RegulationNeurology June 10, 2024 FDA accepts Eisai’s sBLA for intravenous LEQEMBI to treat early Alzheimer’s By PBR Staff Writer A decision on the approval under the Prescription Drug User Fee Act (PDUFA) is anticipated on 25 January 2025. LEQEMBI is intended to treat AD patients having mild
Drug Discovery June 7, 2024 PharmaCord to boost pharma services with Permira’s investment By PBR Staff Writer The investment is managed by the funds of Permira and is expected to close by the fourth quarter of 2024, subject to necessary approvals and conditions. The companies
RegulationRespiratory June 6, 2024 FDA grants orphan drug status to Agomab’s AGMB-447 for IPF treatment By PBR Staff Writer Currently, AGMB-447 is being assessed in an ongoing Phase I clinical trial as a potential treatment for IPF. The single-centre, integrated trial aims to evaluate the safety, tolerability,
ApprovalsOncology June 5, 2024 Repare Therapeutics secures FDA Fast Track designation for ovarian cancer therapy By PBR Staff Writer Fast Track process of the FDA is intended to accelerate the development and review of drugs that address serious conditions and fill unmet medical needs. Lunresertib along with
Drug DiscoveryHematological Disorders June 4, 2024 Pfizer and Abu Dhabi partner to boost sickle cell disease research By PBR Staff Writer The Department of Health (DoH) Abu Dhabi in the UAE has entered into a memorandum of understanding (MoU) with Pfizer Gulf to bolster research in areas including sickle
Research & Development June 3, 2024 Telix seeks BLA for TLX250-CDx aimed at kidney cancer imaging By PBR Staff Writer TLX250-CDx (Zircaix) is the company’s investigational radiodiagnostic PET agent for the renal masses characterisation as ccRCC or non-ccRCC in a non-invasive manner. Initiated in December 2023, the rolling
Drug Discovery May 31, 2024 Weave Bio secures $10m in seed funding round By PBR Staff Writer The company also launched AutoIND, an AI-powered platform designed to optimise the drafting, reviewing, and submitting of regulatory documents in drug development. AutoIND is the first product on
Drug Discovery May 30, 2024 ExpressionEdits secures $13m to develop protein-based therapies By PBR Staff Writer Octopus Ventures and Redalpine co-led the investment round with contributions from Wilbe Capital, BlueYard Capital, Acequia Capital, Amino Collective, and Hawktail. This funding is set to accelerate the
Drug DiscoveryNeurology May 29, 2024 Lucy Therapeutics secures $12.5m for neurological treatment development By PBR Staff Writer The funding round was spearheaded by existing investors Engine Ventures and Safar Partners, with new participations from Bill Gates, Parkinson’s UK, and the Michael J. Fox Foundation, which
Drug Discovery May 28, 2024 RevolKa signs deal with Daiichi Sankyo for functional proteins By PBR Staff Writer Under the terms of the agreement, RevolKa will utilise its protein engineering platform, aiProtein, integrated with artificial intelligence (AI), to create and deliver highly functional proteins. The companies