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Glaukos’ Epioxa allows cross-linking therapy for keratoconus without requiring an incision. The biotech expects to launch the drug early next year.

Recent headlines proclaim a ‘potential’ or ‘functional’ cure for multiple myeloma, but the fight against the disease must continue.

After a chaotic year that has seen the attrition of over half the FDA’s senior leadership, many of these individuals have landed new roles—at Eli Lilly, Pfizer, Iovance and more. The FDA’s loss, it seems, is largely the pharmaceutical industry’s gain.

CMS Administrator Mehmet Oz clarified that a deal has not yet been sealed with the manufacturer of semaglutide, Novo Nordisk, or any other GLP-1 drugmaker.

Roche will gain worldwide rights outside of the Greater China region to Hansoh’s HS-20110, an antibody-drug conjugate in early-stage development for colorectal cancer.

The Commissioner’s National Priority Voucher awards companies that align with specific national priorities—such as boosting domestic manufacturing and lowering drug prices—with faster reviews and more frequent interactions with the FDA.

With more than $1.5 billion on the line, Gilead looks to bolster its CAR T portfolio.

EMD Serono will offer its fertility treatments on TrumpRx at a steep discount, and Roche’s direct-to-consumer offering will cover its flu pill Xofluza.

During this webinar BioSpace sits down with former FDA Chief Information Officer Vid Desai to discuss the potential advantages and pitfalls of deregulation stemming from one of President Donald Trump’s first executive orders. Together, they uncover what this shift means for drugmakers, compliance and patient safety.

In this episode presented by PII, BioSpace’s head of insights discusses decentralized clinical studies and how connected technology can improve patient compliance with guests Oliver Eden and Travis Webb.

The partners have yet to disclose what their priority indications are, though EVOQ’s NanoDisc technology aims to enable the development of potentially curative treatments for autoimmune conditions such as celiac disease and type 1 diabetes.

An unnamed source clarified that Sandra Retzky has not been fired from the FDA, but it remains unclear where she was reassigned.

• 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.

◆ 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