United States

INC Research to manage Leukemia & Lymphoma Society umbrella trial

Friday, November 11, 2016

INC Research, a global phase I to IV CRO, has announced its involvement in The Leukemia & Lymphoma Society’s (LLS) recently-launched precision medicine Master Trial to treat acute myeloid leukemia (AML). The Beat AML Master Trial is breaking ground in a number of areas, including the first time a nonprofit organization is working with multiple biotech and pharma sponsors and other key collaborators to professionally operationalize a study. The trial will provide principal investigators and their patients consolidated access to test novel therapies matched to specific molecular aberrations in AML.

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Aerie reports results of phase III trial of rhopressatm for glaucoma

Wednesday, November 2, 2016

Aerie Pharmaceuticals, a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of glaucoma and other diseases of the eye, has reported the successful 90-day topline efficacy results of its Rocket 4 phase III clinical trial of product candidate Rhopressa, a novel once-daily eye drop being tested for its ability to lower intraocular pressure (IOP) in patients with glaucoma or ocular hypertension. The Rocket 4 trial is designed to provide adequate six-month safety data for European regulatory filing purposes. Rocket 4 is not necessary for new drug application (NDA) filing purposes.

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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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