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.

An interview with Steffen Thirstrup, chief medical officer, European Medicines Agency (EMA).

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.

In this exclusive Drug Digest video interview, Felicity Thomas, Europe/senior editor, Pharmaceutical Technology Group, interviews an esteemed panel of experts from IPEC Americas about excipient grades.

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

The company issued the recall because of a package mislabeling problem.

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

The annual industry report of the Pharmapack Europe event suggests there will be significant innovation in inhaled pulmonary and intranasal drug delivery in 2024.

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.

According to the Pharmapack Europe 2024 survey results, contract packaging will see growth over the coming 12 months.

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.

Boehringer Ingelheim is investing €120 million (US$131 million) into its Koropi, Greece site to expand production for new therapeutics.

As innovation accelerates, pharmaceutical regulators continue their path of maintaining proportion, balance, and restraint.

Pluri has launched PluriCDMO, a new contract development and manufacturing organization business that will offer cell therapy manufacturing services.

Regulators from around the world will gather to help shape the mRNA and RNA therapeutics landscape at an exceptional April 2024 Washington, D.C. convocation.