Emergent BioSolutions announced today that it closed a new credit facility agreement with Oak Hill Advisors for a $250 million term loan. Gaithersburg, Maryland-based Emergent, a maker of Narcan nasal spray for opioid overdose reversal, used a portion of the proceeds of the new term loan to repay all amounts outstanding under the senior term…

Emergent BioSolutions says it will donate 50,000 doses of its ACAM2000 smallpox vaccine to help against the mpox outbreak in Africa. According to Emergent, the FDA is presently reviewing a supplemental Biologics License Application (sBLA) to expand ACAM2000’s indication to include mpox immunization. The company expects the FDA to complete its review in the third…

Emergent BioSolutions this week announced it entered into a definitive agreement to sell its Baltimore-Camden drug product facility. The Gaithersburg, Maryland-based company will sell the facility to an affiliate of Bora Pharmaceuticals for approximately $30 million. Emergent’s Camden site is part of the company’s Contract Development and Manufacturing Organization (CDMO) and has clinical and commercial…

A new congressional report concluded that Emergent BioSolutions (NYSE:EBS) attempted to hide evidence related to quality problems before informing the FDA that 15 million COVID-19 vaccines were contaminated. Prepared for Rep. Carolyn Maloney (D-NY) and James E. Clyburn (D-SC), the report from the House and the Select Subcommittee on the Coronavirus Crisis scrutinizes the quality controls in…

Emergent BioSolutions (NYSE:EBS) saw its stock plunge today after the U.S. nixed a contract to manufacture COVID-19 vaccine doses for Johnson & Johnson (NYSE:JNJ). Earlier this year, the company disposed of tens of millions of COVID-19 vaccine doses after identifying a manufacturing error in a Baltimore plant. FDA released a scathing inspection report related to…

After facing months of setbacks concerning its contract production of COVID-19 vaccine, Emergent BioSolutions (NYSE:EBS) is making progress. Most recently, the FDA announced that “certain lots” of AstraZeneca (LON:AZN) COVID-19 vaccine drug substance produced in a facility in Baltimore are acceptable for export. Last week, the FDA gave the company permission to restart Johnson &…

The Baltimore-based company Emergent BioSolutions (NYSE:EBS) is the subject of at least four lawsuits asking for refunds and pushing for change in the company’s executive ranks. Some of the lawsuits targeting Emergent accuse the company of securities fraud and insider trading. Emergent has denied the allegations. “Our executives strictly follow the law and our own…

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.…

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…

Johnson & Johnson will cut COVID-19 vaccine shipments by 86% in the coming week, according to CDC projections. The week of April 5, the company shipped nearly 5 million doses. Next week, that figure could fall to approximately 700,000.  The company anticipates that it can eventually deliver up to 8 million doses weekly, assuming FDA authorizes…