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MediciNova receives FDA approval to proceed with initial trial of ibudilast

MediciNova Inc, a biopharmaceutical company publicly traded on the NASDAQ Global Market and the Hercules Market of the Osaka Securities Exchange (Code Number:4875), today reported FDA's approval to proceed with an initial trial of the company's neurological drug candidate, ibudilast (MN-166/AV411), as a potential new pharmacotherapy for methamphetamine addiction.

27 Sep 2010

Study shows regadenoson is safe and effective for chronic lung disease

Patients at risk of coronary disease who have reactive airways may breathe easier thanks to new data released today at the 15th Annual Scientific Session of the American Society of Nuclear Cardiology. A new study shows that regadenoson may be safely tolerated by patients with chronic lung disease, providing an alternative to adenosine, which is known to induce brochoconstriction in some patients.

27 Sep 2010

Takeda announces SGN-35 ADC trial results in Hodgkin lymphoma patients

Seattle Genetics, Inc. and Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, today announced positive top line results from the pivotal trial of single agent brentuximab vedotin (SGN-35), an antibody drug conjugate (ADC) targeted to CD30. The trial was conducted in 102 relapsed or refractory Hodgkin lymphoma (HL) patients.

27 Sep 2010

Hospira's Nivestim receives Australian TGA approval

Hospira, Inc., the world leader in generic injectable pharmaceuticals, today announced that it has received Australian Therapeutic Goods Administration approval for its biosimilar filgrastim product, Nivestim.

27 Sep 2010

ARTES acquires ANAVAX virus-like particle technology from Select Vaccines

ARTES Biotechnology announces today the acquirement of the ANAVAX virus-like particle (VLP) technology from Select Vaccines Ltd. ANAVAX is a patent-protected VLP technology that can be applied to the prevention of several infectious diseases.

27 Sep 2010

FDA approves Beyaz tablets to increase folate level in women

The U.S. Food and Drug Administration today approved Beyaz tablets, an estrogen/progestin combined oral contraceptive that also contains a folate (levomefolate calcium 0.451 mg).

27 Sep 2010

FDA, European regulators restrict Avandia use

The Food and Drug Administration and European regulators said they were taking action on Avandia, made by GlaxoSmithKline PLC, because of data tying it to increased risk of heart attacks.

27 Sep 2010

Bio-Dome wound interface dressings superior than GranuFoam

ConvaTec, a world-leading developer and marketer of innovative medical technologies for community and hospital care, today announced new in vitro study results. The Engenex Negative Pressure Wound Therapy (NPWT) system's Bio-Dome wound interface showed superior tensile strength and lower simulated bioadhesion when compared with GranuFoam (polyurethane foam).

27 Sep 2010

Calcitonin combination therapy may help treat osteoarthritis: Study

Tarsa Therapeutics, Inc. and Unigene Laboratories, Inc. today reported preclinical data showing that calcitonin may have synergistic effects in combination with other drugs in reducing the collagen degradation associated with osteoarthritis.

27 Sep 2010

Stirling Products’ drug delivery technology interests big ‘pharma’

Healthcare group, Stirling Products Limited (ASX:STI) has advised that following the recent TeleMedCare e-health acquisition and the conditional addition of the recently announced pathology business (subject to due diligence completion and shareholder approval), the Company is now in process of its strategised business integration.

26 Sep 2010

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