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Vaccine Manufacturing Innovators Awarded Fraunhofer Prize
June 14, 2013 9:00 am | News | CommentsDr. Vidadi Yusibov, Executive Director of the Fraunhofer USA Center for Molecular Biotechnology (CMB), has received international recognition for development of the Center’s plant-based protein expression technology that lead to the construction of first in-its-kind good manufacturing practices (GMP) compliant automated bio-manufacturing plant.
FDA Seeks Better Security for Medical Devices
June 14, 2013 8:56 am | Videos | CommentsThe Food and Drug Administration is proposing new regulations to require medical device makers to guard against cyber attacks. Even though there have been no cases thus far of “hacking” medical devices – the FDA wants companies to be prepared for this eventuality.
New Lungs Buy Time But Don't Cure Cystic Fibrosis
June 14, 2013 8:36 am | by LAURAN NEERGAARD,AP Medical Writer | News | CommentsThe 10-year-old Pennsylvania girl who fought for a lung transplant has a difficult journey ahead. The transplant isn't a cure for her cystic fibrosis, and new lungs don't tend to last as long as other transplanted organs. But it can extend life by years, buying some time.
Indiana City Sues Over Failed Pharmaceutical Facility
June 14, 2013 8:33 am | News | CommentsA suburban Indianapolis city has filed a foreclosure lawsuit against a pharmaceutical company that failed to open after receiving $8.4 million in loans and other assistance from the city. Greenwood officials had tried for months to help with talks involving possible investors in hopes of saving Elona Biotechnologies before deciding to file the lawsuit, Mayor Mark Myers said.
FDA Backs New for Amgen Drug for Rare Bone Tumors
June 14, 2013 8:29 am | by The Associated Press | News | CommentsAmgen Inc. said yesterday that the Food and Drug Administration has approved a new use for its bone drug Xgeva. The company, based in Thousand Oaks, Calif., said it now can market Xgeva for treating a rare condition, giant cell tumor of bone, when surgery isn't practical.
Bristol-Myers Squibb and Simcere Enter Partnership to Co-Develop and Co-Commercialize Orencia(R) SC (abatacept) in China
June 14, 2013 8:25 am | News | CommentsBristol-Myers Squibb Company and Simcere Pharmaceutical Group, a leading pharmaceutical company in China, today announced that the companies have expanded their strategic relationship formed in 2010. The companies have agreed to collaborate in China on the development and commercialization of the subcutaneous (SC) formulation of Bristol-Myers Squibb's biologic medicine, Orencia, for the treatment of rheumatoid arthritis.
Lilly Stops Mid-Stage Alzheimer's Drug Study
June 13, 2013 6:09 pm | by The Associated Press | News | CommentsEli Lilly and Co. said Thursday that it stopped a mid-stage clinical trial of an experimental Alzheimer's disease drug because of potential side effects on patients' livers. The company stopped testing LY2886721 because of abnormal results in liver biochemical tests. Lilly says the results were...
Dedusters
June 13, 2013 3:45 pm | Product Releases | CommentsThe PharmaFlex dedusters series now includes high-containment, dust-tight models; wash-in-place models; and wash-offline models. It also includes the company’s complete AIO tablet deduster and tester system.
Supreme Court Says Human Genes Are Not Patentable
June 13, 2013 12:17 pm | by Wall Street Journal | Videos | CommentsThe Supreme Court unanimously ruled that human genes isolated from the body can’t be patented, a victory for doctors and patients who argued that such patents interfere with scientific research and the practice of medicine. The patentability of those isolated genes was challenged by researchers and scientists and other scientists.
Forest Announces U.S. Availability of NAMENDA XR
June 13, 2013 9:52 am | News | CommentsForest Laboratories, Inc. announced today that NAMENDA XR(TM) (memantine hydrochloride) once-daily formulation is now available in pharmacies throughout the United States. NAMENDA XR is approved by the U.S. Food and Drug Administration (FDA) for the treatment of moderate to severe dementia of the Alzheimer's type.
Astellas Introduces Option for Men with Advanced Prostate Cancer
June 13, 2013 9:39 am | News | CommentsOn May 30, 2013, Health Canada approved Xtandi for the treatment of patients with metastatic castration-resistant prostate cancer, or mCRPC, who have received prior docetaxel therapy (chemotherapy medication). The announcement was made today by Astellas Pharma Canada, Inc., the Canadian subsidiary of Tokyo-based Astellas Pharma, Inc.
Verastem Receives Orphan Medicinal Product Designation for VS-6063 in Mesothelioma
June 13, 2013 9:32 am | News | CommentsVerastem, Inc. announced that VS-6063 has received orphan medicinal product designation from the European Commission for use in mesothelioma. The designation is to encourage the development of drugs which may provide significant benefit to patients suffering from rare diseases.
HIV Drug Can Also Protect Injection Drug Users
June 13, 2013 9:27 am | by MIKE STOBBE, AP Medical Writer | News | CommentsDoctors should consider giving a daily AIDS drug to another high risk group to help prevent infections — people who shoot heroin, methamphetamines or other injection drugs, U.S. health officials said Wednesday. The latest advice was triggered by the results of a study done in Thailand that showed the AIDS drug tenofovir protected many drug users.
Epizyme Enrolls First Patient in Phase 1/2 Clinical Trial of EPZ-6438, an Inhibitor of EZH2
June 13, 2013 9:23 am | News | CommentsEpizyme, Inc., a clinical stage biopharmaceutical company creating innovative personalized therapeutics for patients with genetically defined cancers, announced today that the first patient has been enrolled in a Phase 1/2 clinical trial of EPZ-6438 (E7438).
WellDoc Launchesthe First FDA-Cleared, Mobile Prescription Therapy for Type 2 Diabetes
June 13, 2013 9:18 am | News | CommentsWellDoc®, a healthcare behavioral science and technology company, announced the launch of BlueStar ™, announced a new product in a novel class of diabetes therapy. BlueStar will be reimbursed and adjudicated as a pharmacy benefit similar to other prescription products.
