Food News and Research

RSS

Alza files patent infringement suit against Impax in connection with Concerta

Impax Laboratories, Inc. today confirms that Alza Corporation has filed suit for patent infringement against Impax in the United States District Court for the District of Delaware in connection with Concerta® (methylphenidate hydrochloride) extended-release 54 mg tablets.

30 Nov 2010

FDA approves Axiron topical solution CIII for testosterone replacement therapy in men

Acrux , a drug delivery company that develops and commercializes patented pharmaceutical products for global markets, and Eli Lilly Company today announced that the United States Food and Drug Administration (FDA) has approved the Axiron® topical solution CIII for testosterone replacement therapy in men. Axiron is the first testosterone topical solution approved for application via an underarm applicator.

29 Nov 2010

Majority of African nations to miss MDG target on water, sanitation, UNEP says

The majority of African nations will fail to meet the U.N. Millennium Development Goal (MDG) targets related to water and sanitation, the U.N. Environment Program (UNEP) said Friday, Agence France-Presse reports.

29 Nov 2010

GlobalNet Services awarded $6.2M contract to support Agency Wide Business Objects Support project

GlobalNet Services, Inc., a premier information technology provider for businesses and the Federal government, today announced that it was awarded a $6.2 million contract to support the U.S. Food and Drug Administration's (FDA) Agency Wide Business Objects Support (AWBOS). Under this five-year contract, which includes one base year and four option years, GlobalNet Services will support an Agency-wide SAP Business Objects implementation to report, manage and maintain public health information.

29 Nov 2010

Synthon receives FDA final approval for generic Xyzal

Perrigo today announced that its licensor and supplier Synthon has received final approval from the U.S. Food and Drug Administration (FDA) for Levocetirizine tablets, a generic version of Xyzal® tablets from UCB/Sepracor, which is marketed in the U.S. by Sanofi-Aventis. Perrigo has the exclusive rights from Synthon to sell and distribute the product in the U.S.

29 Nov 2010

Wolters Kluwer Health subsidiary to acquire Pharmacy OneSource

Wolters Kluwer Health today announced that one of its wholly- owned subsidiaries has entered into an agreement to acquire Pharmacy OneSource, a leading healthcare Software-as-a-Service (SaaS) provider that helps hospitals manage the complex challenges of patient safety, compliance and efficiency. The transaction will allow Wolters Kluwer Health to extend its Clinical Decision Support (CDS) solutions into the hospital pharmacy market and will further strengthen the company's leadership position in the growing point-of-care market.

29 Nov 2010

FDA approves Merit's phase 3 clinical trial protocol to treat primary liver cancer with QuadraSphere Microspheres

The Food and Drug Administration (FDA) has approved Merit Medical Systems, Inc.'s phase 3 clinical trial protocol to treat primary liver cancer with QuadraSphere™ Microspheres (hqTACE) for delivery of doxorubicin. The clinical trial will involve U.S. and international interventional radiologists who treat patients with localized, unresectable hepatocellular carcinoma (HCC), the most common form of liver cancer.

29 Nov 2010

Spectrum's FUSILEV sNDA accepted by FDA for review

Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing and review the complete response regarding its supplemental New Drug Application (sNDA) for FUSILEV® (levoleucovorin) for Injection for treatment of patients with advanced metastatic colorectal cancer.

29 Nov 2010

Weight Watchers introduces PointsPlus weight loss program in the U.S.

The new era of Weight Watchers is here. Today Weight Watchers, the world-renowned leader in weight management, has announced it is introducing in the United States a successor to its popular POINTS weight loss system–the new PointsPlus program.

29 Nov 2010

AMAG updates product label of Feraheme Injection

AMAG Pharmaceuticals, Inc. today announced that the company has reached agreement with the U.S. Food and Drug Administration (FDA) regarding an update to the product label for Feraheme (ferumoxytol) Injection for intravenous (IV) use.

