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Novo Nordisk CEO Maziar Mike Doustdar acknowledged the market pressure facing the company’s GLP-1 products but sought to assure investors that Novo has the situation under control.

Amgen believes that it can transcend the expected tradeoff between convenience and efficacy, anticipating that its investigational obesity drug MariTide will continue to provide competitive weight loss even at monthly or longer schedules.

After review, Amgen is certain that Tavneos is effective and has a favorable benefit-risk profile. The company informed the FDA on January 28 that they would not pull the drug.

Instead of joining the increasingly crowded GLP-1 arena, GSK will focus its efforts downstream of obesity—a push currently anchored by its Phase III-ready FGF21 analog efimosfermin alfa for liver fibrosis.

Rep. Jake Auchincloss of Massachusetts said the Commissioner’s National Priority Voucher program did not receive congressional backing. The FDA has also not yet made disclosures for eight senior reviewers, according to Auchincloss.

Mounjaro and Zepbound combined for $11.7 billion in the fourth quarter, which beat analyst consensus of $10.6 billion.

Novartis will still be on the lookout for early-stage deals under $2 billion, and later-stage agreements around a product that could reach the market within five years, CEO Vas Narasimhan said Wednesday.

Pfizer announces the first data from its Metsera-acquired pipeline just ahead of its earnings call, where analysts pressed execs for more details; Merck and Roche also released Q4 and full year earnings, with Eli Lilly, Novo Nordisk and others reporting Wednesday; REGENXBIO hits a regulatory snag ahead of its upcoming PDUFA; more.

Investor enthusiasm and evolving FDA pathways are accelerating rare disease drug development, with ultrarare conditions like MPS II moving into the spotlight.

Nearly 100 biotechs went public amid the industry’s IPO frenzy in 2021, driven by an influx of pandemic-driven investments. But many of those companies have little to show investors.

U.S. President Donald Trump signed a spending package into law Tuesday that reauthorizes the FDA’s previously stalled rare pediatric disease priority review voucher program, among other initiatives, while ending a three-day partial government shutdown.

Novo Nordisk beat analyst expectations for the fourth quarter, but the result was overshadowed by softened expectations for this year.

• 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