EMA validates Pfizer and Valneva’s Lyme disease vaccine
The European Medicines Agency (EMA) has validated the marketing authorisation application (MAA) from Pfizer and Valneva for their Lyme disease vaccine candidate, PF-07307405.
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).
Piramal Pharma Solutions and NewAmsterdam Pharma have announced the inauguration of an oral solid dosage (OSD) suite at the former’s facility located in Sellersville, Pennsylvania, US.
The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) to PharmaTher concerning its ketamine abbreviated new drug application (ANDA).
RTI International has announced a strategic collaboration with Codetta Bio, a company specialising in multi-omics for precision medicine development, to fast-track healthcare innovation.