While the annual State of the Union address has morphed over the years from a summation of the state of the U.S. government and the president’s legislative agenda into political theater on both sides of the aisle, President Donald Trump did include some recommendations to Congress in his Feb. 24 speech. Among those recommendations was a request for Congress to codify his most-favored-nation pricing policy for prescription drugs.
Coming off a U.S. FDA approval of the first GLP-1 in pill format, Novo Nordisk A/S leaned further into oral drug delivery efforts, partnering with Vivtex Corp. to develop next-generation oral formulations of peptide and protein therapeutics in a potential $2.1 billion deal that marks the highest-profile news for Vivtex since the firm spun out of MIT in 2018.
In yet another upheaval in an agency already racked by upheaval, the U.S. CDC announced Feb. 23 that Ralph Abraham, its principal deputy director, chose to step down, effective immediately, so he could “address unforeseen family obligations.”
Minimed Group Inc., Medtronic plc’s diabetes business, is looking to raise up to $784 million in its IPO. Medronic last May revealed plans to spin off the unit as an independent public company and expected to complete the separation within 18 months.
In handing a win to Regenxbio Inc., the U.S. Court of Appeals for the Federal Circuit also cleared some leaves from the 101 patent eligibility threshold after years of Supreme Court decisions cluttering the passageway.
Astellas Pharma Inc. and Vir Biotechnology Inc. have signed a global co-development pact to advance VIR-5500, Vir’s PRO-XTEN dual-masked CD3 T-cell engager targeting prostate-specific membrane antigen for treating prostate cancer. Under the deal terms, San Francisco-based Vir will receive $335 million in up-front and near-term payments, including $240 million in cash, $75 million in equity investment and a $20 million near-term milestone. Vir is also eligible to receive up to $1.37 billion in development, regulatory and sales-based milestones plus royalties on ex-U.S. sales.
Almost three months to the day after Protara Therapeutics Inc. made known positive interim data from the phase II trial testing cell-based therapy TARA-002 in pediatric patients with macrocystic and mixed cystic lymphatic malformations (LMs), Palvella Therapeutics Inc. scored positive top-line results from the phase III Selva study evaluating Qtorin 3.9% rapamycin anhydrous gel for microcystic LMs.
Targeting an ultrarare disease affecting about 250 U.S. residents, Immedica Pharma AB’s Loargys (pegzilarginase) won accelerated FDA approval to treat hyperargininemia in those ages 2 and older with arginase 1 deficiency (ARG1-D).
Gilead Sciences is stepping deeper into synthetic lethality, licensing a clinic-ready MAT2A (methionine adenosyltransferase 2a) inhibitor from Suzhou, China-based Genhouse Bio Co. Ltd. in a deal worth up to $1.53 billion.
CSL Ltd. is out-licensing its interleukin-6 (IL-6) monoclonal antibody, clazakizumab, to Eli Lilly and Co. in a deal that brings CSL $100 million in up-front fees. A CSL spokesperson told BioWorld the deal includes undisclosed milestone payments and sales-based royalties. CSL will retain rights to develop and commercialize clazakizumab for prevention of cardiovascular events in patients with end-stage kidney disease, while Lilly will explore the MAb in all other indications.
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