Regulatory

Canada’s National Advisory Council on Immunization (NACI) has recommended that Canadians wait to receive the messenger RNA (mRNA) vaccines from Moderna (NSDQ:MRNA) and Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) when feasible. The advice stands in contrast to prior guidance that Canadians seek the first-available vaccines. “What we’re saying and what we’ve said all along is that mRNA vaccines are the…

FDA has sent its first notice of noncompliance to Acceleron Pharma (NSDQ:XLRN), accusing the company of failing to submit summary results information to ClinicalTrials.gov for a Phase 2 trial. The agency sent the company a letter warning of potential noncompliance in July 2020. The National Library of Medicine, a part of the National Institutes of Health, operates the…

Biogen (NASDAQ: BIIB) posted first-quarter results that beat the Wall Street consensus forecast, with the company raising its 2021 earnings guidance. However, Biogen’s outlook for the rest of the year largely hinges on FDA decisions regarding its pipeline drugs aducanumab and zuranolone. The Cambridge, Mass.-based biotech earned $410 million, or $2.69 per share, off sales…

An FDA report cites multiple failures in an Emergent BioSolutions plant tapped to produce vaccines for Johnson & Johnson and AstraZeneca. The vaccine plant had been forced to discard up to 15 million doses of Johnson & Johnson’s COVID-19 vaccine in a single manufacturing batch. Emergent BioSolutions recently paused production of the vaccine during the FDA inspection and…

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.…