Tetra Bio-Pharma Inc. has signed an agreement with Cellvera Global Holdings LLC for the co-development of ARDS-003 (onternabez) as a combination product with Qifenda (favipiravir) 400 mg, a commercial-stage broad-spectrum antiviral drug.
LONDON – New data have arrived to allay concerns about shortages of COVID-19 vaccines disrupting dosing schedules, and also answering the question of whether third – booster – doses will restore waning immunity and be effective against viral variants.
LONDON – The Delta variant of SARS-CoV-2 originally identified in India is causing more serious illness and reducing the effectiveness of vaccines compared to the Alpha (Kent) variant, according to a nationwide study covering Scotland’s whole population of 5.4 million.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Canada invests in variant research; Time needed to develop immunity with Sputnik V.
LONDON – Exevir Bio NV added a further €15 million (US$17.9 million) to close its series A round at €42 million, providing the means to take its nanobody therapy for treating COVID-19 infection through to registration.
As expected, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) looked favorably upon the latest COVID-19 entry: Ad26.COV2.S, a one-shot product that emerged from the same Johnson & Johnson (J&J) platform, AdVac, that let the firm devise an Ebola vaccine cleared in Europe last year.
The EMA issued a guidance Feb. 25 outlining the requirements for manufacturers planning to modify COVID-19 vaccines to address emerging variants of the SARS-CoV-2 coronavirus.
Lexagene Holdings Inc. has successfully configured its Miqlab system to detect the U.K. and South African variants of SARS-CoV-2. The open-access point-of-care system can simultaneously screen for multiple respiratory pathogens and identify COVID-19 strains. Lexagene started studies to support its filing for U.S. FDA emergency use authorization (EUA) in late December 2020. If authorized, it would be the first open-access point-of-care (POC) device to gain an EUA.
LONDON – The EU is taking concerted action to detect new variants of SARS-CoV-2, investing €225 million (US$270 million) to increase viral genome sequencing to 5% of positive cases across Europe, and to carry out research on their evolution and transmissibility.
Governments across the globe are struggling to keep pace with the SARS-CoV-2 virus’s impact on public health, but the new variants are presenting their own challenges. The next task facing governments across the globe is to sequence the latest mutated variants of the virus and keep track of any further mutations, all while validating new and revamped existing tests, a task that is likely to prove difficult to meet for at least the next few months.
