Patrick Lavery

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.

Matthew Stober and Campbell Bunce of Abzena talk about the CDMO’s role in accelerating the path of newer and more effective modalities to market.

The department’s newly announced partnerships were part of a weeklong visit that included discussions held at BIO 2025.

Some of the companies that received American samples, FDA said, are partially owned or controlled by the Communist Party in China.

FUJIFILM representatives talked about the rebrand of the company’s life sciences businesses, partnerships with Regeneron and other companies, and the importance of having a presence at conferences like BIO 2025.

Bartłomiej Czubek, director of Business Development at Mabion, discussed what’s working, and the challenges set forth by what isn’t working, in the relationships built within the present biologics CDMO market.

Korro Bio CEO and president Ram Aiyar, PhD, delves into his company’s partnership with Novo Nordisk as a means of reaching a larger patient population with new ideas and approaches.

Korro Bio CEO Ram Aiyar discusses his company’s platform that tunes the RNA editing process to target a wider range of rare diseases.

The company’s successful completion of facility and equipment qualifications gives it another biologics manufacturing option alongside its United States campus in Morgan Hill, Calif.

The collaboration will focus on identifying pre-clinical candidates for high-priority targets, including a small molecule oral therapy for immunological diseases.

The agreement, which covers a period of five years, has been designed to offer a turnkey service to companies seeking faster time to market for ADCs and bioconjugates.

The partnership leverages the Hesperos organ-on-a-chip platform in the preclinical development of Psilera’s lead compound targeting the progressive neurological disorder for which treatment options are few.

The facility is on the company’s Bedford, NH campus, where another existing building will be repurposed into a Development Center of Excellence.