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Remdesivir Manufacturer

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Last Updated: 02 July 2021

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General | Latest Info

Pfizer has agreed to manufacture and supply Gilead Sciences antiviral drug Remdesivir, pharmaceutical giant announced Friday. The multiyear agreement will support efforts to scale up the supply of intravenous Drug, which has been shown to help shorten recovery time of some hospitalized coronavirus patients, company say. Pfizer will manufacture the drug at its McPherson, Kansas, facility. From the beginning, it was clear that no one company or innovation would be able to bring an end to the COVID - 19 crisis. Pfizer's agreement with Gilead is an excellent example of members of the innovation ecosystem working together to deliver medical solutions, Pfizer CEO Albert Bourla said in a statement. Together, we are more powerful than alone. There are no FDA - approved drugs for the coronavirus, which has infected more than 19 million people worldwide and killed at least 715 163 in about seven months, according to data compiled by Johns Hopkins University. But doctors have been using Remdesivir on COVID - 19 patients in recent months. In May, Food and Drug Administration granted Remdesivir emergency use authorization, allowing hospitals and doctors to use the drug to hospitalize COVID - 19 patients even though medication has not been formally approved by the agency. Pfizer declined to comment, saying it does not disclose agreement terms. Gilead did not immediately respond to a request for comment. A day earlier, Gilead said it would be able to make enough of its antiviral drug Remdesivir to meet global demand due to pandemic in October. Additionally, Gilead says it plans to produce more than 2 million treatment courses of drug by the end of the year and anticipates being able to make several million more in 2021, adding it has increased the supply of drugs more than fiftyfold since January. Its manufacturing network now includes more than 40 companies in North America, Europe and Asia. The Department of Health and Human Services announced a June 29 deal that gives the US more than 500 000 treatment courses of antiviral Drug for US hospitals through September. That represents 100% of Gilead's project production for July and 90% of production for August and September, according to the agency. The deal comes as Pfizer continues its effort to produce a potential vaccine for coronavirus. Last week, company said it beginning a late - stage trial that will include about 30 000 participants. If it is successful, Pfizer and its vaccine development partner BioNTech expect to submit it for final regulatory review as early as October. They plan to supply up to 100 million doses by the end of 2020 and approximately 1. 3 billion doses by the end of 2021.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Manufacturing Process

Drug manufacturing today is like a bucket brigade, explains Princeton University chemist Paul Reider, who previously held chemistry leadership positions at Amgen and Merck & Co. One supplier sends raw materials to another, which uses those basic chemicals to do the first step in synthesis of moleculesay, creating a simple side chain. The result get passed on to another company in the brigade, which performs the next step, and so on. Two or more of those bucket lines might converge to put together now - complex pieces into final molecule. The efficiency of brigade varies from drug to drug. One variable is the complexity of molecule. Antimalarial hydrochloroquine, also being tested in COVID - 19, is at the easy end of the spectrum. Making it in large quantities, if need arises, will require little more than high - quality manufacturing capacity. Remdesivir, with its six chiral centers, is a medium - complexity project, said Ian Davies, director of internal and external scientific relationships for Princeton Catalysis Initiative. But beyond the molecule itself, ease of scale - up has much to do with company manufacturing design philosophy, Davies notes. While all firms design safe route, most companies approach this on sufficiency, rather than efficiency, said Davies, who previously led Merck & Co. S process chemistry group. They estimate drugs market size and likely price tag, and weigh that against how much manufacturing active ingredient will cost. If margins look good enough, many companies will invest in making the process more efficient, he say. And when it comes to remdesivir, experts say Gilead might not have been incline, or even had time, to make the process as efficient as it could be. Gilead developed a compound during the 2014 Ebola virus outbreak in West Africa and speeded it along with the goal of testing it before the outbreak wan. Process likely reflects anticipated demand for Ebola treatment: 2014 Ebola outbreak saw 29 000 cases over 2. 5 years; current coronavirus pandemic is approaching 2. 5 million cases in under 5 months. In public communication in early April, CEO Daniel ODay outlined a series of measures Gilead was taking to increase access to remdesivir. At the time, company said it had on hand enough active ingredients to create about 1. 5 million doses, enough for roughly 140 000 treatment courses, based on a 10 - day regimen. The company has been working to increase both internal capacity and external partnerships to generate an additional 500 000 courses by October, 1 million courses by the end of year, and, if needed, several million courses in 2021. Indeed, David LaPre, who leads the team at Roche that is scaling up Tamiflu production, says the first question for companies with promising COVID - 19 treatments is how many doses they will need. There were lot of debates as to what is right number, is and I am sure that problem people are facing today as they think about antivirals as weapon in our arsenal against COVID - 19, says LePre, who is now a pharmaceutical consultant.

