United States

Certara’s Simcyp division awarded FDA modeling and simulation grant

Thursday, October 20, 2016

Certara, a provider of decision support technology and consulting services for optimizing drug development and improving health outcomes, has announced that the Office of Generic Drugs (OGD), FDA has awarded it a multi-year research grant to create and validate a physiologically-based pharmacokinetic (PBPK) modeling and simulation framework that complements existing models within the Simcyp Population-based Simulator. The new models will predict and simulate the behavior of supersaturating orally-dosed drug products in the human gastro-intestinal (GI) tract. This platform will also permit new product performance to be assessed and compared to reference products.

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Congresswoman DeLauro proposes pharma price legislation

Tuesday, October 18, 2016

Congresswoman Rosa DeLauro (CT-03) has announced the Prescription Drug and Medical Device Review Board Act, new legislation that would create a national review board to stop pharmaceutical corporations from charging consumers excessive prices. According to a recent report released by IMS Health Holdings, annual spending on prescription medications has skyrocketed in the U.S. in recent years, and is projected to increase by 22% over the next five years, climbing to as high as $400 billion by 2020.

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True North Therapeutics receives FDA Orphan Designation for TNT009

Monday, October 17, 2016

True North Therapeutics, a clinical stage biotechnology company developing novel product candidates that selectively inhibit the Complement system to treat certain rare diseases, has announced that the FDA has granted Orphan Drug Designation for the company’s lead product candidate TNT009, for the treatment of autoimmune hemolytic anemia, including Cold Agglutinin Disease (CAD), a form of autoimmune hemolytic anemia for which there are limited treatment options available for patients.

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FDA approves Carnexiv (carbamazepine) injection for seizures

Wednesday, October 12, 2016

Lundbeck announced that the FDA has approved Carnexiv (carbamazepine) injection as a short-term replacement therapy for oral carbamazepine formulations in adults with certain seizure types when oral administration is temporarily not feasible. Carnexiv received orphan drug designation for this indication and will be the first available intravenous (IV) formulation of the antiepileptic drug (AED) carbamazepine. Lundbeck plans to make Carnexiv commercially available in the United States in early 2017.

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NIH Common Fund announces 2016 high-risk, high-reward research awards

Tuesday, October 11, 2016

The High-Risk, High-Reward Research (HRHR) program, supported by the NIH’s Common Fund, awarded 88 grants to highly creative and exceptional scientists with bold approaches to major challenges in biomedical research. The awards span the broad mission of the NIH and include groundbreaking research: engineering immune cells to produce drugs at sites of diseased tissue, developing a sensor to rapidly detect antibiotic resistant bacteria, understanding how certain parasites evade host detection by continually changing their surface proteins and developing implants that run off the electricity generated from the motion of a beating heart.

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AbbVie’s HCV regimen receives FDA Breakthrough Therapy designation

Tuesday, October 4, 2016

The FDA has granted Breakthrough Therapy Designation (BTD) for AbbVie’s investigational, pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) for the treatment of patients with chronic hepatitis C virus (HCV) who failed previous therapy with direct-acting antivirals (DAAs) in genotype 1 (GT1), including therapy with an NS5A inhibitor and/or protease inhibitor.

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NCI collaborates with Multiple Myeloma Research Foundation

Friday, September 30, 2016

The National Cancer Institute (NCI) has announced a collaboration with the Multiple Myeloma Research Foundation (MMRF) to incorporate MMRF’s wealth of genomic and clinical data about the disease into the NCI Genomic Data Commons (GDC), a publicly available database that promotes the sharing of genomic and clinical data among researchers and facilitates precision medicine in oncology. The MMRF, located in Norwalk, Connecticut, is the first non-profit to donate information to the GDC, which will include data on more than 30,000 patients who have many other types of cancers by the end of the year. NCI is part of the NIH.

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