Research & Development November 27, 2025 BeOne’s sonrotoclax gains priority FDA review for mantle cell lymphoma By PBR Staff Writer The decision is intended for those who have previously been treated with a Bruton’s tyrosine kinase (BTK) inhibitor. This application is based on data from a global, open-label,
Production & Sales November 27, 2025 Corstasis Therapeutics partners CVL for Enbumyst integration By Salong Debbarma The approach is consistent with outpatient settings as per US Food and Drug Administration (FDA)-approved use. The initiative enhances access to non-oral diuretic therapy throughout CVL’s cardiovascular practice
Research & Development November 26, 2025 UNICEF and Gavi to widen affordable malaria vaccine access By PBR Staff Writer The deal sets the vaccine price at $2.99 per dose and is expected to take effect within a year, supporting Gavi’s goal to fully vaccinate 50 million more
Research & Development November 26, 2025 FDA grants accelerated approval for Otsuka’s IgAN therapy By PBR Staff Writer Voyxact is administered as a self-injected subcutaneous dose every four weeks. Its approval was based on the interim results of the Phase III VISIONARY trial, which demonstrated a
Drug Manufacturing November 25, 2025 Made Scientific and Cellergy partner to advance CLG-001 By PBR Staff Writer Cellergy will utilise the good manufacturing practices (GMP) expertise of Made Scientific to enhance its mitochondrial isolation and purification process for the clinical-grade production of CLG-001. This work
Research & Development November 25, 2025 Novartis secures approval from FDA for Itvisma to treat SMA By PBR Staff Writer This therapy is intended for children aged two years and above, teens and adults with SMA who have a confirmed mutation in the survival motor neuron 1 (SMN1)
Research & Development November 24, 2025 AstraZeneca to expand biomanufacturing in Maryland, US By PBR Staff Writer The investment covers both expansion of the Frederick biologics manufacturing facility and a new plant construction in Gaithersburg, targeting operational readiness by 2029. The Frederick site, which produces
Research & Development November 24, 2025 Vaximm and BCME link on oral cancer immunotherapy platform By PBR Staff Writer The agreement includes an exclusivity period of six months for negotiating and finalising a definitive agreement, pending due diligence and board approvals. Vaximm is eligible for an upfront
Research & Development November 21, 2025 Aspen closes $115m in Series C to advance Parkinson’s cell therapy By PBR Staff Writer This round will also bolster the company’s manufacturing offerings and support additional pipeline therapies. It was jointly led by OrbiMed, Frazier Life Sciences, ARCH Venture Partners and Revelation
Research & Development November 21, 2025 Alvotech and Advanz announce EC approval for Gobivaz biosimilar By PBR Staff Writer The authorisations cover Gobivaz in both 100mg/ml and 50mg/0.5ml formulations, provided in pre-filled syringes with autoinjector formats and passive needle safety guards, to treat adults with axial spondyloarthritis,