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.
Two Janus kinase (JAK) inhibitors, Abbvie Inc.'s Rinvoq (upadacitinib) and Pfizer Inc.'s Cibinqo (abrocitinib), have won U.S. FDA approvals for the treatment of people with moderate to severe atopic dermatitis. Reviews of both products for the indication were delayed due to FDA concerns about class risks. Accordingly, each is labeled with a boxed warning regarding risks of serious infection, mortality, malignancy, major adverse cardiovascular events and thrombosis.
Targeting VEGF and DLL4 at the same time in solid tumors is an approach that continues to entice researchers, with such firms as Abbvie Inc., Compass Therapeutics Inc. and Oncxerna Therapeutics Inc. working to come up with oncology solutions.
With licensed Humira (adalimumab) biosimilar competition a little more than a year away in the U.S., Abbvie Inc. is trying to fend off competitors that have not signed an agreement with the North Chicago-based company.
With the U.S. biosimilar pathway clearly developed, industry and the FDA are turning their attention to interchangeables in the third iteration of the biosimilar user fee agreement (BsUFA).
Abbvie Inc.’s FDA clearance of Vuity (pilocarpine HCl ophthalmic solution) 1.25% for the treatment of presbyopia in adults, could bring relief to about 128 million Americans: almost half of the U.S. population, the company said. It’s the first and only eye drop given U.S. regulators’ go-ahead for what’s known as age-related blurry near vision – but plenty more have generated clinical data.
