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Growth and Advancements in Fill/Finish
Employing novel technologies and more patient-centric approaches
Delving into Biopharmaceutical Development and Manufacturing
Quality Considerations in Changing Excipient Providers
April 25, 2022
FDA has approved Veklury to treat COVID-19 in pediatric patients under 12 years of age.
Pfizer has issued a voluntary nationwide recall of lots of Accupril due to N-nitroso-quinapril content.
EMA is recommending EU conditional approval of Roche’s potential first-in-class bispecific antibody mosunetuzumab for people with relapsed or refractory follicular lymphoma.
EMA has granted Novo Nordisk a positive scientific opinion on human insulin with more flexible storage without refrigeration.
April 22, 2022
FDA is requesting comment on draft document “Pharmaceutical Quality/Chemistry Manufacturing and Controls Data Exchange.”
FDA has approved commercial production at Kite’s new CAR T-cell therapy manufacturing facility in Frederick, Maryland.
Catalent will invest $350 million into integrated biologics drug substance and drug product manufacturing at Bloomington, Indiana facility.
April 21, 2022
The European Investment Bank has provided €15 million to fund coronavirus research at IRBM.
April 20, 2022
Otsuka Pharmaceutical and Osaka University have entered an exclusive license agreement on a new anti-tumor antibody.
Takeda’s TAKHZYRO prefilled syringe is now available for patients with hereditary angioedema aged 12 years and older in the United States.