Pharma News

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.

In the war against cancer, one of the most critical battles is waged on a cellular level as T cells from the immune system are altered in the lab to attack cancer cells. This form of immunotherapy, called chimeric antigen receptor (CAR) T-cell therapy, can be a life-saving treatment resulting in tumor control lasting ten years or longer. 

Researchers from Trinity College Dublin have developed a new gene therapy approach that shows promise for treating the dry form of Age Related Macular Degeneration (AMD) – a progressive eye disease that affects up to 10% of adults over 65 years of age and is a leading cause of severe vision impairment and blindness in this age group.

Many tumor cells mist themselves with a protective perfume that disables the immune system. But a drug already approved for other purposes can apparently render this weapon harmless. This is shown in a study by the University of Bonn and the University Medical Center Hamburg-Eppendorf, which has now appeared in the Journal for ImmunoTherapy of Cancer. The researchers now want to further optimize the compound. In the medium term, this could pave the way for new anti-cancer drugs.

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.

Tamil Nadu All Registered Pharmacists Welfare Association requesting Pharmacy council of India to not conduct the exit examination for Pharmacists.

The General Secretary, of TNARPW association said that, we have received notification about exit exam for pharmacy students for upcoming November 2022. We are not happy by this announcement actually. Our association clearly stands with welfare of public at all the time. But we are expecting some response from PCI for our questions.