LONDON – There’s mixed news about emerging variants of SARS-CoV-2, with Pfizer Inc. and Biontech SE reporting their vaccine Comirnaty maintains its protective effect against B 1.1.7, first detected in the U.K., while researchers in South Africa say virus variant 501Y.V2 is able to escape neutralization by both monoclonal antibodies and convalescent plasma from previously infected individuals. Read More
Vericiguat became the first oral soluble guanylate cyclase stimulator to win FDA approval for use in heart failure patients. The drug, branded Verquvo, was developed by Merck & Co. Inc. as part of a $1 billion deal with Bayer AG. But its commercial potential could be hampered by its modest clinical efficacy and increasing competition in the space, as well as difficulties launching a new drug during a pandemic. Read More
When it comes to leveling the playing field for foreign-based biopharma and medical device companies, China has made a lot of promises, but delivering on those promises is what matters. Throughout its annual assessment for Congress of China’s commitment to World Trade Organization principles, the U.S. Trade Representative (USTR) noted the many promises China has made over the years that have yet to be kept. Read More
The frenetic and record pace of biopharmas filing for IPOs in the U.S. continues as five more companies filed SEC paperwork, looking for gross proceeds totaling $356 million. In 2020, 106 new offerings were completed and raised $22.5 billion, which was more than double the previous record of $10.7 billion set in 2018. The race is on for a new record in 2021. Read More
It was a turbulent year for publicly traded biopharmaceutical companies, but after a lackluster first quarter that saw biopharma equities plunge dramatically, particularly at the beginning of March, there was a gradual recovery over the final three quarters of the year. In order to determine just how well the sector performed on the capital markets, BioWorld examined the fortunes of 516 U.S. biopharma and related stocks. Read More
Researchers at the National Institute of Allergy and Infectious Diseases have shown that optimal control of tuberculosis (TB) infection necessitated immune regulation as well as immune activation – and that PD-1 checkpoint blockers exacerbated TB infections in macaque monkeys by disrupting the balance between the two. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alkermes, Apnimed, Eloxx, Evelo, Faron, Forma, Jemincare, Ocular, Ocuphire, Seneca, Sumitomo, Dainippon, Synairgen, Theralase, Tris. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adamis, Aptorum, Arcutis, Astrazeneca, Biocelect, BMS, Daiichi, Eutilex, Haisco, Histogen, Impel, Lytix, Merck, Novo Nordisk, Sobi, Taysha, Terns. Read More
