Industry News

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.

The Subject expert committee, SEC of CDSCO recommended grant of permission for manufacturing and marketing and permission to conduct the Phase IV Clinical trial of Sovateltide injection by Pharmazz India.

Pharmazz India has submitted an application to receive permission for manufacturing, marketing and conduct phase IV trial in the country. Earlier SEC meeting held on 28.06.2022, the firm presented a proposal for permission for manufacturing and marketing along with Phase IV Clinical trial protocol before the committee.

National Pharmaceutical Pricing Authority, NPPA has rejected the application of Intas Pharmaceuticals for exemption from the provisions of Drug Price Control Order, DPCO, 2013 under Para 32 (iii) for the formulations Clozapine Extended Release Capsules.

The expert committee of NPPA had received application from Intas Pharmaceuticals for exemption from the provisions of DPCO 2013 under para 32 (iii) for the formulations Clozapine extended release capsules 12.5 mg, 25 mg, 50 mg, 100 mg and 200 mg.

Glenmark Pharma Monroe, North Carolina (USA) based Facility has received a communication from the US FDA indicating the inspection classification as Official Action Indicated (OAI).

The OAI classification implies interalia that the US FDA may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations are resolved.

Global pharma major Lupin Limited (Lupin) has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), Formoterol Fumarate Inhalation Solution.