Daily Newsletter

08 December 2023

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Daily Newsletter

08 December 2023

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Spotlight

Ipsen and Genfit secure FDA priority review for chronic liver disease drug

If approved in June 2024, Ipsen and Genfit’s elafibranor will compete with Intercept’s Ocaliva as second-line treatment options for primary biliary cholangitis (PBC).

Latest news

FDA accepts Alpha Cognition’s NDA for Alzheimer’s disease

Adverse events associated with ALPHA-1062 in studies were reported to be under 2%.

08 December 2023

Vanda acquires rights to Actelion’s multiple sclerosis drug

Ponvory has an established safety profile with more than a decade of data.

08 December 2023

AbelZeta and AstraZeneca enter CAR-T cell therapy development deal

AbelZeta is eligible to receive upfront milestone and royalty payments from AstraZeneca.

08 December 2023

Sosei wins South Korean approval for brain injury drug

South Korean regulators approved Sosei’s brain injury drug Pivlaz despite previous negative Phase III results.

08 December 2023

Pfizer and Arvinas plan vepdegestrant programme expansion after data at SABCS

The companies presented positive Phase Ib data at the 2023 SABCS meeting, and announced plans to expand the protein degrader programme.

08 December 2023

ARTBIO secures $90m to advance ART pipeline

The company is progressing the development of three pipeline programmes with its lead programme, AB001, currently in human trials.

08 December 2023

LTS wins $1.2m grant to develop mRNA therapy patches

The Bill & Melinda Gates Foundation grant will fund the development of dissolvable microneedle array patches for administering mRNA therapies.

08 December 2023

Multiple Myeloma (MM) pipeline is dominated by CAR-T cells

The success of CAR-Ts in MM has fueled R&D investment into this class of therapy, with more CAR-Ts in development than all other cell and gene therapy classes combined. The approval of the autologous CAR-T cell therapies Abecma and Carvykti sees the CAR-T pipeline mostly constituted of autologous drugs. However, there are also multiple allogeneic CAR-Ts in the pipeline.

Acute Renal Failure (ARF) - Market Landscape

Only a handful of approved therapeutic drugs are currently available for the treatment of ARF, all belonging to the solute carrier family 12 member 1 inhibitor. The clinical trial space in ARF consists of almost an equal mix of commercial as well as academic sponsors, with Iran and the US emerging as the key countries for conducting Phase III trials.