In an exclusive interview with Thiruamuthan, Assistant Editor at India Pharma Outlook, Amit Chopra, CEO – South Asia and Middle East, Cotecna Group, discusses how FDA and EMA have intensified nitrosamine scrutiny, and explains why it has become
Merck reported fresh momentum for Winrevair, releasing positive topline data from its phase 2 CADENCE trial in adults with combined post- and precapillary pulmonary hypertension (CpcPH) due to heart failure with preserved ejection fraction (HFpEF)...
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Zydus Lifesciences receives final USFDA approval for its Leuprolide Acetate injection, the generic version of Lupron, used in the palliative treatment of advanced prostate cancer. The approval strengthens Zydus’s oncology portfolio in the US market.
Novartis announced positive Phase III results on its innovative malaria drug GanLum. This research, referred to as KALUMA, demonstrated that GanLum achieved its primary objective and was as effective, at least, as existing standard therapies...
Shilpa Medicare announced favorable topline Phase 3 results of its new drug OERIS (Ondansetron Extended Release Injection). OERIS is a weekly medication that is used to prevent chemotherapy-induced nausea and vomiting (CINV). The multicentric...
Eli Lilly and Company has signed an agreement with MeiraGTx Holdings plc that grants Lilly global exclusive rights to MeiraGTx’s investigational gene therapy for a severe inherited retinal condition. The centerpiece of the deal is the programme...
Roche’s experimental multiple sclerosis (MS) drug fenebrutinib has reached a major milestone, meeting its main goal in one of two late-stage trials for relapsing MS. The treatment sharply reduced annualised relapse rates over 96 weeks compared with..
Positive results from the pivotal LIBERTY-AFRS-AIMS Phase 3 trial reveal that Dupixent considerably enhanced symptoms in adults and children aged six years and older with allergic fungal rhinosinusitis (AFRS). The investigational treatment met...
Bayer’s Kerendia™ (finerenone) approved in India for HFpEF/HFmrEF, offering dual heart-kidney protection and improving outcomes in high-risk cardiovascular patients.
For the first time, Sun Pharmaceutical has seen its U.S. sales of innovative medicines overtake generics in the second quarter of FY26, marking a major shift for India’s largest drug maker. The surge came on the back of strong sales of Ilumya...
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