Industry News

Novartis said its Scemblix was approved by the European Commission for adult patients with chronic myeloid leukemia (CML), offering a new treatment approach for patients with intolerance to other therapies, as reported by Reuters.

Scemblix provides much-needed and long-awaited new option for patients with chronic myeloid leukemia (CML) who suffer with intolerance or inadequate response after at least two previous tyrosine kinase inhibitor (TKI) treatments.

Bharat Biotech International Limited rotavirus oral vaccine Rotavac has been introduced by Nigeria to immunize its children from the life- threatening diarrhoeal disease that affects millions of children worldwide.

Nigeria currently accounts for 14 percent of all childhood rotavirus deaths globally, making it the country with the second-highest number of rotavirus deaths in the world. Rotavirus infection causes about 50,000 child fatalities under the age of five each year in Nigeria.

Moderna is filing patent infringement lawsuits against Pfizer and BioNTech in the United States District Court for the District of Massachusetts and the Regional Court of Dusseldorf in Germany. Moderna believes that Pfizer and BioNTech copied two key features of it patented technologies.

Local supply of a medicine used to prevent malaria across Africa received a boost recently, as the World Health Organization (WHO) issued a quality certification to the first African manufacturer of a key antimalarial drug used to prevent infection in pregnant women and children. Called pre- qualification, this certification will enable Kenyan manufacturer Universal Corporation Ltd (UCL) to support regional efforts to combat malaria through local production of high-quality sulfadoxine-pyrimethamine (SP).

Pfizer Inc. and BioNTech SE announced updated efficacy results from a Phase 2/3 trial evaluating a three 3 ug dose series of the Pfizer-BioNTech COVID-19 Vaccine in children 6 months through 4 years of age, reinforcing previously reported interim vaccine efficacy data collected in March and April 2022.

Dr Reddys Labs has received the Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA) for the formulations manufacturing facility in Srikakulam, Andhra Pradesh.

USFDA had conducted an inspection on 7th July 2022 at formulations manufacturing facility (FTO 11) in Srikakulam, Andhra Pradesh.

Bayer launches its blockbuster drug finerenone to treat chronic kidney disease (CKD) associated with type-II diabetes in India.This drug will be available as brand name of Kerendia in India.

India is becoming the hub of diabetes and CKD is common in people with diabetes. Approximately 1 in 3 adults with diabetes has CKD. Both type 1 and type 2 diabetes can cause kidney disease. where, finerenone is used to treat CKD associated with type-II diabetes.

Novartis announced its intention to separate Sandoz, its generics and biosimilars division into a new publicly traded standalone company, by way of a 100% spin-off.

The spin-off aims to maximize shareholder value by creating the #1 European generics company1 and a global leader in biosimilars, allowing Novartis shareholders to participate fully in the potential future upside for both Sandoz and Novartis Innovative Medicines.

Lupin Limited announced that it has entered into an exclusive licensing agreement with I'rom Group Co. Ltd (Irom), a leading pharmaceutical company in Japan. Under the terms of the Agreement, Irom will conduct clinical trials along with Lupin, register, distribute and market biosimilar Denosumab in Japan on an exclusive basis.