FDA says no to AstraZeneca’s Saphnelo Subcutaneous Formulation for Lupus Patients | iPharmaCenter
The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for AstraZeneca’s Biologics License Application (BLA) seeking approval of Saphnelo (anifrolumab) for subcutaneous administration in adults with systemic lupus erythematosus (SLE). This is despite Saphnelo SC meeting primary endpoint in clinical trial. AstraZeneca has provided the additional information requested and stated its commitment to working closely with the FDA to advance the appli
CDSCO Clears Durvalumab with FLOT as New Perioperative Standard for Gastric Cancer Patients in India | iPharmaCenter
CDSCO Clears Durvalumab AstraZeneca received regulatory approval from the Central Drugs Standard Control Organisation (CDSCO) for the use of durvalumab in combination with FLOT chemotherapy, a regimen including fluorouracil, leucovorin, oxaliplatin, and docetaxel, as a perioperative treatment for adults with resectable gastric and gastroesophageal junction (GEJ) adenocarcinoma. This marks the first and only immunotherapy-based perioperative regimen to demonstrate a survival a
AHA Urges HRSA to Block Eli Lilly’s Expanded 340B Claims-Data Policy; Lilly Hits Back | iPharmaCenter
The American Hospital Association (AHA) has called on the Health Resources and Services Administration (HRSA) to stop a new Eli Lilly and Company policy that would expand claims‑data reporting requirements for 340B hospitals, warning that the change is unlawful, unworkable, and threatens patient access to discounted medicines. Also read: Top 10 pharmaceutical companies by revenues On January 15, 2026, Lilly notified 340B covered entities that, effective February 1, all enti
Top 10 pharmaceutical companies by revenues | 2025 | iPharmaCenter
Top pharmaceutical companies by revenues in 2025. The revenues are captured from the official websites of pharmaceutical companies
Roche’s GLP‑1/GIP receptor agonist CT‑388 demonstrated strong efficacy in patients with obesity | iPharmaCenter
Roche announces positive Phase II results for its dual GLP-1/GIP receptor agonist CT-388 in people living with obesity. A once-weekly subcutaneous injection of CT-388 achieved a statistically significant placebo-adjusted weight loss of 22.5% at 48 weeks at the highest dose tested (24 mg), without reaching a weight loss plateau 54% of participants on the 24 mg dose achieved resolution of obesity (BMI <30 kg/m2) vs. 13% in the placebo group. CT-388 demonstrated a safety and tol
NICE greenlights Dupixent as add-on therapy for uncontrolled COPD with raised eosinophils in England, marking first targeted biologic for this indication | iPharmaCenter
The UK's National Institute for Health and Care Excellence (NICE) issued final draft guidance on January 26, 2026, recommending Dupixent (dupilumab ; Sanofi/Regeneron) for adults with moderate-to-severe chronic obstructive pulmonary disease (COPD) that remains uncontrolled despite maximal inhaled therapy. Eligible patients must show elevated blood eosinophils (≥300 cells/μL), indicating type 2 inflammation, and have had ≥1 severe or ≥2 moderate exacerbations in the prior year