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Sinobiopharma's solid dosage Perindopril production facility receives Chinese SFDA approval

Sinobiopharma, Inc. is pleased to announce that its production facility for solid dosage Perindopril has passed the required Chinese State Food and Drug Administration (SFDA) inspection and is now approved for production and marketing.

27 Jan 2010

UCSB research: Rapamycin drug, a potential treatment for ADPKD

Research performed at UC Santa Barbara points to the drug rapamycin as a potential treatment for kidney disease. The study builds on past research and shows that studies performed on mice are more likely to translate to humans than previously thought.

27 Jan 2010

Prometheus Laboratories executes commercialization agreement with Novartis

Prometheus Laboratories Inc., a specialty pharmaceutical and diagnostic company, today announced the execution of a commercialization agreement with Novartis under which Prometheus acquired exclusive rights to distribute, promote and sell PROLEUKIN® (aldesleukin) in the United States.

27 Jan 2010

EpiCept's NP-1 for treatment of PHN receives FDA orphan drug designation

EpiCept Corporation announced today that EpiCeptTM NP-1 has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of post-herpetic neuralgia (PHN). NP-1 is a prescription topical analgesic cream designed to provide long-term relief from the pain of peripheral neuropathies.

27 Jan 2010

FDA approves oral pain relief solution for opioid-tolerant patients

The U.S. Food and Drug Administration today approved Morphine Sulfate Oral Solution for the relief of moderate to severe, acute and chronic pain in opioid-tolerant patients. This medicine will be available in 100 milligrams per 5 mL or 20 milligrams per 1 mL.

27 Jan 2010

Patients with COPD could benefit from treatment with drugs that block sestrin function

Chronic obstructive pulmonary disease (COPD) is defined by emphysema and/or chronic bronchitis. It destroys the normal architecture of the lung and inhibits the mechanical aspects of breathing, which prevents necessary gas exchange. Patients suffer from coughing fits, wheezing, and increased incidence of lung infections.

27 Jan 2010

Neoprobe completes license amendment with The Dow Chemical

Neoprobe Corporation, a diversified developer of innovative oncology surgical and diagnostic products, announced today that it has completed a license amendment with The Dow Chemical Company for a variety of antibodies used in its proprietary surgical oncology system called radioimmunoguided surgery or RIGS®.

27 Jan 2010

UCF researcher develops first dual vaccine to fight malaria and cholera

A University of Central Florida biomedical researcher has developed what promises to be the first low-cost dual vaccine against malaria and cholera.

27 Jan 2010

AAN guideline finds diazepam drug is effective for treating children with cerebral palsy

A new guideline from the American Academy of Neurology and the Child Neurology Society finds botulinum toxin type A to be an effective treatment for spasticity, muscle tightness that interferes with movement, in children and adolescents with cerebral palsy, but poses some risk.

27 Jan 2010

Merck to appeal against U.S. court's ruling in TEMODAR patent infringement lawsuit

Merck & Co., Inc. announced today that the U.S. District Court for the District of Delaware ruled against the company in a patent infringement suit against Teva Pharmaceuticals USA Inc.

27 Jan 2010

FDA approves Victoza to treat type 2 diabetes in some adults

The U.S. Food and Drug Administration today approved Victoza (liraglutide), a once-daily injection to treat type 2 diabetes in some adults.

27 Jan 2010

Antibiotics may be effective in fighting MRSA infections

Researchers at the University of Illinois at Chicago and Israel's Weizman Institute of Science have found that two antibiotics working together might be more effective in fighting pathogenic bacteria than either drug on its own.

27 Jan 2010

ERYtech Pharma receives ODD for its GRASPA from FDA

ERYtech Pharma announces that FDA has granted an Orphan Drug Designation (ODD) for GRASPA®, the company’s lead product in Acute Lymphoblastic Leukaemia.

27 Jan 2010

FDA approves Novo Nordisk's Victoza for type 2 diabetes

Novo Nordisk, a global healthcare company, announced today the U.S. Food and Drug Administration (FDA) approved the new drug application for Victoza® (liraglutide [rDNA origin] injection), the first once-daily human glucagon-like peptide-1 (GLP-1) analog for the treatment of type 2 diabetes. Victoza is indicated as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.

