Emergent BioSolutions

[2] It develops vaccines and antibody therapeutics for infectious diseases and opioid overdoses, and it provides medical devices for biodefense purposes.

[15] In June 2012, Emergent, along with Novartis and the Texas A&M University System was selected by the U.S. Department of Health and Human Services as one of the three Centers for Innovation in Advanced Development and Manufacturing.

The public-private partnership granted Emergent $163 million over eight years to assist in the development of countermeasures for health, nuclear and radiological epidemics.

[24] On March 31, 2017, Emergent signed a modification to its contract with BARDA to "manufacture and store bulk drug substance for its botulism antitoxin, BAT."

The contract modification was technical in nature; it allows Emergent to file and deliver the final drug product to the Strategic National Stockpile in the future.

[25] Soligenix Inc. and Emergent agreed to establish a "commercially viable production technology" for the development of RiVax, a potential vaccine aimed to protect against ricin exposure.

[30] In 2018, Emergent acquired Adapt Pharma, the manufacturer of Narcan (naloxone), a widely used nasal spray opioid-overdose antidote, for $735 million.

[40] On April 19, 2021, the United States House Select Oversight Subcommittee on the Coronavirus Crisis announced an investigation into Emergent BioSolutions, requesting documents and testimony from El-Hibri and Kramer regarding "federal contracts since 2015, all communication with Kadlec as well as information on audits and inspections of its facilities, drug pricing and executive compensation.

The share price subsequently fell, and a lawsuit was filed by investors regarding misrepresentation of the size of the U.S. government's order for anthrax vaccine from the company.

[44] Executive compensation documents made public by the House subcommittee show that the company's board praised El-Hibri, who cashed in stock shares and options worth more than $42 million in 2020.

[49] Following a study by scientists from the Centers for Disease Control and Prevention,[50] on December 19, 2008, Emergent received final FDA licensing for use of BioThrax five doses for intramuscular injection.

Following lobbying from Emergent BioSolutions, VaxGen's contract was cancelled in 2006 due to "poor performance", and development of their anthrax vaccine stopped.

Additionally, the Biomedical Advanced Research and Development Authority (BARDA) released a notice of intent to purchase around $100 million of BioThrax for the SNS in 2017.

[62] A company facilities in Canton, Massachusetts was cited by the FDA in 2017 for failing to eliminate low levels of mold and yeast detected in the plant.

[63] The New York Times reported in March 2021 that the US government had spent nearly a quarter of a billion dollars annually, nearly half of its budget to maintain the Strategic National Stockpile, to purchase BioThrax from Emergent during the preceding decade.

[65] In 2012, concerned about inconsistency of dosage, along with the need for a responder having some specialized training in making the naloxone injection in a tense, highly- charged emergency environment, Phil Skolnick, then director of the Division of Therapeutics & Medical Consequences at the National Institute on Drug Abuse and Roger Crystal, the chief executive officer of Lightlake Therapeutics (now Opiant Pharmaceuticals), teamed to develop an intranasal version of the drug.

[71][72] However, the plant experienced multiple production issues, and audits in 2020 from several institutions, including internal audits from Emergent, as well as external ones from AstraZeneca, Johnson & Johnson, and U.S. federal government agencies identified issues with deficiencies in employee training, cross-contamination, improper disinfection, and inadequate testing of raw materials.

The FDA cleared a total of 25 million vaccine doses for domestic and international distribution, but with a warning to recipients that "regulators cannot guarantee that Emergent BioSolutions ... followed good manufacturing practices.

"[76][78] In July 2021 the US Food and Drug Administration (FDA) authorized the company's Baltimore plant to restart the manufacturing of J&J Janssen one-dose vaccines, based upon "current observations of the implemented corrective actions".

Emergent petitioned the federal government's Biomedical Advanced Research and Development Authority (BARDA) to be chosen for the project,[85] and was selected to produce the vaccine in one of its Maryland facilities.

[87] The company has been developing a vaccine to counter chikungunya, a mosquito-borne virus that was mostly found, until the past decade, only in central and East Africa.

[89] In 2018 the FDA conferred its "Fast Track" designation on the company's investigational chikungunya virus virus-like particle (CHIKV VLP) vaccine candidate.

[91] In May 2021, the company reported that its single-dose vaccine demonstrated strong efficacy two years after injection, with an increase in immune response when measured by serum neutralizing antibodies (SNA).

The product, used internationally, was tested in a study conducted by the US Army Medical Research Institute of Chemical Defense, where RSDL was found to provide superior protection against soman when decontamination was commenced within three minutes of exposure.

[96] The company joined forces with New York City's Mount Sinai Health System and ImmunoTek Bio Centers (New Orleans LA) to research, develop, conduct clinical trials, and manufacture COVID-HIG, hyperimmune globulin, also known as polyclonal antibodies, a concentrated antibody made from plasma acquired from individuals infected with and recovered from COVID-19.

With the focus of healthcare resources extended to quell the coronavirus emergency, more substance abuse users found it difficult to obtain treatment and medication.

The campaign, called Reverse the Silence, provides an unbranded website and national television and radio commercials focused on diminishing the ignominy of opioid addiction and overdose.

Program participants include former Congresswoman Mary Bono, NFL star Darren Waller and four addiction advocacy groups.

The campaign's website is not tied to Narcan specifically but offers a plethora of naloxone resources and information on how the drug works and where to obtain it.

[102] Emergent Biosolutions PAC donated tens of thousands of dollars in 2020 to both Republicans and Democrats from Joe Biden and Dick Durbin to Andy Harris and Mitch McConnell.