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,
Drug Manufacturing November 20, 2025 Pfizer and Tris reach settlement with Texas over ADHD drug allegations By PBR Staff Writer This is in breach of the Texas Health Care Program Fraud Prevention Act. The ADHD drugs case centred on the medication Quillivant XR, provided to children on Medicaid.
Research & Development November 20, 2025 EC authorises Roche’s Lunsumio SC for follicular lymphoma By PBR Staff Writer The approval follows positive results from the Phase I/II GO29781 study, which demonstrated that Lunsumio SC has pharmacokinetic non-inferiority to intravenous (IV) administration. No unexpected safety issues were
Approvals November 19, 2025 USPTO grants patent to Genprex’s Reqorsa gene therapy By PBR Staff Writer The protection for this patent will last until 2037. Genprex has also obtained similar patent protection for the gene therapy used with PD-L1 antibodies in Korea, and is