RegulationDrug Filing December 29, 2022 US FDA accepts BLA for Pfizer’s meningococcal vaccine candidate By PBR Staff Writer The company submitted the vaccine candidate to prevent meningococcal disease, which is caused by the most common serogroups, in individuals aged 10 to 25 years. MenABCWY combines the
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
Neurology December 22, 2022 Vistagen agrees to acquire Pherin Pharmaceuticals By vbandhakavi Under the deal, Vistagen will offer nearly 12.4 million shares of the company’s common stock as well as a nominal cash payment. Pherin works on discovering and developing
Oncology December 21, 2022 Kite signs agreement to acquire biotech company Tmunity Therapeutics By vbandhakavi Kite will purchase all outstanding shares of Tmunity other than those the company already owns. The acquisition complements the existing in-house cell therapy research capabilities of Kite with
Gastric Cancer December 20, 2022 Daiichi Sankyo and AstraZeneca’s ENHERTU gets approval in EU By PBR Staff Writer ENHERTU is a particularly engineered HER2 directed antibody drug conjugate (ADC) being jointly developed and commercialised by the two firms. Around 136,000 cases of gastric cancer are diagnosed
Drug DiscoveryResearch & Development December 19, 2022 Alchemab, MDC receive grant to develop Huntington’s disease therapy By PBR Staff Writer Innovate UK awarded the grant as part of its Biomedical Catalyst 2022 research and development (R&D) competition. Alchemab is currently undertaking the preclinical studies to progress its antibodies
Drug DiscoveryResearch & Development December 16, 2022 Gilgamesh raises funds to advance treatments for mental health By PBR Staff Writer The company has also received additional funding from JLS Fund, Gron Ventures, Alumni Ventures, Palo Santo, Satori Capital, Negev Capital, and Route 66. It intends to use the