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ZENPEP CF Cycle for Life to be launched to support research and cure for cystic fibrosis

Thousands of cyclists will take to the streets this summer and fall as the Cystic Fibrosis Foundation launches a new cycling tour in 18 cities across the country to support research to find new therapies and a cure for cystic fibrosis. The tour series, known as ZENPEP CF Cycle for Life, begins in San Francisco on June 26.

4 May 2010

Teva reports 31% increase in non-GAAP net income for first-quarter 2010

Teva Pharmaceutical Industries Ltd. today reported results for the quarter ended March 31, 2010.

4 May 2010

Informative session on TP-drug interactions

AAPS is pleased to present the workshop on Strategies to Address Therapeutic Protein Drug Interactions during Clinical Development. This event will feature a review of pre-clinical tools, test systems, and relevant documented Therapeutic Protein-drug interactions.

4 May 2010

Despite FDA black box warning, prescription of Reglan for premature infants continue

Recently, researchers have observed a disturbing trend in neonatal units across the country: doctors prescribing Reglan -- also known by its generic name, metoclopramide -- to treat premature infants. This alarming development has raised serious concerns from many consumer safety advocates, particularly because the drug was never approved for use in infants.

4 May 2010

EpiCept's first Ceplene commercial shipment to the EU triggers $2M milestone payment from Meda

EpiCept Corporation today announced that it has earned a $2 million milestone payment from Meda AB, for the first commercial shipment of Ceplene® (histamine dihydrochloride) to a major country in the European Union, as defined in the agreement.

4 May 2010

Statins may improve longevity of hip replacement surgery

The use of statins - drugs commonly prescribed to help lower cholesterol levels - may play an important role in decreasing complications among patients undergoing total hip replacement (THR), according to a study published in the May 2010 issue of the Journal of Bone and Joint Surgery (JBJS).

4 May 2010

Par Pharmaceutical signs exclusive licensing agreement with Glenmark to market ezetimibe in the U.S.

Par Pharmaceutical Companies, Inc. today announced that its generic division, Par Pharmaceutical, has entered into an exclusive licensing agreement with Glenmark Generics Limited and Glenmark Generics Inc., USA to market ezetimibe 10 mg tablets, the generic version of Merck & Co. Inc.'s Zetia, in the U.S. Zetia is a cholesterol modifying agent with annual U.S. sales of approximately $1.4 billion, according to IMS Health data.

4 May 2010

Sepracor issued FDA Complete Response Letter for STEDESA NDA

Sepracor Inc., a U.S. subsidiary of Dainippon Sumitomo Pharma Co., Ltd. (DSP), today announced that the U.S. Food and Drug Administration (FDA, or Agency) has issued a Complete Response Letter to Sepracor's New Drug Application (NDA) for its antiepileptic drug candidate, STEDESA™, which is the company's proposed trade name for eslicarbazepine acetate.

4 May 2010

Fate of the unused swine flu vaccines

The United States Government in an announcement on Monday revealed that the U.S. still has 71 million doses of unused H1N1 swine flu vaccine but there is still time left before it is wasted. They have urged the providers to keep the vaccines and continue to supply them to people until pharmaceutical manufacturers start distributing seasonal vaccine for the coming influenza season in the autumn.

4 May 2010

Boost for biologics manufacturing in Australia

AusBiotech has welcomed the news that Australia’s first major contract manufacturing facility for biologic medicines has secured backing and is set to be built in Queensland by 2012.

3 May 2010

Health care practitioners call for national database to crack down on prescription drug abuse

The Associated Press reports on efforts in California, where "a state online drug database went into effect last year to thwart addicts who bounce from doctor to doctor to feed a habit or make a small fortune peddling meds" and efforts to set up a national program "to snare so-called doctor shoppers and curb drug abuse.

3 May 2010

Today's Opinions and Editorials: The end of insurance rescissions, lessons from the health care rollout and the deficit panel's tough decisions

A lot of people laughed when Sue Lowden, the Nevada Republican running for the U.S. Senate, suggested last month that people start paying for their medical care with chickens. I didn't (Jonathan Cohn, 5/3).

