Drugs

FDA Fast Track for Lilly/AstraZeneca Alzheimer’s Drug

FDA has granted Eli Lilly and AstraZeneca a fast track designation for AZD3293, an oral beta secretase cleaving enzyme (BACE) inhibitor currently in Phase 3 clinical trials for treating Alzheimer’s. In addition to the AMARANTH phase 2/3 study, the companies says they will begin a second Phase 3 trial called DAYBREAK-ALZ, which will evaluate the therapy in patients with mild Alzheimer’s dementia.

AZD3293 has been shown in studies to reduce levels of amyloid beta in the cerebro-spinal fluid of people with Alzheimer’s and healthy volunteers, according to the companies. “The progression of Alzheimer's disease is characterized by the accumulation of amyloid plaque in the brain,” they say. “BACE is an enzyme associated with the development of amyloid beta. Inhibiting BACE is expected to prevent the formation and build-up of amyloid plaque which in turn may help slow the progression of the disease.”

AstraZeneca and Lilly announced a development alliance in 2014 for AZD3293. Under the agreement, Lilly will lead clinical development, working with researchers from AstraZeneca’s research and development team, while AstraZeneca will be responsible for manufacturing. The companies will take joint responsibility for commercialization and will share all future costs equally for development and commercialization, as well as net global revenues post-launch.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome