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US District Court dismisses all claims and counterclaims in thalidomide patent cases

Celgene Corporation announced that as a result of Barr Laboratories, Inc., withdrawing its Abbreviated New Drug Application (ANDA) for thalidomide with the US Food and Drug Administration, the US District Court for the District of New Jersey has granted the requested dismissal of all claims and counterclaims in the thalidomide patent cases.

27 May 2010

BDSI partners with Kunwha to develop and commercialize BEMA Fentanyl in Republic of Korea

BioDelivery Sciences International, Inc. announced that it has entered into a license and supply agreement with Kunwha Pharmaceutical Co., Ltd., for the exclusive rights to develop and commercialize BEMA Fentanyl (marketed as ONSOLIS in the U.S.) in the Republic of Korea. The agreement results in potential milestone payments to BDSI of up to $1,275,000, which includes an upfront payment of $300,000. In addition, BDSI will receive an ongoing royalty based on net sales.

27 May 2010

Prohibiting cap messages will increase medication errors: Survey

At a meeting today of the United States Pharmacopeia's (USP) Nomenclature Expert Committee, the Consortium for the Advancement of Patient Safety (CAPS) presented results of an independent study producing a landmark three-part report, including a human factors engineering (HFE) analysis, on the relationship between patient safety and printed messages on ferrule and cap overseals used to secure injectable drug vials.

27 May 2010

Dosage of statin drugs given to patients with heart disease should be monitored: Study

The type and dosage of statin drugs given to patients to treat heart disease should be proactively monitored as they can have unintended adverse effects, concludes a new study published on bmj.com.

27 May 2010

Use of bisphosphonates associated with risk of developing BON after dental surgery: Study

People undergoing bisphosphonate therapy to prevent or treat osteoporosis (a thinning of the bones) may be unfamiliar with the drug and possible adverse side effects on oral health, according to a study in the May issue of The Journal of the American Dental Association.

27 May 2010

Shark cartilage extract shows no benefit for patients with advanced non-small cell lung cancer

In the first scientific study of its kind, shark cartilage extract, AE-941 or Neovastat, has shown no benefit as a therapeutic agent when combined with chemotherapy and radiation for patients with advanced non-small cell lung cancer, according to researchers at The University of Texas MD Anderson Cancer Center.

27 May 2010

HZI researchers develop new method to produce insulin for treatment of diabetes

More than eight million diabetics live in Germany. Diabetes is not restricted to our prosperous society and the highest growth rates often occur in countries with aspiring economies such as in Asia. Worldwide, more than 285 million people suffer from this illness; with 50 million diabetics, India is the country with the most people affected by this disease.

27 May 2010

Patients with transformed lymphoma show positive response to lenalidomide: Research

New research illustrates that some patients with transformed lymphoma showed "remarkable" response to lenalidomide, an oral drug with few side effects.

27 May 2010

Naturxan expands production and distribution capabilities to provide worldwide availability of Aquasta

Naturxan, LLC, a joint venture between Archer Daniels Midland Company and Igene Biotechnology, Inc., today announced that it has completed an expansion of its production and distribution capabilities to provide worldwide availability of Aquasta, a naturally sourced astaxanthin made from Phaffia yeast for enriching and pigmenting salmon and trout consuming aquaculture feeds.

27 May 2010

Montana and other states struggle to contain medical marijuana boom, related violence

The Wall Street Journal: "Fourteen states plus the District of Columbia have passed laws intended to give certain ill people legal access to medical marijuana. But, in many instances, municipalities are left to figure out how to implement state laws that are often vague when it comes to the day-to-day operations of the medical-pot business. Those laws have led to confusion in communities and pushed states including Colorado and Maine to clarify what is legal for the industry."

27 May 2010

FDA advises consumers, health care professionals about Xenical, Alli

The U.S. Food and Drug Administration today advised consumers and health care professionals about potential rare occurrences of severe liver injury in patients taking the weight-loss medication orlistat, marketed as Xenical and Alli.

27 May 2010

Nottingham scientists given green light to test new vaccine for malignant melanoma

Nottingham scientists have been given the green light to test a vaccine which they hope could reverse, and even cure malignant melanoma, the most deadly type of skin cancer.

