Formulation and Drug Delivery

FDA Approves Merck’s 15-Valent Pneumococcal Vaccine

July 27, 2021

Merck announced that FDA approved Vaxneuvance for active immunization for the prevention of invasive pneumococcal disease.

FDA Approves Amneal’s Generic Version of TobraDex

July 27, 2021

Amneal Pharmaceuticals received ANDA approval from FDA for the generic version of TobraDex.

Meissa’s Intranasal COVID-19 Vaccine Yields Promising Preclinical Data

July 27, 2021

Meissa Vaccines’s MV-014-212, an intranasal recombinant live attenuated COVID-19 vaccine, induced mucosal and systemic antibodies against SARS-CoV-2 and two variants of concern.

EMA’s CHMP Adopts Positive Opinion for Moderna COVID-19 Vaccine Use in Adolescents

July 23, 2021

The EMA’s CHMP has adopted a positive opinion recommending marketing authorization for Moderna’s COVID-19 vaccine (Spikevax) to include adolescents 12 years of age and older.

Pfizer and BioNTech Announce Collaboration with Biovac to Manufacture and Distribute COVID-19 Vaccine Doses Within Africa

July 22, 2021

Pfizer Inc. and BioNTech SE announced the signing of a letter of intent with The Biovac Institute Ltd to manufacture the Pfizer-BioNTech COVID-19 vaccine for distribution within the African Union.

Sinovac’s Eupolio Vaccine Gains Market Authorization in China

July 22, 2021

Sinovac Biotech’s Eupolio vaccine, a Sabin inactivated poliovirus vaccine (sIPV), has gained marketing authorization in China.

Advanz Pharma Launches Generic Lanreotide in Germany

July 22, 2021

Specialty pharmaceutical company, Advanz Pharma, has launched a generic version of lanreotide, MYTOLAC, in Germany.

AstraZeneca’s Extensive-Stage Small Cell Lung Cancer Treatment Approved in China

July 20, 2021

In combination with etoposide and either carboplatin or cisplatin, Imfinzi has been approved in the first-line setting of ES-SCLC by China’s National Medical Products Administration.

GSK Pilots Digital Twin for Vaccine Manufacturing

July 19, 2021

Modeling the manufacturing process benefits both development and operations.

Zendal and IAVI to Advance Tuberculosis Vaccine Candidate into Efficacy Trials

July 16, 2021

MTBVAC has the potential to be used as an alternative to BCG vaccination in infants and for prevention of TB disease in adolescents and adults.