Drugs

AbbVie Abandons Alpha-Synuclein Parkinson’s Program

AbbVie has terminated its partnership with BioArctic AB to develop its portfolio of alpha-synuclein antibodies, including ABBV-0805 — a humanized monoclonal antibody targeting alpha-synuclein being investigated for treating Parkinson’s Disease. Their collaboration began in 2016 and in 2019 a Phase 1 study of ABBV-0805 was started. Results from the study were presented at the International Congress of Parkinson's Disease and Movement Disorders 9/2021, which BioArctic says “supports a continuation into Phase 2 with once-monthly dosing.” The Phase 1 study concluded that ABBV-0805 selectively targets soluble toxic α-synuclein oligomers with a “high affinity and demonstrates excellent in vivo efficacy,” according to the study abstract.

A disappointed BioArctic says that all available data indicate that ABBV-0805 has “uniquely high selectivity for the pathological forms of aggregated alpha-synuclein, as well as Phase 1 data supporting progression to Phase 2. We believe that ABBV-0805 has the potential to become a disease-modifying treatment for people with Parkinson's disease and will now investigate options to continue the development of this asset.”

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