Patrick Lavery

VeonGen provided the first update to its lead investigational gene therapy since announcing a company rebrand in June 2025.

The decision was based on results of a Phase III trial that showed a median overall survival of 33.8 months with enfortumab vedotin plus pembrolizumab versus 15.9 with platinum-based chemotherapy.

Orlynvah is the first new, branded product for the treatment of uncomplicated UTIs to be introduced in the US in more than 25 years.

The agency has completed both pre-license and bioresearch monitoring inspections with no observations, and no safety-related concerns have been raised to date.

The company was one of 17 to receive letters from the White House on July 31 detailing the steps each company must take to bring prescription drug prices down for Americans.

There are no approved therapies for RRP that completely eliminate the need for repeated surgical procedures.

Type 1 diabetes is a lifelong condition that currently affects approximately 400,000 people in the UK.

The company is not developing an mRNA vaccine, but had been using one as the control in a 10,000-subject Phase IIb trial.

Surveyed by PharmTech Group, this collection of industry players offers their thoughts on HHS’ latest policy move.

While no new mRNA-based projects will be eliminated, other uses of mRNA technology within HHS are not impacted by the announcement.

The new platform delivers CAR-T DNA and transposase directly in vivo, potentially lowering manufacturing complexity and expanding treatment access.

The acquisition highlights growing investor interest in gamma delta T-cell therapies and reflects increased monetization of biotech licensing agreements.

If action is not taken within 60 days, the White House said it would “deploy every tool in our arsenal” to improve drug pricing practices for American patients.

Smart technology, personalized medicine, and the customization of CDMO relationships are helping manufacturers meet shifts in client demand.

While little information is known about this particular case, its possible implications are far-reaching.

Mirvetuximab soravtansine, brand name Elahere, is the first licensed treatment for women with platinum-resistant ovarian cancer in the UK in more than 10 years.

Following an overhaul at ACIP, the HHS secretary took the advice of the committee’s new members, saying he was acting on guidance that dated back to 1999.

Manufacturing sites and a control site will work together in a hub-and-spoke model that has key differences from conventional manufacturing operations.

Three deaths attributed to acute liver failure appear to have occurred following regular treatment or investigational therapy.

Stoboclo and Osenvelt (both denosumab-bmwo) reference Amgen’s Prolia and Xgeva, respectively.

Increased capacity will help Circio progress development of circVec AAV gene therapy and in-vivo cell therapy, with the company setting a goal of selecting its first therapeutic candidate in 2026.

Biocon said that, according to clinical data, both Vevzuo and Evfraxy demonstrated a safety and efficacy profile comparable to that of the reference product.

Linvoseltamab-gcpt, marketed as Lynozyfic, is a bispecific antibody designed to facilitate T cell activation and cancer cell killing.

The expansion of the Kentucky site accounts for $80 million of the announced investment, with the remaining money earmarked for facilities in Michigan.

The new building will create 150 new jobs and expands total production area to nearly 12,000 square meters.

Using its proprietary Optimer delivery vehicle, the company said it uncovered a previously unexploited protein marker expressed on activated hepatic stellate cells.

In contrast to earlier conferences in 2025, experts interviewed as part of the BIO conference in Boston did not come to a consensus about lasting impacts of recent changes in US government policy.

In preclinical trials in mice, the vaccine delivery system provided protection against malaria that was strong enough to stand up to the efficacy of traditional multi-dose regimens.

A key property included in the acquisition is farabursen, an investigational next-generation oligonucleotide targeting the microRNA miR-17 with preferential kidney exposure, intended to treat people with autosomal dominant polycystic kidney disease.

Amyotrophic lateral sclerosis, or Lou Gehrig’s disease, is the most common form of motor neurone disease (MND), with more than 5000 people in the United States being diagnosed with MND annually.