IPP Bureau
Apitoria Pharma receives 5 observations from USFDA for API facility
By IPP Bureau - August 31, 2025
At the end of the current inspection, a 'Form 483' was issued with 5 observations which are procedural in nature and no data integrity issues were reported
Novo Nordisk’s Wegovy cuts risk of heart attack, stroke or death by 57% compared to tirzepatide
By IPP Bureau - August 31, 2025
The study showed a significant 29% reduction in the risk for heart attack, stroke and death from any cause in the Wegovy users
FDA suspends Valneva’s license of chikungunya vaccine IXCHIQ in US
By IPP Bureau - August 31, 2025
The sudden subsequent decision to suspend IXCHIQ is based on updated VAERS data
FDA approves Novavax's Nuvaxovid 2025-2026 formula for prevention of COVID-19
By IPP Bureau - August 31, 2025
Nuvaxovid is the only protein-based, non-mRNA COVID-19 vaccine available in the U.S. for the 2025-2026 vaccination season
Lilly's Verzenio scores first OS improvement in breast Cancer
By IPP Bureau - August 30, 2025
Treatment with Verzenio also resulted in sustained invasive disease-free survival and distant relapse-free survival benefit
Accro Bioscience and Fosun Pharma ink agreement for TYK2/JAK1 Inhibitor in Greater China
By IPP Bureau - August 30, 2025
Accro will retain global rights to develop, manufacture, and commercialize AC-201 (excluding Chinese Mainland, Hong Kong SAR, and Macau SAR)
MHRA approves UK’s first new type of antibiotic for urinary tract infections
By IPP Bureau - August 30, 2025
As with any medicine, the MHRA will keep the safety of gepotidacin under close review
Dr Agarwal's Eye Hospital merges with parent Dr Agarwal's Health Care
By IPP Bureau - August 29, 2025
Merger is expected to streamline operations and provide unified management focus, driving efficiency and strategic alignment
FDA approves Teva Pharmaceuticals' first GLP-1 obesity drug
By IPP Bureau - August 29, 2025
Generic Saxenda is the first-ever generic GLP-1 indicated for weight loss, addressing increased demand for this category of therapies in the US market
Piramal Pharma Solutions supports George Medicines in developing new drug for hypertension
By IPP Bureau - August 29, 2025
WIDAPLIK is the first and only FDA-approved triple combination medication for use as an initial therapy in patients likely to need multiple drugs to achieve blood pressure goals
Lilly's oral GLP-1 orforglipron succeeds in Phase 3 trial
By IPP Bureau - August 29, 2025
Triggering global regulatory submissions this year for the treatment of obesity
Moderna receives FDA approval for updated COVID-19 vaccines for LP.8.1 Variant of SARS-CoV-2
By IPP Bureau - August 29, 2025
The updated formula for Spikevax is now approved for individuals 6 months through 64 years of age
Sai Life Sciences completes Phase II of production block 11 at Bidar
By IPP Bureau - August 29, 2025
With the addition of Phase II (~91 KL) in Q1 FY26, the combined capacity of the block now stands at ~200 KL
Zydus Therapeutics reports positive phase-3 results in rare liver disease
By IPP Bureau - August 29, 2025
Saroglitazar was generally well tolerated, with overall adverse events generally balanced between Saroglitazar-treated and placebo-treated patients
