Emergent BioSolutions (NSYE:EBS) announced today that it plans to put its over-the-counter Narcan nasal spray on U.S. shelves next month. FDA approved the over-the-counter Narcan spray in May. Approval enabled direct-to-consumer sales in places like drug stores, convenience stores and more. The FDA nod came about six weeks after an agency committee voted unanimously in favor […]
Emergent BioSolutions
FDA committee unanimously votes in favor of over-the-counter Narcan from Emergent BioSolutions
Emergent BioSolutions (NYSE:EBS) announced today that its over-the-counter Narcan (naloxone HCl) nasal spray received unanimous approval from governing bodies. The vote came from the FDA Nonprescription Drugs Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee. A total of 19 voters decided in favor of the benefit-risk profile for Narcan. The voters support […]
J&J must reportedly throw out 60M COVID-19 vaccine doses from Emergent plant
Another large amount of doses of Johnson & Johnson’s COVID-19 vaccine produced at an embattled manufacturing plant reportedly have to be thrown out. The New York Times reported that the FDA told J&J that about 60 million doses of the single-dose vaccine produced at Emergent BioSolutions’ Baltimore plant can’t be used because of possible contamination. Get the full […]
DeviceTalks Weekly Podcast – iRhythm CEO Mike Coyle, New Podcast!
In this podcast, iRhythm CEO Mike Coyle discusses his decision to join the digital health leader in January. Coyle’s had to hit the ground running as iRhythm manages some challenging decisions from regional Medicare payors, but he also sees great opportunity for the company’s Zio platform across the healthcare spectrum. In this conversation, Coyle discusses […]
FDA releases scathing inspection report regarding Emergent BioSolutions plant
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 […]
Emergent has reportedly had serious problems at Baltimore vaccine plant
Emergent BioSolutions was not prepared to take on the mammoth task of churning out millions of COVID-19 vaccine doses to support U.S. efforts to end the pandemic, according to a report published today in The New York Times. Emergent was ill-equipped despite a $163 million federal contract to prepare the facility for high-volume production, according to the Times investigation, […]
Feds put J&J in charge of vaccine production at Emergent plant
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. Get the full story at our sister site, […]
Amid controversy, Biden cancels Emergent Biosolutions visit
The White House scrapped plans to hold a meeting today at a Baltimore-based vaccine plant run by Emergent BioSolutions following an exposé from The New York Times. The Biden administration also announced plans to conduct an audit of the Strategic National Stockpile after the publication of the article, which described how the biopharmaceutical company lobbied […]
How Johnson & Johnson is expanding manufacturing for a potential coronavirus vaccine
Johnson & Johnson (NYSE:JNJ) recently announced that its Janssen Pharmaceutical Cos. will collaborate with Emergent BioSolutions to support the manufacturing of its lead investigational COVID-19 vaccine candidate. The New Brunswick, N.J.–based pharmaceutical and medical device giant described the deal as the first in a series of contract manufacturing agreements that it expects to ink as it seeks […]
