PPF Group | May 2025 Biotechnology: Review of news from the most innovative therapeutic areas and the business development transactions

Market

Stocks tumbled as sweeping tax and spending bill could dramatically increase federal deficit

US court has ruled that President Trump overstepped his authority when imposing his tariffs. But an appeals court later suspended the earlier judgment. Stocks also tumbled as investors kept close tabs on a sweeping tax and spending bill that could dramatically increase the federal deficit.

Detail článku

Antibody-Drug Conjugates

Merck withdrawn BLA for patritumab dx in NSCLC based on Phase 3 modest PFS benefit

RemeGen announced that disitamab vedotin, a novel HER2-targeted ADC, has been granted approval by the Center for Drug Evaluation (CDE) of China’s NMPA for its third indication of HER2-positive advanced breast cancer with liver metastasis previously treated with trastuzumab or its biosimilar and taxanes.

Detail článku

Interleukin-15 and Interleukin-2

ImmunityBio requested urgent meeting with FDA to address change in Agency’s guidance

ImmunityBio announced that it received a Refusal to File (RTF) letter from the FDA for the sBLA for use of Anktiva plus BCG in BCG-unresponsive NMIBC for the indication of papillary disease.

Detail článku

Cell Therapies

Autolus announced positive CHMP opinion for obe-cel for adults with R/R B-ALL

Autolus announced that the EMA’s CHMP has recommended European Commission approval of obe-cel for the treatment of adult patients, 26+, with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

Detail článku

May 2025 Biotechnology: Review of news from the most innovative therapeutic areas and the business development transactions

Stocks tumbled as sweeping tax and spending bill could dramatically increase federal deficit

Merck withdrawn BLA for patritumab dx in NSCLC based on Phase 3 modest PFS benefit

ImmunityBio requested urgent meeting with FDA to address change in Agency’s guidance

Autolus announced positive CHMP opinion for obe-cel for adults with R/R B-ALL

Merus’ petosemtamab with Keytruda interim data demonstrated robust efficacy in HNSCC

Legal Notice 5/2025