Acquired through its purchase of Ajax, the drug showed encouraging effects in patients with hard-to-treat myelofibrosis. To analysts, such results could lead to competition for Incyte’s Jakafi.

Original title: “Lilly scores early positive data for new JAK drug”

The latest results studying Talvey in combination with Darzalex Faspro support J&J’s efforts to expand the immunotherapy's use.

Original title: “J&J multiple myeloma drug gains edge in earlier stage disease”

DemeRx is launching the first U.S. clinical trial of an ibogaine-derived drug candidate, marking a pivotal moment for a controversial psychedelic long sidelined by safety concerns.

Original title: “Despite FDA trial clearance, ibogaine metabolite won’t receive red carpet treatment”

The U.S. Food and Drug Administration today cleared for marketing the first over-the-counter (OTC) continuous glucose monitor (CGM) for children, Dexcom Inc.’s Stelo Glucose Biosensor System, an integrated CGM (iCGM) indicated for people two years of age and older who do not use insulin.

Original title: “FDA Clears First Over-the-Counter Continuous Glucose Monitor for Children”

PRAC concludes evidence of potential risk of neurodevelopmental disorders in children born to men treated with valproate is inconsistent  Committee recommends updating product…, Agenda Agenda of the PRAC meeting 8-11 June 2026Draft Reference Number: EMA/PRAC/115322/2026…, PRAC statistics: June 2026 , , Glossary Safety signal assessments. A safety signal is information which suggests a new potentially causal association, or a new aspec

Original title: “Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 June 2026”

The therapy works by genetically modifying cells to enable the body’s own immune system to recognise and attack problem cells I’m taking every gift that UCLH and that trial has given me, and I’m running with it.” · The new study enrolled nine patients aged 12 to 65 with active, severe disease who had not responded to multiple treatments for lupus. ... Senior Clinical Practice Facilitator Nicole Prescott administering breakthrough treatment to patient Katie Tinkler for lupus at University College London Hospital in London (PA) “These findings provide early evidence that CAR T-cell therapy may be able to reset the immune system and drive meaningful clinical improvements after a single treatment. “Although these are still early days, the results mark an important step forward in exploring how cellular therapies could transform the treatment of autoimmune diseases.” ... In the new NHS trial, led by University College London Hospitals NHS Foundation Trust (UCLH) and University College London (UCL), five out of six patients with severe lupus went into remission within a few months of receiving CAR-T (PA) A new NHS trial, spearheaded by University College London Hospitals NHS Foundation Trust (UCLH) and University College London (UCL), saw five out of six severe lupus patients achieve remission within months of CAR-T treatment. Over an average 11-month follow-up, rapid improvements in disease markers were observed, including stabilisation or enhancement of kidney function previously damaged by lupus. The CAR-T in the trial was obecabtagene autoleucel (obe-cel), developed by UCL spinout firm Autolus Therapeutics. Obe-cel is designed to target and deplete CD19-positive B cells, which play a central role in lupus. Katie Tinkler was forced to give up her job as a fitness instructor because of debilitating pain and fatigue caused by the severe lupus she has had since she was 20. Lupus caused her to suffer very swollen and painful joints, kidney damage that meant she was close to needing dialysis, lung and heart disease, and a tendency to develop blood clots.

Original title: “Groundbreaking NHS immune therapy sees lupus patients go into remission”

Takeda eyes an FDA run for its investigational psoriasis pill after the drug elicited total skin clearance in more than 35% of patients at 16 weeks—more than 2.5 times that in controls taking Bristol Myers Squibb’s Sotyktu.

Original title: “Takeda’s AI-designed pill bests BMS’ Sotyktu in head-to-head psoriasis trial”

FDA today issued an Emergency Use Authorization (EUA) for generic Nitenpyram Tablets (nitenpyram) for the treatment of New World screwworm (NWS) infestations (myiasis) in dogs, puppies, cats, and kittens that weigh at least two pounds and are at least four weeks old.

Original title: “FDA Issues Emergency Use Authorization for Generic Over-the-Counter Drug to Treat New World Screwworm in Dogs and Cats”

Today, EMA released its 2025 annual report, highlighting progress in bringing innovative, safe and effective medicines to patients. The report outlines the most important…

Original title: “EMA’s 2025 annual report shows strong approval numbers for human and veterinary medicines”

Final draft guidance recommends D‑VRd on the NHS in England and Wales

Original title: “NICE backs daratumumab quadruplet for newly diagnosed transplant‑ineligible myeloma”

Company begins phase 1 treatment in multi‑centre VIDAR‑1 trial

Original title: “Anocca doses first patients with precision TCR‑T therapy”

AI in clinical trials holds great promise for the entire drug development lifecycle. However, any new technology should always be implemented with the end goal in mind—helping patients. That predicted trajectory becomes the placebo arm, while the patient’s actual treatment response becomes the experimental data—in essence, the patient becomes their own control, supercharging both methodology and timelines. For patients with rare and ultra-rare diseases, this could be a genuine lifeline. Traditional placebo-controlled recruitment has long been one of the greatest barriers to advancing development programs in these areas. With the FDA reportedly considering · single-trial efficacy data for drug approval in rare diseases, artificial twin methodology may prove to be exactly the tool that makes that viable, helping sponsors identify the right patients and dose before running one pivotal study. However, amidst that buzz, it’s important to remember that cutting-edge tools should ultimately serve a purpose—and in the case of clinical trials, the ultimate purpose is helping patients. AI-powered artificial twins are a good example of what that might look like. Using AI, researchers can model how a patient’s illness is likely to progress without treatment. Amidst all the new technology, the ultimate goal remains the same: to help patients with new and improved treatments and cures. We should not lose sight of this as AI in clinical trials becomes more prevalent—and we should measure every technology advancement by the same standard we apply to the drugs themselves: Does it ultimately help the patient? Artificial intelligence is transforming every stage of clinical trials, from asset identification, to protocol development, to patient selection and document management. However, as the pace of technological adoption continues to accelerate, it’s important to remember that AI tools are only as good as the people implementing them.

Original title: “Author Post: AI In Clinical Trials: Technology Is Only As Good As The People Behind It”

The failure adds to a series of mixed or negative readouts and leaves in doubt the future of a therapy Sanofi has viewed as a potential blockbuster.

Original title: “Sanofi stops immune drug trial in latest research setback”

Study marks major milestone for CTH120 as company advances disease‑modifying ambitions

Original title: “Connecta launches phase 2a trial of neuroplasticity modulator”

Guidance paves the way for NHS access for eligible adults in England and Wales

Original title: “Aquipta recommended by NICE for acute migraine treatment”

The discontinuation of Sanofi’s Phase 3 study for its complement inhibitor drug in chronic inflammatory demyelinating polyneuropathy delivers an ‘obviously disappointing’ blow to the broader drug class, according to William Blair.

Original title: “Sanofi cans late-stage study for rare autoimmune disease on underwhelming efficacy”