In what the U.S. FDA has dubbed a milestone move toward fewer animal studies in drug development, the agency published a draft guidance to help sponsors validate new approach methodologies that can bring safe, effective drugs to market sooner based on human-centric data rather than starting off with nonclinical animal pharmacology and toxicology data.

Crossbow Therapeutics Inc. closed a $77 million series B round to support an ongoing phase I Crosscheck-001 trial of lead program, CBX-250, and additional T-Bolt immunotherapies targeting a broad range of cancers.

Minimed Group Inc. secured U.S. FDA approval for Minimed Flex, its next-generation discreet, smartphone-controlled insulin pump. The nod from the FDA follows the company’s debut on Nasdaq March 6. About half the size of the Minimed 780G pump and roughly the size of two stacked insulin vials, the screenless pump was designed in collaboration with people living with diabetes to offer a more intuitive, lifestyle‑friendly way to manage the condition.

With the U.S. FDA’s approval of GSK plc’s ileal bile acid transporter (IBAT) inhibitor, Lynavoy (linerixibat), patients with primary biliary cholangitis no longer need off-label treatments for a debilitating internal itch symptom called cholestatic pruritus.

Embecta Corp. agreed to acquire Owen Mumford Holdings Ltd. for up to £150 million (US$200 million) in a bid to boost its drug-delivery platforms and medical device technologies. Specifically, the deal will bring to Embecta’s portfolio Owen Mumford’s Aidaptus autoinjector, a two-step, single use platform designed to accommodate both 1-mL and 2.25-mL prefilled glass syringes in the same base device.

In a sea of uncertainty, a large-scale, long-term Swedish study is the first to show that people using GLP-1 receptor agonists are less likely to have worsening mental illness. The study involved a national cohort of 95,490 people diagnosed with depression or anxiety disorder, who also were treated with any diabetes drug (apart from insulin).

In what the U.S. FDA has dubbed a milestone move toward fewer animal studies in drug development, the agency published a draft guidance to help sponsors validate new approach methodologies that can bring safe, effective drugs to market sooner based on human-centric data rather than starting off with nonclinical animal pharmacology and toxicology data.

As AI continues to storm into global life, biopharma companies are figuring out ways to incorporate it into their operations, all with the goal of bringing better therapies to patients faster. At Pharma USA, a Reuters Events meeting in Philadelphia March 16-17, numerous AI companies presented their offerings to attendees, driving interest and partnerships.

Imperative Care Inc. secured $100 million through an oversubscribed convertible note financing round to support commercialization of its stroke and vascular thrombectomy technologies. The round was co-led by new investors Elevage Medical Technologies and Perceptive Advisors alongside existing investor Catalio Capital Management LP. Also participating were new backers Longaeva Partners LP and Brown Advisory, with continued support from existing investors, including Ally Bridge Group and Bain Capital Life Sciences.

Even though case law has established that 340B-covered providers can’t sue drug companies for overcharging on the steeply discounted drugs, the Adventist Health System of West tried a new door into court – as a whistleblower under the False Claims Act.