Daily Newsletter

17 August 2023

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Daily Newsletter

17 August 2023

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Spotlight

Ipsen gains FDA approval for fibrodysplasia ossificans progressiva therapy

The FDA approval is based on pivotal safety and efficacy data from the Phase III MOVE study.

Latest news

FDA will not meet ahead of bluebird bio’s sickle cell disease gene therapy PDUFA date

Bluebird bio eyes hattrick of gene therapy approvals, with a PDUFA date for sickle cell disease therapy lovo-cel set in December.

17 August 2023

FDA approves Artiva’s AlloNK and rituximab combo IND to treat SLE

AlloNK is currently under evaluation in two cancer trials, being tested alongside antibody or NK-engager biologics.

17 August 2023

Diffusion Pharma’s stockholders support merger with EIP Pharma

The merger will be finalised today, transforming the businesses into a single company CervoMed focused on neurodegenerative diseases.

17 August 2023

Eyenovia acquires US licencing rights for Formosa’s topical eye steroid

Eyenovia hopes for near-term revenue, with APP13007’s PDUFA date set for 4 March 2024.

17 August 2023

Amicus gears up to launch Pompe disease combination therapy in the UK

Amicus’ Pombiliti and Opfolda received approval from the UK MHRA through the Innovative Licensing and Access Pathway.

17 August 2023

Galecto terminates development for its lead candidate

The Phase IIb trial in idiopathic pulmonary fibrosis for GB0139 did not meet its endpoint.

17 August 2023

Digital transformation of the healthcare industry is driving the demand and development for precision and personalized medicine

Per GlobalData estimates, the precision and personalized medicine market is expected to achieve a CAGR of more than 43% between 2022 and 2029. The digital transformation of the healthcare industry is driving the market demand. For example, advances in biomarker testing with NGS are improving patient selection, use of AI in identifying trends in big datasets is accelerating the time from drug discovery to commercialization, and the use of Industry 4.0 technologies is improving the quality and efficiency of manufacturing complex drugs such as cell and gene therapies.