Troubled Vaccine Maker and Its Founder Gave $2 Million in Political Donations

Emergent BioSolutions faces scrutiny in Congress for ruining Covid-19 vaccines and securing lucrative federal contracts. Executives will appear before some lawmakers who benefited from the company’s spending.

#biomedical-advanced-research-and-development-authority, #campaign-finance, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #el-hibri-fuad, #elections-house-of-representatives, #emergent-biosolutions-inc, #factories-and-manufacturing, #government-contracts-and-procurement, #hoyer-steny-h, #johnsonjohnson, #kadlec-robert-p, #kramer-robert-g, #lobbying-and-lobbyists, #maryland, #political-action-committees, #scalise-steve, #united-states-politics-and-government, #vaccination-and-immunization

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How Emergent BioSolutions Put an ‘Extraordinary Burden’ on the U.S.’s Troubled Stockpile

The shortage of lifesaving medical equipment last year was a searing example of the government’s failed coronavirus response. As health workers resorted to wearing trash bags, one Maryland company profited by selling anthrax vaccines to the country’s emergency reserve.

#anthrax, #atlanta-ga, #bernard-kenneth, #biological-and-chemical-warfare, #biomedical-advanced-research-and-development-authority, #bright-rick-a, #coronavirus-2019-ncov, #coronavirus-risks-and-safety-concerns, #drugs-pharmaceuticals, #emergent-biosolutions-inc, #frieden-thomas-r, #hatchett-richard-j, #hoekstra-peter, #kadlec-robert-p, #obama-barack, #stockpiling, #terrorism, #trump-donald-j, #united-states-politics-and-government

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Hospitals Are Still Facing Shortages of Masks and Other Protective Gear

Health care workers are urging the incoming Biden administration to use the Defense Production Act to increase domestic manufacturing of personal protective equipment.

#biomedical-advanced-research-and-development-authority, #coronavirus-2019-ncov, #coronavirus-risks-and-safety-concerns, #defense-production-act, #masks, #protective-clothing-and-gear, #trump-donald-j, #workplace-hazards-and-violations, #your-feed-healthcare

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Coronavirus Vaccine: Early Data Show Moderna’s Version Is 94.5% Effective

Moderna is the second company to report preliminary results from a large trial testing a vaccine. But there are still months to go before it will be widely available to the public.

#biomedical-advanced-research-and-development-authority, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #food-and-drug-administration, #moderna-inc, #national-institute-of-allergy-and-infectious-diseases, #pfizer-inc, #politics-and-government, #research, #rna-ribonucleic-acid, #vaccination-and-immunization, #your-feed-healthcare

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Whistle-Blowing Scientist Quits Government With Final Broadside

Dr. Rick Bright, who said he was demoted at the health department for blowing the whistle on a politicized coronavirus response, remains concerned about White House interference.

#biomedical-advanced-research-and-development-authority, #bright-rick-a, #coronavirus-2019-ncov, #health-and-human-services-department, #masks, #national-institutes-of-health, #tests-medical, #united-states-politics-and-government

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Citrus Flavoring Is Weaponized Against Insect-Borne Diseases

The E.P.A. has approved nootkatone, which is found in cedars and grapefruit. It repels ticks, mosquitoes and other dangerous bugs for hours, but is safe enough to eat.

#biomedical-advanced-research-and-development-authority, #centers-for-disease-control-and-prevention, #chemicals, #deet-insect-repellent, #environmental-protection-agency, #evolva-holding-sa, #foreign-aid, #grapefruit, #insects, #inventions-and-patents, #lyme-disease, #malaria, #mosquitoes, #pesticides, #ticks-insects

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How Novavax Won $1.6 Billion From Operation Warp Speed For Coronavirus Vaccine

Novavax just received the Trump administration’s largest vaccine contract. In the Maryland company’s 33-year history, it has never brought a vaccine to market.

#biomedical-advanced-research-and-development-authority, #bright-rick-a, #clinical-trials, #coronavirus-2019-ncov, #emergent-biosolutions-inc, #factories-and-manufacturing, #gates-bill-and-melinda-foundation, #government-contracts-and-procurement, #hatchett-richard-j, #health-and-human-services-department, #influenza, #kadlec-robert-p, #novavax-inc, #public-private-sector-cooperation, #respiratory-syncytial-virus-rsv, #stocks-and-bonds, #united-states-politics-and-government, #vaccination-and-immunization

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Will We Be Hostages to Drug Makers’ Covid Vaccine Pricing?

