Author name: Leonardo Arias

Single-trial approvals are raising the bar on trial design and execution. The new paradigm is pushing sponsors to plan earlier, step up their data and risk‑based quality management and use modeling and AI to generate one compelling, regulator‑ready evidence package.

Industry groups have identified upfront costs as a barrier to streamlining U.S. drugmaking. The nonprofit API Innovation Center has a proposed answer for how to tilt finances in favor of investments in continuous manufacturing.

Shortages of behavioral healthcare providers have been a bottleneck to UHS’ growth. Monday’s acquisition of Talkspace for $5.25 a share should help the for-profit hospital giant get around that.

Biocare’s strong growth in immunohistochemistry is expected to strengthen Agilent’s ability to develop new in vitro diagnostic antibodies.

Biocare’s strong growth in immunohistochemistry is expected to strengthen Agilent’s ability to develop new in vitro diagnostic antibodies.

The companies have been embroiled in a row about compounded GLP-1 drugs that escalated to a lawsuit last month. The legal action has now been dropped and the former adversaries have struck a deal that could increase access to Novo’s obesity medicines.

AbbVie’s foray into the obesity space is successful so far, analysts agree, as amylin analog ABBV-295 elicited as much as 9.73% weight loss at 13 weeks in the multiple ascending dose portion of a Phase 1 trial.

Some biotechs that had seen regulatory setbacks under Center for Biologics Evaluation and Research director Vinay Prasad experienced stock bumps Monday morning. Under Prasad’s leadership, the rare disease space has suffered a series of controversial rejections.

The deal is yet another divestiture for CHS, which has embarked on a sales spree as it looks to pay down debt. Last month, executives said they could slow the pace of divestitures as its leverage declines.

Hansoh’s olatorepatide achieved 19% weight loss at 48 weeks in a Phase 3 trial in China, handing partner Regeneron a glimmer of hope for a pipeline in desperate need of reinvigoration.