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Transcept announces resubmission of NDA for Intermezzo to FDA

Transcept Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the development and commercialization of proprietary products that address important therapeutic needs in the field of neuroscience, today announced that the company has resubmitted the New Drug Application for Intermezzo (zolpidem tartrate sublingual tablet) to the U.S. Food and Drug Administration.

28 Sep 2011

Benefits and harms vary among atypical antipsychotics for off-label use

A review of previous studies suggests that even though atypical antipsychotic medications are commonly used for off-label conditions such as behavioral symptoms of dementia, anxiety, and obsessive-compulsive disorder, these medications are effective for only a few off-label conditions, and that the benefits and harms of these medications for these uses vary, according to an article in the September 28 issue of JAMA.

28 Sep 2011

DMARDs appear to be more effective for children with arthritis

Medications known as disease-modifying anti-rheumatic drugs, or DMARDs, appear to be more effective than other treatments for children with arthritis, but there is not enough evidence to support one kind of DMARD over another, according to a new report from HHS' Agency for Healthcare Research and Quality.

28 Sep 2011

Asians struggling with alcoholism may benefit from naltrexone

New UCLA psychology research indicates that Asians who are struggling with alcoholism may benefit especially from naltrexone, one of three medications approved by the U.S. Food and Drug Administration for the treatment of alcoholism.

28 Sep 2011

Study sheds light on when to start antiretroviral therapy

Findings from a study published in the current issue of the journal Archives of Internal Medicine, when "taken together with other studies published over the last few years," show that beginning people living with HIV on highly active antiretroviral therapy (HAART) when their CD4 cell count is between 350 and 500 "appears to be beneficial over the long term.

28 Sep 2011

Photocure, Ipsen partner to commercialise Hexvix for diagnosis of bladder cancer

Ipsen announces today a partnership with Photocure, a specialty pharmaceutical company focused on photodynamic technologies in cancer and dermatology.

27 Sep 2011

MSU creates new malaria vaccine with immune-stimulating gene

Continuing a global effort to prevent malaria infections, Michigan State University researchers have created a new malaria vaccine - one that combines the use of a disabled cold virus with an immune system-stimulating gene - that appears to increase the immune response against the parasite that causes the deadly disease.

27 Sep 2011

Link between changes in malaria parasite and absorption of pharmaceutical compounds

Professor Max Petzold at the Nordic School of Public Health shows in a recent article a link between changes in the malaria parasite and the absorption of pharmaceutical compounds. Increased knowledge of the malaria parasite and the connection with the development of resistance may contribute to the development of new malaria treatments.

26 Sep 2011

New insights into actions of NSAIDs

Ibuprofen, naproxen, and related non-steroidal anti-inflammatory drugs (NSAIDs) - the subjects of years of study - still have some secrets to reveal about how they work.

26 Sep 2011

Vaxent, PREVENT sign license agreement to develop and commercialize Strep-A vaccine

An international collaboration between Vaxent, a Memphis-based early stage vaccine development company in the Memphis Bioworks Foundation Incubator, and The Pan-Provincial Vaccine Enterprise Inc. (PREVENT), a Centre of Excellence for Commercialization and Research (CECR) in Saskatchewan, has put a vaccine for group A streptococcus (Strep-A) back on the path for potential commercialization.

26 Sep 2011

Isis files patent infringement lawsuit against Santaris for antisense drugs

Isis Pharmaceuticals, Inc. announced today it has filed a patent infringement lawsuit against Santaris Pharma A/S and Santaris Pharma A/S Corp. in the United States District Court of the Southern District of California.

26 Sep 2011

Cannabidiol may help prevent paclitaxel-induced peripheral neuropathy

Cannabidiol—a compound derived from marijuana—may be a promising new treatment to prevent the development of painful neuropathy in patients receiving the chemotherapy drug paclitaxel, according to animal experiments reported in the October issue of Anesthesia & Analgesia, official journal of the International Anesthesia Research Society.

26 Sep 2011

No link between duration or depth of general anesthesia and subsequent cancer risk

Helping to allay fears raised by previous studies, a new report finds no link between the duration or depth of general anesthesia and the subsequent risk of developing cancer, according to the October issue of Anesthesia & Analgesia, official journal of the International Anesthesia Research Society.

26 Sep 2011

Self-reported mental health disability more prevalent among U.S. adults

The prevalence of self-reported mental health disabilities increased in the U.S. among non-elderly adults during the last decade, according to a study by Ramin Mojtabai, MD, PhD, of the Johns Hopkins Bloomberg School of Public Health.

26 Sep 2011

Sodium Stibogluconate & Paromomycin combination treatment for Kala azar

East Africa is fighting the worst kala azar outbreak in a decade. Collaboration across the region through the Leishmaniasis East Africa Platform (LEAP) has resulted in the development of a new combination therapy (SSG&PM) which is cheaper and nearly halves the length of treatment from a 30 day course of injections to 17 days.

26 Sep 2011

Rotavirus vaccine saved 65,000 hospitalizations and $278 million in healthcare costs: Study

The latest research shows that since the 2006 introduction of routine inoculation against rotavirus -- a leading cause of diarrhea in infants and young children -- almost 65,000 fewer American children have been hospitalized and about $278 million in healthcare costs have been saved.

26 Sep 2011

Primatene inhalers to be phased out this December: FDA

According to the Food and Drugs Administration (FDA), the Armstrong Pharmaceutical's Primatene mist inhaler will be discontinued on Dec. 31, and prescription inhalers are the only alternative to the over-the-counter asthma drug.

26 Sep 2011

EMA CHMP adopts positive opinion for Optimer's DIFICLIR to treat C. difficile infection

Optimer Pharmaceuticals, Inc. today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for DIFICLIR (fidaxomicin) tablets for the treatment of adults suffering with a Clostridium difficile infection (CDI), also known as C. difficile-associated diarrhea.

26 Sep 2011

CytoDyn files provisional patent application for humanized version of Cytolin to treat HIV

CytoDyn Inc., a biotechnology company focused on the development of new therapies for combating infection with immune deficiency viruses, HIV/AIDS, announced today that it has filed a provisional patent application in the United States for its humanized version of its lead product Cytolin, a monoclonal antibody for the treatment of HIV infection.

26 Sep 2011

Janssen Biotech receives FDA approval for Remicade to treat UC in children

The U.S. Food and Drug Administration today approved Remicade (infliximab) to treat moderately to severely active ulcerative colitis (UC) in children older than 6 years who have had inadequate response to conventional therapy.

26 Sep 2011