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A conference the neuroscience biotech company Biogen held in a Boston hotel Feb. 26-27 appears to have been a “superspreader event” for COVID-19, ultimately leading to hundreds of thousands of cases, according to a new study. Read More
The World Trade Organization (WTO) has agreed to continue deliberating a proposal made by India and South Africa to temporarily suspend intellectual property (IP) rights protecting COVID-19 therapies and vaccines during the pandemic. Read More
Pharmacies won and pharmacy benefit managers (PBMs) lost when the Supreme Court decided 8-0 Thursday that states can regulate the amounts that PBMs reimburse pharmacies and could, over the long term, help lower drug prices. Read More
COVID-19 patients treated with Eli Lilly’s rheumatoid arthritis drug Olumiant (baricitinib) in combination with Gilead Sciences’ antiviral Veklury (remdesivir) were less likely to die after 28 days than those receiving remdesivir alone, according to peer-reviewed phase 3 trial results published online Friday in the New England Journal of Medicine. Read More
Boehringer Ingelheim (BI) Pharmaceuticals has filed a petition with the FDA arguing that the agency’s use of the word “strength” squelches competition from makers of biosimilars and runs afoul of FDA’s Biologics Price Competition and Innovation Act (BPCIA). The company has asked the FDA to change its interpretation of the word. Read More
President Trump signed a stopgap funding bill Friday that averts a government shutdown until the end of the week and keeps the FDA at its current fiscal 2020 funding levels. Read More
AstraZeneca (AZ) will soon launch a study evaluating a double-dose regimen of its COVID-19 candidate AZD1222 in combination with adenovirus-based vaccine Sputnik V, developed by Russia’s sovereign wealth fund and using the same technology as the AZ vaccine. Read More
Sanofi and GlaxoSmithKline (GSK) have decided to push back the phase 2b trial of their adjuvanted COVID-19 vaccine after finding it produced only a weak immune response in older patients, delaying the potential delivery of a vaccine that could contribute to the mass vaccination effort in the U.S. Read More
The first U.S. COVID-19 vaccinations are to be given today using Pfizer/BioNTech’s vaccine, following the announcement late Friday that the FDA had granted the first emergency clearance for a coronavirus vaccine, a pivotal and unprecedented moment in the battle against the pandemic. Read More
Gilead Sciences has announced plans to purchase German biotech firm MYR GmbH for an estimated $1.4 billion (€1.15 billion), with the potential for additional milestone-based payments of up to $364.3 million (€300 million). Read More
The FDA said Thursday that it has developed a test for COVID-19 in fecal matter, in an attempt to prevent the disease from being inadvertently transmitted during fecal transplantation. Read More