Development

Daiichi Sankyo is investing approximately €1 billiion (US$1.08 billion) to expand its Pfaffenhofen an der Ilm, Germany, site for ADC development and production.

Webinar Date/Time: Wed, Mar 20, 2024 11:00 AM EDT

Webinar Date/Time: Thu, Mar 21, 2024 11:00 AM EDT

BioVaxys has acquired the full portfolio of discovery, preclinical, and clinical development-stage assets of the former IMV.

Under the new partnership, Samsung Biologics will develop and manufacture an antibody for a LegoChem Biosciences ADC candidate.

Webinar Date/Time: Tue, Mar 5, 2024 2:00 PM EST

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

In the ATMP space, CGTs are hitting their stride with unprecedented approvals in the past year alone.

Despite slow growth over recent years, the CAR-T cell therapy space is expected to see considerable advancements in the near future.

Buffers, stabilizers, and cryoprotectants play major roles in cell therapy formulations.

The milestone approval of a gene-edited therapeutic paves the way for gene-editing technologies.

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 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.

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

Webinar Date/Time: Wed, Feb 28, 2024 11:00 AM EST

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.

Webinar Date/Time: Thu, Feb 8, 2024 11:00 AM EST

In a deal worth up to $1.4 billion, GSK aims to acquire Aiolos Bio and gain an expanded pipeline of biologic-based respiratory therapeutic candidates.

MediWound has been granted an additional $6.7 million by the DoD to advance NexoBrid as a non-surgical field care solution for the US military.

Under the collaboration, Boehringer Ingelheim and Ribo will develop RNA-based therapeutics to treat NASH/MASH.

AstraZeneca’s acquisition of Gracell includes a clinical-stage autologous cell therapy targeting hematologic malignancies and autoimmune diseases and a proprietary manufacturing platform.

The new Europe headquarters will be the hub for the company’s European operations, including production of product.

The authors give an overview of scaling approaches and present good scaling practices for the biopharma industry.