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Taxol drug promotes regeneration of nerve cells in CNS after spinal cord injury: Study

In a study published today in Science, a global research team reports that the cancer drug Taxol promotes the regeneration of injured nerve cells in the central nervous system after spinal cord injury.

28 Jan 2011

FDA schedules fourth orphan drug designation workshop

The U.S. Food and Drug Administration has scheduled its fourth orphan drug designation workshop for academics, biotechnology companies, and those unfamiliar with the process for Feb. 28 – March 1, 2011, in Claremont, Calif. in collaboration with Keck Graduate Institute.

28 Jan 2011

Bill Gates, crown prince of Abu Dhabi announce $100m pledge for vaccines for Afghan, Pakistani children

Bill Gates, co-chair of the Bill & Melinda Gates Foundation, and Sheikh Mohammed bin Zayed al-Nahayanm, the crown prince of Abu Dhabi, "pledged $100 million Wednesday to deliver vaccines to children in Afghanistan and Pakistan," Reuters reports.

28 Jan 2011

Tibotec grants multiple non-exclusive licenses to generic manufacturers for rilpivirine hydrochloride

Tibotec Pharmaceuticals today announced that it has granted multiple non-exclusive licenses to generic manufacturers including Hetero Drugs Limited, Matrix Laboratories Limited (a Mylan company) of India and Aspen Pharmacare of South Africa to manufacture, market and distribute the investigational non-nucleoside reverse transcriptase inhibitor rilpivirine hydrochloride (TMC278), pending its approval for use with other antiretroviral agents in the treatment of treatment-naive HIV-1 infected adults.

28 Jan 2011

New research: Retired NFL players more likely to misuse painkillers

Retired NFL players use painkillers at a much higher rate than the rest of us, according to new research conducted by investigators at Washington University School of Medicine in St. Louis.

28 Jan 2011

Frequency of analgesic drug errors in hospitals is nearly 3 per 1000 prescriptions: Study

The frequency of analgesic drug errors in hospitals is nearly 3 per 1,000 prescriptions, based on a study performed in a 631-bed tertiary care facility and published in The Journal of Pain, the peer-review journal of the American Pain Society.

28 Jan 2011

Matrix enters licensing agreement with Tibotec for generic Rilpivirine Hydrochloride

Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has signed an agreement with Tibotec Pharmaceuticals for a non-exclusive license to manufacture, market and distribute a generic version of the non-nucleoside reverse transcriptase inhibitor Rilpivirine Hydrochloride (TMC278), pending its regulatory approval for the treatment of treatment-naive HIV-1-infected adults.

28 Jan 2011

CSL Behring receives marketing approval for HAE drug Berinert in Israel

CSL Behring announced today it has been granted national marketing authorization in Israel to market Berinert® for the treatment of acute hereditary angioedema (HAE) attacks in any body location. With this most recent approval, Berinert is now licensed in 30 countries, including Europe, Japan, North America, South America and Australia.

28 Jan 2011

Reuters examines how Russia's 'drug problem' has 'become an AIDS problem'

Reuters, in a piece exploring the issue of heroin use in Russia describes how the country's "drug problem has now become an AIDS problem."

28 Jan 2011

FDA accepts Pain Therapeutics NDA resubmission for REMOXY

Pain Therapeutics, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) resubmission for REMOXY (controlled-release oxycodone) and has classified it as a Class 2 resubmission.

27 Jan 2011

Medisafe to develop barcoded system to confirm origin of prescription medications

Medisafe 1 Technologies Corp., a developer of patented technologies that physically prevent unauthorized administration of prescription medications, announced today that the company intends to begin development of a barcoded system to confirm the origin and authenticity of prescription medications. The product is aimed at reducing ingestion of counterfeit medications.

27 Jan 2011

Antibiotic use in first six months of life may result in childhood asthma

When babies are given antibiotics, their risk of developing asthma by age 6 may increase by 50 percent. This relationship between antibiotic use in babies less than six months old and risk of developing asthma was documented in a study conducted by Norwegian University of Science and Technology researcher Kari Risnes.

27 Jan 2011

Metanx promotes restoration of lost cutaneous sensation in Diabetic Neuropathy patients

PamLab L.L.C., developer and marketer of Metanx®, announced today that the results of a study to determine if nutritional management with Metanx® improves numbness in the feet of patients with Diabetic Neuropathy (DN) was published in the fourth quarter 2010 issue of Reviews in Neurological Diseases. The study demonstrated that Metanx®, a medical food available by prescription, promotes restoration of lost cutaneous sensation in DN patients.

