Pfizer and Astellas' Xtandi combo extends survival in early prostate cancer setting

Xtandi is approved in over 80 countries, including the U.S., EU, and Japan

Shilpa Pharma Lifesciences Unit-1 inspected by ANVISA

The audit has been concluded with no major observations

INmune Bio reports core findings from Phase 2 trial in early Alzheimer’s disease

Treatment with XPro was well-tolerated and safe, even in the high risk ApoE4+/+ patient group, and ARIA-E or ARIA-H was not observed in any patients

Briefs: Neuland Laboratories and Granules India

Granules India receives 1 observation from USFDA for Chantilly facility

SMS Pharmaceuticals completes USFDA inspection at Central Laboratory Analytical Services

The inspection concluded with zero Form 483 observations

AbbVie announces new data demonstrating Atogepant achieves superiority in Phase 3 study

TEMPLE, a Phase 3 multicenter, randomized, double-blind, head-to-head study, evaluated the tolerability, safety and efficacy of atogepant compared to topiramate for the preventive treatment of migraine in adult patients with a history of four or more migraine days per month

USFDA concludes inspection of NATCO’s Pharma Division, Kothur

The company received seven observations in the Form-483

USFDA concludes inspection at Zydus' oncology injectable plant at Ahmedabad

Briefs: Hikal and Sun Pharma

Sun Pharma gets 8 observations from USFDA for Halol facility

USFDA inspection at the API manufacturing plant located in Mekaguda, Hyderabad

The company received one observation in the Form-483