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Lupin's Nagpur Injectable Facility Receives Six Observations in USFDA Inspection
Lupin’s injectable facility in Nagpur has received six observations from the US Food and Drug Administration (USFDA), following an inspection conducted between the 8th and 16th of September 2025.
PMO Steps In to Support Pharma MSMEs Facing Regulatory-Driven Crisis
The Prime Minister’s Office (PMO) has directed the Ministry of Micro, Small & Medium Enterprises to take urgent action after pharma MSMEs sounded an alarm over regulatory pressures affecting quality control compliance.
ICMR and CDSCO Release First Set of 39 Standard IVD Evaluation Protocols
Standard In-Vitro Diagnostic (IVD) Evaluation Protocols, jointly developed by ICMR and CDSCO, include protocols for performance evaluation of IVD kits used for detecting tuberculosis, malaria, dengue, chikungunya, Zika virus, typhoid fever, various respiratory viruses, Chandipura virus, and Nipah virus.
Wegovy (Semaglutide 2.4 mg) reduced risk of heart attack, stroke, or death by 57 percent when compared to Tirzepatide, and 29 percent across all patients, showing heart-protective benefits unique to the Semaglutide molecule.
Aurobindo's Subsidiary CuraTeQ Biologics Completes Phase 3 Clinical Study for Denosumab Biosimilar
CuraTeQ Biologics, a wholly owned subsidiary of Aurobindo Pharma, has successfully completed a pivotal clinical study of its denosumab biosimilar, evaluated against Amgen’s Prolia in 446 women with postmenopausal osteoporosis.
Alnylam Pharmaceuticals Joins Alliance for Genomic Discovery to Advance RNAi Therapeutics
Alnylam Pharmaceuticals has become the ninth member of the Alliance for Genomic Discovery (AGD), joining AbbVie, Amgen, AstraZeneca, Bayer, Bristol Myers Squibb, GSK, Merck, and Novo Nordisk.
Amber Implants Secures FDA 510(k) Clearance for VCFix Spinal System
The VCFix Spinal System, a novel treatment for vertebral compression fractures, has received FDA clearance following one-year trial results that confirmed its safety, performance, and significant clinical benefits. A US commercial pilot launch is planned for early 2026, with broader physician availability expected by summer 2026.
Enzene, Aurobindo and Biocon Boost US Manufacturing with Major New Jersey Expansions
This month, three leading Indian firms — Enzene Biosciences, Aurobindo Pharma, and Biocon — have inaugurated major facilities in New Jersey, underscoring a growing trend of onshore investment by Indian pharma companies.
Laborate Pharmaceuticals Appoints IPS Veteran Sanjay Kundu as Independent Director
As Independent Director at Laborate Pharmaceuticals, Sanjay Kundu will provide independent oversight, strengthen corporate governance, and promote transparent decision-making.
NPPA Extends Price Cap on Orthopaedic Knee Implants Until November 15, 2025
The National Pharmaceutical Pricing Authority (NPPA) has extended the ceiling price on orthopaedic knee implants for knee replacement systems by two months, pushing the deadline to 15 November 2025. The ceiling price, originally imposed in August 2017 in public interest, had been extended periodically, most recently up to 15 September 2025.
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