Industry News

The U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) of the Moderna COVID-19 Vaccine, Bivalent and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent to authorize their use as a single booster dose in younger age groups. The Moderna COVID-19 Vaccine, Bivalent is authorized for administration at least two months following completion of primary or booster vaccination in children down to six years of age.

Pharmaceutical company Novartis has announced plans to cut up to 400 jobs from its Dublin operations The changes will take place over the next two years at its Global Service Centre at Elm Park in Dublin.

The company said the development was a strategic decision and resulted from an ongoing review of its operations in many locations.

It added that the centre will continue to play a critical role, focused on commercial and scientific operations.

Subject Expert committee of CDSCO recommends for grant of permission to import and market Delamanid Dispersible Tablets 25mg against pulmonary multi drug resistant tuberculosis (MDR-TB) in adults, adolescents, children and infants.

Nanoscope Therapeutics Inc., a clinical-stage biotechnology company developing gene therapies for retinal degenerative diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to MCO-010, an ambient-light activatable Multi-Characteristic Opsin (MCO) optogenetic monotherapy to restore vision in blind patients, for the treatment of retinitis pigmentosa (RP) via intravitreal injection.

Panacea Biotec, one of India's leading biotechnology companies, has received long-term supply awards worth USD 127.30 million (around INR 1,040 Crore) from UNICEF and Pan American Health Organization (PAHO) for supply of its WHO pre-qualified fully liquid Pentavalent vaccine, Easyfive-TT'" (DTwP-HepB-Hib).

Pfizer Inc announced the completion of its acquisition of Global Blood Therapeutics, Inc. (GBT), a biopharmaceutical company dedicated to the discovery, development and delivery of life-changing treatments that provide hope to underserved patient communities starting with sickle cell disease (SCD). The acquisition reinforces Pfizer’s commitment to SCD, building on a 30-year legacy in the rare hematology space.

It has come to notice that controversial syrups exported by India based Maiden Pharmaceutical are linked to the death of 66 children in Gambia. Regulators informed that the company has manufactured and exported these products only to Gambia.

Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the investigation of tirzepatide for the treatment of adults with obesity, or overweight with weight-related comorbidities. The FDA grants Fast Track designation to facilitate the development and expedite the review of medicines to treat serious conditions and fill an unmet medical need. Fast Track designation is intended to bring promising medicines to patients sooner.

MSD announced the opening of a new secondary packaging facility to support the production of vaccines and biologics, including the company’s cancer immunotherapy products. MSD also broke ground for a new inhaler production facility for the manufacture of new generation inhaler medicines in Singapore.