Novartis has secured exclusive worldwide rights to an undisclosed preclinical radioligand therapy from BoomRay Pharma in a licensing agreement worth up to $900 million.

The European Medicines Agency has opened consultation on a draft guideline addressing the design and interpretation of studies assessing drug absorption interactions within the gastrointestinal tract.

The latest regulatory package is intended to reduce uncertainty, development costs and delays for generic manufacturers as the US government increases pressure to bring lower-cost medicines to patients more quickly.

The agreement gives a newly formed company backed by Population Health Partners and ARCH Venture Partners ex-China rights to Haisco’s Phase II-ready oral THR-β agonist for obesity and metabolic disorders.

The designation broadens regulatory support for the CLDN18.2 × CD47 bispecific antibody as Phanes advances its chemotherapy combination through Phase II development in metastatic pancreatic ductal adenocarcinoma.

The submission seeks approval for a next-generation mitomycin formulation designed for intravesical treatment of recurrent low-grade intermediate-risk non-muscle invasive bladder cancer, building on the same drug-delivery platform as FDA-approved Zusduri.

The agreement gives Zydus subsidiary Sentynl Therapeutics an option for exclusive US commercial and global manufacturing rights to Mereo BioPharma’s oral neutrophil elastase inhibitor, with Mereo leading preparations for pivotal development.

The collaboration pairs BeOne’s oncology pipeline with four clinical-stage RAS(ON) inhibitors while giving BeOne regional rights to the Revolution Medicines assets across selected Asian markets.

The restructuring concentrates aTyr’s resources on a new late-stage study in patients with restrictive lung disease after its first Phase III trial missed its primary endpoint.

The draft guidance could reduce reliance on animal studies for some oncology products while increasing the importance of analytical characterisation and weight-of-evidence approaches during development.

The guidance gives sponsors clearer recommendations for addressing trial design, safety monitoring, abuse potential and the operational challenges associated with hallucinogenic drug effects.