Many respiratory syncytial virus (RSV) disease vaccines are for older adults but Merck & Co. Inc.’s monoclonal antibody, MK-1654 (clesrovimab), which just produced positive top-line phase IIb/III data, aims at a far smaller and younger market. Data for protecting healthy preterm and full-term infants from RSV disease show the double-blind, randomized, placebo-controlled clinical trial hit all its primary efficacy and safety endpoints, including the incidence of RSV-associated medically attended lower respiratory infection for 150 days compared to placebo.
The industry is looking, with renewed hope, to the “promise” of messenger RNA (mRNA) therapeutics for a wide range of diseases beyond COVID-19, and not only in vaccine form but also for gene and cell therapies.
Hillevax Inc. is turning its attention to preventing moderate or severe acute gastroenteritis events (AGEs) in adults with norovirus after the phase IIb NEST-IN1 trial testing virus-like particle-based vaccine HIL-214 in infants missed its primary and secondary endpoints, news that sent shares of the company (NASDAQ:HLVX) plummeting 88% to close July 8 at $1.64, a significant drop from the IPO price of $17 two years ago.
Curevac AG is casting off the deadweight of its pandemic push to translate its mRNA technology into a marketed COVID-19 vaccine, in a new €1.45 billion (US$1.6 billion) deal in which GSK plc will acquire full rights to infectious disease vaccines the two were co-developing.
South Korea’s SK Bioscience Co. Ltd. has entered a cross-shareholding acquisition deal with Germany’s Klocke Pharma-Service GmbH to acquire its contract development and manufacturing organization (CDMO), IDT Biologika Corp.
The African Vaccine Manufacturing Accelerator is up and running, with more than $1 billion already pledged to the effort that’s aimed at supporting the sustainable growth of Africa's manufacturing base and contributing to the African Union's goal of producing 60% of the vaccines required by African countries by 2040.
Becoming the first pneumococcal conjugate vaccine specifically designed for adults 18 and older, Merck & Co. Inc.’s 21-valent candidate, Capvaxive (V-116), gained U.S. FDA approval on its June 17 PDUFA date. The Rahway, N.J.-based company expects to take significant market share based on positive phase III findings from the Stride-3 trial. Analysts have estimated the product could reach $2 billion in annual global sales.
Moderna Inc. is gearing up to meet with regulators on the next steps for mRNA-1083, the first combination vaccine for influenza and COVID-19 to succeed in phase III testing, not only demonstrating noninferiority to individually licensed competitor vaccines but also eliciting statistically significant higher immune responses.
The EMA has been sent back to the drawing board to re-evaluate PTC Therapeutics Inc.’s Duchenne muscular dystrophy therapy Translarna (ataluren), after failing to get the usual rubber stamp following its recommendation in January that the drug’s conditional approval be withdrawn.
Moderna Inc. gained U.S. FDA approval on May 31, nearly three weeks past its original PDUFA date, for its respiratory syncytial virus (RSV) vaccine Mresvia (mRNA-1345), which had both breakthrough therapy and fast track designations in the U.S.
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