Amgen Inc.’s head of R&D James Bradner said his firm was “surprised” by the request from the U.S. FDA Jan. 16 to take Tavneos (avacopan) off the market – and the company said no. “We're in discussions with FDA, and we'll answer questions as we talk with them,” he added.
Amgen Inc. quit a development deal with Kyowa Kirin Co. Ltd., returning global rights for rocatinlimab, Kyowa Kirin’s T-cell rebalancing therapy being investigated for moderate to severe atopic dermatitis.
Amgen Inc. quit a development deal with Kyowa Kirin Co. Ltd., returning global rights for rocatinlimab, Kyowa Kirin’s T-cell rebalancing therapy being investigated for moderate to severe atopic dermatitis.
The EMA has started a review of Amgen Inc.’s Tavneos (avacopan) after questions were raised about the integrity of the data in the Advocate study that the agency assessed when granting approval of the vasculitis treatment in January 2022.
The structurally similar cytokines IL-2 and IL-15, and their shared beta subunit CD122, are keeping developers busy across a range of indications. Though some scientific confusion has plagued the space historically, drug candidates have drawn deals and Wall Street interest aplenty. Amgen Inc., Novartis AG, and Incyte Corp. are among those who’ve made their interest known.
Amgen Inc. has swooped on two European cancer specialists, buying Dark Blue Therapeutics Ltd. for up to $840 million plus royalties, and sealing a $618 million license agreement with Disco Pharmaceuticals GmbH for rights to a novel cancer cell surface target.
It’s been a decade since Sandoz Inc. launched Zarxio, referencing Amgen Inc.’s Neupogen (filgrastim), as the first biosimilar in the U.S. Zarxio was expected to be the beginning of a biosimilar boom that would deliver big savings by finally providing direct competition for costly biologics. Neither the pipeline nor the uptake of biosimilars has lived up to expectations, as only 6% of the 313 biologics approved by the FDA’s CDER have been targeted by biosimilars and fewer than 5% are actually competing with the follow-ons.
Ten years after the first biosimilar launched on the U.S. market, the FDA is taking steps to make biosimilar development and pharmacy substitution more like that of generics, reducing the cost of the drugs in the process. “We want to see more biosimilars. We want to see more competition,” FDA Commissioner Marty Makary said at an Oct. 29 media briefing in which he announced new guidance to streamline biosimilar development, cut through the red tape and shorten the timeline.
.webp?height=488&t=1769119579&width=650 "Molecular model of interleukin-15 (IL-15)")
