Good day. The U.S. Food and Drug Administration seeks to accelerate clinical trials of new medicines by using artificial intelligence to streamline the laborious process of collecting and submitting study data.

Typically, medical centers involved in clinical trials pull study data from electronic-health records and enter them manually into a data-capture system. Then, the drug company developing the medicine reviews the data and submits them to the FDA.

The FDA this summer plans to pilot an approach that would upend this practice, which hasn’t changed much in decades. Through the program, AI would extract data directly from electronic records so they can be submitted in real-time to both the FDA and the pharmaceutical company.

If successful and adopted widely, the new approach could speed drug development and help the U.S. compete with other nations making a strong push into biotechnology, officials said.

Advances in AI and electronic-health records enable this initiative, but it is also driven by a recognition of inefficiencies in U.S. trials, said Dr. Emma Meagher, senior vice dean for clinical and translational research at Penn Medicine.

“In general, we have a sense that the way we do clinical trials is dysfunctional in many ways,” she added.

After reviewing industry comments the FDA intends to launch a pilot that includes five to nine companies, said Jeremy Walsh, the FDA’s chief AI officer.

“The whole purpose here is to accelerate cures,” Walsh said.

As a prelude to the pilot, drugmakers AstraZeneca and Amgen agreed to test real-time data reporting in clinical trials of specific cancer medicines.

The University of Pennsylvania and the University of Texas MD Anderson Cancer Center are participating in the AstraZeneca study of patients with treatment-naïve mantle cell lymphoma. Site selection for the Amgen trial, focused on patients with limited-stage small cell lung carcinoma, is under way.

Startup Paradigm Health is providing AI capabilities for this proof-of-concept work.

Read the full article.

And now on to the news...

Dual-use technology. Ridgeline, a venture firm led by investors experienced in government and the private sector, has secured $180 million to back technology companies with civilian and defense applications. Its fundraising got a lift from a new federal effort to spark private investment in sectors vital to national and economic security.

• Ben Walker, Ryan Clinton and Andrew McMahon co-founded Memphis, Tenn.-based Ridgeline in October 2019 to finance technology startups and help them navigate their way to industry and defense department contracts. “We help companies take their commercial capabilities and translate them into a language that is resonant with a DoD audience,” said Walker, a general partner.
   
• Initially, they raised individual pools of capital to back specific companies, such as Opentrons Labworks, a lab-automation company. In 2021, they closed on just more than $52 million for Ridgeline’s first fund, securing FedEx as an anchor investor.
   
• The new fund combines private dollars and government debt Ridgeline can call down. The firm secured the debt by becoming, in 2024, one of the first early-stage venture firms to participate in the Small Business Investment Company Critical Technologies Initiative, a joint program between the Small Business Administration and the defense department’s Office of Strategic Capital.

Ligand Pharmaceuticals said it has reached a deal to acquire Xoma Royalty, a company that invests in a range of biotech firms, for around $740 million. Under the terms, Ligand will pay $39 a share in cash for Xoma, a 2.9% premium over the $37.90 closing price on Friday. Both Ligand and Xoma are known as royalty aggregators for investing in drugs while they are in development and then, if they work out, collecting royalties from their sales.

• By absorbing Xoma, Ligand’s total portfolio would more than double in size to more than 200 drugs and experimental treatments, including a handful of medicines on the market and several in late-stage studies.

SoftBank Group is forming a new venture focused on the intersection of artificial intelligence and robotics, an area CEO Masayoshi Son sees as the “next frontier” for the Japanese conglomerate. The new venture, called Roze AI, aims to make the physical buildout of AI infrastructure more efficient, including by using autonomous robotics to build data centers, people familiar with the matter said. It plans to take the new venture public as soon as the second half of the year, the people said.

People

Ambulatory infusion services provider Medix Infusion appointed Carmine DeNardo as president and chief executive officer. He most recently served as vice president and general manager of Omnicell's specialty pharmacy division.

Nuevocor, a startup developing novel therapies for genetic cardiomyopathies, appointed Monica Shah as chief medical officer. She most recently served as CMO of CTI Clinical Trial & Consulting.

Genetic medicine company Strand Therapeutics appointed Kunal Bhatia as chief financial officer. He was previously a managing director in the healthcare investment banking group at Cowen.

Exits

CareDx, a precision medicine company focusing on improving outcomes for transplant patients and advancing organ health, agreed to acquire Naveris, a precision oncology diagnostics provider. The deal includes an upfront payment of $160 million in cash, with up to an additional $100 million in payments based on revenue milestones.

Aidoc, a startup helping physicians turn clinical data and signals into actionable insights, scored $150 million in Series E funding. The growth equity business within Goldman Sachs Alternatives led the round, which saw participation from General Catalyst and others. Aidoc has offices in New York and Israel.

Coultreon Biopharma, a Belgian startup developing treatments for autoimmune diseases such as psoriasis and ulcerative colitis, closed a $125 million Series A round. Investors included Sofinnova Investments, Forbion, Novo Holdings, Regeneron Ventures and Samsara BioCapital. The company was previously known as Onco3R Therapeutics.

Axoft, a Cambridge, Mass.-based neurotechnology startup building implantable brain-computer interfaces, secured $55 million in Series A funding. C.P. Group Innovation led the round, which included additional support from Alumni Ventures, Hillhouse Investment and Gaorong Ventures.

Nervonik, a Los Angeles-headquartered startup developing peripheral nerve stimulation technologies, secured $52.5 million in Series B financing led by Amzak Health.

Fathom Therapeutics, a New York-headquartered startup using quantum chemistry and AI to design novel drug molecules by predicting their behavior inside living cells, landed $47 million in Series A funding. Sutter Hill Ventures led the round, which included contributions from Chemistry and others. In addition to the investment, Mandana Honu has joined Fathom as chief business officer.

Hypervision Surgical, a London-based provider of real-time hyperspectral imaging for surgery, closed a £17 million (about $23 million) Series A round. Heal Capital led the investment, which included contributions from Angelini Ventures and others.

Moleculent, a Stockholm-headquartered startup that is decoding cellular networks to advance human health, picked up a $20 million investment. Rubicon Healthcare Partners led the funding, with Managing Partner Ole Dahlberg joining Moleculent’s board. Investors including ARCH Venture Partners and Eir Ventures also participated in the round.

Crazy Mountain, a non-alcoholic beer brand, was seeded with a $15 million investment led by CAVU Consumer Partners. 

Greatly Health, a New York-based cancer-care startup, was seeded with a $4 million investment co-led by Pear and Commonweal Ventures.

Fermeate, a San Francisco-based industrial biotechnology startup using light to control gene expression during fermentation, nabbed $2 million in seed funding led by Newfund Capital.

• There’s a Revolution in Cancer. But Can Big Pharma Afford It?

• FDA Study Finds Baby Formula Safe From Heavy Metals

• Purdue Pharma to Pay $225 Million to Justice Department

• Canada Approves Dr. Reddy’s Generic Version of Ozempic

• A Breakthrough Heart Procedure Comes With Risky Tradeoffs

• What Heart-Valve Patients Need to Know Before Treatment

• We’re All Talking to Each Other Less Than We Did a Decade Ago

• Year one as a CEO: what leadership actually feels like (Life Sci VC)
   
• Why conversations around health AI may be evolving beyond hype (STAT)
   
• Could at-home brain stimulation reduce psychiatry’s reliance on SSRIs? (New York Times)

This newsletter was compiled by Brian Gormley, Matthew Strozier and Zachary Cole. 

Share your tips, comments and questions: vcnews@wsj.com

The team: Matthew Strozier, Yuliya Chernova, and Brian Gormley.

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