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Taiwan approves RBC Life Sciences' Stem-Kine for importation and sale

RBC Life Sciences, Inc. announced today that the Company's stem cell supplement, Stem-Kine, has been approved for importation and sale in Taiwan. Stem-Kine is marketed in Taiwan under the name SK Plus.

27 Aug 2012

FDA approves Mallinckrodt's EXALGO (32 mg) sNDA to manage opioid-related pain

Zalicus Inc., a biopharmaceutical company that discovers and develops novel treatments for patients suffering from pain and immuno-inflammatory diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) filed by Mallinckrodt Inc., a subsidiary of Covidien plc, for the 32 mg dose strength of EXALGO (hydromorphone HCl) Extended-Release Tablets (CII), for the management of moderate to severe pain in opioid-tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time.

27 Aug 2012

XJB-5-131 prevents secondary damage of severe traumatic brain injury

Treatment with an agent that blocks the oxidation of an important component of the mitochondrial membrane prevented the secondary damage of severe traumatic brain injury and preserved function that would otherwise have been impaired, according to a research team from the University of Pittsburgh School of Medicine, Graduate School of Public Health and Department of Chemistry in a report published online today in Nature Neuroscience.

27 Aug 2012

EC grants marketing authorization to Meda's Zyclara for treatment of actinic keratosis

Meda announced today that the European Commission (EC) has granted marketing authorization for Zyclara in the European Union. Zyclara (imiquimod 3.75% cream) is a patented product for the treatment of actinic keratosis.

27 Aug 2012

Genzyme receives Refuse to File letter from FDA for LEMTRADA

Genzyme, a Sanofi company, announced it has received a Refuse to File letter from the U.S. Food and Drug Administration (FDA) in response to the supplemental Biologics License Application (sBLA) for the approval of LEMTRADA (alemtuzumab) as a treatment for relapsing multiple sclerosis.

27 Aug 2012

Despite controversy, WHO not likely to change its stance on misoprostol use

Highlighting a recent report by the Journal of the Royal Society of Medicine about the use of the drug misoprostol to prevent postpartum hemorrhage and the WHO's inclusion of the drug on its Essential Medicine List, Guardian health editor Sarah Boseley writes in this post in her "Global Health Blog," "Seldom has there been a drug that has excited as much controversy as misoprostol."

27 Aug 2012

PEI adjuvant improves effect of vaccines against flu, HIV and herpes

Oxford University scientists have discovered a compound that greatly boosts the effect of vaccines against viruses like flu, HIV and herpes in mice.

26 Aug 2012

Research roundup: Who do patients seek for primary care?; Treating kids with antipsychotics

n order to find out what kind of doctor patients were visiting for primary care service, researchers analyzed the frequency in which patients visited generalists and specialists in 1999 and 2007 by using a nationally representative sample of outpatient visits.

26 Aug 2012

Dominican Republic establishes commission to examine implications of including ART in country health plan

"The Dominican Republic is one step closer to ensuring that all people living with HIV access treatment," UNAIDS reports in an article on its webpage, adding, "The country's National Social Security Council has established a commission to look into the technical, financial and operational implications of including antiretroviral therapy (ART) in the Basic Health Plan."

26 Aug 2012

Novira secures $23M in Series A financing to support antiviral development for HBV, HIV

Novira Therapeutics Inc. today announced it has secured $23 million in Series A financing to support the development of its capsid-targeting antivirals for the treatment of chronic hepatitis B (HBV) and HIV infections.

24 Aug 2012

Religion not a barrier to HIV testing, treatment, study finds

"Preachers who promise divine healing have often been blamed for turning desperate HIV-positive people against their life-prolonging antiretroviral (ARV) medication and risking their health, but recent research suggests that religious beliefs may not be a barrier to treatment after all," IRIN/Plus News reports.

24 Aug 2012

Study demonstrates how DBP production is modulated by daily variations of temperature

Numerous processes in our body fluctuate in a regular pattern during the day. These circadian (or daily) variations can be driven by local oscillators present within our cells or by systemic signals controlled by the master pacemaker, located in the brain. Ueli Schibler, professor at the University of Geneva (UNIGE), Switzerland, unveils a molecular mechanism by which body temperature rhythms influence the expression of 'clock genes' and synchronize local oscillators.

