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Home » Topics » Regulatory » BARDA

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Capsules in blister packs

U.S. to invest $3.2B in COVID-19 antivirals R&D, manufacturing

June 17, 2021
By Michael Fitzhugh
The U.S. government on June 17 announced plans for a multi-faceted $3.2 billion investment in the development and manufacture of new antivirals for preventing serious COVID-19 illness and death.
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Stratagraft

Mallinckrodt wins FDA nod for regenerative skin therapy for burns

June 16, 2021
By Jennifer Boggs
More than four months after its original PDUFA date of Feb. 2, 2021, Mallinckrodt plc’s Stratagraft gained FDA approval for use in deep partial-thickness thermal burns.
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Product image

Visby lands $12.3M for development of POC and consumer versions of combined rapid influenza/COVID-19 PCR test

Feb. 2, 2021
By Annette Boyle
Visby Medical Inc. secured $12.3 million in funding from the U.S. Biomedical Advanced Research and Development Authority (BARDA) to develop a next generation device to detect influenza and COVID-19 in a single point-of-care rapid PCR test and, subsequently, as an over-the-counter test for consumer use. The contract may be extended up to a total of $48.7 million over a period of 38 months based on meeting certain milestones in the base period, according to Visby Founder and CEO Adam de la Zerda.
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Packaging and kit components

Ellume signs $231M supply agreement with U.S. government for COVID-19 home tests

Feb. 2, 2021
By Tamra Sami
PERTH, Australia –Digital diagnostics company Ellume Ltd. announced a US$231.8 million agreement with the U.S. Department of Defense (DoD), in coordination with the Department of Health and Human Services (HHS), to accelerate domestic U.S. production of its COVID-19 home tests. The agreement includes funding to support the establishment of Ellume’s U.S.-based manufacturing facility and the delivery of 8.5 million COVID-19 home tests that will be distributed across the U.S.
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Decade of ‘Bank of BARDA’ under investigation

Jan. 28, 2021
By Mari Serebrov
For at least the past decade – under both the Obama and Trump administrations, and perhaps even in previous administrations – the U.S. Department of Health and Human Services has been using the “Bank of BARDA” to routinely cover millions of dollars of unrelated spending at the Office of Assistant Secretary for Preparedness and Response, the U.S. Office of Special Counsel said in letters yesterday to President Joe Biden and Congress.
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European Commission headquarters

European Commission president announces plan for EU version of BARDA

Sep. 16, 2020
By Nuala Moran
LONDON – The EU is to set up an equivalent to the U.S. Biomedical Advanced Research and Development Authority (BARDA), after coming under criticism from pharma companies about Europe’s inability to swiftly seal advance purchase agreements for COVID-19 vaccines. The plan was announced on Sept. 16 by European Commission President Ursula von der Leyen, in her first state of the union address since coming into office at the start of 2020. The new agency will support capacity and readiness to respond to cross-border health threats and emergencies, “whether of natural or deliberate origin,” she said.
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Moderna searches for the right participants in its phase III COVID-19 trial

July 27, 2020
By Lee Landenberger
Moderna Inc. dosed the first of what could be as many as 30,000 healthy volunteers Monday morning as it began its phase III COVID-19 vaccine trial.
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U.S. Capitol building

Witnesses at Senate hearing press for annual appropriation for vaccine infrastructure

June 23, 2020
By Mark McCarty
The Senate Health, Education, Labor and Pensions (HELP) Committee met again June 23 to discuss the federal government response to the COVID-19 pandemic, and one clear signal that emerged from the hearing is that Congress will have to provide annual funding to build a sustainable infrastructure for vaccine development and manufacture if the nation is to deal appropriately with the next pandemic.
Read More
Scientist injecting vaccine into Earth

Astrazeneca moving at Warp Speed with $1.2B in BARDA funding for COVID-19 vaccine

May 21, 2020
By Nuala Moran
LONDON – Astrazeneca plc is to get up to $1.2 billion from the new U.S. COVID-19 vaccines program, Operation Warp Speed, to support further development and manufacturing of a vaccine developed at Oxford University’s Jenner Institute. The company said it will begin to ship the product in September 2020, with the U.K. and U.S. first in line for deliveries.
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HHS-industry partnership to ramp up U.S.-based drug manufacturing

May 19, 2020
By Mari Serebrov
Responding to COVID-19’s wakeup call as it exposes the risks of relying heavily on foreign biopharma supply chains, the U.S. Department of Health and Human Services (HHS) signed a four-year, $354 million agreement with a team of private industry partners, led by Phlow Corp., to expand U.S. manufacturing of essential medicines at risk of shortage during the pandemic and in future public health emergencies.
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