Development

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.

The agency has extended the review period for GSK’s biologics license application for belantamab mafodotin-blmf for the treatment of relapsed/refractory multiple myeloma.

The investment is part of CGT Catapult’s Cross-Catapult Investment Pilot and will accelerate the pre-clinical development of Spliceor’s trans-splicing gene therapy platform.

Genascence’s first-in-class gene therapy blocking interleukin 1, GNSC-001, will enter a Phase IIb/III study in 2026.

Webinar Date/Time: Tue, Jul 29, 2025 10:00 AM EDT

Mechanistic toxicity hypothesis is essential in guiding decision-making and predicting toxicities during the preclinical stages of drug development. The authors highlight the growing importance of integrating advanced technologies like mass spectrometry imaging into toxicology to enhance preclinical translation, foster innovation in therapeutic development, and ultimately improve drug safety and efficacy.

Scientists at MIT and other institutions have discovered compounds that activate a defense pathway inside host cells that could be used as antiviral drugs.

Webinar Date/Time: Wed, Jul 23, 2025 11:00 AM EDT

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

Webinar Date/Time: Tue, Jul 22, 2025 11:00 AM EDT

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

Advanced modeling provides greater understanding for more-informed decision making across all phases of drug development.

As development of novel drugs accelerates, enhanced downstream production processes maintain product efficacy, safety, and quality.

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

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.

The next-generation monoclonal antibody could potentially be used to prevent and treat active COVID-19 infections, according to its developer, providing a non-vaccine option.

EDQM is providing the 12th edition of the European Pharmacopoeia as an all-digital, redesigned, user-friendly issue.

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.

Webinar Date/Time: Thu, Jul 10, 2025 11:00 AM EDT

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 agency has recommended conditional marketing authorization for Zemcelpro (dorocubicel/unexpanded umbilical cord cells) to treat adults with hematological malignancies (blood cell cancers).

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.