24 Aug 2012

Proposed U.S. legislation would 'set the standard' for global efforts to combat counterfeit drugs

In this Forbes opinion piece, John Lechleiter, president and chief executive officer of Eli Lilly and Company, examines the business of counterfeit medicines, writing, "With global sales last year estimated as high as $200 billion, counterfeit medicine is big business, and it's growing."

24 Aug 2012

FDA approves Watson’s ANDA for lidocaine topical patch 5%

Watson Pharmaceuticals, Inc. today announced that its subsidiary, Watson Laboratories, Inc., has received final approval from the United States Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for lidocaine topical patch 5%, the generic equivalent to Endo's Lidoderm.

24 Aug 2012

Early exposure to antibiotics primes children for obesity later in life

Researchers at NYU School of Medicine have made a novel discovery that could have widespread clinical implications, potentially affecting everything from nutrient metabolism to obesity in children.

23 Aug 2012

VOA examines new tests to rapidly identify counterfeit medications

"Counterfeit medications are a serious and sometimes deadly problem in developing countries," but "two teams of U.S.-based scientists have developed quick tests can identify counterfeit drugs before they can cause harm," VOA News reports.

23 Aug 2012

Positron submits Drug Master File with FDA for production of API grade Sr-82

Positron Corporation, a leading molecular imaging healthcare company, is pleased to announce the submission of a Drug Master File (DMF), with the Federal Drug Administration (FDA), for the production of Active Pharmaceutical Ingredient (API) grade strontium-82, through its wholly owned subsidiary Manhattan Isotope Technology, LLC.

23 Aug 2012

Article describes immune-related adverse events with newly approved melanoma drug

An internationally recognized melanoma researcher at Moffitt Cancer Center and colleagues at the University of Kiel in Germany, including Axel Hauschild, M.D. and Katharina C. K-hler, M.D., have published an article in the current issue of The Journal of Clinical Oncology that describes immune-related adverse events for patients receiving either tremelimumab or ipilimumab, the latter a drug approved last year by the U.S. Food and Drug Administration for treating metastatic melanoma and other cancers.

23 Aug 2012

New results describe development of DC cancer vaccine with enhanced immunogenic potential

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, and collaborators at Radboud University Nijmegen Medical Centre in the Netherlands announced today that they have published new pre-clinical results in the journal Cancer Immunology Immunotherapy describing the development of a dendritic cell (DC) cancer vaccine with enhanced immunogenic potential.

23 Aug 2012

Statin's potency may cause muscle problems in patients with cardiovascular disease

A study from the University of California, San Diego School of Medicine, published August 22 online by PLoS ONE, reports that muscle problems reported by patients taking statins were related to the strength or potency of the given cholesterol-lowering drugs.

23 Aug 2012

Pharmaceutical News

Taiwan approves RBC Life Sciences' Stem-Kine for importation and sale

FDA approves Mallinckrodt's EXALGO (32 mg) sNDA to manage opioid-related pain

XJB-5-131 prevents secondary damage of severe traumatic brain injury

EC grants marketing authorization to Meda's Zyclara for treatment of actinic keratosis

Genzyme receives Refuse to File letter from FDA for LEMTRADA

Despite controversy, WHO not likely to change its stance on misoprostol use

PEI adjuvant improves effect of vaccines against flu, HIV and herpes

Research roundup: Who do patients seek for primary care?; Treating kids with antipsychotics

Dominican Republic establishes commission to examine implications of including ART in country health plan

Novira secures $23M in Series A financing to support antiviral development for HBV, HIV

Religion not a barrier to HIV testing, treatment, study finds

Study demonstrates how DBP production is modulated by daily variations of temperature

Proposed U.S. legislation would 'set the standard' for global efforts to combat counterfeit drugs

FDA approves Watson’s ANDA for lidocaine topical patch 5%

Early exposure to antibiotics primes children for obesity later in life

VOA examines new tests to rapidly identify counterfeit medications

Positron submits Drug Master File with FDA for production of API grade Sr-82

Article describes immune-related adverse events with newly approved melanoma drug

New results describe development of DC cancer vaccine with enhanced immunogenic potential

Statin's potency may cause muscle problems in patients with cardiovascular disease

Exploring the nanoscale: How AFM is transforming cosmetic science

Innovating Texture and Culture in Plant-Based Foods

Advancing brain microphysiological systems (bMPS)

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