27 Jan 2010

Researchers simplify confusing warnings labels on prescription bottles

Replacing confusing language and icons on standard warnings labels for prescription medicine and listing only the most important warnings could make a big difference in how well patients understand the instructions that are critical to their health, according to a new study from Northwestern University Feinberg School of Medicine.

27 Jan 2010

Abbott submits Premarket Approval application for the ARCHITECT HIV Ag/Ab Combo assay to FDA

An assay to aid in the early detection of HIV infection may soon be available in the United States. Abbott announced today it has submitted a Premarket Approval application for the ARCHITECT HIV Ag/Ab Combo assay to the U.S. Food and Drug Administration (FDA) for expedited review. Upon approval, the assay is expected to be the first test available in the United States to simultaneously detect the combined presence of HIV antigens (proteins produced by the HIV virus) and antibodies (proteins produced by the body to fight HIV antigens), which would allow for the early detection and ongoing monitoring of the virus.

26 Jan 2010

Spectrum Pharmaceuticals to submit additional data for FUSILEV sNDA

Spectrum Pharmaceuticals, a commercial-stage biotechnology company with a primary focus in oncology, today announced that it has met with the FDA regarding it’s supplemental New Drug Application (sNDA) for FUSILEV® (levoleucovorin) for injection for the treatment of patients with advanced metastatic colorectal cancer. In October 2009, the FDA issued a Complete Response letter regarding its sNDA for FUSILEV.

25 Jan 2010

Formulations market: Network to place the Yorkshire and Humber region at the forefront launched

A collaborative network that aims to put the Yorkshire and Humber region at the forefront of the development of product formulations to improve everyday products is being launched in Leeds.

25 Jan 2010

Elan Drug Technologies issues statement on FDA approval of AMPYRA

Elan Drug Technologies, a business unit of Elan Corporation, plc (NYSE: ELN) today issued the following statement regarding the U.S. Food and Drug Administration (FDA) approval of AMPYRA™ (dalfampridine) as a treatment to improve walking in patients with multiple sclerosis (MS).

25 Jan 2010

AMT reaches another milestone in the official marketing authorisation process for Glybera

Amsterdam Molecular Therapeutics, a leader in the field of human gene therapy, has reached another important milestone in the official marketing authorisation process for its lead product Glybera(R), AMT's proprietary product for lipoprotein lipase deficiency (LPLD).

25 Jan 2010

Pharmaceutical News

Sinobiopharma's solid dosage Perindopril production facility receives Chinese SFDA approval

UCSB research: Rapamycin drug, a potential treatment for ADPKD

Prometheus Laboratories executes commercialization agreement with Novartis

EpiCept's NP-1 for treatment of PHN receives FDA orphan drug designation

FDA approves oral pain relief solution for opioid-tolerant patients

Patients with COPD could benefit from treatment with drugs that block sestrin function

Neoprobe completes license amendment with The Dow Chemical

UCF researcher develops first dual vaccine to fight malaria and cholera

AAN guideline finds diazepam drug is effective for treating children with cerebral palsy

Merck to appeal against U.S. court's ruling in TEMODAR patent infringement lawsuit

FDA approves Victoza to treat type 2 diabetes in some adults

Antibiotics may be effective in fighting MRSA infections

ERYtech Pharma receives ODD for its GRASPA from FDA

FDA approves Novo Nordisk's Victoza for type 2 diabetes

Researchers simplify confusing warnings labels on prescription bottles

Abbott submits Premarket Approval application for the ARCHITECT HIV Ag/Ab Combo assay to FDA

Spectrum Pharmaceuticals to submit additional data for FUSILEV sNDA

Formulations market: Network to place the Yorkshire and Humber region at the forefront launched

Elan Drug Technologies issues statement on FDA approval of AMPYRA

AMT reaches another milestone in the official marketing authorisation process for Glybera

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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