Within a few weeks, government price negotiations for some prescription drugs, as well as limits on annual price increases, could be the law of the land in the U.S. With the Senate passing a slimmed-down version of H.R. 5376 through reconciliation Aug. 7, the House is expected to make a brief return Friday from its August recess to vote on the changes and conference the differences between its bill and the Senate version. Then it’s on to the president’s desk for the signature that will enact the package of health care, tax and climate provisions.
How many patents does it take to violate U.S. antitrust law? That question isn’t a lead-in to a lame joke. Neither is it a valid question for a patent challenge, according to the U.S. Court of Appeals for the Seventh Circuit, which Aug. 1 affirmed the dismissal of a payer suit against Abbvie Inc. that claimed the North Chicago drug company violated the Sherman Antitrust Act when it obtained 132 patents on Humira (adalimumab) and then invoked them against biosimilars.
Abbvie Inc. and Istar Medical SA inked a deal to develop and commercialize Istar’s Miniject device to treat patients with primary open-angle glaucoma. The minimally invasive glaucoma surgical (MIGS) device won CE mark approval in November and has been available in some European countries since early 2022.
As the American Society of Clinical Oncology (ASCO) meeting began, researchers discussed abstracts related to findings due to roll out during the course of the weekend event. On the table June 3 were primary results from the double‐blind, placebo‐controlled, phase III Shine study of Imbruvica (ibrutinib) from Abbvie Inc. and Johnson & Johnson (J&J) in combination with bendamustine‐rituximab and rituximab maintenance therapy as a first‐line treatment for patients ages 65 and over with mantle cell lymphoma.
Targeted protein degradation (TPD) specialist Plexium Inc.’s potential $565 million deal with Abbvie Inc. came on the heels of a tie-up with Amgen Inc. in February worth as much as $500 million-plus, as well as an oversubscribed $102 million financing the same month – all of which translates into “optionality, moving forward, to keep our heads down, do the work we’re really good at and continue to watch the market,” said CEO Percival Barretto-Ko.
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.
