The U.K. is stepping up its response to the Omicron COVID-19 variant after the country’s regulatory agency approved Xevudy (sotrovimab), the antibody therapy from Glaxosmithkline plc and Vir Biotechnology Inc. At the same time the country placed orders for 114 million more doses of COVID-19 vaccines from Pfizer Inc. and Moderna Inc., for use in 2022 and 2023.
Abogen Biosciences Co. Ltd. has raised $300 million in a series C+ round to support the development of its mRNA products, specifically to support the development of its COVID-19 mRNA vaccine and expand to the global market.
Whether it’s the highly mutated Omicron variant emerging in South Africa as biopharma researchers scramble to create custom-made vaccines in record time or the institutional mandates juxtaposed with waning vaccine immunity and the ongoing ups and downs of cases and deaths, the SARS-CoV-2 virus continues to dig its ugly spikes into an uncertain and anxious world.
Pricing of VBI Vaccines Inc.’s just-approved hepatitis B virus (HBV) vaccine, Prehevbrio, won’t be known before launch in the first quarter of next year, but CEO Jeff Baxter said the company will take into account that the sector is “one of the most price-intensive and price-competitive. A lot of the market-access research says that the wholesale acquisition cost is one of the key determinants” in avoiding sluggish adoption, he said, so that by staying moderate the firm can “supply [its] product on a much quicker basis than you might do, say, if you went with a 30% or 40% premium to standard of care.”
Emergent Biosolutions Inc.’s Bayview facility in Baltimore passed its manufacturing inspection with international regulators, clearing the way for shipment of batches of Johnson & Johnson’s (J&J) COVID-19 vaccine containing drug substance made at the plant.
Former FDA Commissioner Stephen Hahn is being asked to spill the beans on political interference at the U.S. agency during the emergence of COVID-19 last year.
The Coalition for Epidemic Preparedness Innovations (CEPI) has agreed to provide Clover Biopharmaceuticals Ltd. with an additional $36.9 million to support development of SCB-2019, a recombinant trimeric Spike-protein subunit COVID-19 vaccine.
DUBLIN – A meaty licensing deal with Regeneron Pharmaceuticals Inc. is as good a time as any to unveil a new corporate identity. Nykode Therapeutics AS, the Norwegian immunotherapy firm formerly known as Vaccibody, is banking $30 million up front, another $20 million as an equity investment, and could earn up to $875 million more in development and commercial milestones across a multiproduct deal to develop vaccines for cancer and infectious disease.
Pfizer Inc. scored a $5.29 billion deal with the U.S. government to provide 10 million courses of the company’s oral antiviral candidate Paxlovid (PF-07321332; ritonavir) for COVID-19, as Astrazeneca plc and Novavax Inc. also generated news in the space. Paxlovid, if approved or authorized, would be the first oral antiviral of its kind: a 3CL protease inhibitor specifically designed to combat SARS-CoV-2. New York-based Pfizer is seeking emergency use authorization (EUA) from the FDA. Rolling submissions have also commenced in several other countries, and the company continues to build its case for regulatory agencies around the world.
LONDON – Cancer immunotherapy specialist Valo Therapeutics Oy has raised €11 million (US$12.6 million) in an oversubscribed round that will fund the final preparations to move the lead program into the clinic at the start of 2022, and to prepare for an IPO later next year. The phase I will be the first test in humans of Valo’s Pepticrad (peptide-coated conditionally replicating adenovirus technology), which combines two different approaches for which there is there is separate clinical proof: oncolytic adenoviruses and peptide cancer vaccines.
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