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409 News Found

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


Briefs: Biocon, Laurus Labs and Smruthi Organics
Drug Approval | February 13, 2023

Briefs: Biocon, Laurus Labs and Smruthi Organics

Laurus Labs has announced that the USFDA completed inspection of the formulations manufacturing facility Unit-2, APSEZ, Atchutapuram, Visakhapatnam, Andhra Pradesh.


Sun Pharma Announces USFDA Approval for Generic Lenalidomide Capsules
News | February 11, 2023

Sun Pharma Announces USFDA Approval for Generic Lenalidomide Capsules

The respective product approval is based on Revlimid Capsules, 5mg, 10mg, 15mg, 25mg and 2.5mg, 20mg as a reference product


Artificial intelligence facilitates low-cost drug repurposing, says GlobalData
Digitisation | February 11, 2023

Artificial intelligence facilitates low-cost drug repurposing, says GlobalData

The Innovation Explorer database of GlobalData’s Disruptor Intelligence Center highlights the key company collaborations in pharma to advance AI-powered drug repurposing techniques.


Theramex select CARA Life Sciences Platform to consolidate and digitise Regulatory Processes
Digitisation | February 03, 2023

Theramex select CARA Life Sciences Platform to consolidate and digitise Regulatory Processes

Theramex were searching for a platform to digitise the manual processes across their R&D landscape


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


ProBioGen’s vaccine production cell line AGE1.CR.pIX used for clinical production
News | January 20, 2023

ProBioGen’s vaccine production cell line AGE1.CR.pIX used for clinical production

The AGE1.CR.pIX cell line is derived from primary cells of a duck embryo and was designed to comply with health authority guidelines


Lupin and Exeltis announce reimbursement approval of NaMuscla in Spain
News | January 10, 2023

Lupin and Exeltis announce reimbursement approval of NaMuscla in Spain

NDM disorders are a group of rare, inherited neuromuscular disorders with an estimated prevalence of 1 case per 100,000 inhabitants in Spain, and are characterized by the inability to relax muscles following voluntary contraction (myotonia)


Samples taken from Marion Biotech Noida facility sent to RDTL, Chandigarh for testing
News | December 30, 2022

Samples taken from Marion Biotech Noida facility sent to RDTL, Chandigarh for testing

There have been reports from Uzbekistan concerning contaminated cough syrup Dok1 Max made by Indian company Marion Biotech, Noida, Uttar Pradesh