3 May 2010

ImmunoCellular Therapeutics seeks FDA orphan drug status for ICT-107 dendritic-cell based vaccine for GBM

ImmunoCellular Therapeutics announced today it has filed an orphan drug application with the U.S. Food and Drug Administration (FDA) for its cancer treatment candidate ICT-107. ICT-107 is a dendritic-cell based cancer vaccine product which targets glioblastoma multiforme (GBM), the most prevalent, aggressive and malignant form of primary brain tumors.

3 May 2010

FDA approves Abbott's CREON sNDA including dosing guidance for treating EPI due to CP, pancreatectomy

Abbott announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for CREON® (pancrelipase) Delayed-Release Capsules that now includes dosing guidance in the prescribing information specific to patients with limited production of enzymes in the pancreas (exocrine pancreatic insufficiency) due to chronic pancreatitis (CP) or removal of the pancreas (pancreatectomy). Prior to this FDA approval, dosing guidance for medications such as CREON was based on patients with cystic fibrosis.

3 May 2010

Investment report on Spectrum Pharmaceuticals

MicroStockProfit.com announces an investment report featuring Spectrum Pharmaceuticals Inc. The report includes financial, comparative and investment analyses, and industry information you need to know to make an educated investment decision.

3 May 2010

TGRD presents positive results from Phase 3 studies of azilsartan medoxomil for lowering SBP at 25th ASH

Takeda Global Research & Development Center, Inc., U.S., (TGRD U.S.) today announced results from pivotal phase 3 studies of azilsartan medoxomil (development code: TAK-491), an angiotensin II receptor blocker (ARB), demonstrating greater 24-hour systolic blood pressure (SBP) reduction compared to commonly prescribed ARBs olmesartan medoxomil and valsartan.

3 May 2010

Researchers discuss challenges to improve vaccine coverage for American children

While national immunization rates remain high, vaccine refusals are troubling. In some parts of the country, pockets of unimmunized children have left communities vulnerable to vaccine-preventable diseases, leading to outbreaks.

3 May 2010

Inspire Pharmaceuticals reports net loss of $14.8M for first-quarter 2010

Inspire Pharmaceuticals, Inc. announced today financial results for the first quarter ended March 31, 2010, reporting a net loss of $14.8 million or ($0.18) per share.

3 May 2010

Belatacept preserves kidney function in transplant recipients better than cyclosporine, says study

Two-year results from phase III clinical trials show the experimental immunosuppressive drug belatacept can better preserve kidney function in kidney transplant recipients while preventing graft rejection when compared with the standard immunosuppressive drug cyclosporine.

3 May 2010

Extended hepatitis C treatment increases sustained virological response after liver transplant

Extending hepatitis C treatment for liver transplant patients beyond current standards results in high clearance rates of the hepatitis C virus from the blood, and a low relapse rate, according to a study by Henry Ford Hospital.

3 May 2010

Pharmaceutical News

ZENPEP CF Cycle for Life to be launched to support research and cure for cystic fibrosis

Teva reports 31% increase in non-GAAP net income for first-quarter 2010

Informative session on TP-drug interactions

Despite FDA black box warning, prescription of Reglan for premature infants continue

EpiCept's first Ceplene commercial shipment to the EU triggers $2M milestone payment from Meda

Statins may improve longevity of hip replacement surgery

Par Pharmaceutical signs exclusive licensing agreement with Glenmark to market ezetimibe in the U.S.

Sepracor issued FDA Complete Response Letter for STEDESA NDA

Fate of the unused swine flu vaccines

Boost for biologics manufacturing in Australia

Health care practitioners call for national database to crack down on prescription drug abuse

Today's Opinions and Editorials: The end of insurance rescissions, lessons from the health care rollout and the deficit panel's tough decisions

ImmunoCellular Therapeutics seeks FDA orphan drug status for ICT-107 dendritic-cell based vaccine for GBM

FDA approves Abbott's CREON sNDA including dosing guidance for treating EPI due to CP, pancreatectomy

Investment report on Spectrum Pharmaceuticals

TGRD presents positive results from Phase 3 studies of azilsartan medoxomil for lowering SBP at 25th ASH

Researchers discuss challenges to improve vaccine coverage for American children

Inspire Pharmaceuticals reports net loss of $14.8M for first-quarter 2010

Belatacept preserves kidney function in transplant recipients better than cyclosporine, says study

Extended hepatitis C treatment increases sustained virological response after liver transplant

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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