The United States is the only developed nation unable to balance cost, efficacy and social good in setting prices.

#biomedical-advanced-research-and-development-authority, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #food-and-drug-administration, #gilead-sciences-inc, #health-insurance-and-managed-care, #inventions-and-patents, #medicare, #national-institutes-of-health, #prices-fares-fees-and-rates, #vaccination-and-immunization

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Coronavirus Attacks the Lungs. A Federal Agency Just Halted Funding for New Lung Treatments.

The shift, quietly disclosed on a government website, highlights how the Trump administration is favoring development of vaccines over treatments for the sickest patients.

#biomedical-advanced-research-and-development-authority, #clinical-trials, #coronavirus-2019-ncov, #dexamethasone-drug, #drugs-pharmaceuticals, #health-and-human-services-department, #lungs, #national-institutes-of-health, #research, #tests-medical, #trump-donald-j, #united-states-politics-and-government, #vaccination-and-immunization, #ventilators-medical, #your-feed-healthcare

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Cue Health raises $100 million to speed development of rapid, portable COVID-19 diagnostics

San Diego-based startup Cue Health has closed a $100 million Series C funding round, including participation from Decheng Capital, Foresite Capital, Madrone Capital Partners, Johnson & Johnson Innovation, ACME Capital and others. The funding will be used to help Cue finish up development, validate and scale production of its Cue Health Monitoring System and test cartridges, including test kits designed to diagnose COVID-19, which are currently being reviewed by the U.S. Food and Drug Administration (FDA) for emergency use authorization.

Cue has been developing its connected, portable lab to provide on-site care including molecular diagnostic tests since its founding a decade ago. The company also secured a $13 million contract in March specifically targeted towards development of a portable point-of-care COVID-19 test. Cue co-founder and CEO Ayub Khattak says that this pandemic has only re-emphasized the need for its product, which is primarily aimed at providing rapid, simple-to-use diagnostics that can be implemented quickly by a wide range of frontline workers in a variety of settings.

Concurrently with its EUA process for the Cue COVID-19 test, the company is also finishing up validation of the results for its influenza A and B tests, which will be used to submit to the agency for final approval of those tests as well. Its tests would provide at-home molecular based testing, with a connected results platform that can immediately provide diagnostics to certified healthcare providers within 20 minutes, unlocking a new level of remote care.

In total, Cue has $30 million in contract from the U.S. HHS’ Biomedical Advanced Research and Development Authority (BARDA) across its efforts both for flu testing and for COVID-19 diagnostics.

#biomedical-advanced-research-and-development-authority, #coronavirus, #covid-19, #cue-health, #flu, #foresite-capital, #funding, #health, #johnson-johnson, #madrone-capital-partners, #san-diego, #science, #tc

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Could Trump Turn a Vaccine Into a Campaign Stunt?

In a desperate search for a boost, he could release a coronavirus vaccine that has not been shown to be safe and effective as an October surprise.

#biomedical-advanced-research-and-development-authority, #bright-rick-a, #clinical-trials, #coronavirus-2019-ncov, #coronavirus-reopenings, #ethics-and-official-misconduct, #hydroxychloroquine-drug, #presidential-election-of-2020, #trump-donald-j, #united-states-politics-and-government, #vaccination-and-immunization

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$1.2 Billion From U.S. to Drugmaker to Pursue Coronavirus Vaccine

The Trump administration announced a grant to AstraZeneca, which has licensed a potential vaccine that is in trials by Oxford University.

#astrazeneca-plc, #biomedical-advanced-research-and-development-authority, #clinical-trials, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #health-and-human-services-department, #research, #vaccination-and-immunization, #your-feed-healthcare

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Trump to Tap New Company to Make Covid-19 Drugs in the U.S.

The Trump administration on Tuesday will announce one of the largest-ever contracts to bring pharmaceutical manufacturing from abroad to a new plant in Virginia.

#biomedical-advanced-research-and-development-authority, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #factories-and-manufacturing, #generic-brands-and-products, #navarro-peter, #richmond-va, #shortages, #trump-donald-j, #united-states-politics-and-government

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Trump Picks Ex-Drug Company Executive to Lead Accelerated Coronavirus Vaccine Effort

The chief operating officer will be an Army general who specializes in logistics.

#biomedical-advanced-research-and-development-authority, #bright-rick-a, #coronavirus-2019-ncov, #glaxosmithkline-plc, #johnsonjohnson, #perna-gustave-f, #slaoui-moncef-m, #trump-donald-j, #vaccination-and-immunization

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Whistle-Blower Exposes Infighting and Animus in Trump’s Coronavirus Response

The allegations suggest personal clashes influenced how the administration responded to the pandemic.

