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news.FDA grants orphan status for AlzeCure’s pain drug candidate
The company completed a positive Phase IIa trial of the candidate for chronic subjects with peripheral neuropathic pain. It is now preparing for further clinical development and has
The company completed a positive Phase IIa trial of the candidate for chronic subjects with peripheral neuropathic pain. It is now preparing for further clinical development and has
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
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
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
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
The application is underpinned by the multi-centre, open-label Phase III UNITI-Jr clinical trial data, which assessed the therapy’s safety, pharmacokinetics, and efficacy in paediatric subjects. At present, Stelara
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
This status signifies the potential of the gel to broaden its therapeutic applications in chronic wound healing, accelerating its availability to patients. SolasCure noted that this hydrogel releases
This collaboration is expected to strengthen the country’s role as an international hub for drug discovery. This new support is part of several programmes under the Medical Innovation
The designation is granted to iopofosine I 131 for the treatment of relapsed/refractory Waldenstrom macroglobulinemia (r/r WM), a subtype of lymphoplasmacytic lymphoma currently without a cure. WM remains