Takeda (NYSE:TAK) has announced that it has won manufacturing and marketing approval from the Japan Ministry of Health, Labour and Welfare (MHLW) for Nuvaxovid, a novel COVID-19 vaccine. Nuvaxovid (NVX-CoV2373) was initially developed by Novavax (Nasdaq:NVAX). The approval covers the use of the vaccine as both a primary and booster immunization in adults at least […]
COVID-19
Moderna says bivalent COVID-19 boosters could offer more robust protection against variants
Moderna (Nasdaq:MRNA) announced that its first bivalent booster vaccine candidate, mRNA-1273.211, offered superior protection against SARS-CoV-2 variants of concern compared with its first-gen mRNA-1273 vaccine. A 50-µg booster of the mRNA-1273.211 vaccine offered protection against the beta, delta and omicron variants for six months and appeared to provide similar tolerability to the FDA-approved mRNA-1273 vaccine. […]
Johnson & Johnson rises on mixed bag Q1, increased 2022 guidance
Johnson & Johnson (NYSE:JNJ) shares ticked up today on first-quarter results that were mixed compared to the consensus forecast. The New Brunswick, New Jersey-based company posted profits of $5.1 billion, or $1.93 per share, on sales of $23.4 billion in the first quarter for a 16.9% bottom-line slide on sales growth of nearly 5%. Adjusted […]
FDA grants EUA for breathalyzer that detects COVID-19
The FDA has authorized the first COVID-19 diagnostic test that detects chemicals associated with an infection in a person’s breath. The company’s maker InspectIR (Frisco, Texas) expects to manufacture roughly 100 instruments per week, the FDA said in an announcement posted yesterday. The devices can each evaluate roughly 160 samples per day. Someone taking the […]
How medtech is tackling supply chain challenges
Join us at DeviceTalks Boston on May 10-11 to hear how medical device companies are propping open supply lines and ensuring a steady flow of products to customers in a constantly changing world. Sharing best practices is more important than ever because supply chain challenges aren’t expected to diminish post-pandemic. That’s because superstorms, fires, droughts and other extreme […]
Cue Health, Major League Baseball partner on COVID-19 testing
Cue Health (Nasdaq:HLTH) and Major League Baseball (MLB) announced today that will expand on league-wide COVID-19 testing. Under a national partnership, Cue Health — MLB’s trusted at-home testing solution — will provide MLB clubs as well as the league office with its integrated care platform that includes the portable and reusable Cue Health monitoring system […]
Visby Medical triggers $25.5M contract option with BARDA to develop at-home COVID-19/flu test
Visby Medical announced today that it picked up $25.5 million in government funding to develop an at-home flu/COVID-19 diagnostic. San Jose, California-based Visby executed an option in a contract from the Biomedical Advanced Research and Development Authority (BARDA) on the additional $25.5 million for the development and validation of the at-home combination test. The incremental […]
Medtronic survey says pandemic has negatively impacted those with chronic back and leg pain
Medtronic (NYSE:MDT) today released data from a survey demonstrating several struggles for those with chronic pain during the COVID-19 pandemic. The survey, commissioned by Medtronic and conducted by public opinion research firm The Harris Poll, found that 44% of current chronic back and leg pain sufferers experienced care delays during the COVID-19 pandemic despite 87% […]
Vaxxas licenses COVID-19 vaccine for patch delivery system, expects to finish Phase 1 trial this year
Vaxxas announced today that it was granted an exclusive license for a next-generation COVID-19 vaccine to be used with its delivery patch. Cambridge, Massachusetts-based Vaxxas received the license from The University of Texas at Austin for its HexaPro SARS-CoV-2 spike subunit vaccine. Get the full story at our sister site, Drug Delivery Business News.
FDA advisory panel to convene to consider second booster dose
The Vaccines and Related Biological Products Advisory Committee (VRBPAC) is scheduled to meet on April 6 to discuss the potential use of COVID-19 vaccine booster does. Both Pfizer (NYSE:PFE) and Moderna (Nasdaq:MRNA) are seeking to amend the emergency use authorization of their respective vaccines to allow for an additional booster. Pfizer and its partner BioNTech SE (Nasdaq:BNTX) […]
Engineered yeast could be a key for more affordable COVID-19 vaccines
Researchers at MIT and Beth Israel Deaconess Medical Center are exploring a yeast-based alternative to RNA vaccines. A new paper highlights a vaccine, which comprises fragments of the SARS-CoV-2 spike protein arrayed on a virus-like particle, that reportedly elicited a strong immune response and protected animals against viral challenge, according to a post on MIT’s […]