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Diabetic drug may retard growth of fluid-filled cysts in PKD: Research

Researchers report that a drug commonly used to treat diabetes may also retard the growth of fluid-filled cysts of the most common genetic disorder, polycystic kidney disease.

12 Nov 2010

Aeras receives grant to develop new vaccines for TB

The Aeras Global TB Vaccine Foundation is pleased to announce that the Netherlands Ministry of Foreign Affairs has renewed its funding to Aeras with a pledge of an additional 11.7 million over four years (2011-2014) to further its efforts to develop new vaccines to help combat the global epidemic of tuberculosis.

12 Nov 2010

COMP issues positive opinion for Celsion's ThermoDox Orphan Drug Designation

Celsion Corporation, a leading oncology drug development company, today announced that the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) has issued a positive opinion on the application for Orphan Drug Designation for ThermoDox, a proprietary heat-activated liposomal encapsulation of doxorubicin, for the treatment of hepatocellular carcinoma (HCC), commonly referred to as primary liver cancer.

12 Nov 2010

Nature News examines meningitis vaccine program to roll out in Africa

Nature News reports on an immunization campaign kicking off in Africa in December that will offer protection to some areas of Africa's meningitis belt. Millions will receive a new vaccine, MenAfriVac, that promises protection against the meningococcal bacterium Neisseria meningitides, the news service writes, noting the effort is the culmination of ten years' work by an international consortium to develop a vaccine at a price low enough for massive use in Africa: just US$0.40 a dose.

12 Nov 2010

FDA grants SEDASYS System appeal

Ethicon Endo-Surgery, Inc. (EES) today announced that the Commissioner's Office of the U.S. Food and Drug Administration (FDA) has granted the appeal of the Center for Devices and Radiological Health's (CDRH) denial of the SEDASYS System Premarket Approval Application (PMA). As a result, a new Independent Advisory Panel will be appointed to reconsider the SEDASYS System clinical trial data and application.

11 Nov 2010

Meda acquires Pyralvex, Spasmonal and Waxsol from Norgine

Meda has acquired three well established OTC products from Norgine, a Dutch pharma company. The products are Pyralvex (relief of pain associated with e.g. aphthous ulcers), Spasmonal (treatment of for example Irritable Bowel Syndrome) and Waxsol (ear drops). The largest product is Pyralvex, which has a turnover of about 90 MSEK.

11 Nov 2010

FDA identifies promising steps to enhance safety of CT scans

The U.S. Food and Drug Administration has been investigating reports that patients undergoing computed tomography (CT) brain perfusion scans were accidently exposed to excess radiation. The FDA found that when properly used, the CT scanners did not malfunction. Instead, it is likely that the improper use of the scanners resulted in these overdoses. However, the FDA has identified a series or promising steps to enhance the safety of these procedures. These steps could reduce the likelihood of radiation overexposure in the event of improper use of the CT scanners.

11 Nov 2010

Most drug and biological product makers meet postmarketing requirements and commitments

Most makers of approved drug and biological products are meeting their regulatory obligations and meeting targets for postmarketing studies/clinical trials in a timely manner, according to a study released today by the U.S. Food and Drug Administration (FDA).

11 Nov 2010

Adolor receives U.S. Patent for beloxepin to treat pain

Adolor Corporation today announced that the U.S. Patent and Trademark Office has issued U.S. Patent No. 7,829,576 covering the use of ADL6906 (beloxepin), a small molecule, for the treatment of pain. The issued patent will expire on February 19, 2029.

11 Nov 2010

New 'magic bullet' can eradicate side effects of drug used to treat cystinosis

A 'magic bullet' designed by pharmaceutical scientists at an English university could eradicate the side effects of a drug used to treat a rare genetic disease. Researchers at the University of Sunderland have chemically modified a drug used to treat cystinosis a disease which occurs when the body's mechanism to remove excess cystine (an amino acid) breaks down, leading to kidney problems and eventually affecting other organs to remove unpleasant side effects such as nausea, vomiting, severe halitosis, body odour and a noxious taste.

