News
Innovation drives CROs to win new business, but unchecked customization creates complexity that undermines reproducibility, weakens renewals and leads to turnover—making standardization a strategic necessity, not a constraint.
FEATURED STORIES
A recent FDA reversal sparked new hope for patients with Huntington’s disease. Flying under the radar, Skyhawk Therapeutics revealed 12-month functional data from a midstage trial of its own candidate showing improvements on a key disease measurement scale.
Recent approvals for Corcept Therapeutics and Merck have injected momentum into the space, where GSK, Allarity Therapeutics, OSE Immunotherapies and others are advancing their own candidates.
The FDA plans to hold an advisory committee meeting to discuss Capricor Therapeutics’ application for deramiocel, which the agency rejected last July. The news surprised CEO Linda Marbán, who told BioSpace the FDA has not communicated any issues of concern with the company’s resubmitted application.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
If cell and gene therapy makers are going to achieve their mission to improve patients’ lives, the industry must come together to share information across stakeholders, from regulators to manufacturers to payers.
THE LATEST
Pfizer and BioNTech reported positive data Friday from their Omicron BA.4/BA.5-adapted bivalent booster. This followed a similar announcement by Moderna Monday.
Therapeutics to halt the progression of chronic kidney disease are in Phase III trials, and others will enter that stage soon. NDAs could follow as early as 2024 with regulatory determinations in 2025.
Iovance Biotherapeutics announced the FDA’s Biologics License Application for lifileucel will likely be completed in Q1 of 2023, a short delay after the agency requested additional data.
The FDA has approved Provention’s BLA for intravenous antibody TZIELD to delay stage 3 type 1 diabetes, making it the first disease-modifying drug indicated to slow disease progression.
With the Thanksgiving season upon us, there are many reasons for biopharma and life sciences companies to say thanks, including for new leaders.
Editas Medicine is pausing its ocular gene therapy program after demonstrating a favorable safety profile and seeking a potential partner to develop EDIT-101, the company announced Thursday.
Regeneron and CytomX Therapeutics inked a deal valued at up to $2 billion to develop next-generation bispecific immunotherapies for cancer, the companies announced Thursday.
GSK has pulled out of its partnership focused on developing T-cell receptor therapeutics for solid tumors with Immatics, the German biotech revealed in its Q3 financial results published Thursday.
Alloy Therapeutics inked an antibody discovery deal with Normunity Thursday to advance the latter’s immune normalizers, antibody therapies that boost the body’s natural immune system to fight cancer.
Astellas’ Phase III SPOTLIGHT trial studying zolbetuximab in CLDN18.2-positive, HER2-negative gastric or gastroesophageal junction adenocarcinoma returned positive results.