Emergent hid quality problems from FDA, House report concludes

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’s Bayview plant in Baltimore.

In particular, the House report concluded that Emergent workers removed quality-assurance “hold” tags from Johnson & Johnson vaccine batches before an FDA inspection.

The Bayview plant had served as the only U.S. manufacturing site for the J&J COVID-19 vaccine.

The report relies on internal communications from Emergent executives to determine whether the company attempted to elude government oversight.

It also noted that the FDA, J&J and AstraZeneca employees identified problems at the …

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FDA OKs AstraZeneca’s Emergent-produced vaccine for export

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 & Johnson’s (J&J) COVID-19 vaccine production.

While Emergent BioSolutions signed an agreement with AstraZeneca to produce that company’s vaccine in July 2020, the Biden administration required Johnson & Johnson to manage the plant after identifying potential contamination. As a result, FDA ultimately required Johnson & Johnson to discard 60 million doses produced at the Emergent plant.

While the Johnson & Johnson vaccine has won emergency use authorization in the U.S., the AstraZeneca vaccine hasn’t.

The AstraZeneca vaccine, however, has found bro…

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Emergent BioSolutions facing a shareholder lawsuits

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 internal policies to prevent any improper securities trading,” Emergent spokesperson Matt Hartwig told The New York Times.

In any event, the past year has not been kind to Emergent BioSolutions, the multinational biopharma company focused on vaccines and antibody therapeutics.

After initially scoring the support of Johnson & Johnson (NYSE:JNJ) and AstraZeneca (LON:AZN) to manufacture their respective COVID-19 vaccines, the company saw its stock leap to a peak value of $133.42 on Aug. 14, 2020.

In afternoon trading today, its stock’s value was $61.87.

The drop in valuation resu…

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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 story at our sister site, Pharmaceutical Processing World.

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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.

In a news release announcing the extension of the shelf life of J&J’s COVID-19 vaccine, the FDA confirmed the allowance of two batches from the Emergent facility (The New York Times reported that those batches total about 10 million doses). However, the FDA mentioned that it “determined several other batches are not suitable for use, but additional batches are still under review,” likely referring to the 60 million or so doses as reported by The New York Times.

This comes as the latest blow to Emergent and J&J after news broke in April that a factory error…

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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

How he came to join the Medtech industry. The potential for its ZIO cardiac monitoring technology How the company is dealing with a disappointing reimbursement How the company will pursue the large asymptomatic market What’s expected to come from the company’s partnership with Verily

We also introduce the newest member of our DeviceTalks Podcast family! Catch an excerpt of the first episode in this week’s podcast. Subscribe to hear future episodes.

Caffeine-fueled Chris Newmarker, executive editor of life sciences at Mass Device, takes a break from earnings week to roll out a powerful #newmark…

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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 had quarantined doses it had in reserve. The FDA will subject those vaccines to further testing before clearing the way for their distribution, explained two head FDA officials, Peter Marks and Janet Woodcock, in a statement.

Get the full story from our sister site, Pharmaceutical Processing World. 

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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 had quarantined doses it had in reserve. The FDA will subject those vaccines to further testing before clearing the way for their distribution, explained two head FDA officials, Peter Marks and Janet Woodcock, in a statement.

It is possible that other batches of vaccine need to be discarded. “There is no assurance that other batches have not been subject to cross-contamination,” the FDA concluded.

“The issuance of findings by the FDA is normal following a facility inspection and provides direction on the necessary steps to improve operations. Emergent is committed to workin…

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Johnson & Johnson COVID-19 vaccine shipments plunge

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 an Emergent BioSolutions plant in Baltimore to produce the vaccine. 

Johnson & Johnson (NYSE:JNJ) announced that it would assume complete control over the production of its COVID-19 vaccine at the facility of Emergent BioSolutions Bayview, which is a contract manufacturing partner of J&J. 

A factory error at the Emergent BioSolutions plant ruined up to 15 million COVID-19 vaccine doses. An additional 62 million doses of the vaccine could be discarded if the company determines they are at risk of contamination. 

FDA has not indicated when it might authorize production lines at the Emergent BioSolu…

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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, which relied on previously undisclosed internal documents and interviews with current and former federal officials and former company workers.

Get the full story on our sister site Pharmaceutical Processing World. 

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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, which relied on previously undisclosed internal documents and interviews with current and former federal officials and former company workers.

Johnson & Johnson (NYSE:JNJ) this week announced that it will assume full responsibility for the production of its COVID-19 vaccine at the Emergent BioSolutions Bayview (Baltimore) facility — news that came days after the disclosure that a factory error resulted in 15 million discarded COVID-19 vaccines.

The New York Times — citing internal logs, a government official and a former company supervisor — claims that contamination or suspect…

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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, Pharmaceutical Processing World.

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