Other Diseases July 9, 2025 Rallybio sells REV102 programme to Recursion for up to $25m By PBR Staff Writer The deal, valued at up to $25m, includes an upfront equity payment of $7.5m and near-term milestones, extending Rallybio’s cash runway into mid-2027. The REV102 programme originated from
Production & Sales July 8, 2025 Sagent, Qilu partner to commercialise complex injectable products in US By PBR Staff Writer Through this partnership, Sagent will gain sole rights to commercialise a select portfolio of Qilu’s complex injectable products in the US. These products encompass high-impact therapeutic areas,
Research & Development July 7, 2025 Biosynth opens expanded GMP bioconjugation facility in Germany By PBR Staff Writer The new facility is claimed to enhance Biosynth’s ability to manufacture GMP bioconjugates, supporting the production of intermediates and active pharmaceutical ingredients from early clinical stages till late-phase
Infectious Disease July 4, 2025 FDA approves Hikma’s Tyzavan for multiple infections By PBR Staff Writer Tyzavan is indicated for the treatment of several serious infections in adults and children one month and above, including septicemia, infective endocarditis, skin and skin structure infections, bone
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
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
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
RegulationApprovalsDrug Manufacturing June 18, 2025 Ferrer’s progressive supranuclear palsy therapy gains FDA fast track status By PBR Staff Writer In-licensed from Asceneuron, this new molecular entity is currently undergoing a Phase II trial. The trial aims to assess the therapy’s efficacy, pharmacokinetics, and safety in adults diagnosed