Industry News

Heron Therapeutics, Inc  a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs,  announced that the U.S. Food and Drug Administration (FDA) has approved APONVIE (aprepitant) injectable emulsion, for intravenous use for the prevention of postoperative nausea and vomiting (PONV) in adults.

Pfizer announced positive top-line results from its pivotal E.U. Phase 3 study in infants (NCT04546425) evaluating its 20-valent pneumococcal conjugate vaccine candidate (20vPnC) for the prevention of invasive pneumococcal disease (IPD), pneumonia, and acute otitis media caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes contained in the vaccine for the pediatric population.

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®.