03/06/2026  |  Millie Hoe  |  BioXconomy

https://www.bioxconomy.com/modalities/peptide-therapeutics-market-set-soar-investments-clinical-trials-rise 

The US is driving innovation in the peptide therapeutics space, especially around GLP-1s.

Investment in peptide therapies is set to soar in the next decade. A recent financial report from Grand View Research predicts a market value of almost $300 billion by 2033, more than double their 2025 evaluation of $140 billion. The US currently dominates the peptide space at more than 60% of the market share. 

What appears to be driving this growth is the stratospheric success of glucagon-like peptides (GLP-1s). These have fueled clinical trial investments to discover additional indications for GLP-1s while spotlighting the abilities of other peptide drugs. 

From uses in oncology to the treatment of rare diseases, peptide popularity is attracting significant investor attention.

More than weight loss
Much of the focus on GLP-1s has been on weight loss, with the World Health Organization (WHO) releasing guidelines recommending their use for the “long-term management” of obesity. While this will certainly generate significant capital within the peptide therapies market, multiple studies have highlighted that GLP-1s aren’t just a one-trick pony.
A landmark study published in the Journal of the American Medical Association (JAMA) evaluated data from over 58,000 patients with type II diabetes, heart failure, and obesity. The study found a 42% risk reduction of death or hospitalization from heart failure in patients treated with GLP-1s compared to the placebo group. What’s more, there was nearly double the incidence of hospitalization and death in patients treated…

03/05/2026  |  Jacob Becraft  |  Washington Post/Opinion

https://www.washingtonpost.com/opinions/2026/03/05/offshore-china-clinical-trials-biotechnology/ 

A burdensome regulatory environment is pushing clinical trials overseas.

In the late 20th century, the United States made a bet that it could offshore manufacturing to countries with cheaper labor, such as China, while leading innovations at home. But although that bet delivered cheaper goods, it also hollowed out domestic manufacturing capacity, weakened supply chains, cost millions of jobs, and fueled the rise of foreign competitors who now rival or surpass American industry.

Today, the U.S. is making the same mistake with biotechnology.

More companies are running clinical trials in China, where early-stage medical research is faster and cheaper. From 2010 to 2021, the number of clinical trials conducted in China by Western companies more than tripled, and by 2023 China was registering roughly 50 percent more interventional clinical trials than the U.S. This shift is often justified by the view that it doesn’t matter where drugs are first tested, so long as Americans eventually gain access to them.

After more than a decade working in genetic medicine, I believe this view is deeply flawed. Early clinical development is not interchangeable, low-value work. Where trials are run determines where expertise accumulates, where data are generated and where the next generation of therapies is conceived. Forfeiting this stage of innovation to China threatens American science and national security.

But offshoring early-stage innovation isn’t inevitable. With one targeted change to clinical trial approval policies, the U.S. could reverse this trend, making new medicines cheaper and more accessible for Americans.

03/05/2026  |  European Medicine Agency

https://www.ema.europa.eu/en/news/new-guidance-conduct-clinical-trials-during-public-health-emergencies-eu 

Recommendations to streamline authorisation of new clinical trials and changes to ongoing trials to generate clinical evidence

The Accelerating Clinical Trials in the EU (ACT EU) initiative has published a draft guidance document outlining how clinical trials should be conducted during public health emergencies (PHEs). The guidance, now open for stakeholder consultation, is intended for sponsors and all parties involved in the design and conduct of clinical trials in the EU.

This is the first guidance on PHEs to reflect the EU’s current legislative framework as well as the guidelines from the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) developed following the COVID‑19 pandemic. It recommends a harmonised approach to ensure that clinical trials can be initiated, adapted and continued efficiently and safely when public health emergencies arise.

The guidance proposes regulatory mechanisms aiming to accelerate the authorisation of new clinical trials and the approval of modifications to ongoing trials during a PHE. Sponsors are encouraged to seek scientific advice from EMA’s Emergency Task Force (ETF) to ensure trials are well designed, efficient and capable of delivering meaningful data for regulatory assessment.

The draft also provides guidance for situations in which trial participants can be transferred across investigational sites. Adapted procedures or alternative approaches may be required due to the specific challenges posed by public health emergencies. The rights, safety and well-being of trial participants and the generation of scientifically…

03/04/2026  |  University College London  |  Science Daily

https://www.sciencedaily.com/releases/2026/03/260304184215.htm 

An experimental therapy for children with a severe and difficult to treat form of epilepsy appears to be both safe and highly effective at reducing seizures, according to results from an international clinical trial led by UCL (University College London) and Great Ormond Street Hospital. The findings suggest the treatment could significantly improve the health and daily lives of affected children.

The study, published in The New England Journal of Medicine, found that children with Dravet syndrome experienced seizure reductions of up to 91 percent while regularly receiving an investigational drug called zorevunersen.

Researchers also reported early evidence that the therapy may help ease some of the disorder's effects on thinking and behavior. Over a three year period, children participating in the study showed improvements in quality of life, and most reported side effects were mild.

Understanding Dravet Syndrome

Dravet syndrome is a rare and severe genetic epilepsy that causes frequent seizures that are often difficult to control. The condition is also linked to long term neurodevelopmental challenges, feeding problems, movement difficulties, and a higher risk of premature death.

For many families, treatment options remain limited. Existing medications fail to fully control seizures in many patients, and no currently approved therapies directly address the cognitive and behavioral complications associated with the disorder.

How the Drug Targets the Underlying Genetic Cause

Zorevunersen (produced by Stoke Therapeutics in collaboration with Biogen) is designed to address the root cause of Dravet syndrome by acting on a faulty gene.

Most…

03/04/2026  |   Ann & Robert H. Lurie   |  Medical Xpress

https://medicalxpress.com/news/2026-03-gene-clinical-trials-epilepsy-results.html

A Phase I/IIa clinical trials co-led by Linda Laux, MD, from Ann & Robert H. Lurie Children's Hospital of Chicago, show that the first gene regulation treatment for epilepsy is safe and well tolerated by patients with Dravet syndrome for whom antiseizure medications are not effective.

Results, published in the New England Journal of Medicine, include significant seizure reduction and improvement in other symptoms of Dravet syndrome, such as language, motor, and behavior issues. Researchers also report sustained treatment benefits in ongoing open-label extension studies.

"Our results are highly promising, especially since currently there are no approved treatments that address the underlying cause of Dravet syndrome," said Dr. Laux, Head of the Epilepsy Center and Associate Division Head of Neurology at Lurie Children's, as well as Associate Professor of Pediatrics at Northwestern University Feinberg School of Medicine.

"Since this gene regulation product targets the actual root cause of Dravet syndrome, we observed improvements in other developmental and cognitive symptoms, in addition to seizure control. This is unprecedented."

Understanding Dravet syndrome and its cause
Dravet syndrome includes a spectrum of symptoms that emerge in infancy and evolve. Most patients experience cognitive deficits, communication and behavioral impairments, motor dysfunction, growth delays, and autistic traits. Difficulties with feeding, poor appetite, and weight loss are also common.

As Dr. Laux explained, patients with Dravet syndrome have a mutation on one SCN1A (sodium channel receptor) gene with one normal SCN1A gene.…