Moderna Inc. blamed a switcheroo by the U.S. FDA for the refusal-to-file (RTF) letter on the seasonal influenza vaccine mRNA-1010. Shares of the firm (NASDAQ:MRNA) closed Feb. 11 at $40.51, down $1.49, having traded as low as $36.66 as investors learned of the RTF letter, which Moderna said is “inconsistent with feedback” the company was given by regulators during pre-phase III as well as pre-BLA-submission talks.
Zhejiang Difference Biological Technology Co. Ltd. (Diff Biotech)’s proprietary nasal spray influenza attenuated live vaccine, DIFF-flu, has received clinical trial approval from China’s National Medical Products Administration (NMPA).
BioWorld’s 2022 end-of-year highlights included a toast to the future – of universal vaccines. Even before SARS-CoV-2 vaccines were developed in record time and saved countless lives during the COVID-19 pandemic, vaccines were a rare bright spot in the fight against infectious diseases. Bacteria are becoming multidrug resistant far faster than new classes of antibiotics are being developed, viral spillover events and vector ranges are increasing, and climate change is helping bacteria and fungi alike breach human thermal protections against infections.
CSPC Pharmaceutical Group Ltd. has obtained clinical trial approval from China’s National Medical Products Administration (NMPA) for SYH-2085 tablets for the treatment of uncomplicated influenza A and B in adults and adolescents age 12 years and older.
NIH researchers report that in severe influenza, survival improves at late stages only when antivirals are combined with therapies that repair lung damage or limit harmful T-cell responses, explaining why anti-inflammatory treatments alone are often ineffective.
NIH researchers report that in severe influenza, survival improves at late stages only when antivirals are combined with therapies that repair lung damage or limit harmful T-cell responses, explaining why anti-inflammatory treatments alone are often ineffective.
Merck & Co. Inc. is buying Cidara Therapeutics Inc. for $9.2 billion to acquire a late-stage flu candidate and also to outrace blockbuster Keytruda’s looming patent expiration. CD-388, Cidara’s lead candidate, is in a phase III study of adolescents and adults for preventing influenza A and B in those who are at a high risk of developing complications.
Ena Respiratory Pty Ltd. raised an AU$34 million (US$22.4 million) series B round to advance INNA-051, its nasal spray for symptomatic viral respiratory infections, to phase II trials. New investors in the Melbourne-headquartered company include the Gates Foundation and Flu Lab. Existing investors Brandon Capital, Uniseed and Stoic Venture Capital also participated in the round.
Ena Respiratory Pty Ltd. raised an AU$34 million (US$22.4 million) series B round to advance INNA-051, its nasal spray for symptomatic viral respiratory infections, to phase II trials. New investors in the Melbourne-headquartered company include the Gates Foundation and Flu Lab. Existing investors Brandon Capital, Uniseed and Stoic Venture Capital also participated in the round.
CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co. Ltd. has synthesized prodrugs of deuterated baloxavir marboxil derivatives acting as cap-dependent endonuclease (CEN) (influenza virus) inhibitors reported to be useful for the treatment of influenza viral infections.