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The House approves six health-related measures, including legislation related to the disposal of unused prescription drugs

The Hill's Healthwatch Blog: "The House passed six health-related bills Wednesday evening, including efforts to combat Medicare fraud and dispose of unused prescription drugs." The measures were approved under suspension of the rules, "an expedited procedure that only allows for 40 minutes of debate followed by a voice vote."

24 Sep 2010

Amgen announces voluntary recall of certain lots of EPOGEN and PROCRIT

Amgen announced today that certain lots of EPOGEN® and PROCRIT® (Epoetin alfa) vials are being voluntarily recalled from specialty distributors, wholesalers, pharmacies and healthcare providers as a precaution. The product that is being recalled may contain extremely thin glass flakes (lamellae) that are barely visible in most cases. The lamellae result from the interaction of the formulation with glass vials over the shelf life of the product.

24 Sep 2010

Perrigo files NDA with FDA for generic Zegerid OTC

Perrigo Company announced that it has filed with the U.S. Food and Drug Administration (FDA) an Abbreviated New Drug Application (ANDA) for omeprazole 20mg/sodium bicarbonate 1100mg, the generic equivalent of Zegerid OTC™, and that it provided prior notice of this filing to Schering-Plough HealthCare Products, Inc. a subsidiary of Merck & Co., Inc., the owner of the brand regulatory approval and the Curators of the University of Missouri, the listed patent owner.

24 Sep 2010

Health Council of Canada applauds Nova Scotia for initiative towards ensuring low drug prices

The Health Council of Canada applauds the Nova Scotia Department of Health for their steps towards ensuring low drug prices in their province. The plan includes meeting with groups, such as community pharmacies, doctors, medical staff at health authorities, senior groups and drug manufacturers for input on how to lower prices for prescription drugs and contain drug costs.

24 Sep 2010

Consumers need to be made aware of benefits of low-calorie sweeteners

Leading experts in the field of food additive safety and risk communication gathered at a symposium hosted today by the Nutrition Research Foundation at the 2nd World Congress of Public Health Nutrition to discuss the safety of low-calorie sweeteners and reaffirm the positive role they can play in the diet.

24 Sep 2010

Warner Chilcott to acquire U.S. rights to Enablex from Novartis for $400 million

Warner Chilcott plc today announced that it has agreed to terminate its existing co-promotion agreement with Novartis and signed a definitive agreement to purchase the U.S. rights to Enablex® from Novartis for $400 million in cash. Enablex (darifenacin) is a product indicated to treat adults with symptoms of overactive bladder, which had U.S. sales of approximately $190 million for the year ended December 31, 2009.

24 Sep 2010

Pharmaceutical manufacturers to provide 50% discount on brand-name prescription drugs

Vice President Joe Biden, the U.S. Department of Health and Human Services and the Centers for Medicare & Medicaid Services (CMS) today announced that the nation's pharmaceutical manufacturers will provide 50 percent discounts on the cost of covered brand-name prescription drugs for beneficiaries in the Medicare Part D coverage gap, or donut hole, starting in 2011.

24 Sep 2010

Tufts CTSI releases report from multi-state study on psychotropic medication oversight in foster care

The Tufts Clinical and Translational Science Institute (CTSI) today issued a landmark report from a multi-state study on psychotropic medication oversight in foster care.

24 Sep 2010

Takeda underscores commitment to ACTOS following FDA and EMA announcements for rosiglitazone

Following today’s announcements by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for rosiglitazone in the U.S. and Europe, Takeda Pharmaceuticals North America, Inc. and Takeda Pharmaceuticals Europe Limited underscore the company’s commitment to ACTOS® (pioglitazone HCl) and ACTOS-containing medications, and to the millions of people living with type 2 diabetes.

24 Sep 2010

EMA, FDA announce regulatory decisions on Avandia drug

GlaxoSmithKline confirms that following a review of Avandia (rosiglitazone maleate) by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), each agency has today announced their individual regulatory decisions and the resulting actions.

24 Sep 2010

Balsamic rub cream now available in innovative dispensing stick

Laboratorios Cinfa launched in the Spanish market Respirub and Respirub infantil, a non-greasy, clean balsamic rub cream available in an innovative dispensing stick.

24 Sep 2010

Simple treatment may counteract widespread problem of subnormal vitamin levels in acute-care patients

Treatment with vitamin C rapidly improves the emotional state of acutely hospitalized patients, according to a study carried out by researchers at Montreal's Jewish General Hospital (JGH) and the affiliated Lady Davis Institute for Medical Research (LDI).

