News

FDA has approved a new mAb therapy from Regeneron Pharmaceuticals as well as a higher dose version of Eylea, the company’s eye disease therapeutic.

The immunization, meant to protect infants aged six months or lower, is given to pregnant individuals at a gestation period of 32 to 36 weeks.

Sartorius’ Biostat STR now incorporates Repligen’s XCell ATF hardware.

FDA has halted enrollment in clinical studies for Gilead Sciences’ magrolimab, a biologic treatment in development for acute myeloid leukemia.

With this agreement, Chiesi Global Rare Diseases will co-develop drug delivery systems with Aliada Therapeutics for large molecule therapeutics that can cross the blood-brain barrier.

A major grant from the Bill & Melinda Gates Foundation will bolster efforts to fight the global HIV/AIDS epidemic.

The collaboration between Parexel and Partex is designed to leverage artificial intelligence-powered solutions to accelerate drug discovery and development.

FDA granted accelerated approval to Elrexfio (elranatamab-bcmm) for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy.

The launch of Alpha Teknova’s new manufacturing facility in Hollister, Calif., increases its capacity for custom reagents for life sciences applications.

CPHI 2024 will return to the Fiera Milano in Milan, Italy.

The completion of three acquisitions of Versanis Bio, Sigilon Therapeutics, and DICE Therapeutics boosts Eli Lilly and Company’s product pipeline in obesity, diabetes, and immunology.

Under the exclusive agreement, Hikma will commercialize products in Rakuten Medical’s pipeline for cancer treatment in the Middle East and North Africa region.

A report from the UK Bioindustry Association report indicated that biotech venture and public financing rose from £295 million in the first quarter to £382 million in the second quarter.

Cytomos will use the £4 million in funding to develop its dielectric spectroscopy technology.

Novartis has completed its acquisition of biopharma company Chinook Therapeutics.

The guidance can help both applicants and manufacturers limit the mutagenic and carcinogenic potential of NDSRIs.

Under a manufacturing agreement, Northway Biotech will develop a manufacturing process for iTolerance’s fusion protein in development for regenerative therapy.

Waters XBridge Premier GTx BEH size exclusion chromatography (SEC) columns are designed to improve analysis while lowering the cost of gene therapies.

Kiefel’s new machine is designed to form, fill, and seal up to 6,000 infusion, parenteral nutrition, or dialysis bags per hour.

The program aims to aid submissions from external stakeholders and FDA staff.

Biogen’s acquisition of Reata will grant them access to Reata’s FDA-approved treatment for Friedreich’s ataxia.

AstraZeneca, via its subsidiary Alexion Pharmaceuticals, will purchase a portfolio of preclinical rare disease gene therapies from Pfizer in a deal worth up to $1 billion.

The guidance document outlines recommendations to limit potential carcinogenic risk.

Pandemic, PBM, and other policies on hold during the summer recess.

Teva Pharmaceuticals and Alvotech will expand their partnership for the development and commercialization of biosimilar candidates.

Roche will pay up to $2.8 billion for the rights to Alnylam’s RNA-based hypertension therapeutic.

Janssen has received a positive opinion from the EMA for two novel bispecific antibodies, TALVEY (talquetamab) and TECVAYLI (teclistamab), which the company is developing to treat blood cancer.

MilliporeSigma has invested $25 million to expand its cell culture media production facility in Lenexa, Kan.