The European Commission (EC) has granted orphan designation to Lundbeck’s investigational monoclonal antibody asedebart (Lu AG13909) for the treatment of Cushing’s syndrome of endogenous origin.
BeOne Medicines, the BeOne Care Foundation, and The Max Foundation have extended their partnership to expand Brukinsa (zanubrutinib) access for chronic lymphocytic leukaemia (CLL) treatment in low- and middle-income countries until 2028.
Fulcrum Therapeutics and Slate Medicines have signed a definitive agreement to merge in an all-stock transaction backed by a $245m private placement financing from a syndicate of healthcare investors.
The European Medicines Agency (EMA) has validated the marketing authorisation application (MAA) from Pfizer and Valneva for their Lyme disease vaccine candidate, PF-07307405.
Remepy has closed a $36m Series A financing round to accelerate its pharmaceutical co-development partnerships and expand its hybrid drug pipeline.
Mereo BioPharma and Zydus Lifesciences subsidiary Sentynl Therapeutics have signed an option and licence agreement related to the US commercial and worldwide manufacturing rights to alvelestat, a potential oral treatment for Alpha-1 antitrypsin deficiency-associated lung disease (AATD-LD).
China-based IMPACT Therapeutics and Pharmanovia have entered an exclusive licensing deal worth up to €423.5m ($488.3m), giving Pharmanovia rights to manufacture, develop, and commercialise senaparib in 66 countries.
Aptar Pharma has launched a collaborative system-level framework designed to support the development of injectable drug delivery systems.
The UK’s Joint Committee on Vaccination and Immunisation (JCVI) has recommended a routine programme with the 4CMenB vaccine for adolescents.
The US Food and Drug Administration (FDA) has granted priority review to Roche’s supplemental biologics licence application (sBLA) for Gazyva/Gazyvaro (obinutuzumab) to treat adults with primary membranous nephropathy (pMN).
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