News

FDA Approves First Oral Treatment for Postpartum Depression

August 11, 2023

The new drug could be a powerful tool for patients suffering depressive symptoms after birth.

AGC Biologics Completes Expansion at CGT Manufacturing Site in Milan

August 10, 2023

The site was acquired by AGC Biologics in July 2020, and the Milan location is the first cell and gene therapy site approved in Europe for GMP manufacturing of clinical and commercial supplies.

Regeneron Pharmaceuticals to Acquire Decibel Therapeutics

August 10, 2023

The initial collaboration between the two companies began in 2017 with an extension announced in 2021.

Sparian Biosciences Awarded Five-Year NIH/NDA Grant for Development of SBS-518

August 09, 2023

SBS-518 is a first-in-class dual sigma receptor (SR) antagonist/dopamine transporter (DAT) inhibitor in development for the treatment of stimulant use disorder (StUD).

FDA Grants Orphan Drug Designation to Treatment of Malignant Glioma

August 08, 2023

The investigational drug was developed to activate a novel uptake pathway, allowing antineoplastic drugs to combat solid tumors more successfully.

Sartorius and Emerson Collaborate to Expedite New Therapies to Market

August 08, 2023

The bioreactors can integrate with Emerson’s DeltaV PK Controller in addition to S-Series and M-Series controllers.

FDA Warns that Tydemy May Have Reduced Effectiveness

August 08, 2023

Lower levels of an active ingredient may result in unexpected pregnancies.

BlueRock Therapeutics and bit.bio Collaborate for Manufacture of Regulatory T cell Based Therapies

August 07, 2023

BlueRock will be responsible for the global development and commercialization of therapeutic candidates emerging from this collaboration.

iTolerance and Northway Biotech Form Manufacturing Pact for Fusion Protein

August 04, 2023

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

Waters Launches SEC Columns for Gene Therapy Applications

August 03, 2023

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