FDA Policy/General

Since Our last Issue ...

Turing Pharmaceuticals says it has begun dosing the first group of subjects in a single ascending dose study, to evaluate the safety, tolerability and pharmacokinetics of an oral formulation of TUR-004 in healthy young adult subjects. The company says the study is aimed at obtaining approval for treating epileptic encephalopathies, a diverse group of severe epilepsy disorders in which uncontrolled epileptic activity contributes to a progressive decline in cognitive and motor function. It adds that FDA has granted fast-track designation for TUR-004.

Avanir Pharmaceuticals has begun enrollment into a Phase 3 clinical trial evaluating AVP-786 for treating agitation in patients with Alzheimer’s disease. It is one of two Phase 3 studies (TRIAD-1 and TRIAD-2), which will evaluate two doses of AVP-786 versus placebo over a period of 12-weeks with endpoints including the Cohen Mansfield Agitation Inventory, the agitation/aggression domain of the Neuropsychiatry Inventory (NPI), other domains of the NPI, measures of global clinical change, and measures of caregiver burden and quality of life. Avanir says it recently received fast-track designation from FDA for the development of AVP-786 for this indication.

New Jersey-based generic pharmaceutical company Teligent, Inc. says it has completed the acquisition of the assets of Alveda Pharmaceuticals for $47 million CAD in cash. According to the company, Alveda had net sales of approximately $16.0M CAD for its fiscal year ended 9/30 and has a pipeline of eight injectable products, 4 of which are under review by Health Canada.

Array BioPharma and Pierre Fabre will collaborate to globally develop and commercialize Array’s late-stage novel oncology products, binimetinib and encorafenib, which are currently advancing in three Phase 3 trials for melanoma and ovarian cancer. According to the companies, Array will receive an upfront payment of $30 million and retain exclusive commercialization rights for the products in the U.S., Canada, Japan, Korea and Israel and Pierre Fabre will have exclusive rights to commercialize both products in all other countries, including Europe, Asia and Latin America.

Alphaeon Corp. has entered into a definitive agreement with PhysIOL of Belgium to jointly develop and commercialize an Alphaeon-branded Trifocal lens technology.

Epic Sciences will collaborate with the Abramson Cancer Center of the University of Pennsylvania on multiple studies to explore biomarkers, identified by analysis of circulating tumor cells (CTC) at a single cell resolution, that are predictive of response to personalized cancer therapeutics. According to the company, its no cell left behind CTC detection and characterization platform is used to quantify the proteomic and genomic changes that accumulate in tumor cells over time and in response to successive rounds of therapy.

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

Read more

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