avian influenza vaccine candidate, protected against lethal challenge with avian influenza virus.

15 Sep 2010

Stroke risk with common pain killers dismissed by manufacturer

An eight-year Danish study, which involved more than 2.5 million healthy Danes found there was a higher risk of stroke for those taking high doses of ibuprofen, which is in the painkiller Nurofen. The manufacturers of Nurofen, Reckitt Benckiser, have dismissed these reports. The spokesperson for the company said, “it is important to note that the conclusions drawn by the study authors are based on high doses of ibuprofen…The results of this study should not be confused with non-prescription low doses of NSAIDs, such as ibuprofen, which are available over-the-counter and used by millions of people around the world, for short periods of time, every day.”

14 Sep 2010

Cetaphil launches Restoraderm for management of eczema and atopic dermatitis skin

The Cetaphil® brand, the #1 dermatologist-recommended brand of cleansers and moisturizers announced the launch of Cetaphil® Restoraderm® products, formulated specifically for the needs of eczema and atopic dermatitis skin. Cetaphil® Restoraderm® Skin Restoring Body Wash and Skin Restoring Moisturizer soothes itching associated with skin affected by eczema and atopic dermatitis.

14 Sep 2010

UBM Live anticipates CPhI Worldwide attendance to exceed 25,000

Leading events organiser UBM Live today announced that it expects the attendance for CPhI Worldwide, the annual flagship tradeshow for pharma ingredients, now in its 21st year and the year being held in Paris, to exceed the 25,000 seen at last year's event, held in Madrid.

14 Sep 2010

SAMHSA to unveil results of 2009 National Survey on Drug Use and Health

The Substance Abuse and Mental Health Services Administration (SAMHSA) will unveil the results of the latest (2009) National Survey on Drug Use and Health (NSDUH) at a press conference on Thursday, September 16. The annual survey is the largest of its kind, and is the government's primary vehicle for determining how many persons are abusing illegal drugs, pharmaceuticals, alcohol and tobacco.

14 Sep 2010

AMCP supports legislation to prohibit financial agreements for delaying marketing of lower-cost generic drugs

The Academy of Managed Care Pharmacy (AMCP) supports the inclusion of legislative language similar to S. 369 — the Preserve Access to Affordable Generics Act — in appropriations legislation now under consideration by the Senate. S. 369 would prohibit financial agreements between brand-name and generic pharmaceutical manufacturers to delay the marketing of lower-cost generic drugs.

14 Sep 2010

Gilead Sciences announces Quad regimen Phase II clinical trial results for HIV infection treatment

Gilead Sciences, Inc. today announced Phase II clinical trial results showing that its investigational fixed-dose, single-tablet "Quad" regimen of elvitegravir, cobicistat and Truvada (emtricitabine and tenofovir disoproxil fumarate) for the treatment of HIV infection maintained a high rate of virologic suppression through 48 weeks, exhibiting antiretroviral activity comparable to that of Atripla(efavirenz 600 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg).

14 Sep 2010

NCCN Oncology Policy Summit focuses on off-label use of drugs and biologics

The National Comprehensive Cancer Network (NCCN) announced today that key policy organizations and thought leaders will convene to discuss the critically important subject of the use of drugs and biologics for indications that are supported by evidence and compendia, but that are beyond the indications listed in the FDA label. This invitation-only Policy Summit will be held on December 17, 2010 at the National Press Club in Washington DC.

14 Sep 2010

$Bisphosphonates drug may lead to atypical femur fractures in osteoporosis patients: Report$

Bisphosphonates drug may lead to atypical femur fractures in osteoporosis patients: Report

A widely prescribed class of drugs is highly effective in reducing common bone fractures in people with osteoporosis, but an expert panel announced today that these same drugs - when used long term - may be related to unusual but serious fractures of the thigh bone.

14 Sep 2010

Neoprobe Corporation presents information on Lymphoseek at TERACHEM Symposium

Neoprobe Corporation a diversified developer of innovative oncology surgical and diagnostic products, today announced that Senior Vice President of Pharmaceutical Research and Clinical Development, Dr. Frederick O. Cope, presented information on the Company's lead pipeline initiative, Lymphoseek, at the International Symposium on Technetium and Other Radiometals in Chemistry and Medicine (TERACHEM), held September 8-11, 2010 in Bressanone (Bolzano), Italy.

14 Sep 2010

$Cell Therapeutics to appeal FDA decision on pixantrone NDA for relapsed/refractory aggressive NHL$

Cell Therapeutics to appeal FDA decision on pixantrone NDA for relapsed/refractory aggressive NHL

Cell Therapeutics, Inc. today announced that it intends to appeal the U.S. Food and Drug Administration's previously disclosed decision regarding the pixantrone New Drug Application ("NDA") to treat patients with relapsed/refractory aggressive non-Hodgkin's lymphoma ("NHL").