#biomedical-advanced-research-and-development-authority, #bright-rick-a, #coronavirus-2019-ncov, #corruption-institutional, #drugs-pharmaceuticals, #government-contracts-and-procurement, #health-and-human-services-department, #kadlec-robert, #trump-donald-j, #united-states-politics-and-government

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Who is Rick Bright? The Coronavirus Whistle-Blower Who Said The Trump Administration Steered Contracts to Cronies

Rick Bright, the ousted chief of the Biomedical Advanced Research and Development Agency, said he was pressured to steer millions of dollars to the clients of a well-connected consultant.

#biomedical-advanced-research-and-development-authority, #bright-rick-a, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #government-contracts-and-procurement, #health-and-human-services-department, #hydroxychloroquine-drug, #trump-donald-j, #united-states-politics-and-government, #whistle-blowers

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Find a Vaccine. Next: Produce 300 Million Vials of It.

Scaling up the manufacturing of syringes and other medical products required to deliver a vaccine to millions of Americans will be just as important as the vaccine itself.

#biomedical-advanced-research-and-development-authority, #coronavirus-2019-ncov, #epidemics, #factories-and-manufacturing, #federal-emergency-management-agency, #hypodermic-needles-and-syringes, #medical-devices, #medicine-and-health, #shortages, #vaccination-and-immunization, #your-feed-healthcare

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Trump Seeks Push to Speed Coronavirus Vaccine, Despite Safety Concerns

The president wants a coronavirus vaccine widely available by the end of the year, even though his public health experts say it will take at least a year to 18 months.

#azar-alex-m-ii, #biomedical-advanced-research-and-development-authority, #clinical-trials, #coronavirus-2019-ncov, #emergent-biosolutions-inc, #epidemics, #fauci-anthony-s, #food-and-drug-administration, #health-and-human-services-department, #johnsonjohnson, #moderna-inc, #presidential-election-of-2020, #trump-donald-j, #united-states-politics-and-government, #vaccination-and-immunization

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F.D.A. Warns of Heart Problems From Malaria Drugs Used for Coronavirus

The drugs, hydroxychloroquine and chloroquine, have been repeatedly promoted by President Trump. But they should be used only in clinical trials or hospitals, the agency said.

#azithromycin-drug, #biomedical-advanced-research-and-development-authority, #bright-rick-a, #chloroquine-drug, #coronavirus-2019-ncov, #food-and-drug-administration, #hahn-stephen-m-1960, #hydroxychloroquine-drug, #national-institute-of-allergy-and-infectious-diseases, #nature-medicine-journal, #nyu-langone-health, #trump-donald-j, #your-feed-healthcare

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House to Examine Ouster of Health Official Who Doubted Drugs Trump Pushed

The chairwoman of the Energy and Commerce health subcommittee said she planned to hold hearings on Rick Bright’s dismissal as the head of an agency helping to develop a coronavirus vaccine.

#appointments-and-executive-changes, #biomedical-advanced-research-and-development-authority, #bright-rick-a, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #eshoo-anna-g, #health-and-human-services-department, #house-committee-on-energy-and-commerce, #house-of-representatives, #trump-donald-j, #united-states-politics-and-government

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Coronavirus Vaccine Doctor Says He Was Fired Over Doubts on Hydroxychloroquine

Rick Bright was abruptly dismissed this week as the director of the Department of Health and Human Services’ Biomedical Advanced Research and Development Authority.

#biomedical-advanced-research-and-development-authority, #bright-rick-a, #chloroquine-drug, #coronavirus-2019-ncov, #health-and-human-services-department, #hydroxychloroquine-drug, #national-institutes-of-health, #trump-donald-j, #united-states-politics-and-government, #vaccination-and-immunization, #whistle-blowers

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The U.S. Tried to Build a New Fleet of Ventilators. The Mission Failed.

As the coronavirus spreads, the collapse of the project helps explain America’s acute shortage.

#biomedical-advanced-research-and-development-authority, #centers-for-disease-control-and-prevention, #coronavirus-2019-ncov, #covidien-plc, #epidemics, #federal-budget-us, #frieden-thomas-r, #health-and-human-services-department, #medtronic-inc, #newport-medical-instruments, #philips, #shortages, #stockpiling, #united-states, #ventilators-medical

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