27 May 2010

Health Canada approves Victoza for treatment of adults with type 2 diabetes

Diabetes is growing at an alarming rate in Canada, with an estimated 3.7 million people expected to be diagnosed by 2020. It is a progressive disease that, if not properly monitored and managed over time, will lead to serious long term complications. Canadians now have a novel treatment available to help them maintain optimal blood glucose levels. Health Canada has approved Victoza (liraglutide), the first GLP-1 analogue, for once-daily administration for the treatment of adults with type 2 diabetes to improve glycemic control in combination with metformin or metformin and a sulfonylurea.

27 May 2010

GSK Consumer Healthcare announces update of alli product label

GSK Consumer Healthcare today announced it will update the alli product label to alert consumers to certain symptoms that have been associated with rare instances of severe liver injury reported in people taking orlistat, the active ingredient in alli. This update follows FDA's completion of its safety review of orlistat and is being implemented in conjunction with Roche, the manufacturer of the prescription dose of orlistat (Xenical). The agency stated that a cause and effect relationship has not been established.

27 May 2010

Study assesses possible links between pain medications and recurrent breast cancer risk

Women who receive one common pain drug during mastectomy are less likely to develop recurrent breast cancer in the years following surgery, suggests a study in the June issue of Anesthesia & Analgesia, official journal of the International Anesthesia Research Society.

27 May 2010

Restanza shows greater efficacy against species of Plasmodium that cause malaria

Advanced Life Sciences Holdings, Inc., a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, oncology and respiratory diseases, today announced positive results from in vitro and in vivo studies assessing the efficacy of Restanza (cethromycin), its novel oral antibiotic, against the species of Plasmodium that cause malaria.

27 May 2010

FDA accepts Horizon Pharma's DUEXA NDA for review

Horizon Pharma, Inc., a late-stage biopharmaceutical company focused on the development and commercialization of innovative medicines for pain-related diseases and inflammation, today announced that its New Drug Application (NDA) for DUEXA®, a proprietary tablet formulation containing a fixed-dose combination of ibuprofen and high-dose famotidine, was accepted by the U.S. Food and Drug Administration (FDA) for review.

27 May 2010

Important milestone in development of ORMD-0801 published in DOM journal

Oramed Pharmaceuticals Inc., a developer of alternative drug delivery systems, announced today that the paper entitled, "Open-label study to assess the safety and pharmacodynamics of five oral insulin formulations in healthy subjects," authored by Dr. Roy Eldor, Dr. Miriam Kidron and Dr. Ehud Arbit, was accepted and published in the Diabetes, Obesity and Metabolism journal.

26 May 2010

Lymphoma Foundation Canada applauds Ontario government's decision to publicly fund Rituxan for CLL

Lymphoma Foundation Canada (LFC) applauds Ontario's recent decision to publicly fund Rituxan (rituximab) in combination with Fludarabine-based chemotherapy for patients with previously untreated chronic lymphocytic leukemia (CLL).

26 May 2010

EMEND indication helps women prevent CINV

More women fighting cancers such as breast, lung, colorectal and ovarian can now help prevent the nausea and vomiting associated with their treatment of moderately emetogenic (vomit-inducing) cancer chemotherapy. Although new treatment entities have been developed in the past 10 years for control of chemically-induced nausea and vomiting, CINV remains a significant problem in the context of current practice.

26 May 2010

Pharmaceutical News

US District Court dismisses all claims and counterclaims in thalidomide patent cases

BDSI partners with Kunwha to develop and commercialize BEMA Fentanyl in Republic of Korea

Prohibiting cap messages will increase medication errors: Survey

Dosage of statin drugs given to patients with heart disease should be monitored: Study

Use of bisphosphonates associated with risk of developing BON after dental surgery: Study

Shark cartilage extract shows no benefit for patients with advanced non-small cell lung cancer

HZI researchers develop new method to produce insulin for treatment of diabetes

Patients with transformed lymphoma show positive response to lenalidomide: Research

Naturxan expands production and distribution capabilities to provide worldwide availability of Aquasta

Montana and other states struggle to contain medical marijuana boom, related violence

FDA advises consumers, health care professionals about Xenical, Alli

Nottingham scientists given green light to test new vaccine for malignant melanoma

Health Canada approves Victoza for treatment of adults with type 2 diabetes

GSK Consumer Healthcare announces update of alli product label

Study assesses possible links between pain medications and recurrent breast cancer risk

Restanza shows greater efficacy against species of Plasmodium that cause malaria

FDA accepts Horizon Pharma's DUEXA NDA for review

Important milestone in development of ORMD-0801 published in DOM journal

Lymphoma Foundation Canada applauds Ontario government's decision to publicly fund Rituxan for CLL

EMEND indication helps women prevent CINV

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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