Privately held Orasis Pharmaceuticals Ltd. is a step closer to challenging Abbvie Inc.’s Vuity (pilocarpine hydrochloride) ophthalmic solution for treating presbyopia, a version of farsightedness. Orasis plans to submit an NDA to the U.S. FDA in the second half of the year based on phase III results from two studies showing CSF-1 hit its primary and secondary endpoints.
Abbvie Inc. is stepping away from a 2016 deal with Bioarctic AB to develop alpha-synuclein antibodies for treating Parkinson’s disease, originally valued at up to $775 million. Bioarctic said it plans to stay the course without its big-pocketed partner. Bioarctic’s stock (Stockholm:BIOA-B) fell 14.6% to SEK90 (US$9.40) on April 20.
Although broader use of biosimilars in the U.S. would reduce Medicare Part D spending and save beneficiaries nearly $2 million in out-of-pocket costs, plan formularies continue to discourage the use of the more affordable follow-ons, according to a recent report from the Department of Health and Human Services’ Office of Inspector General.
By combining an activator of the pro-apoptotic protein Bax with an inhibitor of the anti-apoptotic protein BCL-XL, researchers at Albert Einstein College of Medicine have been able to overcome resistance to apoptosis in both a wide range of cell lines and animal studies. The team reported its findings in the March 7, 2022, issue of Nature Communications.
2023 may be a pivotal year for biosimilars in the U.S. with a number of approved Humira (adalimumab) biosimilars set for staggered launches under agreements with Abbvie Inc. How successful those launches are, including the launch of Boehringer Ingelheim GmbH’s interchangeable, Cyltezo, and potential other interchangeables, will be determined in large part by three pharmacy benefit managers that together control the prescription drug formularies for nearly 80% of Americans covered by Medicare and private insurance.
There’s nothing like beginning-of-the-year price increases to turn up the heat on the prescription drug pricing debate in the U.S. This year is no exception. Citing a mean price increase of 5.1% on brand drugs in the first 25 days of 2022, 13 Democratic lawmakers, led by Sen. Elizabeth Warren (D-Mass.), wrote this week to Steven Ubl, president and CEO of the Pharmaceutical Research and Manufacturers of America, demanding an explanation for those hikes.
Abbvie Inc. has paid $130 million up front to acquire Syndesi Therapeutics SA, a company working on a new mechanism to mitigate synaptic dysfunction associated with cognitive deficits. The deal includes up to $870 million in milestone payments for Syndesi's first-in-class modulators of the synaptic vesicle protein 2A, which Abbvie said could have applications across a range of neuropsychiatric and neurodegenerative disorders, such as Alzheimer's disease and major depressive disorder.
Even as the U.S. Congress continues to kick the can down the road on prescription drug pricing, pressure to finally confront the issue is increasing. But as lawmakers debate price controls via direct Medicare negotiations vs. innovation, along with inflationary caps on price increases, one factor often gets downplayed: the role biologics are playing in the country’s overall spend on prescription drugs. While generics account for 90% of the drugs prescribed in the U.S., the other 10% of drugs prescribed account for more than 80% of the annual spending, according to the Association for Accessible Medicines.
The U.S. International Trade Commission (USITC) reported Jan. 26 that it will investigate whether Alvotech Hf and Teva Pharmaceutical Industries Ltd. misappropriated trade secrets when developing a potential interchangeable biosimilar to Abbvie Inc.’s mega-blockbuster, Humira (adalimumab).
Destroying senescent cells in the aging stem cell niche, either genetically or pharmacologically using the small-molecule senolytic ABT-263 (navitoclax; Abbvie Inc.), enhanced hippocampal neurogenesis and cognitive function in mice, a Canadian study led by scientists at the University of Toronto has found.
