New data on the COVID-19 antibody therapy Ronapreve (casirivimab + imdevimab), already used to treat non-hospitalized patients in multiple countries, could potentially support expanding its use to certain recently hospitalized patients with the disease.
While much of the global pandemic response has focused on vaccines, the World Health Organization is now calling on drug manufacturers to ramp up their supply and donations of monoclonal antibodies used to treat COVID-19 infections.
Biogen Inc. and Samsung Bioepis Co. Ltd. gained FDA clearance for Byooviz (ranibizumab-nuna), a biosimilar that references the VEGF therapy Lucentis (ranibizumab) from Roche Holding AG, as a treatment for wet age-related macular degeneration, macular edema following retinal vein occlusion and myopic choroidal neovascularization. Byooviz is the first ophthalmology biosimilar to win the go-ahead in the U.S., and was approved in the EU on Aug. 18, 2021, followed by the U.K. on Aug. 31, 2021.
A new deal between Adaptimmune Therapeutics plc and Roche Holding AG's Genentech Inc. aims to develop allogeneic cell therapies for up to five shared cancer targets. Should the agreement win regulatory clearance, still pending, Adaptimmune will receive $150 million up front and additional payments of $150 million over five years. In addition, it could be eligible for development, regulatory and commercial milestones payments from Roche exceeding $3 billion, plus royalties.
DUBLIN – AC Immune SA and partner Genentech reported Aug. 31 that their Tau-targeting antibody, semorinemab, brought about a dramatic 43.6% reduction in cognitive decline vs. baseline in a phase II trial in patients with mild to moderate Alzheimer’s disease. The effect was statistically significant (p<0.0025) and is clinically meaningful. Indeed, it represents the biggest single treatment effect ever reported in a clinical trial in this population of Alzheimer’s patients and sets the stage for an extensive phase III program that could set the agenda for Alzheimer’s research for the foreseeable future.
In one of the biggest collaboration deals of the year, Shape Therapeutics Inc. entered a collaboration and license agreement with Roche Holding AG to develop gene therapies for targets in areas that include Alzheimer’s disease, Parkinson’s disease and rare diseases. Seattle-based Shape is eligible to receive an initial payment, development, regulatory and sales milestone payments that could exceed $3 billion in aggregate value.
Astrazeneca plc, en route to potentially delivering a new protection against COVID-19 for people inadequately protected by or unable to be vaccinated, has cleared a crucial hurdle with its long-acting combination therapy, AZD-7442, which met the goals of a phase III pre-exposure prophylaxis trial. The U.K.-based pharma’s readout arrived just as Regeneron Pharmaceuticals Inc. announced the MHRA’s conditional marketing authorization for its Roche Holding AG-partnered COVID-19 antibody therapy Ronapreve (casirivimab + imdevimab), also known as REGEN-COV.
PERTH, Australia – As the Delta variant of SARS-CoV-2 sweeps across the globe, drugs like Roche Holding AG’s interleukin-6 receptor inhibitor Actemra (tocilizumab) are being used, often off-label, to treat serious cases of COVID-19. That usage, however, is resulting in serious drug shortages that may leave some without treatment options.
LONDON – Hemab ApS has closed a $55 million series A to take forward treatments for bleeding and thrombosis disorders based on antibodies in-licensed from Novo Nordisk A/S, where the newco’s founder, Johan Henrik Faber, previously led hemophilia drug research.
Japan’s Ministry of Health, Labour and Welfare approved the Regen-Cov (casirivimab/imdevimab, also known as Ronapreve) antibody cocktail for the treatment of patients with mild to moderate COVID-19 via intravenous infusion.
