Formulation and Drug Delivery

Pfizer Vaccine Approval Key to Boosting Vaccination Rates

August 24, 2021

FDA’s full approval of the Pfizer-BioNTech COVID-19 vaccine raises hopes that this action will help overcome vaccine hesitancy.

FDA Approves First COVID-19 Vaccine from Pfizer-BioNTech

August 24, 2021

FDA approved the Pfizer-BioNTech COVID-19 vaccine, which will be marketed as Comirnaty.

KGI Team Adapts Vaccine Development Work to Address COVID-19

August 12, 2021

A research team at the Keck Graduate Institute will work to adapt its decade-long low-cost vaccine R&D for developing countries into a COVID-19 vaccine.

Aldevron and Ginkgo Bioworks Collaboration Yields mRNA Manufacturing Enhancement

August 12, 2021

A collaboration between Aldevron and Ginkgo Bioworks has resulted in a manufacturing enhancement that can improve production of an enzyme used for mRNA therapeutics.

Moderna Plans to Build mRNA Vaccine Manufacturing Facility in Canada

August 12, 2021

Moderna will build an mRNA vaccine manufacturing facility in Canada to provide access to domestically manufactured vaccines against respiratory viruses.

EMA Recommends Including Adverse Reaction Warning to Janssen COVID-19 Vaccine

August 09, 2021

The agency’s Pharmacovigilance Risk Assessment Committee recommended updating the product information for Janssen’s COVID-19 vaccine to list immune thrombocytopenia as an adverse reaction.

EMA’s PRAC Requests Additional Data on Guillain-Barré Syndrome in COVID-19 Vaccine

August 09, 2021

EMA’s Pharmacovigilance Risk Assessment Committee has requested more data for its evaluation of reports of Guillain-Barré syndrome after vaccination.

Syngene Announces Senior Level Appointments

August 06, 2021

Syngene International appoints two US-based executives to senior level positions.

CHMP Approves Manufacturing Scale-Up for Spikevax

August 04, 2021

EMA’s CHMP has approved the increased manufacturing capacity and supply of Moderna’s COVID-19 vaccine active substance in its US manufacturing site.

Analysis Demonstrates No Increased Incidence of Thrombosis with TTS After Vaxzevria Second Dose

August 04, 2021

A global safety database analysis has demonstrated no increased incidence of thrombosis with TTS after the second dose of Vaxzevria.