Industry News

GSK plc announced that the US Food and Drug Administration has approved a new presentation of Menveo [Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diptheria CRM197 Conjugate Vaccine] for individuals aged 10 to 55 years to help prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W. The Menveo one-vial presentation now comes in a ready to use single vial giving healthcare providers a more convenient option.

Hetero announced the acquisition of a brownfield manufacturing plant at Penjerla located in Telangana from Johnson & Johnson.

The facility spread across 55.27 acres, will be Hetero’s flagship sterile pharmaceutical and biologics manufacturing unit, bolstered by state-of-the-art technology.

US based Baxter started its global pharmaceuticals research and development (R&D) centre in Ahmedabad, India. This centre will also support Baxter's global manufacturing facilities, including those in Ahmedabad, Germany, Ireland, Italy, and the United States, among others.

GSK plc and Tempus, a US-based precision medicine company, have entered into a three-year collaboration agreement that provides GSK with access to Tempus’ AI-enabled platform, including its library of de-identified patient data. Through its leading Artificial Intelligence and Machine Learning (AI/ML) capability, GSK will work together with Tempus to improve clinical trial design, speed up enrolment and identify drug targets. This will contribute to GSK’s R&D success rate and provide patients with more personalised treatment faster.    

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.