14 Sep 2010

IGI submits first ANDA to FDA

IGI Laboratories, Inc., a New Jersey based formulation and manufacturing company, today announced that it has submitted its first abbreviated new drug application (ANDA) to the US FDA. IGI President and CEO Charlie Moore commented "This is a significant step forward in validating IGI's commitment to pharmaceutical product development.

14 Sep 2010

ADHD medication improves childhood cancer survivors: Research

A medicine widely used to treat attention-deficit/hyperactivity disorder (ADHD) also provides long-term relief from the attention and behavior changes that affect many childhood cancer survivors, according to a multicenter trial led by St. Jude Children's Research Hospital investigators.

14 Sep 2010

Sanofi Pasteur files Fluzone Intradermal influenza virus vaccine sBLA with FDA

Sanofi Pasteur, the vaccines division of sanofi-aventis Group, announced today that it has filed a Supplemental Biologics License Application (sBLA) with the U.S. Food and Drug Administration (FDA) for Fluzone® Intradermal (Influenza Virus Vaccine). The file has been accepted by the FDA and an action date is anticipated in the first half of 2011.

From BD (Becton, Dickinson and Company) 14 Sep 2010

Complementary medicine to save millions: Report

According to a new report substituting pharmaceutical antidepressants with St John’s Wort could save the health system $50 million a year. This research was conducted by Access Economics for the National Institute of Complementary Medicine (NICM) at the University of Western Sydney. It showed that cost effectiveness of complementary and alternative therapies have the potential to cut costs without compromising patient outcomes.

13 Sep 2010

Counterfeit drugs become growing problem

"Last year, nearly 1,700 incidents of counterfeit drugs were reported worldwide, triple the number in 2004, says the Pharmaceutical Security Institute (PSI), a group funded by drugmakers," USA Today reports. "Estimates for the size of the counterfeit drug market range from $75 billion to $200 billion a year. The market is likely much bigger because many cases are hard to detect.

13 Sep 2010

FDA updates Shire's ProAmatine medicine for symptomatic orthostatic hypotension treatment

Shire, the global specialty biopharmaceutical company, announces that the United States Food and Drug Administration today posted an update on its website related to ProAmatine (known generically as midodrine), a medicine approved for the treatment of symptomatic orthostatic hypotension.

13 Sep 2010

AB SCIEX, University of Melbourne join to develop drug metabolism studies of biopharmaceuticals

AB SCIEX, a global leader in life science analytical technologies, and the University of Melbourne today announced a joint technology development project to improve drug metabolism studies of biopharmaceuticals.

13 Sep 2010

InterMune's development program for pirfenidone, IPF to be presented at Annual Congress of ERS

InterMune, Inc. today announced that four oral presentations related to the company's development program for pirfenidone and idiopathic pulmonary fibrosis will be presented at the Annual Congress of the European Respiratory Society, to be held September 18-22 in Barcelona, Spain.

13 Sep 2010

Pharmaceutical News

Apricus Biosciences announces reformulation of Rituxan enables rectal delivery of biologics

CytoGenix reports positive results of CYDBA507 avian influenza vaccine candidate

Stroke risk with common pain killers dismissed by manufacturer

Cetaphil launches Restoraderm for management of eczema and atopic dermatitis skin

UBM Live anticipates CPhI Worldwide attendance to exceed 25,000

SAMHSA to unveil results of 2009 National Survey on Drug Use and Health

AMCP supports legislation to prohibit financial agreements for delaying marketing of lower-cost generic drugs

Gilead Sciences announces Quad regimen Phase II clinical trial results for HIV infection treatment

NCCN Oncology Policy Summit focuses on off-label use of drugs and biologics

Bisphosphonates drug may lead to atypical femur fractures in osteoporosis patients: Report

Neoprobe Corporation presents information on Lymphoseek at TERACHEM Symposium

Cell Therapeutics to appeal FDA decision on pixantrone NDA for relapsed/refractory aggressive NHL

IGI submits first ANDA to FDA

ADHD medication improves childhood cancer survivors: Research

Sanofi Pasteur files Fluzone Intradermal influenza virus vaccine sBLA with FDA

Complementary medicine to save millions: Report

Counterfeit drugs become growing problem

FDA updates Shire's ProAmatine medicine for symptomatic orthostatic hypotension treatment

AB SCIEX, University of Melbourne join to develop drug metabolism studies of biopharmaceuticals

InterMune's development program for pirfenidone, IPF to be presented at Annual Congress of ERS

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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