Regulatory factors in rare disease studies
The rare disease landscape poses myriad challenges for researchers, policymakers, and CROs, particularly in navigating its intricate regulatory environment. Rare …
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House passes bill that reauthorises the FDA’s paediatric priority voucher pathway
The US House of Representatives has passed a new piece of legislation that reauthorises the US Food and Drug Administration’s …
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In a Honduran city, biotechs create gene therapy cocktails to fight aging
Próspera, a charter city on Roatán island in Honduras, hosts two biotechs working to combat ageing through gene therapy, as …
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Oncology trials: Delivering precision and reliability in data management
Clinical trials for oncology are filled with data management complexities that must be carefully navigated, with challenges and solutions outlined …
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Solid Biosciences’ SGT-212 gains FDA rare paediatric disease status
Solid Biosciences has secured the US Food and Drug Administration (FDA) rare paediatric disease designation for SGT-212, its investigational gene therapy …
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What matters in the API market as 2026 approaches
The active pharmaceutical ingredient (API) landscape is shifting. Companies are rethinking their sourcing strategies, upgrading their technological capabilities, and relying …
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CKD-HPT, HP and HK market to reach $4bn across 7MM by 2034
The chronic kidney disease (CKD)-hyperparathyroidism (HPT), hyperphosphatemia (HP) and hyperkalemia (HK) market is poised to grow at a compound annual …
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Lotus submits NDA for VIZZ in South Korea to treat presbyopia
Lotus Pharmaceutical has submitted a new drug application (NDA) to the Ministry of Food and Drug Safety (MFDS) for VIZZ …
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UK and US strike “landmark” zero-tariff pharma deal
The UK and US governments have come to an agreement that will see the UK subject to zero tariffs on …
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Regeneron and Tessera join forces to forge in vivo AATD gene therapy
Regeneron Pharmaceuticals has teamed up with Tessera Therapeutics to develop and commercialise Tessera’s rare disease in vivo gene writing programme, …
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“Sharp” funding cuts disrupt PrEP access to millions of HIV patients
The World Health Organization (WHO) has called for access expansion to newly approved human immunodeficiency virus (HIV) medication amid “sharp …
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Eisai seeks PMDA approval for subcutaneous Leqembi in Japan
Eisai has submitted a new drug application seeking approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for Leqembi’s (lecanemab) subcutaneous (SC) …
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Potentially “groundbreaking” FDA gene therapy pathway leaves key issues unresolved
The US Food and Drug Administration’s (FDA’s) new pathway for gene therapies could be “groundbreaking” if applied broadly, though the …
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US FDA approves Lupin’s Armlupeg injection
Lupin has received US Food and Drug Administration (FDA) approval for Armlupeg (pegfilgrastim-unne) 6mg/0.6ml injection in a single-dose prefilled syringe …
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Pharmaceutical Technology Excellence Awards 2025: West Pharmaceutical Services
West Pharmaceutical Services has long been a reference point in primary packaging for injectable therapies. Its latest launch—the West Synchrony™ …
