News

The three non-commercial developers of ATMPs will benefit from enhanced support from the agency.

Through a €2.7 billion (US$2.9 billion) acquisition of MorphoSys, Novartis will get pelabresib, a late-stage drug candidate in development for cancer treatment.

The guidance discusses how to timely notify the agency of changes in production of APIs and finished products.

Purolite and Repligen have commercially launched a new CH1 affinity resin for the purification of specialized mAbs.

The addition of another amino acid recognizer as well as improvements in surface chemistry, reagents, and software expand the proteome coverage of Quantum-Si’s Platinum sequencing platform.

The CDMOs are joining together to offer end-to-end development and manufacturing services for protein expression systems and viral vectors in Europe.

Novo Holdings has entered into a merger agreement with Catalent and will acquire Catalent in a deal valued at $16.5 billion.

NICE has recommended the use of AbbVie's Tepkinly as a treatment option for eligible adults with diffuse large B-cell lymphoma.

Under a new collaboration, Lonza and Oxford Nanopore aim to commercialize a CGMP-validated test for advanced analysis of mRNA products.

With the formation of the new R&D unit, Regeneron will assume full development and commercialization rights to 2seventy bio’s preclinical- and clinical-stage cell therapy pipeline.

The final guidance provides specific recommendations for CMC, pharmacology, toxicology, and clinical study design for CAR-T cell products.

The immune-resetting peptide, developed by Revolo Biotherapeutics, received positive results from its Phase IIb study.

The final guidance provides recommendations for developing gene therapy products incorporating genome editing of human somatic cells.

IMU Biosciences has secured £11.5 million in its Series A financing round.

The acquisition adds a potential rare disease asset to Sanofi’s alpha-1 antitrypsin deficiency pipeline.

The 2024 Pharmapack Europe Award winners include companies involved in ground-breaking innovations in novel drug delivery solutions, reusable connected devices, and recyclable packaging.

Takeda has received FDA approval for HYQVIA, a subcutaneous immunoglobulin for the maintenance treatment of chronic inflammatory demyelinating polyneuropathy.

Under a new alliance, KBI Biopharma and Argonaut Manufacturing Services will combine their strengths to offer end-to-end biopharma development and CGMP manufacturing solutions.

Abzena has launched its AbZelect platforms, designed for improving cell line development.

The agency recommended 77 drugs for marketing authorization in 2023, including 39 new APIs.

The acquisition will give Novartis full rights to CALY-002, Calypso’s lead product candidate.

FDA’s Center for Drug Evaluation and Research released its report on new drugs approved in 2023.

Charles River’s off-the-shelf rep/cap plasmids are intended to simplify gene therapy supply chains.

The acquisition marks a pivotal expansion for the company into the US market.

The agency is reviewing data on secondary malignancies related to T-cells for approved CAR T-cell medicines.

Through the acquisition of Harpoon Therapeutics, Merck will gain an investigational delta-like ligand 3-targeting T-cell engager under development for cancer treatment.

CellVoyant has raised £7.6 million in seed funding to speed up the development of novel cell therapies.

The European Medicines Agency safety committee says there is a potential risk of neurodevelopment disorders in children born to men treated with valproate.