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Lupin has obtained U.S. FDA approval of Armlupeg, a biosimilar of Neulasta. The product is pegfilgrastim 6mg/0.6ml prefilled injection in a single-dose syringe to be used as a subcutaneous injection. The manufacturing will be done in the biotech...
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Thermo Fisher Scientific, the world leader in serving science, today inaugurated two new facilities in Hyderabad’s Genome Valley. The Bioprocess Design Center (BDC) a technology scale-up facility was set up in partnership with Govt. Of Telangana; oth
Novo Nordisk’s obesity drug amycretin delivered a major boost to the company today, after new mid-stage trial results showed the treatment helped patients with type 2 diabetes lose up to 14.5% of their weight in 36 weeks. The update quickly...
Bayer reported a major step forward today as its experimental drug asundexian reduced the risk of recurrent ischemic stroke without increasing bleeding risk in a global phase III study. The OCEANIC-STROKE trial hit both its primary efficacy and...
Merck has secured a major win today as the US FDA approved KEYTRUDA and KEYTRUDA QLEX, used with Padcev, for adults with muscle-invasive bladder cancer (MIBC) who cannot receive cisplatin. This marks the first time a PD-1 inhibitor has been...
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...
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