27 Jan 2011

FDA, Simulations Plus sign RCA to develop QSAR toxicity models

Simulations Plus, a leading provider of software for pharmaceutical discovery and development, announced that the U.S. Food and Drug Administration and Simulations Plus have signed a five-year research collaboration agreement to work together to develop Quantitative Structure-Activity Relationship toxicity models for FDA regulatory and research applications.

27 Jan 2011

FDA issues Complete Response letter for Avodart sNDA for reduction of prostate cancer risk

GlaxoSmithKline (GSK) today announced that the Company has received a Complete Response letter from the U.S. Food and Drug Administration (FDA) for the supplemental New Drug Application (sNDA) for Avodart® (dutasteride) for reducing the risk of prostate cancer in men at increased risk for the disease, defined as those who have had a prior negative biopsy due to clinical concern and have an elevated serum prostate-specific antigen (PSA).

27 Jan 2011

Quest Diagnostics releases new data on oral fluid testing system

OraSure Technologies, the market leader in oral fluid diagnostics, announced today that Quest Diagnostics Incorporated released new data indicating that oral fluid revealed approximately five times more heroin use in the general U.S. workforce than previously believed.

From Quest Diagnostics 27 Jan 2011

WSJ: Biotech generics battle heats up

A battle is heating up over the meaning of a single word in the health overhaul that could mean billions of dollars to the makers of biotechnology drugs (Mundy, 1/26).

27 Jan 2011

Teva, APP enter agreement for launch of generic Gemzar

Teva Pharmaceutical Industries Ltd. and APP Pharmaceuticals, Inc. announced today the commercial launch of Gemcitabine HCI for Injection in 200 mg and 1 g single dose vials, the generic version of Gemzar®, in the United States, pursuant to a commercialization, manufacture and supply agreement signed by the two companies.

26 Jan 2011

Pill for multiple sclerosis in the pipeline

Multiple Sclerosis or MS is a severely disabling disease that affects 100,000 in the UK. Now a new pill has been developed to treat multiple sclerosis which means there would be no need for injections. European health experts - European Medicines Agency (EMA) have given the new drug Gilenya, the brand name for the drug fingolimod, approval which would grant it EU wide acceptance.

25 Jan 2011

Nordion and Sterigenics sign five year contract for Cobalt-60 supply

Nordion Inc., a leading provider of products and services to the global health science market, today announced it has signed a five-year contract with Sterigenics International, a global leader in contract sterilization and ionization services, for the supply of Cobalt-60. Under the terms of the agreement, this contract extends until October 31, 2015.

25 Jan 2011

Pharmaceutical News

Taxol drug promotes regeneration of nerve cells in CNS after spinal cord injury: Study

FDA schedules fourth orphan drug designation workshop

Bill Gates, crown prince of Abu Dhabi announce $100m pledge for vaccines for Afghan, Pakistani children

Tibotec grants multiple non-exclusive licenses to generic manufacturers for rilpivirine hydrochloride

New research: Retired NFL players more likely to misuse painkillers

Frequency of analgesic drug errors in hospitals is nearly 3 per 1000 prescriptions: Study

Matrix enters licensing agreement with Tibotec for generic Rilpivirine Hydrochloride

CSL Behring receives marketing approval for HAE drug Berinert in Israel

Reuters examines how Russia's 'drug problem' has 'become an AIDS problem'

FDA accepts Pain Therapeutics NDA resubmission for REMOXY

Medisafe to develop barcoded system to confirm origin of prescription medications

Antibiotic use in first six months of life may result in childhood asthma

Metanx promotes restoration of lost cutaneous sensation in Diabetic Neuropathy patients

FDA, Simulations Plus sign RCA to develop QSAR toxicity models

FDA issues Complete Response letter for Avodart sNDA for reduction of prostate cancer risk

Quest Diagnostics releases new data on oral fluid testing system

WSJ: Biotech generics battle heats up

Teva, APP enter agreement for launch of generic Gemzar

Pill for multiple sclerosis in the pipeline

Nordion and Sterigenics sign five year contract for Cobalt-60 supply

How industrial hygiene flow calibration supports defensible exposure data

How electrical engineering ensures accurate calibration and patient safety

The importance of ketones from a clinical and medical perspective

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