Industry News

Roche announced that the European Commission (EC) approved Vabysmo (faricimab) for the treatment of neovascular or wet age-related macular degeneration (nAMD) and visual impairment due to diabetic macular edema (DME). These retinal conditions are two of the leading causes of vision loss worldwide, affecting more than 40 million people.

AnaCipher CRO, based in Hyderabad, is a USFDA inspected clinical research facility and is spread over 40,000 sq. ft area with 98 beds and staffed by experienced professionals providing clinical trial solutions and conducts Bioequivalence and Bioavailability (BA/BE) studies at its facility.

Sandoz announces the release of positive results from the integrated ROSALIA Phase 3 clinical trial study for its proposed biosimilar denosumab.

Mallinckrodt plc a global specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved Terlivaz (terlipressin) for injection. Terlivaz is the first and only FDA-approved product indicated to improve kidney function in adults with hepatorenal syndrome (HRS) with rapid reduction in kidney function, an acute and life-threatening condition requiring hospitalization.

The Federal Executive Council of Nigeria has approved the process to set up a vaccine production plant in Ota, Ogun State with help of Serum Institute of India which will join hands with Bio Vaccine Nigeria, to build their manufacturing plant in Nigeria.

The Minister of Health, Dr Osagie Ehanire said yesterday, "The council considered a memorandum from the Ministry of Health today, which has to do with the first stage in indigenizing vaccine production in Nigeria, the standard programme on immunization, not COVID-19 vaccine."

Novartis announced it is investing in next-generation biotherapeutics with the creation of a fully integrated, dedicated USD 300m scientific environment that will bolster its capacity and capabilities for early technical development of biologics. Spanning both drug substance and drug product development, the multi-year investment will be implemented across existing Novartis locations in Switzerland, Slovenia and Austria, strengthening Novartis ability to deliver on the increasing growth and diversity of its early-stage biotherapeutics portfolio.

Zydus Lifesciences Limited’s has received approval from the United States Food and Drug Administration (USFDA) to market Lenalidomide Capsules, USP 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg. The company has received final approvals for 5 mg, 10 mg, 15 mg and 25 mg strengths and tentative approvals for 2.5 mg and 20 mg strength. USRLD: Revlimid®.

Lupin Limited announced that Health Canada has approved Rymti, its biosimilar to Enbrel (etanercept), for use in Canada.

Rymti® is indicated in the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis (including ankylosing spondylitis and non-radiographic axial spondyloarthritis), plaque psoriasis and paediatric plaque psoriasis.

Bristol Myers Squibb announced new two-year results from the POETYK PSO long-term extension (LTE) trial demonstrating clinical efficacy was maintained with continuous Sotyktu™ (deucravacitinib) treatment in adult patients with moderate-to-severe plaque psoriasis. This analysis assessed patients from the pivotal POETYK PSO-1 trial who transitioned into the LTE trial.