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Venus Remedies awarded Saudi GMP approval for all its production facilities in Baddi
Drug Approval | February 28, 2023

Venus Remedies awarded Saudi GMP approval for all its production facilities in Baddi

The company expects the GMP approval from Saudi Food and Drug Authority (SFDA) to soon pave the way for marketing authorizations from the largest market in the GCC region


Pfizer and BioNTech submit sBLA for approval of Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine
Drug Approval | February 25, 2023

Pfizer and BioNTech submit sBLA for approval of Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine

This sBLA submission is supported by clinical, pre-clinical, and manufacturing data demonstrating the safety, tolerability, and immunogenicity of the bivalent vaccine.


Pfizer’s Elranatamab receives FDA and EMA filing acceptance
Drug Approval | February 25, 2023

Pfizer’s Elranatamab receives FDA and EMA filing acceptance

Submissions based on favorable MagnetisMM-3 trial results in patients with relapsed or refractory multiple myeloma


USFDA accepts biologics license application for Pfizer’s respiratory syncytial virus maternal vaccine candidate for priority review
Drug Approval | February 22, 2023

USFDA accepts biologics license application for Pfizer’s respiratory syncytial virus maternal vaccine candidate for priority review

This action follows the recent acceptance of the Marketing Authorization Application (MAA) for Pfizer’s RSV vaccine candidate by the European Medicines Agency


NATCO files generic Olaparib Tablets in USA
News | February 14, 2023

NATCO files generic Olaparib Tablets in USA

Olaparib is indicated primarily for certain forms of ovarian, breast, pancreatic, and prostate cancer


Pfizer appoints Meenakshi Nevatia as MD and Additional Director
People | February 10, 2023

Pfizer appoints Meenakshi Nevatia as MD and Additional Director

She is a seasoned leader with nearly 30 years of business leadership and consulting experience with top companies such as Mckinsey and Co, Novartis Pharmaceuticals and Stryker India Pvt. Ltd.


Healthcare Global Enterprises revenue up 19%
News | February 10, 2023

Healthcare Global Enterprises revenue up 19%

Technology and innovation play a pivotal role towards enhancing healthcare systems, increasing access to healthcare services, and reducing costs of therapies and consultations


Umesh Kunte appointed CEO of Albert David
People | February 06, 2023

Umesh Kunte appointed CEO of Albert David

A pharma industry veteran with over three decades of experience in domestic as well as international markets


CHMP recommends Bayer’s darolutamide for the treatment of metastatic hormone-sensitive prostate cancer
Drug Approval | January 31, 2023

CHMP recommends Bayer’s darolutamide for the treatment of metastatic hormone-sensitive prostate cancer

CHMP recommendation is based on Phase III data, which demonstrated that darolutamide plus androgen deprivation therapy (ADT) in combination with docetaxel significantly reduced the risk of death by 32.5%


Dr. Reddy’s completes clinical studies of its rituximab biosimilar for filing in the U.S., Europe
Drug Approval | January 21, 2023

Dr. Reddy’s completes clinical studies of its rituximab biosimilar for filing in the U.S., Europe

Following successful completion of full set of clinical studies of proposed rituximab biosimilar candidate DRL_RI, Dr. Reddy’s will now prepare to file in the United States, European Union and other regions