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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

McNeil Consumer Healthcare implements voluntary recall of infant and children's liquid products

Working in consultation with the United States Food and Drug Administration, McNeil Consumer Healthcare is implementing a voluntary recall of infant and children's liquid products due to manufacturing deficiencies which may affect quality, purity or potency.

3 May 2010

Pfizer to maintain top spot in prescription sales through mergers and acquisitions

The rheumatoid arthritis treatment Humira will replace Lipitor as the world's biggest-selling drug in 2016, but a familiar name, Pfizer, will still be the biggest seller of medicines after the patent cliff according to the World Preview 2016 report published today by EvaluatePharma, the premier provider of pharma and biotech analysis.

3 May 2010

Triple combination therapy with OM, AML, HCTZ more effective at lowering blood pressure

Results of a new study found that the investigational triple combination therapy of olmesartan medoxomil (OM), amlodipine besylate (AML), and hydrochlorothiazide (HCTZ) demonstrated significantly greater mean reductions at week 12 in blood pressure (37.1/21.8 mm Hg versus 27.5 to 30.0/15.1-18.0 mm Hg LS Mean Reductions, P< 0.0001), as compared to corresponding dual combination therapy (dual components).

3 May 2010

DSM Biologics partners with Australian Governments to build cGMP mammalian CMO

DSM Biologics is pleased to announce the signing of preliminary agreements to enter a partnership with the Australian Governments (Queensland State Government and the Commonwealth of Australia) to design, build and operate the first major Australia-based mammalian biopharmaceutical manufacturing facility, which will be located in Brisbane.

3 May 2010

Celgene seeks court declaration over claims of romidepsin injection usage for T-cell lymphomas

Cyclacel Pharmaceuticals, Inc., a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious disorders, today announced that it received a complaint filed by Celgene Corporation seeking a declaration from the court that four Cyclacel-owned patents, which claim the use of romidepsin injection in T-cell lymphomas, are not infringed by Celgene's products and are invalid.

3 May 2010

Promising results from combination therapy of pemetrexed concurrent with radiation in lung cancer

The first trial of an important new combination therapy of treatment with the chemotherapy drug pemetrexed concurrent with radiation in lung cancer has delivered promising results, French researchers report at the 2nd European Lung Cancer Conference.

3 May 2010

AVANIR Pharmaceuticals announces filing of Complete Response to FDA Approvable Letter for Zenvia

AVANIR Pharmaceuticals, Inc. (NASDAQ: AVNR) today announced the submission of its Complete Response to the October 2006 Approvable Letter issued by the U.S. Food and Drug Administration (FDA) for Zenvia™ (dextromethorphan/quinidine) for the treatment of pseudobulbar affect (PBA). AVANIR expects the FDA to classify the response as a Class 2 resubmission, which would result in an expected review period of 180 days and potential approval of Zenvia in the fourth calendar quarter of 2010.

3 May 2010

Pharmaceutical News

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

McNeil Consumer Healthcare implements voluntary recall of infant and children's liquid products

Pfizer to maintain top spot in prescription sales through mergers and acquisitions

Triple combination therapy with OM, AML, HCTZ more effective at lowering blood pressure

DSM Biologics partners with Australian Governments to build cGMP mammalian CMO

Celgene seeks court declaration over claims of romidepsin injection usage for T-cell lymphomas

Promising results from combination therapy of pemetrexed concurrent with radiation in lung cancer

AVANIR Pharmaceuticals announces filing of Complete Response to FDA Approvable Letter for Zenvia

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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