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Pernix obtains marketing rights to new gastroenterology product in the U.S.

Pernix Therapeutics Holdings, Inc., a specialty pharmaceutical company, today announced it has entered into a license and supply agreement with a private company for a new FDA-approved prescription product to treat gastroenterology disease.

24 Jan 2012

Perrigo files ANDA and confirms Astepro Nasal Spray patent challenge

Perrigo Company announced that it has filed with the U.S. Food and Drug Administration (FDA) an Abbreviated New Drug Application (ANDA) for azelastine hydrochloride nasal spray (0.15%) and has notified Meda Pharmaceuticals, Inc., the owner of the New Drug Application (NDA) of its filing. The ANDA filing involved contributions from both Perrigo and Impax Laboratories, Inc., who will share costs and benefits of this project.

24 Jan 2012

Takeda receives FDA approval for VELCADE sNDA to treat MM

Millennium: The Takeda Oncology Company with its parent company Takeda Pharmaceutical Company Limited today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for VELCADE(bortezomib), which updates the label to include the subcutaneous method of administration in all approved indications: multiple myeloma and mantle cell lymphoma after at least one prior therapy.

24 Jan 2012

Ikaria receives FDA orphan drug designation for use of iNO in PAH

Ikaria, Inc., a critical care company focused on developing and commercializing innovative therapies for critically ill patients, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for the use of inhaled nitric oxide (iNO) with the INOpulse DS drug-delivery system as a combination product for pulmonary arterial hypertension.

23 Jan 2012

FzioMed's DYNAVISC adhesion barrier gel receives European CE Mark approval

FzioMed, Inc. is pleased to announce that it has received CE Mark approval to market DYNAVISC adhesion barrier gel in Europe for tendon and peripheral nerve surgery.

23 Jan 2012

Haymarket Media launches ChemotherapyAdvisor.com

Haymarket Media Inc., publisher of Monthly Prescribing Reference (MPR), MPR Hematology/Oncology Edition, and Oncology Nurse Advisor (ONA), is pleased to announce the launch of ChemotherapyAdvisor.com, offering oncologists and their support teams a unique clinical decision support tool.

23 Jan 2012

Potential role of omega-3 fatty acid in preventing psychological consequences of accidents

A report in the 5th 2011 issue of Psychotherapy and Psychosomatics suggests the potential role of omega-3 fatty acid in preventing the psychological consequences of an accident.

23 Jan 2012

Study describes new pharmacological resistance to colon cancer

Doctors and researchers of Hospital del Mar and its research institute, the IMIM, have lead a study describing a new pharmacological resistance to cancer. This new mechanism is a mutation in an oncogene called EGFR (epidermal growth factor receptor) causing resistance to treatment using a drug called cetuximab, a monoclonal antibody which specifically attacks the EGFR.

23 Jan 2012

Chronic inflammation combines with DNA methylation to promote development of colorectal cancer

Chronic inflammation combines with DNA methylation, a process that shuts down cancer-fighting genes, to promote development of colorectal cancer, scientists at The University of Texas MD Anderson Cancer Center report today in the advance online publication of the journal Nature Medicine.

23 Jan 2012

Multiple sclerosis drug Gilenya under investigation by FDA and EMA

The US Food and Drugs Administration (FDA) and European Medicines Agency (EMA) are looking at the pros and cons of using Gilenya (fingolimod) in treating the neurological autoimmune disease Multiple Sclerosis (MS).

23 Jan 2012

EMA CHMP issues positive opinion to MSD's REMICADE for treatment of pediatric UC

MSD today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the use of REMICADE (infliximab) in the treatment of severely active ulcerative colitis (UC) in pediatric patients ages 6 to 17 years, who have had an inadequate response to conventional therapy, including corticosteroids and 6-mercaptopurine or azathioprine, or who are intolerant to or have medical contraindications for such therapies.

21 Jan 2012

Risperdal lawsuit settlement: Largest Medicaid fraud case in Texas

Texas and Janssen Pharmaceuticals reach a $158 million settlement on a suit claiming that the company lied about the efficacy of the anti-psychotic medicine.

