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Investor optimism has waned as final minutes from uniQure’s pre-BLA meeting with the FDA convey that data from the company’s Phase I/II studies of AMT-130 are “unlikely” to provide the primary evidence to support a biologics license application.

Writing in separate editorials in two leading medical journals, former chiefs of federal scientific agencies issued warnings about the changes being proposed to vaccine frameworks by current officials.

The partnership will focus on Crescent’s PD-1/VEGF inhibitor CR-001 and Kelun-Biotech’s SKB105, both of which the companies plan to push into Phase I/II development for solid tumors early next year.

The field of women’s health suffers from a lack of specific and standardized tools optimized for the study of the human vaginal microbiome. Learn about the OMNIgene™•VAGINAL device for the self-collection and stabilization of vaginal samples, and OMNIgene™•XTRACT ULTRA extraction kits for the recovery of vaginal microbial DNA and RNA to support vaginal microbiome discovery.

The OMNIgene™•XTRACT ULTRA kit enables the optimal recovery of large quantities of high-quality DNA and RNA from a wide range of sample types including vaginal samples collected with the OMNIgene™•VAGINAL device. The OMNIgene™•XTRACT ULTRA kit is the first solution validated to provide significantly higher DNA and RNA yields from vaginal samples to better support multi-omic analysis of microbial communities.

Companies who run their early-stage clinical development outside the U.S. would “experience higher fees” according to an FDA proposal made during the negotiation process for the eighth cycle of the user fee program.

Last week, Center for Biologics Evaluation and Research Director Vinay Prasad claimed in an internal memo—without providing evidence—that COVID-19 vaccines were responsible for the deaths of 10 children between 2021 and 2024.

Høeg is the fifth person to lead the Center for Drug Evaluation and Research this year.

In this episode of Denatured, Jennifer C. Smith-Parker speaks to Stacey Adam, PhD, Vice President of Science Partnerships at the Foundation for the National Institutes of Health and Patrick Smith, Senior Vice President, Translational Science at Certara, to discuss the latest regulatory news and the future for new approach methologies (NAMs) development.

For the second month in a row, job postings on BioSpace increased in key biopharma disciplines. However, application rates also increased.

Job listings in the area have ticked up in the last month. These seven companies are hiring in South San Francisco right now, including scientist and clinical roles.

With new UK clinical trial rules landing in 2026, the EU Biotech Act on the horizon and China and Australia gaining ground, CROs are zeroing in on study timelines, AI/ML and data privacy as the industry’s next pressure points.

● CANDID-CNS™ is the new state-of-the-art AI model for BBB penetration: it achieves 87% AUPRC on bRo5 small molecules compared to 56% by Pfizer’s CNS MPO. ● CANDID-CNS™ distinguishes CNS penetrant stereoisomers at 68% compared to 50% by Pfizer’s CNS MPO. ● Published in the Journal of Chemical Information and Modeling, CANDID-CNS™ presents a breakthrough in AI Drug Discovery by unlocking the potential of bRo5 and stereochemistry to significantly expand the chemical space of small molecules that can be developed into CNS therapeutics.

Event to Take Place December 11th at 4:30 P.M. ET

Enterololin uses a novel mechanism of action to attack the infection. New treatment has potential use in Crohn’s Disease. License is under existing Research and Collaboration Agreement with McMaster.

Oral MDL-001 Demonstrated Equivalence to Remdesivir and Sofosbuvir in Head-to-Head Animal Model Studies Performed at The Icahn School of Medicine at Mount Sinai and Scripps Research, and Superiority to Nirmatrelvir in a Literature Comparison of Equivalent Animal Models. The Potential First-in-Category, Direct-Acting, Broad-Spectrum Antiviral Targets A Novel Conserved Site on The Viral Polymerase Across Six Viral Families.

Success demonstrates the power of EMMI, Terray’s proprietary AI platform integrated with its rapidly expanding 13B+ target-ligand binding database and highly automated lab