11 Nov 2010

Dendreon requests licensure for additional capacity to manufacture PROVENGE at New Jersey facility

Dendreon Corporation today announced that it has completed the submission of the post-approval supplement to the PROVENGE® (sipuleucel-T) Biologics License Application for the Morris Plains, New Jersey manufacturing facility. Dendreon is requesting licensure for an additional 36 workstations to manufacture PROVENGE. The standard U.S. Food and Drug Administration (FDA) review for a post-approval supplement to a Biologics License Application is typically four months.

11 Nov 2010

Lemon-lime soft drink could improve effectiveness of oral anticancer drug: Study

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.

11 Nov 2010

PolyMedix receives FDA regulatory clearance for PMX-30063 IND application

PolyMedix, Inc. an emerging biotechnology company focused on developing new therapeutic drugs to treat infectious diseases and acute cardiovascular disorders, has received regulatory clearance from the United States Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for PMX-30063, a synthetic defensin-mimetic antibiotic.

11 Nov 2010

Egrifta receives FDA approval for treatment of HIV-lipodystrophy

The U.S. Food and Drug Administration today approved Egrifta (tesamorelin) to treat HIV patients with lipodystrophy, a condition in which excess fat develops in different areas of the body, most notably around the liver, stomach, and other abdominal organs. The condition is associated with many antiretroviral drugs used to treat HIV.

10 Nov 2010

Appeals court upholds five-year exclusivity period for Shire's VYVANSE

Shire plc, the global specialty biopharmaceutical company, announces that the U.S. Court of Appeals for the District of Columbia Circuit has affirmed the ruling of the U.S. District Court for the District of Columbia and the U.S. Food and Drug Administration to grant five-year New Chemical Entity exclusivity to lisdexamfetamine dimesylate, currently marketed by Shire U.S. Inc. under the name VYVANSE(R).

10 Nov 2010

Hemispherx Biopharma awarded grant for Ampligen, Alferon development programs

Hemispherx Biopharma, Inc. announced today grant awards totaling $488,958 from the U.S. Department of Treasury in support of its Ampligen and Alferon development programs.

10 Nov 2010

PPIs, antiplatelet drugs can help treat CV disease patients at high risk of upper GI bleeding

Using proton pump inhibitors and antiplatelet drugs (thienopyridines) together is an appropriate way of treating patients with cardiovascular disease who are at high risk of upper gastrointestinal bleeds, despite recent concerns about an adverse interaction between these two types of drugs, according to an Expert Consensus Document released jointly today by the American College of Cardiology Foundation, the American College of Gastroenterology, and the American Heart Association.

10 Nov 2010

Omeros identifies orphan GPCR compound that potentiates tumor-killing activity of doxorubicin

Omeros Corporation, a biopharmaceutical company committed to discovering, developing and commercializing products focused on inflammation and disorders of the central nervous system, today announced that a compound identified by the Company as an antagonist of GPR87, an orphan GPCR recently unlocked for drug development by Omeros and linked to squamous cell carcinoma, potentiates the tumor-killing activity of doxorubicin (Adriamycin), a widely used chemotherapeutic agent.

10 Nov 2010

Covidien analysis finds lower incidence of GI adverse events with topical NSAIDs versus oral

Covidien, a leading global provider of healthcare products, announced the results of an analysis that will be presented at the American College of Rheumatology's Annual Scientific Meeting. A pooled analysis of safety data suggests that patients with knee osteoarthritis (OA) receiving the topical PENNSAID® (diclofenac sodium topical solution) 1.5% w/w had significantly fewer gastrointestinal (GI)-related adverse events than those receiving an oral non-steroidal anti-inflammatory drug (NSAID).

10 Nov 2010

Women taking HPV vaccine need only two HPV screening tests for rest of their lives: Research

Women who have had the human papillomavirus vaccine could need only two HPV screening tests for the rest of their lives according to new calculations being presented at the NCRI Cancer Conference in Liverpool.

10 Nov 2010