29 Nov 2010

NovaBay announces meeting with FDA to discuss Aganocide compound for impetigo

NovaBay Pharmaceuticals, Inc., a clinical stage biotechnology company developing first-in-class, anti-infective compounds for the treatment and prevention of antibiotic-resistant infections, announces a successful meeting with the US Food and Drug Administration (FDA) to discuss the Company's clinical development of its Aganocide compound NVC-422, intended for use in the treatment of impetigo.

29 Nov 2010

Affymax, Takeda to regulate peginesatide drug for treating anemia in CRF patients

Affymax, Inc. and Takeda Pharmaceutical Company Limited , today announced that following pre-New Drug Application (NDA) discussions with the U.S. Food and Drug Administration (FDA), the companies will move forward with their regulatory strategy for the investigational drug, peginesatide, for the treatment of anemia in chronic renal failure (CRF) patients on dialysis in the United States.

29 Nov 2010

BioTime, CIRM enter agreement for GMP-grade hES cell lines

BioTime, Inc. today announced an agreement with the California Institute for Regenerative Medicine (CIRM) to make five clinical-grade human embryonic stem (hES) cell lines available to California-based researchers. CIRM is the stem cell agency created when California voters supported a $3 billion funding measure for stem cell-related research and clinical translation.

29 Nov 2010

QIAGEN to supply point-of-need molecular veterinary diagnostics for disease detection in emerging countries

QIAGEN has been selected to contribute to the fight against infectious diseases in animals in emerging countries by supplying an international pilot project associated with the United Nations with portable devices to perform ultra-fast molecular testing in the field.

From QIAGEN Manchester Limited 29 Nov 2010

Pfizer, Protalix announce marketing authorization submission in Europe for taliglucerase alfa

Pfizer Inc. and Protalix BioTherapeutics, Inc. today announced the submission of a Marketing Authorization Application to the European Medicines Agency for taliglucerase alfa, a plant-cell expressed form of glucocerebrosidase (GCD)for the treatment of Gaucher disease. Taliglucerase alfa was granted Orphan Designation by the European Commission for the treatment of Gaucher disease on March 23, 2010.

29 Nov 2010

Overexposure to triclosan may negatively influence immune system: Study

Young people who are overexposed to antibacterial soaps containing triclosan may suffer more allergies, and exposure to higher levels of Bisphenol A among adults may negatively influence the immune system, a new University of Michigan School of Public Health study suggests.

29 Nov 2010

SaneVax Team congratulates Senator for examining NCI ethical questions

In a letter addressed to U.S. Senator Charles Grassley, the SaneVax Team congratulated the senator on his recent efforts to examine ethical questions raised by National Cancer Institute (NCI) employees accepting extensive travel sponsored by private companies and identified two senior NCI scientists who knowingly promote unreliable human papillomavirus (HPV) tests for patient care, and the development/monitoring of genotype-specific HPV vaccines to promote an unproven virology-based cervical cancer prevention business agenda.

29 Nov 2010

Superantigens can disrupt immune system, can cause more illnesses

Superantigens, the toxins produced by staphylococcus bacteria, are more complex than previously believed, reveals a team of researchers from the University of Gothenburg in an article published today in the scientific journal Nature Communications. Their discovery shows that the body's immune system can cause more illnesses than realised.

29 Nov 2010

Lame duck session to include votes on Medicare 'doc fix,' health law's 1099 tax provision

Lawmakers, after taking Thanksgiving week off, arrive in town Monday along with the Capitol Christmas tree for the final stretch of the postelection session. Facing a daunting agenda, they could have that tree in their sights well into Christmas week.

28 Nov 2010

Impax initiates patent challenge in connection with SIMCOR

Impax Laboratories, Inc. today confirms that it has initiated a challenge of patents listed in connection with SIMCOR® (niacin/simvastatin) extended-release tablets, 1000/20 mg.

26 Nov 2010