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Dr Jitendra Singh Proposes India-Delaware Biomanufacturing Working Group
Dr Jitendra Singh proposed an India-Delaware Biomanufacturing Working Group to boost biotech collaboration, highlighting startup and R&D linkages. He also stressed supply chain resilience and regulatory cooperation during India-US talks to strengthen innovation, manufacturing and strategic life sciences ties.
Roche's Fenebrutinib Shows Promise in Third Phase III MS Trial
Roche reported positive Phase III FENhance 1 results, with fenebrutinib reducing relapses by 51 percent in relapsing multiple sclerosis, consistent with prior FENhance 2 and FENtrepid data. The company plans regulatory submissions, positioning fenebrutinib as a potential first-in-class BTK inhibitor for relapsing and primary progressive MS.
ACC Extends Dr Rajeev Singh Raghuvanshi's appointment as Drugs Controller (India) for One Year
Dr Rajeev Singh Raghuvanshi receives a second one-year extension as head of CDSCO amid ongoing regulatory reforms and Schedule M implementation.
MindRank Doses First Patient in Phase III Trial of AI-Designed Oral GLP-1RA MDR-001 in China
MindRank has initiated its Phase III MOBILE trial of MDR-001, an AI-designed oral GLP-1 receptor agonist, evaluating long-term efficacy and safety in 750 obesity and type 2 diabetes patients in China.
Viatris Inc sNDA for MR-141 Accepted by U.S. Food and Drug Administration for Presbyopia Treatment
The US FDA has accepted Viatris’ supplemental application for phentolamine ophthalmic solution 0.75 percent to treat presbyopia and advancing to a potential non-invasive therapy.
Japan Grants Orphan Drug Designation to Sanofi's Rilzabrutinib
Sanofi’s rilzabrutinib has received Orphan Drug Designation in Japan for IgG4-related disease (IgG4-RD), supported by positive phase-II study results. The decision marks the therapy’s third global orphan designation in this indication, underscoring Sanofi’s continued focus on advancing treatments for rare immune-mediated diseases.
FDA Clears Novo Nordisk's Sogroya for Three New Paediatric Uses
The US Food and Drug Administration (FDA) has approved Novo Nordisk’s Sogroya for three additional paediatric indications, expanding its use in children aged 2.5 years and older and reinforcing its position as the only once-weekly, long-acting growth hormone with the broadest approved label.
IDEAYA Biosciences Enrols First Patient in Phase I Trial of IDE034 Bispecific TOP1 ADC
Precision oncology firm IDEAYA begins Phase I evaluation of IDE034, a PTK7/B7H3 bispecific TOP1 ADC, advancing its ADC and DNA damage response combination strategy in solid tumours.
Cipla Launches Saxenda for Weight Management
Cipla has strengthened its US portfolio with the launch of a generic version of Saxenda (liraglutide injection), indicated for chronic weight management. The launch follows ANDA approval from the US Food and Drug Administration (FDA), granted to its partner Orbicular, paving the way for expanded access to a more affordable GLP-1 therapy in the US.
Vanda’s imsidolimab moves closer to approval as the FDA accepts its BLA for generalised pustular psoriasis, a rare and life-threatening inflammatory skin disorder.
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