It’s been a patchy year for vaccine specialist Valneva SE, in which it saw European orders for its delayed
COVID-19 vaccine dry up but then received a €90.5 million (US$92.1 million) investment from Pfizer Inc. as its Lyme disease vaccine entered phase III. The firm has now hit another setback after the U.S. Department of Defense decided not to take an option for a second year in contract to supply a Japanese encephalitis vaccine, Ixiaro.
Facing the global threat of antimicrobial resistance (AMR), the EMA issued a final revised guideline on the evaluation of new antibiotics. In accordance with an agreement with the U.S. FDA and Japan’s Pharmaceuticals and Medical Devices Agency, the EMA’s guideline aligns as much as possible with the data requirements of those regulators so drug developers can design clinical trials that meet the evidence needs of all three agencies, the EMA said.
Antifungals specialist F2G Ltd. has signed an agreement with Japanese pharma Shionogi & Co. Ltd. for development and commercialization of its treatment for invasive aspergillosis in both Asia and Europe. Under the terms of the deal, F2G is getting $100 million up front and regulatory and commercialization milestones of up to $380 million. The two partners will share clinical development costs.
Beijing Zhifei Lvzhu Biopharmaceutical Co. Ltd. has picked up rights to a whooping cough vaccine candidate from Intravacc B.V. on undisclosed terms. Zhifei Lvzhu gained exclusive rights to develop and commercialize the vaccine in China, as well as nonexclusive rights in Africa, South America, and selected Asian countries. In turn, Intravacc is eligible to receive milestone and up-front payments plus royalties on net sales of the vaccine, should it reach market.
NEC Corp. subsidiary NEC Oncoimmunity AS recently received $4.8 million from the Coalition for Epidemic Preparedness Innovations to fund the development of vaccines for SARS-CoV-2 variants and other betacoronaviruses.
Ark Biopharmaceutical Co. Ltd.’s phase III testing its ziresovir in infants hospitalized with respiratory syncytial virus (RSV) infection produced positive top-line results, meeting both the primary endpoint of reduction in signs and symptoms (S&S) score (p=0.002) and a key secondary endpoint of reduction in viral load (p=0.006) compared with placebo. The company said it is the first oral RSV antiviral to be successful in phase III.
Nuance Pharma Co. Ltd. signed a licensing deal with Denmark’s Bavarian Nordic A/S for rights to its MVA-BN RSV vaccine for respiratory syncytial virus (RSV) in the Chinese mainland, Hong Kong, Macau, Taiwan, South Korea and certain Southeast Asian countries.
China’s NMPA has given a green light for Walvax Biotechnology Co. Ltd.’s human papillomavirus (HPV) bivalent vaccine to be used against HPV types 16 and 18 to prevent cervical cancer.
Researchers at Inserm have developed a method to direct pre-existing antibodies toward new targets. Their bimodular fusion proteins could be a broadly useful method for expanding access to antibody therapy. In a study that appeared in the Feb. 11, 2022, issue of Science Advances, the teams showed that antibodies to Epstein-Barr virus (EBV), which are present in 95% of the global population, could be redirected to a target cell of their choosing by fusing an EBV antigen to a cellular targeting ligand.
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