Respiratory July 3, 2025 FDA grants priority review for MSD’s Winrevair By PBR Staff Writer This sBLA seeks to update the US product label reflecting the results from the Phase III ZENITH trial. Winrevair was initially approved in 2024 to treat adult people
Ophthalmology July 2, 2025 Formycon, Bio Usawa to introduce ophthalmic medicine in Sub-Saharan Africa By PBR Staff Writer Bioeq is also the exclusive holder of the global commercialisation rights for the medicine, Formycon’s biosimilar candidate for Lucentis (ranibizumab). This agreement allows Bio Usawa to register and
Drug Manufacturing July 1, 2025 Simtra BioPharma constructs production manufacturing building in Germany By PBR Staff Writer The move is said to bolster the company’s North America and Europe presence, meeting the worldwide demand for critical injectable therapeutics. This expansion has enlarged the total production
Oncology June 30, 2025 Mabwell signs Albipagrastim alfa deal with Qilu Pharmaceutical By PBR Staff Writer This agreement grants Qilu exclusive rights to develop, manufacture, enhance, utilise and commercialise Albipagrastim alfa for Injection in Greater China including Chinese Mainland, Macau, Hong Kong and Taiwan.
Approvals June 27, 2025 Innovent’s Mazdutide receives approval for chronic weight management in China By PBR Staff Writer Mazdutide is a dual glucagon (GCG)/glucagon-like peptide-1 (GLP-1) receptor agonist. The therapy’s unique dual mechanism not only promotes weight loss but also targets visceral fat and enhances metabolic
Oncology June 26, 2025 FDA approves Plus Therapeutics’ Reyobiq for paediatric brain cancer By PBR Staff Writer Paediatric HGG, including ependymoma, are not only rare but also very difficult to treat, with current standard care failing to prevent recurrence and with five-year survival rates. Reyobiq
Central Nervous System June 25, 2025 EC grants orphan drug status to JR-446 for MPS IIIB By PBR Staff Writer This follows a similar endorsement by the US Food and Drug Administration (FDA). Sanfilippo syndrome type B is an autosomal recessive disease marked by mutations in the N-acetyl-alpha-glucosaminidase
Other Diseases June 24, 2025 Optime Care collaborates with Tilde Sciences for Vecamyl tablets By PBR Staff Writer This collaboration appoints Optime Care as the exclusive specialty pharmacy provider for the newly FDA-approved tablets, ensuring the medication’s availability to patients. Optime Care general manager Bill Bertetto
Oncology June 23, 2025 Archeus Technologies gets FDA approval for ART-101 application By PBR Staff Writer This new small molecule is designed for prostate cancer imaging and treatment. The FDA’s approval allows Archeus to begin a Phase I clinical study targeting metastatic castration-resistant prostate
RegulationDrug Manufacturing June 20, 2025 CHMP endorses ExCellThera’s stem cell transplantation product By PBR Staff Writer The therapy is intended to treat the adult population with haematological malignancies needing an allogeneic haematopoietic stem cell transplantation after a myeloablative conditioning for those individuals with no