The EMA’s Committee for Medicinal Products for Human Use (CHMP) looked with favor on a bucketload of would-be drugs, issuing positive opinions for the European Commission to consider across a range of indications.
Despite pressure from several lawmakers to declare the new coronavirus a U.S. public health emergency, Health and Human Services (HHS) Secretary Alex Azar said such a declaration isn’t needed, at least not yet.
The pending Abbvie Inc. merger with Allergan plc, expected to close in the first quarter, brought good tidings to another “A” company on Monday, allowing Astrazeneca plc to regain global rights to its late-stage Crohn’s disease and ulcerative colitis (UC) drug, brazikumab.
The pending Abbvie Inc. merger with Allergan plc, expected to close in the first quarter, brought good tidings to another “A” company on Monday, allowing Astrazeneca plc to regain global rights to its late-stage Crohn’s disease and ulcerative colitis (UC) drug, brazikumab, an anti-IL-23 therapy that was out-licensed to Allergan in a $1.27 billion deal in 2016.
For the first time since Congress opened the door to biosimilars in 2010, the FDA approved nearly as many biosimilars in 2019 as it did new biologics. As the first decade of biosimilars came to a close, the agency’s Center for Drug Evaluation and Research (CDER) approved 10 biosimilars referencing seven blockbuster biologics, bringing the total number of approved biosimilars to 26.
After a flurry of activity in December, when the FDA approved seven new molecular entities (NMEs), the total of novel drugs that were given the green light this year reached 48, a number that ranks third behind the record 59 new medicines the agency approved last year and 53 in 1996.
Harpoon Therapeutics Inc. and Abbvie Inc. have cut their second deal in little more than two years as they embark upon an exclusive worldwide option and license transaction for HPN-217, Harpoon’s B-cell maturation antigen T-cell engagers targeting solid tumors and hematologic malignancies.
DUBLIN – Shareholders in Allergan plc voted with alacrity to approve Abbvie Inc.'s $63 billion takeover of the Botox maker at an extraordinary general meeting in Dublin Monday. Investors voted 99.64% in favor, with just .36% voting against. Although the outcome was never in any doubt, an unexpected, last-minute €572 million (US$631 million) charge on the transaction, courtesy of the Irish government, is likely to have swayed all but the most hardened holdouts to cast their votes in favor of the deal, lest Abbvie were to get cold feet.
Reata Pharmaceuticals Inc. has agreed to pay former partner Abbvie Inc. $330 million plus royalties to reacquire ex-U.S. development, manufacturing and commercialization rights for the Nrf2 activators bardoxolone methyl and omaveloxolone, as well as other next-generation candidates in the class. Rights to certain Asian markets for bardoxolone remain licensed to Kyowa Kirin Co. Ltd.
Unexplained price increases are a recurring theme whenever a congressional committee discusses U.S. prescription drug prices, and both state and federal lawmakers have proposed measures to force drug manufacturers to justify those increases.
