What Johnson & Johnson’s AKEEGA opinion means for PARP inhibitors beyond castration resistance
Find out how Johnson & Johnson’s CHMP opinion for AKEEGA could shift prostate cancer treatment toward earlier, biomarker-guided precision therapy.
Pharma & Biotech
Medical Devices & Diagnostics
Merz Therapeutics files XEOMIN pediatric spasticity indication with EMA following Phase 3 success
Merz Therapeutics files EMA application to expand XEOMIN for pediatric spasticity. Find out how this could shift the treatment landscape for cerebral palsy.
Pharma & Biotech
Is ENHERTU plus pertuzumab on track to redefine first-line treatment in HER2-positive metastatic breast cancer?
EMA begins review of ENHERTU plus pertuzumab for first-line HER2-positive metastatic breast cancer. Find out what this means for frontline therapy options.
Medical Devices & Diagnostics
CHMP backs Vueway pediatric expansion, signaling a cautious but meaningful shift in neonatal MRI contrast use
Bracco Imaging S.p.A. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion supporting the use of Vueway gadopiclenol in pediatric patients from birth. The recommendation extends an existing European Union authorization and places the macrocyclic gadolinium-based contrast agent into one of the
Pharma & Biotech
Samsung Bioepis takes over BYOOVIZ commercialization in Europe after Biogen exit
Samsung Bioepis has officially begun direct commercialization of BYOOVIZ, a biosimilar to Lucentis (ranibizumab), across Europe following the complete transfer of rights from Biogen. The move makes BYOOVIZ the fourth biosimilar now independently marketed by Samsung Bioepis in the region, joining EPYSQLI (eculizumab), OBODENCE (denosumab), and XBRYK (denosumab). The company also confirmed that a pre-filled
Pharma & Biotech
What Orphalan’s Orphelia Pharma acquisition reveals about the next phase of rare pediatric drug consolidation
Orphalan, the international pharmaceutical company known for developing orphan drugs, has announced the acquisition of Orphelia Pharma, a specialist in rare and severe pediatric diseases. The deal enhances Orphalan’s position in the European rare disease market, particularly within pediatric neurology and oncology, and signals a strategic pivot toward deeper vertical integration in pediatric formulations and