Industry News

Zydus Lifesciences Limited’s (formerly known as Cadila Healthcare Limited) subsidiary Zydus Worldwide DMCC has received tentative approval from the United States Food and Drug Administration (USFDA) to market Valbenazine Capsules USP 40 mg, 60 mg, and 80 mg (USRLD: Ingrezza®) & Roflumilast Tablets USP, 250 mcg (USRLD: Daliresp®).

scPharmaceuticals Inc a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, today announced that the U.S. Food and Drug Administration (FDA) has approved FUROSCIX® (furosemide injection), a proprietary formulation of furosemide delivered via an On-Body Infusor for the treatment of congestion due to fluid overload in adults with New York Heart Association Class II/III chronic heart failure.

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.