Teesside, United Kingdom (September 14, 2023) – FUJIFILM Diosynth Biotechnologies, a world-leading contract development and manufacturing organization partner for the development and manufacture of biologics, vaccines, cell and gene therapies, and oncolytic viruses, today announced the successful completion of a new facility in Darlington, UK, which is now cGMP operational for
The Novo Nordisk Foundation will invest up to DKK 950 million (€127 million, US$136 million) in a new cell therapy manufacturing facility in Lyngby, Denmark. On Sept. 21, 2023, the Novo Nordisk Foundation announced that it is investing up to DKK 950 million (€127 million, US$136 million) into
The company is currently developing EVX-101 as an adjunctive treatment for MDD due to patients experiencing an inadequate response to first-line antidepressants such as selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors SNRIs. The drug development partnership between Evecxia Therapeutics and Quotient Sciences has seen the success of a
LONDON, UK, and PLEASANTON, CA, USA, 19th September 2023 – Otsuka Pharmaceutical Europe Ltd. (Otsuka) and Astex Pharmaceuticals, Inc. (Astex) today announce that the European Commission (EC) has approved INAQOVI® (oral decitabine and cedazuridine) as monotherapy for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are
Alexion, AstraZeneca Rare Disease, has completed a definitive purchase and licence agreement for a portfolio of preclinical rare disease gene therapy programmes and enabling technologies from Pfizer Inc. (Pfizer). These new resources build on the combined capabilities of Alexion and AstraZeneca in genomic medicine, with the objective to develop new
According to the press release, it is the first turn-key device to utilize Raman spectroscopy for bioprocess control, with no modeling and development required. 908 Devices announced the launch of MAVERICK on Sept. 18, 2023, which is an optical in-line analyzer that provides real-time monitoring and control of glucose, lactate,
Samsung Biologics and Bristol Myers Squibb have further expanded their strategic manufacturing agreement to include the large-scale manufacture of an antibody cancer drug substance. Korean contract development and manufacturing organization (CDMO), Samsung Biologics, has announced, in a Sep. 18, 2023 press release, a new agreement for the large-scale manufacturing of
CN Bio and LifeNet Health LifeSciences have teamed up to provide direct access to a portfolio of highly characterized hepatic cells for the creation of advanced liver-on-a-chip assays. CN Bio, an organ-on-a-chip (OOC) company specializing in the design and manufacture of single-and multi-organ micro physiological systems (MPS), has partnered with
The agency’s work with EUnetHTA 21 helped it to prepare the EU for the implementation of the regulation. The European Medicines Agency (EMA) gave an update on Sept. 15, 2023, about its work with the European Network for Health Technology Assessment (EUnetHTA 21). The consortium worked with the agency
The finalists for this year’s CPHI Barcelona Pharma Awards span 12 categories with awards ranging from accelerating innovations through to improved sustainability and best start-up initiative. On Sept. 15, 2023, CPHI Barcelona announced the finalists for the 2023 CPHI Pharma Awards. The awards ceremony will be held on Oct.
The Regulation on Health Technology Assessment (EU) 2021/228 which entered into force in January 2022 and applies as of January 2025, will govern the European cooperation between medicine regulators and HTA bodies. Under the new framework, EMA and HTA bodies will collaborate in the context of joint clinical assessments,