It didn’t take long for the filing of a second constitutional challenge to the U.S. Inflation Reduction Act’s price negotiations for prescription drugs. In the wake of a similar suit filed three days earlier by Merck & Co. Inc., the Chamber of Commerce filed a complaint June 9 in the U.S. District Court for the Southern District of Ohio.
Researchers at Abbvie Inc. and Calico Life Sciences LLC have described protein tyrosine phosphatase inhibitors, particularly tyrosine-protein phosphatase non-receptor type 2 (PTPN2; TCPTP) and/or PTPN1 (PTP-1B), reported to be useful for the treatment of non-small-cell lung cancer (NSCLC).
Five months after the first anti-CD20xCD3 T-cell engaging bispecific antibody, Roche Holding AG’s Lunsumio (mosunetuzumab), cleared U.S. FDA approval for follicular lymphoma, partners Genmab A/S and Abbvie Inc. won the agency’s approval for epcoritamab as the first subcutaneous CD20xCD3 bispecific antibody for treating diffuse large B-cell lymphoma.
In its first markup of the 118th Congress May 2, the Senate Health, Education, Labor and Pensions (HELP) Committee, under the new leadership of Sen. Bernie Sanders (I-Vt.), devolved into a brief mutiny of sorts as the committee members started to take up four bipartisan bills aimed at taming prescription drug prices.
Researchers from Abbvie Inc. recently presented the discovery and preclinical evaluation of a novel CD19-targeting glucocorticoid receptor modulator (GRM) agonist antibody-drug conjugate (ADC), ABBV-319, being developed for the treatment of B-cell malignancies.
Abbvie Inc. recently disclosed the discovery and structure of the anti-tumor necrosis factor (TNF) glucocorticoid receptor modulator (GRM) immunology antibody-drug conjugate (iADC) ABBV-154. The drug is in phase II clinical development as a subcutaneous treatment for rheumatoid arthritis and polymyalgia rheumatica, and as a subcutaneous or intravenous treatment for active Crohn’s disease.
Research at Abbvie Inc. and Calico Life Sciences LLC has led to the development of proteolysis targeting chimera (PROTAC) compounds comprising an E3 ubiquitin ligase binding moiety covalently linked to tyrosine-protein phosphatase non-receptor type 2 (PTPN2; TCPTP) and/or PTPN1B. They are reported to be useful for the treatment of cancer, type 2 diabetes and nonalcoholic steatohepatitis (NASH).
A lot of biosimilar sponsors and wannabes will be watching as the Humira biosimilar competition unfolds in the U.S. While the competition started Jan. 31 with the launch of Amgen Inc.’s Amjevita, the true test of the strength of the competition will come in five months when other adalimumab biosimilars, including Boehringer Ingelheim GmbH’s interchangeable, hit the market.
With at least six others behind it, Amgen Inc.’s Amjevita is leading a 2023 U.S. biosimilars charge to challenge the all-time biggest-selling drug, Humira (adalimumab), from Abbvie Inc. Amjevita hit the U.S. market Jan. 31, and Amgen has the biosimilar priced at two levels, both lower than Humira’s. One is a list price 55% below Humira’s list price of about $115,000 annually and the second is 5% below Humira’s list price. Boehringer Ingelheim GmbH, Sandoz Inc., Samsung Bioepis Co. Ltd./Organon & Co., Pfizer Inc., Viatris Inc. and Coherus Biosciences Inc. all have biosimilar challengers to Humira that are set to launch in July 2023, all likely to come with a lower price tag than Humira’s.
Taking aim at big pharma’s current penchant for acquisition over in-house innovation, Sen. Elizabeth Warren (D-Mass.) is asking the Federal Trade Commission (FTC) to consider the impact a biopharma merger, whether it’s proposed or a done deal, may have on future innovation.
