An antibody that protects babies against respiratory syncytial virus (RSV) from Astrazeneca Ltd. and Sanofi SA was among a string of recommendations from the EMA’s Committee for Medicinal Products for Human Use, paving the way for approval within the next few months and a potential launch in 2023.
After raising AU$2.2 million in its series A round, University of Western Australia spinout Lixa Pty Ltd. has emerged from stealth mode and is gearing up for clinical trials of its anti-biofilm platform technology that could preserve antibiotics in the fight against antimicrobial resistance.
Takeda Pharmaceutical Co. Ltd.’s dengue fever vaccine, Qdenga, was approved in Indonesia Aug. 23, making it the first global approval for the tetravalent vaccine. The approval marks Takeda’s first marketed vaccine outside of Japan. Indonesia’s National Agency for Drug and Food Control approved the vaccine for prevention of dengue disease caused by any serotype in individuals 6 years to 45 years of age.
The Project to Accelerate New Treatments for Tuberculosis is progressing two investigational tuberculosis combination treatment regimens into phase II trials under a joint development agreement.
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.
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