24 Sep 2010

FDA designates AMT-080 gene therapy for Duchenne muscular dystrophy

Amsterdam Molecular Therapeutics (AMT) Holding N.V. a leader in the field of human gene therapy, announced today that the U.S. Food and Drug Administration (FDA) has designated AMT-080, a gene therapy for Duchenne muscular dystrophy (DMD) as an orphan drug.

24 Sep 2010

ASTMH recommends FDA to include neglected infections of poverty in orphan classification

Today, U.S. scientists committed to finding answers to reducing and eliminating what are known as neglected tropical diseases (NTDs) that plague the world's poorest people in developing countries, urged the FDA to include in its orphan classification the neglected infections of poverty that also affect Americans, and expressed support for stronger relationships with the FDA to ultimately halt these ancient scourges.

24 Sep 2010

FDA grants clearance for HPβCD treatment for Niemann Pick Type C disease

Children's Hospital & Research Center Oakland announced today that the US Food and Drug Administration (FDA) has granted clearance of an Investigational New Drug (IND) application to introduce Trappsol Cyclo (Hydroxypropyl Beta Cyclodextrin or HPβCD) into the brains of six year old identical twin girls dying of a rare brain-destroying cholesterol disease called Niemann Pick Type C (NPC).

24 Sep 2010

Advitech completes UVA testing study on oleosome sunscreen formulation

Advitech Inc. is pleased to announce today that a key UVA testing study has been completed on its oleosome-based sunscreen prototype formulation.

24 Sep 2010

Advanced Targeting Systems receives NCI award to advance SP-SAP drug

Advanced Targeting Systems, the company that pioneered the targeting of specific cell types to manipulate them for the treatment of diseases and for research into the function of biological systems, has been awarded $3 million from the National Cancer Institute (NCI).

24 Sep 2010

Avandia restricted by the FDA and EMEA

The U.S. Food and Drugs Administration (FDA) has restricted the use of the controversial diabetes drug Avandia (rosiglitazone) due to its propensity to increase cardiovascular disease risk.

24 Sep 2010

FDA approves Bionovo's CMC plan for Menerba drug candidate

Bionovo, Inc. announced today that the U.S. Food and Drug Administration (FDA) accepted the Company's Chemistry, Manufacturing and Controls (CMC) plan for its lead drug candidate, Menerba, in a Type "B" or "End of Phase 2" meeting.

24 Sep 2010

Abbott, Reata enter agreement to commercialize bardoxolone drug for CKD

Abbott and Reata Pharmaceuticals today announced that they have entered into a collaboration agreement to develop and commercialize bardoxolone methyl (bardoxolone), which is currently in late Phase 2 trials for the treatment of chronic kidney disease (CKD).

24 Sep 2010

Pharmaceutical News

The House approves six health-related measures, including legislation related to the disposal of unused prescription drugs

Amgen announces voluntary recall of certain lots of EPOGEN and PROCRIT

Perrigo files NDA with FDA for generic Zegerid OTC

Health Council of Canada applauds Nova Scotia for initiative towards ensuring low drug prices

Consumers need to be made aware of benefits of low-calorie sweeteners

Warner Chilcott to acquire U.S. rights to Enablex from Novartis for $400 million

Pharmaceutical manufacturers to provide 50% discount on brand-name prescription drugs

Tufts CTSI releases report from multi-state study on psychotropic medication oversight in foster care

Takeda underscores commitment to ACTOS following FDA and EMA announcements for rosiglitazone

EMA, FDA announce regulatory decisions on Avandia drug

Balsamic rub cream now available in innovative dispensing stick

Simple treatment may counteract widespread problem of subnormal vitamin levels in acute-care patients

FDA designates AMT-080 gene therapy for Duchenne muscular dystrophy

ASTMH recommends FDA to include neglected infections of poverty in orphan classification

FDA grants clearance for HPβCD treatment for Niemann Pick Type C disease

Advitech completes UVA testing study on oleosome sunscreen formulation

Advanced Targeting Systems receives NCI award to advance SP-SAP drug

Avandia restricted by the FDA and EMEA

FDA approves Bionovo's CMC plan for Menerba drug candidate

Abbott, Reata enter agreement to commercialize bardoxolone drug for CKD

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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