Industry News

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.

The USFDA rejected Alvotech’s application to approve its biosimilar of AbbVie’s Humira after an inspection of the company’s Reykjavik, Iceland, manufacturing plant.

Alvotech received communication from the U.S. Food and Drug Administration (USFDA) detailing its assessment of the March 2022 inspection of Alvotech’s manufacturing facility in Reykjavik, Iceland and Alvotech’s subsequent written responses to the FDA.

Global pharma major Lupin Limited announced the launch of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution, 17.5 g/3.13 g/1.6 g per 6 ounces, having received an approval from the United States Food and Drug Administration (FDA).

Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution, 17.5 g/3.13 g/1.6 g per 6 ounces is a generic equivalent of Suprep Bowel Prep Kit Oral Solution, 17.5 g/3.13 g/1.6 g per 6 ounces, of Braintree Laboratories Inc.