Takeda Pharmaceutical Co. Ltd. has voluntarily withdrawn its U.S. BLA for its dengue fever vaccine, Qdenga (TAK-003), following discussions with the FDA centered on “aspects of data collection, which cannot be addressed within the current BLA review cycle,” the company said in a statement.
Moderna Inc. may have risen to prominence during the pandemic with its messenger RNA (mRNA)-based COVID-19 vaccine, but it’s now casting a net far larger and wider. The company said on July 5 that it is readying international approval for its second mRNA vaccine called mRNA-1345 for respiratory syncytial virus (RSV)-associated acute respiratory disease based on positive interim data from the ongoing Conquer RSV study in individuals 60 and older.
In a move to address both prevention and treatment of hepatitis B virus (HBV), Brii Biosciences Ltd. has acquired from VBI Vaccines Inc. a global exclusive license to HBV therapeutic vaccine BRII-179 (VBI-2601) and an exclusive license for HBV prophylactic vaccine Prehevbri in the Asia Pacific region, excluding Japan.
Edding Group Co. Ltd. announced June 23 it filed for an IPO on the Hong Kong Exchange – news that comes amid a steep drop in China’s biopharma IPO market forecasting sluggish activity in a near-frozen “capital winter.”
Shionogi & Co. Ltd.’s U.S. subsidiary Shinogi Inc. will acquire San Diego-based Qpex Biopharma Inc. in a deal worth up to $140 million that expands Shionogi’s pipeline of infectious disease agents and also adds to Brii Biosciences Ltd.’s pipeline.
Nanjing Sanhome Pharmaceutical Co. Ltd.’s Shengnuodi (alfosbuvir tablets), used as part of a combination treatment for hepatitis C, has been approved by China’s National Medical Products Administration (NMPA) through the priority review and approval procedure.
Beijing Luzhu Biotechnology Co. Ltd. raised a net HK$242 million (US$31 million) from an IPO in Hong Kong but shares in the developer of vaccines and therapeutics for infectious diseases, cancer and autoimmune diseases plummeted on the first day of trading. Luzhu’s shares (HK:2480) started trading on May 8 at HK$31.50 and fell about 30% throughout the day to close at HK$22. Founded in 2001, Luzhu has yet to turn a profit. It recorded net losses of ¥725.2 million (US$92 million) in 2022 and ¥539.4 million in 2021.
Immorna Biotechnology Co. Ltd. raised nearly $100 million in series A+ and A++ financing rounds to speed up the clinical development and commercialization of its RNA-based therapeutics. Founded in 2019, Immorna develops therapeutics and vaccines based on its RNA platforms, including conventional, self-replicating and circular RNA.
An international team of researchers has created two bat stem cell lines that reveal an unusual number of viral sequences in bat cells compared with those of other mammals. Writing in an article posted online Feb. 21, 2023, in Cell, the scientists suggested that the unusual amount of viral genetic material found in the bat stem cells could explain why these mammals are largely unaffected by most viral infections, despite being able to transmit them.
Ascletis Pharma Inc. presented subgroup data from a phase II trial showing its subcutaneous PD-L1 antibody envafolimab (ASC-22) was able to functionally cure chronic hepatitis B, according to hepatitis B surface antigen decline following 24-week treatment.
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