Pharmaceutical News

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Patients may not benefit from e-samples of prescription drugs, says UW

Search the Internet to learn about your asthma, high cholesterol or other common disorder, and odds are you'll be directed to a pharmaceutical company-sponsored Web homepage. There you'll often find an offer for a free sample or a one-time discount on a top-selling prescription medication.

25 Nov 2009

Erbitux drug can reverse rare stomach disorder, report researchers

A drug used to treat colorectal cancer also can reverse a rare stomach disorder and should be considered first-line therapy for the disease, researchers at Vanderbilt University Medical Center report this week.

25 Nov 2009

Tibotec Therapeutics' INTELENCE granted FDA traditional approval

The FDA granted traditional approval for INTELENCE® (etravirine) tablets, a non-nucleoside reverse transcriptase inhibitor (NNRTI). INTELENCE is the only NNRTI specifically indicated for use in treatment-experienced adults who are experiencing virologic failure with HIV-1 strains resistant to an NNRTI and other antiretroviral (ARV) agents.

25 Nov 2009

Lethality of H1N1 virus has dropped from its peak of 3.7, shows new data

Biotech firm Replikins Ltd., which has analyzed the H1N1 virus' genomic data from the 1918 pandemic through the prediction, outbreak, and progress of the current H1N1 pandemic, today issued its latest biochemical analysis of the virus.

25 Nov 2009

No evidence of improved survival for epinephrine administered patients during ACLS

Patients with an out-of-hospital cardiac arrest who received intravenous (IV) drug administration during treatment, recommended in life support guidelines, had higher rates of short term survival but no statistically significant improvement in survival to hospital discharge or long-term survival, compared to patients who did not receive IV drug administration, according to a study in the November 25 issue of JAMA.

25 Nov 2009

Data miners can inform drug companies of doctors' prescribing habits

The Baltimore Sun reports: "[P]harmaceutical companies that make … prescription drugs are also looking over the doctor's shoulder, keeping track of how many prescriptions for whose drugs the individual physician is writing."

25 Nov 2009

Sinovac Dalian JV to research, develop, produce and commercialize human-use vaccines

Sinovac Biotech Ltd. ( SVA), a leading developer and provider of vaccines, announced today that it executed a joint venture (JV) agreement to establish Sinovac (Dalian) Vaccine Technology Co., Ltd. (Sinovac Dalian). The JV will research, develop, produce and commercialize human-use vaccines. Sinovac will contribute its expertise and experience in developing and commercializing world-class vaccines; the other party will bring its land use rights, manufacturing facilities and established operating infrastructure.

25 Nov 2009

QLT announces litigation settlement with Massachusetts General Hospital

QLT Inc. ("QLT" or the "Company") today announced the settlement of its litigation with the General Hospital Corporation, doing business as Massachusetts General Hospital ("MGH").

25 Nov 2009

Human Genome Sciences submits BLA for ZALBIN

Human Genome Sciences, Inc. today announced that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ZALBIN™ (albinterferon alfa-2b) for the treatment of chronic hepatitis C. The BLA submission includes the results of two pivotal Phase 3 clinical trials showing that 900-mcg albinterferon alfa-2b dosed every two weeks met its primary endpoint of non-inferiority to peginterferon alfa-2a (Pegasys) dosed once each week.

25 Nov 2009

FDA approves Berinert for treating HAE in adults and adolescents

Berinert®, a human C1 esterase inhibitor (C1-INH) for treating acute episodes of facial or abdominal hereditary angioedema (HAE) in adults and adolescents has obtained approval from the US Food and Drug Administration (FDA).

25 Nov 2009

Pennsylvanians at-risk for H1N1 flu receive H1N1 vaccination

Governor Edward G. Rendell today announced that 100,000 Pennsylvanians at-risk for the H1N1 flu were vaccinated during the weekend at public health clinics held by the Department of Health and local health departments.

25 Nov 2009

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

Pharmaceutical News

Patients may not benefit from e-samples of prescription drugs, says UW

Erbitux drug can reverse rare stomach disorder, report researchers

Tibotec Therapeutics' INTELENCE granted FDA traditional approval

Lethality of H1N1 virus has dropped from its peak of 3.7, shows new data

No evidence of improved survival for epinephrine administered patients during ACLS

Data miners can inform drug companies of doctors' prescribing habits

Sinovac Dalian JV to research, develop, produce and commercialize human-use vaccines

QLT announces litigation settlement with Massachusetts General Hospital

Human Genome Sciences submits BLA for ZALBIN

FDA approves Berinert for treating HAE in adults and adolescents

Pennsylvanians at-risk for H1N1 flu receive H1N1 vaccination

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

Real-time Raman monitoring for pharmaceutical hot melt extrusion

Synthetic Psychedelics: A Growing Public Health Concern

How the Vutara VXL simplifies single-molecule imaging

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