Tag: FDA
Indian pharma industry welcomes FDA move to accelerate biosimilar development
The FDA released a new draft guidance proposing major changes to simplify biosimilarity studies and reduce unnecessary clinical testing
Rotary & UE LifeSciences launch breast cancer screening for 100,000 women...
The screenings will utilize UE LifeSciences’ FDA-cleared iBreastExam, a revolutionary, radiation-free device that provides immediate, objective results
Sun Pharma’s phase 3 trials of ILUMYA support potential U.S. submission...
Both pivotal studies met their primary endpoint with statistically significant improvements based on ACR20 response rates at Week 24 with tildrakizumab 100 mg (ILUMYA) compared to placebo
Sun Pharma completes its acquisition of Checkpoint Therapeutics
As part of the acquisition, Sun Pharma acquires UNLOXCYTTM, the first and only FDA-approved anti-PD-L1 treatment for advanced cutaneous squamous cell carcinoma
“We have invested about $31 million globally including India to enhance...
Dr Anil Gulati, Chairman and CEO, Pharmazz Inc. answers our questions on the company’s current operations in India and globally, its R&D initiatives, key disease areas and long-term plans.
GBA Group’s Eureka acquires majority stake in Teena Biolabs
Through the merger with Teena, Eureka will become a leading service provider for pharmaceutical analysis in India with a total of two US-FDA approved sites
Shilpa’s Unit-2 passes second consecutive FDA inspection
Raichur site is the group’s largest API facility and part of a wider network of seven sites
“There is a growing trend towards outsourcing clinical trials to India”
Dr Mahesh Bhalgat, Managing Director & Group CEO, Veeda Clinical Research Limited shares his vision for the company, latest developments, long-term growth, industry trends and future outlook
FDA approves Accord BioPharma’s biosimilar ‘IMULDOSA’ to treat chronic inflammatory conditions
Accord BioPharma (A division of Intas Pharmaceuticals) anticipates a commercial launch of IMULDOSA in the first half of 2025
OPPI welcomes Indian govt’s move to waive off local clinical trials...
This will be applicable to a few select drugs already approved in well-regulated markets like the USA, UK, Japan, Australia, Canada, and the EU