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Pharma Pro & Pack Expo 2025: CN Water Unveils AQU@Sense and Remote Monitoring Platform
India’s leading high-purity water solutions company, CN Water, concluded a successful showcase at the Pharma Pro & Pack Expo 2025 in India, highlighting two of its industry-leading solutions - AQU@Sense and CNtinel Remote Monitoring platform - which are redefining water operations for pharmaceutical manufacturing.
Rubicon Research, a pharmaceutical formulations company, has announced that in a pre-IPO transaction, General Atlantic Singapore RR transferred 2.889 million equity shares to TIMF Holdings and 360 ONE funds at INR 484.47 per share, aggregating to INR 140 crore.
Akums Highlights Lacosamide's Versatility in Epilepsy Management
Akums Drugs & Pharmaceuticals reaffirmed lacosamide, a well-established antiepileptic drug (AED), as a versatile and effective option for patients with epilepsy across age groups and clinical settings.
Minor Fire at Aurobindo Pharma's Andhra Pradesh Unit Causes Temporary Production Disruption
The incident occurred at Unit IV of APL Healthcare Ltd, located in Naidupeta, Andhra Pradesh (SEZ Unit), on 18 September 2025 at around 8:50 am. The cause was identified as a short circuit in granulation area-10.
China's Leads Biolabs Wins FDA Nod to Begin First-in-Human Trial of Novel Autoimmune Therapy
The US Food and Drug Administration (FDA) has approved Leads Biolabs’ first-in-human Investigational New Drug (IND) application for LBL-047, a novel therapeutic candidate for the treatment of autoimmune diseases such as systemic lupus erythematosus, dermatomyositis, IgA nephropathy and Sjögren's syndrome.
FDA Approves Subcutaneous Version of Keytruda for Solid Tumours
The U.S. Food and Drug Administration (FDA) has granted approval for a new subcutaneous formulation of Merck’s cancer immunotherapy Keytruda, now marketed as Keytruda Qlex.<br />
FDA Introduces Pilot Scheme to Simplify Nicotine Pouch Manufacturers' Research Obligations
The U.S. Food and Drug Administration (FDA) is set to ease research requirements for manufacturers of nicotine pouches under a new pilot scheme, according to internal meeting transcripts. This marks the clearest indication yet of a more relaxed approach to smoking alternatives.
Sanofi and Regeneron's Dupixent Receives Positive CHMP Opinion
The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Dupixent (dupilumab), jointly developed by Sanofi and Regeneron, for the treatment of chronic spontaneous urticaria (CSU) in adults and adolescents in the EU.
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.
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