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* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Current and Projected Supply

On Monday, Department of Health and Human Services announced an agreement to secure large supplies of drug remdesivir for the United States from Gilead Sciences through September, allowing American hospitals to purchase drugs in amounts allocated by HHS and state Health departments. President Trump has struck an amazing deal to ensure Americans have access to the first authorized therapeutic for COVID - 19, said HHS Secretary Alex Azar. To the extent possible, we want to ensure that any American patient who needs remdesivir can get it. The Trump Administration is doing everything in our power to learn more about life - saving therapeutics for COVID - 19 and secure access to these options for the American people. Hhs has secured more than 500 000 treatment courses of drug for American hospitals through September. This represents 100 percent of Gileads project production for July, 90 percent of production in August, and 90 percent of production in September, in addition to allocation for clinical trials. Treatment course of remdesivir is, on average, 6. 25 vials. Hospitals will receive product shipped by AmerisourceBergen and will pay no more than Gileads Wholesale Acquisition Price, which amounts to approximately $3 200 per treatment course. Generally, patients do not pay directly for hospital - administered drugs like remdesivir; rather, for Medicare and most private insurers, drugs cost is incorporated into payments made by insurer,s such as Medicare paying for drugs through diagnostic - relate group. These supplies will be allocated in the same way that Gileads donation of approximately 120 000 treatment courses of remdesivir were allocate: HHS allocates products to state and territorial health departments based on COVID - 19 hospital burden, and Health departments allocate it to hospitals. Delivery of purchase remdesivir will be streamline, going directly to hospital, per States allocation decision, rather than going first to state health departments for subsequent delivery to hospitals. Shipments will likely occur every two weeks, as they have with donated product.S Final allocation of Gileads approximately 120 000 donate treatment courses is being shipped today, June 29.

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* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

About Veklury (remdesivir)

Veklury is an investigational nucleotide analog invented by Gilead, building on more than a decade of companys Antiviral Research. Veklury has broad - spectrum Antiviral Activity both in vitro and in vivo in animal Models against multiple emerging viral pathogens, including Ebola, SARS, Marburg, MERS and SARS - CoV - 2, virus that causes COVID - 19. Multiple ongoing international Phase 3 Clinical trials are evaluating the Safety and Efficacy of Veklury for Treatment of COVID - 19. Base on available data from these studies, Veklury has been approved or authorized for temporary use as COVID - 19 Treatment in approximately 50 countries worldwide. Additional ongoing international clinical trials continue to further evaluate the safety and efficacy of Veklury in different patient populations and formulations, and in combination with other therapies. In the US, US Food and Drug Administration granted Veklury Emergency Use Authorization for Treatment of hospitalized Patients With COVID - 19. This Authorization is temporary and may be revoke, and does not take place of formal New Drug Application submission, Review and approval process. Veklury has not been approved by the US FDA for any use. For information about authorized use of Veklury and mandatory requirements of EUA in the US, please Review Fact Sheets and FDA Letter of Authorization available at www.

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* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Dive Brief:

The Gileads announcement settles lingering questions about a drug that has been shown to have modest benefit but remains only therapy authorized by the Food and Drug Administration to treat hospitalized patients with COVID - 19, disease caused by the novel coronavirus. Clinical trials sponsored by the government show drug invented by GILEAD but developed largely by taxpayer - funded agencies speed up hospital recoveries by four days. It had no statistically significant impact on survival for COVID - 19 patients. Gilead says it will have to spend $1 billion to develop and manufacturer Remdesivir by the end of 2020. Gilead invented the drug about 10 years ago when it was searching for treatments for hepatitis C but did not develop it. Later, drug's potential as antivirals for emerging diseases was explored through partnership with government. Taxpayers spend at least $70 million developing drugs, according to advocates. In a grotesque display of hubris and disregard for the public, GILEAD has a price of several thousand dollars Drug that should be in the public domain, said Peter Maybarduk, access to medicines director for nonprofit group Public Citizen. Gilead does not make Remdesivir alone. Public funding was indispensable at each stage, and government scientists led early drug discovery team. Allowing GILEAD to set terms during the pandemic represents a colossal failure of leadership by the Trump Administration. Hhs will likely send the first shipment of 500 000 treatment courses in about two weeks, senior HHS official said on call with reporters. Agencys look at hospitalization every day, officials say, but do complete dive every two weeks. The current plan is to carefully look at distribution of hospitalized patients across the country in one week and then begin directing where the first shipment should go.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Dive Insight:

Steady tick, tick of counter for confirm COVID - 19 cases worldwide pay no regard to news that as of the first week of July, US Department of Health and Human Services has bought out nearly the entire global supply of Remdesivir for upcoming months. The antiviral drug is one of few supportive medications for COVID - 19 patients, and represents a last glimmer of hope as clinical trials for its alternatives are discontinue. It is unsurprising, then, that the deal struck between HHS and Remdesivir manufacturer GILEAD Sciences, which secured 100 per cent of Gileads project production for July and 90 per cent for August and September, was met with fervent unease. Give capricious nature of the pandemic, degree to which this deal might threaten global health responses over coming months remains unknown. According to Thomas Senderovitz, who leads Danish Medicines Agency, Denmark has enough supply of Remdesivir to make it through summer if the intake of patients is as it is now, though there is fear that challenges may arise if a second wave is to occur. However, what is certain is greater concern that unprecedented buyout signals unwillingness to cooperate with other countries. Calls have been made for the establishment of stronger frameworks that guarantee fair pricing for and access to key medicines. Yet, deeper dive into the history of pharmaceutical giant GILEAD may provide insight as to how Remdesivir deal might be an unsuspecting candidate for executing the very results sought by critics. In early 2019, GILEAD was the face of an innovative new market model known to health economists as the Netflix model. At its core, this model involves two agents: manufacturer and the payer. In exchange for some lump sum payment, manufacturer provides payer with unrestricted access to drug, originally intended as treatment for hepatitis C, and both parties benefit payer negotiates reduced price for medication, while the manufacturer guarantees recovery of production costs. The terms of the Louisiana - GILEAD contract ensure accessibility and affordability of hepatitis C Drug, and Governor John Edwards is confident that this deal is a big step forward in the effort to eradicate hepatitis C in Louisiana. Meanwhile, until 2024, GILEAD will have a monopoly on hepatitis C treatment drugs across the state. When it comes to single - entity market structure in pharma, rules of microeconomic theory are distort. Monopolies are often blamed for drug price inflation, as a single player in control of market supply implies that competitive pricing schedules need not apply. Still, and perhaps counterintuitively, monopolistic market structures can derive benefits that instead lower drug prices and resolve health care inefficiencies, as evidence from the Louisiana - GILEAD contract. Monopsony, on other hand, invokes similar fear but for a different reason: it implies a single buyer has power to restrict product access to everyone else.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Download Fact Sheets Here:

Daily clinical scores for animals infected with SARS - CoV - 2 and treated with remdesivir or vehicle solution. B, Cumulative radiograph scores. Ventrodorsal and lateral radiographs were scored for presence of pulmonary infiltrates by clinical veterinarian according to standard scoring system. Individual lobes were scored and scores per animal per day were total and display. C, Ventrodorsal radiographs for each animal taken at 7 dpi. Areas of pulmonary infiltration are circle. Statistical analysis was performed using two - way ANOVA with Sidaks multiple comparisons test. A, b, Viral loads and infectious virus titres in BAL collected from rhesus macaques infected with SARS - CoV - 2 and treated with remdesivir or vehicle solution. Tcid50 50% tissue culture infectious dose. Statistical analysis was performed using two - way ANOVA with Sidaks multiple comparisons test. C, Viral loads in tissues collected from all six lung lobes at necropsy at 7 dpi from rhesus macaques infected with SARS - CoV - 2 and treated with remdesivir or vehicle solution. Statistical analysis was performed using an unpaired t - test. Centre bars, median. Rhesus macaques infected with SARS - CoV - 2 and treated with remdesivir or vehicle solution were euthanized at 7 dpi., B, Representative dorsal views of lungs from remdesivir - treat animal and vehicle - treat animal with focally extensive areas of consolidation. Histological analysis was performed on three sections from six lung lobes from each of six animals per treatment group and representative images were chosen for c - h. C, Minimal subpleural interstitial pneumonia observed in three out of six remdesivir - treat animals. D, Moderate subpleural interstitial pneumonia with oedema observed in five of six vehicle - treated animals. E, Boxed area from c with alveoli lined by type II pneumocytes and alveolar spaces containing foamy macrophages. F, Boxed area from d with pulmonary interstitium expanded by oedema and moderate numbers of macrophages and neutrophils. Alveoli are lined by type II pneumocytes. Alveolar spaces are filled with oedema and small numbers of pulmonary macrophages. G, Viral antigen in type I pneumocytes and type II pneumocytes of remdesivir - treat animal.S H, Viral antigen in type I pneumocytes and macrophage of vehicle - treat animal.S Scale bars: c, d, 200 m; e - h, 20 m.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Sources

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

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