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NIPTE to develop educational programs on leading edge pharmaceutical technology for FDA reviewers

The U.S. Food and Drug Administration (FDA) has awarded the National Institute for Pharmaceutical Technology and Education, Inc. (NIPTE) a $652,000 two-year contract to develop and deliver a professional development program to help to ensure that FDA reviewers are current in state-of-the-art pharmaceutical manufacturing and technology.

25 Nov 2009

2010 promises to continue acquisition activity as companies seek ways to bolster their pipelines and portfolios

In the past year, drug makers' thirst for innovation combined with small companies' dwindling operating capital to drive merger and acquisition activity. At the high end of the scale, consolidation among industry leaders created some of the richest pharmaceutical mergers in history.

25 Nov 2009

Emerging cancer vaccines: Forecasts, new developments and pipeline analysis

The H1N1 vaccine has spurred media interest in vaccines, as well as predictions of vaccines for a host of new diseases. According to Kalorama Information, certain cancers may be added to the list of diseases for which vaccinations will be employed.

25 Nov 2009

Pharmaceutical research and biotechnology companies test medicines and vaccines to treat HIV/AIDS

America's pharmaceutical research and biotechnology companies are testing 97 medicines and vaccines to treat or prevent HIV/AIDS and related conditions, according to a new report released today by the Pharmaceutical Research and Manufacturers of America (PhRMA).

25 Nov 2009

Incyte enters into collaboration and license agreement with Novartis

Incyte Corporation (NASDAQ: INCY) announced today that it has entered into a collaboration and license agreement with Novartis for two of its investigational hematology-oncology therapies: INCB18424, an oral JAK1/JAK2 inhibitor that is in Phase III development for myelofibrosis, a serious life-threatening neoplastic condition characterized by varying degrees of bone marrow failure, splenic enlargement and debilitating constitutional symptoms, and INCB28060, an oral cMET inhibitor that is about to enter Phase I development as a potential treatment for multiple cancers.

25 Nov 2009

Initiation of Phase II clinical trial to evaluate the efficacy of BN83495 announced

Ipsen today announced the initiation of an international, multi-center, controlled, randomized Phase II clinical trial to evaluate the safety and efficacy of BN83495, its investigational first-in-class steroid sulfatase (STS) inhibitor, in advanced endometrial cancer.

25 Nov 2009

Multiple presentations from clinical and preclinical studies of ISTODAX to be presented

Gloucester Pharmaceuticals today announced multiple presentations from clinical and preclinical studies of ISTODAX® (romidepsin) at the upcoming 51st American Society of Hematology (ASH) Annual Meeting being held in New Orleans, Louisiana, at the Ernest N. Morial Convention Center, December 5 – 8, 2009.

25 Nov 2009

Eisai's NDA for Aricept tablets for treatment of Alzheimer's disease accepted for review

Eisai Inc. and Pfizer Inc announced today that the U.S. Food and Drug Administration (FDA) has accepted for review Eisai's New Drug Application (NDA) for once daily 23 mg Aricept® (donepezil HCl extended release) tablets for the treatment of moderate to severe Alzheimer's disease (AD).

25 Nov 2009

New findings suggest current system of classifying psychoactive drugs in UK may need to be revisited

Drug users are well informed about the harms associated with the drugs they use, and perceive alcohol and tobacco to be amongst the most dangerous substances, according to a survey by UCL (University College London) and Imperial College London researchers.

25 Nov 2009

Worldwide collaboration leads to treatment for rare skin disorder

Researchers at Huntsman Cancer Institute, in collaboration with a worldwide group of physicians and scientists, have discovered a remarkable treatment for a rare, yet debilitating, skin condition.

25 Nov 2009

Several new vaccines require booster shots to remain effective during a lifetime: Study

Preventing disease is the goal of every health care provider and fortunately every year, new vaccines are being added to assist in disease prevention. But do all vaccines boost immunity for the same period of time? And, if not, when are additional 'booster shots' needed to keep immunity strong?

24 Nov 2009

Shanghai Biolaxy receives IND approval for insulin formulation to treat diabetes

Shanghai Biolaxy announced the Chinese State Food & Drug Administration (SFDA) has approved the investigational new drug application (IND) for its oral insulin project (Nodlin), an innovative insulin formulation to treat diabetes. This IND approval allows Biolaxy to initiate its first phase I clinical study.

24 Nov 2009

Reboxetine drug does not alleviate depression, says new study

There is no scientific proof that people suffering from depression can benefit from taking reboxetine. However, clinical trials do provide proof of benefit of bupropion XL and mirtazapine: both agents can alleviate symptoms. This is the conclusion of the final report of the Institute for Quality and Efficiency in Health Care (IQWiG) published on 24 November 2009.

