Oncology January 23, 2023 Genexine receives FTD for DNA vaccine to treat advanced cervical cancer By vbandhakavi MFDS concluded that GX-188E met the criteria for this designation after assessing the complete set of Phase II results from the clinical trial that was recently completed in
Oncology January 20, 2023 US FDA grants fast track designation to Evaxion Biotech’s personalised cancer therapy By PBR Staff Writer In December last year, Evaxion secured the FDA approval to advance with its Phase IIb clinical trial, where EVX-01 is given along with KEYTRUDA to patients with metastatic
Musculoskeletal Disorders January 17, 2023 Bio-Thera Solutions’ BAT1806 receives China NMPA approval By vbandhakavi The tocilizumab injection, BAT1806 is a recombinant humanised monoclonal antibody which has been developed to target interleukin-6 receptor (IL-6R). IL-6R specially binds to soluble and membrane-bound IL-6 receptors
Central Nervous System January 16, 2023 Eisai submits marketing authorization application for AD therapy in Japan By vbandhakavi Lecanemab is intended for the treatment of mild cognitive impairment (MCI) due to AD and mild AD dementia with confirmed amyloid pathology presence in the brain. The application
Infectious Disease January 13, 2023 Daiichi Sankyo seeks marketing approval for mRNA Covid-19 vaccine DS-5670 in Japan By PBR Staff Writer DS-5670 is an mRNA vaccine being developed against the novel coronavirus infectious disease (COVID-19). It is proposed to be used as a booster vaccine to prevent Covid-19. The
Neurology January 12, 2023 Myrtelle, rAAVen Therapeutics announce partnership to develop novel gene therapy vectors By PBR Staff Writer Myelin is an insulating material that allows proper function of neurons. It made of specialised cells of the nervous system called oligodendrocytes. This myelin sheath offers a protective
RegulationApprovals December 28, 2022 US FDA approves Acer’s olpruva to treat urea cycle disorders By PBR Staff Writer Olpruva is a prescription medicine which has been approved as an oral suspension to treat UCD patients with deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic
Drug Manufacturing December 27, 2022 Hikma signs licensing deal with Junshi for toripalimab By PBR Staff Writer Under the deal terms, Hikma will have an exclusive right to develop and market toripalimab injection in all its Middle East and North Africa (MENA) markets. Additionally, the
RegulationApprovals December 26, 2022 Japan’s MHLW approves MediWound’s burn treatment Nexobrid By PBR Staff Writer NexoBrid is indicated to remove eschar in paediatric and adult patients with deep-partial and full-thickness thermal burns without surgery. Japan is claimed to be the world’s first country
Oncology December 23, 2022 Genmab files NDA for large B-cell lymphoma treatment in Japan By vbandhakavi The treatment is intended for such patients who have previously received two or more lines of systemic therapy. The JNDA filing is backed by the multicentre, open-label Phase