Regulatory

The third vaccine to win emergency use authorization in the U.S. could reappear after a 10-day pause, according to Dr. Anthony Fauci, the nation’s top disease expert. FDA and CDC had recommended temporarily suspending the use of the Johnson & Johnson (NYSE:JNJ) vaccine after six women developed serious blood clots within weeks of vaccination. Fauci…

The European Union has decided to exercise an option to purchase additional doses of the Comirnaty COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX).  The two companies will deliver 600 million doses of the vaccine to the EU in 2021.  The Continent’s mass-vaccination efforts have sputtered for much of early 2021, given supply constraints related…

Eli Lilly (NYSE:LLY) announced that it had amended purchase agreements with the U.S. government to prioritize using two monoclonal antibodies — bamlanivimab and etesevimab — in tandem. In March, the U.S. government announced that it would stop using bamlanivimab alone, given its reduced efficacy against some SARS-CoV-2 variants. But pairing anti-SARS-CoV-2 monoclonal antibodies together can offer more…

Johnson & Johnson (NYSE:JNJ) announced that it assumed full responsibility for the production of its COVID-19 vaccine at the Emergent BioSolutions Bayview (Baltimore) facility. The company’s announcement comes days after news broke that a factory error made at that facility resulted in 15 million discarded COVID-19 vaccines. New Brunswick, N.J.–based J&J’s single-dose vaccine was authorized…

A former FDA inspector accused the agency of downplaying safety problems at a Merck plant tapped to manufacture Johnson & Johnson’s COVID-19 vaccine.  The whistleblower alleged that a 2018 inspection uncovered evidence that employees in the facility in Durham, N.C. engaged in a host of unsanitary practices. A letter to President Biden from the U.S.…

The spread of SARS-CoV-2 variants has convinced the U.S. government to stop using Lilly’s COVID-19 monoclonal antibody therapy bamlanivimab when used alone. The U.S. government will continue using bamlanivimab when paired with etesevimab, another monoclonal antibody. The government pointed to the rising number of SARS-CoV-2 variants across the country as the reasoning behind the decision.…

The World Health Organization endorsed the AstraZeneca COVID-19 vaccine after several European countries have halted its use over potential safety risks. AstraZeneca has observed 15 deep vein thrombosis (DVT) reports and 22 pulmonary embolism (PE) cases out of 17 million vaccine recipients in the E.U. and U.K. as of March 8. Based on that data,…

Sotera Health (NASDAQ:SHC) recently announced that it has acquired Bozeman, Mont.–based BioScience Laboratories in a deal that will expand the U.S.-based antimicrobial and antiviral testing capabilities of Sotera Health’s Nelson Labs business. The financial terms of the deal were not disclosed in the March 10 announcement. BioScience Laboratories provides topical antimicrobial product testing in the…

The market for injectable anti-HIV therapeutics will be worth $28 billion by 2029, according to projections from the analyst and consulting firm GlobalData. GlobalData valued the broader HIV therapeutics market at $22.9 billion in 2019 across the U.S., France, Germany, Italy, Spain, U.K. and Japan. While the overall market is growing at a low single-digit…

Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) have submitted data to FDA indicating that their vaccine is stable at –25° C to –15°C. Currently, the vaccine can be stored in an ultra-cold freezer between –80° C and –60° C, according to current CDC guidelines. Updating the companies’ emergency use authorization prescribing information would be simplify logistics. It would…