The company is allocating over $250 million towards its Bloomington, Ind. Manufacturing site. Simtra BioPharma Solutions revealed on February 28, 2024, its plan to invest over $250 million in expanding its sterile fill/finish manufacturing campus in Bloomington, Ind. After Advent International and Warburg Pincus acquired Baxter's BioPharma
Iovance Biotherapeutics’ Amtagvi has been approved by the FDA for treating patients with incurable or metastatic melanoma. On Feb. 16, 2024, FDA announced the approval of Iovance Biotherapeutics’ Amtagvi (lifileucel), which the agency said in a press release is the first cellular therapy indicated for treating adult patients with unresectable
Two public electronic catalogues will be accessible for real-word data sources and real-word data studies On Feb. 15, 2024, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) revealed the launch of two public electronic catalogues for real-word data (RWD). The RWD catalogues are designed to assist
Three organizations have been accepted into the ATMP Pilot Program by EMA. On Feb. 8, 2024, the European Medicines Agency (EMA) announced the acceptance of three academic and non-profit organizations into its pilot scheme for advanced therapy medicinal products (ATMPs) development. The pilot aims to assist non-commercial developers of ATMPs
Novo Holdings and Catalent have recently announced a merger agreement, with Novo Holdings set to acquire Catalent in a significant deal worth $16.5 billion On February 5, 2024, Novo Holdings, a company owned by Novo Nordisk Foundation and the parent company of Novo Nordisk, made an announcement about a
AbbVie's Tepkinly has been recommended by NICE as a treatment option for eligible adults with diffuse large B-cell lymphoma AbbVie recently shared that the United Kingdom's National Institute for Health and Care Excellence (NICE) has given their recommendation for Tepkinly (epcoritamab) as a potential treatment for
The final guidance offers detailed recommendations for CMC, pharmacology, toxicology, and clinical study design for CAR-T cell products. The FDA released a finalized guidance on Jan. 30, 2024, which offers insights into the creation of chimeric antigen receptor (CAR) T-cell products. The FDA states that CAR T-cell products are a
The ultimate guidance offers suggestions for creating gene therapy products that involve editing the genome of human somatic cells. The FDA released a comprehensive guidance document on Jan. 30, 2024, regarding Human Gene Therapy Products Incorporating Human Genome Editing. The document offers suggestions for creating gene therapy products that involve
The addition brings a potential rare disease asset to Sanofi's pipeline for alpha-1 antitrypsin deficiency Sanofi recently revealed its intention to acquire Inhibrx, a clinical-stage biopharmaceutical company. The deal is valued at approximately $1.7 billion, with the possibility of an additional cash consideration of around $296 million.
Companies that have made significant advancements in the field of drug delivery solutions, connected devices, and packaging that can be recycled The winners of the 2024 Pharmapack Awards were announced by Pharmapack Europe on Jan. 24, 2024 at the Paris Expo in France. The winners were selected from four different
In 2023, the agency put forward a total of 77 drugs for marketing authorization, which included 39 new APIs The European Medicines Agency (EMA) released Human Medicines Highlights 2023 on Jan. 16, 2024, providing an overview of the medicines that received recommendations for marketing authorization in 2023. The agency provided
Abzena has recently introduced the AbZelect platforms, which are aimed at enhancing cell line development On January 16, 2023, Abzena introduced AbZelect and AbZelectPRO, their latest cell line development platforms. These platforms are specifically designed to accelerate the creation of production cell lines used in the production of antibodies and