24 Nov 2009

Africa region leaders meet to discuss H1N1 procurement, distribution

Representatives of African countries are meeting in Abuja this week to discuss the procurement and distribution of the H1N1 (swine flu) vaccine, the Daily Trust/allAfrica.com reports (Rabiu, 11/23).

24 Nov 2009

Gilead Sciences and GSK to commercialize Viread in 5 Asian countries

Gilead Sciences, Inc. and GlaxoSmithKline today announced a licensing agreement to commercialize Viread® (tenofovir disoproxil fumarate) for the treatment of chronic hepatitis B (HBV) infection in adults in five countries in Asia. The companies’ combined commercialization activities will expand access to Viread for the treatment of HBV, once approved, to patients in Asia where the prevalence in most countries is greater than 8 percent.

24 Nov 2009

Medical Nutrition launches Diff-Stat pre- and probiotic supplement to prevent the onset of AAD and C-diff

Medical Nutrition USA, Inc., a developer and distributor of uniquely engineered, nutrition-medicine products, announced the introduction of Diff-Stat™, a new supplement containing pre- and probiotics to help restore and maintain beneficial bacteria that prevent the onset of antibiotic-associated diarrhea (AAD) and clostridium difficile (C-diff).

24 Nov 2009

Shire submits a MAA for velaglucerase alfa in Europe

Shire plc, the global specialty biopharmaceutical company, today announced that it has submitted a MAA to the European Medicines Agency for velaglucerase alfa, the company's enzyme replacement therapy in development for the treatment of Type 1 Gaucher disease.

24 Nov 2009

Pharmacy-based intervention improves antipsychotic adherence among patients with mental illnesses

Health systems should consider pharmacy-based interventions when involving patients who have poor follow-through taking medication.

24 Nov 2009

Cardiovascular risks associated with taking Vioxx could have been identified earlier, say researchers

Evidence of cardiovascular risks associated with taking Vioxx, the popular, nonsteroidal anti-inflammatory drug (rofecoxib), could have been identified nearly four years before its manufacturer, Merck & Co. Inc., voluntarily pulled the drug from the market.

24 Nov 2009

NCCN Guidelines adds ofatumumab and romidepsin as therapy options for CLL

Two recent FDA approvals have prompted the National Comprehensive Cancer Network (NCCN) to update the NCCN Clinical Practice Guidelines in Oncology(TM) for Non-Hodgkin's Lymphomas to include ofatumumab (Azerra(TM), GlaxoSmithKline) and romidepsin (Istodax(R), Gloucester Pharmaceuticals) as treatment options for select patients with two types of Non-Hodgkin's Lymphomas.

24 Nov 2009

Pharmaceutical News

NIPTE to develop educational programs on leading edge pharmaceutical technology for FDA reviewers

2010 promises to continue acquisition activity as companies seek ways to bolster their pipelines and portfolios

Emerging cancer vaccines: Forecasts, new developments and pipeline analysis

Pharmaceutical research and biotechnology companies test medicines and vaccines to treat HIV/AIDS

Incyte enters into collaboration and license agreement with Novartis

Initiation of Phase II clinical trial to evaluate the efficacy of BN83495 announced

Multiple presentations from clinical and preclinical studies of ISTODAX to be presented

Eisai's NDA for Aricept tablets for treatment of Alzheimer's disease accepted for review

New findings suggest current system of classifying psychoactive drugs in UK may need to be revisited

Worldwide collaboration leads to treatment for rare skin disorder

Several new vaccines require booster shots to remain effective during a lifetime: Study

Shanghai Biolaxy receives IND approval for insulin formulation to treat diabetes

Reboxetine drug does not alleviate depression, says new study

Africa region leaders meet to discuss H1N1 procurement, distribution

Gilead Sciences and GSK to commercialize Viread in 5 Asian countries

Medical Nutrition launches Diff-Stat pre- and probiotic supplement to prevent the onset of AAD and C-diff

Shire submits a MAA for velaglucerase alfa in Europe

Pharmacy-based intervention improves antipsychotic adherence among patients with mental illnesses

Cardiovascular risks associated with taking Vioxx could have been identified earlier, say researchers

NCCN Guidelines adds ofatumumab and romidepsin as therapy options for CLL

Digital pathology and the PathoVerse: A conversation with Dr. Singh

Bioprocess Efficiency with Cell Density Monitoring

Exploring electron microscopy for plant and microbial imaging at the John Innes Centre

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