21 Jan 2012

FDA allows marketing of Stratify JCV Antibody ELISA test for PML

Today, the U.S. Food and Drug Administration allowed marketing of the first test to help determine the risk for a rare brain infection called progressive multifocal leukoencephalopathy (PML) in people using the drug Tysabri (natalizumab) to treat multiple sclerosis (MS) or Crohn's disease.

21 Jan 2012

FDA approves product label change for Biogen Idec's TYSABRI to treat MS

Today Biogen Idec and Elan Corporation, plc announced that the U.S. Food and Drug Administration (FDA) has approved a product label change for TYSABRI that will help enable individual benefit risk assessment for patients with multiple sclerosis.

21 Jan 2012

ARCA biopharma receives method patent for treatment with bucindolol based on genetic targeting

ARCA biopharma, Inc., a biopharmaceutical company developing genetically targeted therapies for cardiovascular diseases, today announced that the U.S. Patent and Trademark Office has issued a patent on methods for determining whether to administer or prescribe bucindolol to a patient based on whether the patient has a specific genotype - homozygous for the arginine 389 polymorphism in the beta-1 adrenergic receptor.

20 Jan 2012

Combination of gefitinib and miRNA-inhibitor might effectively treat NSCLC

New research published in Nature Medicine indicates that targeted drugs such as gefitinib might more effectively treat non-small cell lung cancer if they could be combined with agents that block certain microRNAs.

20 Jan 2012

CHORI senior scientist reveals mechanism for iron absorption from non-meat sources

A groundbreaking study conducted by Children's Hospital Oakland Research Institute (CHORI) Senior Scientist Elizabeth Theil, PhD, is the first to reveal the existence of at least two independent mechanisms for iron absorption from non-meat sources-and a potential treatment for iron deficiency, the most common nutrient deficiency worldwide.

20 Jan 2012

Shortages of anti-infective drugs can put patients at risk and alter clinical care

Shortages of key drugs used to fight infections represent a public health emergency and can put patients at risk, according to a review published in Clinical Infectious Diseases and available online.

20 Jan 2012

EMA CHMP may issue an opinion on CTI's Pixuvri MAA in mid-Feb.

Cell Therapeutics, Inc. ("CTI") announced today that, following discussions with the European Medicines Agency's ("EMA") Committee for Medicinal Products for Human Use ("CHMP"), the CHMP may issue an opinion on CTI's Marketing Authorization Application ("MAA") for Pixuvri in mid-February.

20 Jan 2012

New research could lead to cheaper, easier production of malaria drug artemisinin

"Artemisinin, a crucial drug in the global fight against malaria, could soon become cheaper and easier to make, thanks to researchers who have found a better way to synthesize the compound," Science NOW reports, providing an overview of the research published in Angewandte Chemie on Monday.

20 Jan 2012

Pharmaceutical News

Pernix obtains marketing rights to new gastroenterology product in the U.S.

Perrigo files ANDA and confirms Astepro Nasal Spray patent challenge

Takeda receives FDA approval for VELCADE sNDA to treat MM

Ikaria receives FDA orphan drug designation for use of iNO in PAH

FzioMed's DYNAVISC adhesion barrier gel receives European CE Mark approval

Haymarket Media launches ChemotherapyAdvisor.com

Potential role of omega-3 fatty acid in preventing psychological consequences of accidents

Study describes new pharmacological resistance to colon cancer

Chronic inflammation combines with DNA methylation to promote development of colorectal cancer

Multiple sclerosis drug Gilenya under investigation by FDA and EMA

EMA CHMP issues positive opinion to MSD's REMICADE for treatment of pediatric UC

Risperdal lawsuit settlement: Largest Medicaid fraud case in Texas

FDA allows marketing of Stratify JCV Antibody ELISA test for PML

FDA approves product label change for Biogen Idec's TYSABRI to treat MS

ARCA biopharma receives method patent for treatment with bucindolol based on genetic targeting

Combination of gefitinib and miRNA-inhibitor might effectively treat NSCLC

CHORI senior scientist reveals mechanism for iron absorption from non-meat sources

Shortages of anti-infective drugs can put patients at risk and alter clinical care

EMA CHMP may issue an opinion on CTI's Pixuvri MAA in mid-Feb.

New research could lead to cheaper, easier production of malaria drug artemisinin

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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