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TOP STORIES
The layoffs will allow Ironwood to dedicate more resources to pushing its lead molecule apraglutide through a Phase III trial and a rolling NDA submission.
Kennedy’s confirmation hearing on Wednesday became heated as Democratic senators grilled the nominee for HHS Secretary on his previous statements about vaccine safety.
Inhibikase’s setback continues biopharma’s losing streak against Parkinson’s, marked by several clinical failures and abandoned assets in recent months.
The J.P. Morgan Healthcare Conference started off with a flurry of deals that reinvigorated excitement across the biopharma industry. Johnson & Johnson moved to acquire Intra-Cellular Therapies for $14.6 billion, breaking a dealmaking barrier that kept Big Pharma’s 2024 biotech buyouts to under $5 billion.
The layoffs follow an announcement in early January that I-Mab will re-prioritize resources to focus on advancing a CLDN18.2 and 4-1BB bispecific antibody for gastric cancers.
The move is part of a strategic restructuring aimed at getting azenosertib to the market for patients with gynecological malignancies.
The approval continues the trend of GLP-1s expanding into indications outside of diabetes and weight loss.
The discontinuation comes after the investigational drug, volenrelaxin, failed a related heart failure study in an overlapping patient population.
IRA
The U.S. Centers for Medicare and Medicaid Services has named Novo Nordisk’s Wegovy, Ozempic and Rybelsus as part of the second round of the IRA drug price negotiation program, even as the pharma challenges the program.
Donald Trump continues to make waves in biopharma; Sage rejects Biogen’s unsolicited takeover offer; the obesity space sees more action with new company launches, IPOs and fresh data; and experts get ready for an important era in the Duchenne muscular dystrophy space.
FDA
Ahead of Robert F. Kennedy Jr.’s confirmation hearings, experts—and RFK’s own family—expressed concerns about his vaccine-related views, though the same experts are largely unfazed by the level of power he and Marty Makary could ultimately wield over the FDA.
It’s been a rocky few months for BioAge Labs, which shuttered a Phase II trial of its lead candidate azelaprag Tuesday after the molecule caused liver-based side effects.
PRESS RELEASES
• The capacity expansion in Bubendorf reached another important milestone with the inspection of Building K. The announced start-up is proceeding according to plan. • In Vista, CA, Bachem acquired a property adjacent to its existing facility. The acquisition will enable a future capacity expansion at the Vista site, thereby strengthening Bachem’s presence in the US market.
Dedicated solutions for these complex products can help enable confidence in the accuracy of analytical results
◆ VIAL-INHBE is a novel, GalNAc-conjugated INHBE (Activin E) siRNA for the treatment of obesity and other cardiometabolic indications with a projected Q6M dosing intervall ◆ VIAL-INHBE DIO mouse model data demonstrated compelling fat-selective weight-loss and lean mass preservation ◆ Combination therapy with a low-dose GLP-1 resulted in synergistic weight loss and lean mass preservation that was maintained off-GLP-1 treatment ◆ A Phase 1 open-label study in Australia is initiating to evaluate safety, pharmacokinetics, and pharmacodynamic responses ◆ Interim subcutaneous safety and pharmacokinetic data are expected in H1 2026