remdesivir

Gilead Reports Results of Veklury (remdesivir) in P-III Trial for the Treatment of COVID-19

Shots: The P-III trial evaluates the efficacy & safety of a 3-day course of Veklury (IV) vs PBO in a ratio (1:1) in 562 non-hospitalized patients ≥aged 12yrs. with COVID-19 who are at high risk for disease progression. The results will be presented at IDWeek 2021 The results showed an 87% & 81% reduction in …

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Improving access to treatments in challenging markets

The COVID-19 pandemic has highlighted the importance of ensuring a reliable supply of treatments across the globe at pace and speed. Jirair Ratevosian, executive director of global patient solutions and government affairs at Gilead Sciences, tells us how his company utilised previously developed partnerships and their knowledge of providing global access to HIV treatments to distribute …

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Gilead says Veklury should work against COVID-19 variants

Gilead Sciences says its antiviral Veklury should be effective against the new, more contagious COVID-19 variants discovered in the UK and South Africa. According to the US biopharma company, genetic analyses of publicly available sequences for the new variants of SARS-CoV-2 suggest the mutations in the viral spike protein that have made them more transmissible …

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Eli Lilly and Incyte Receive FDA’s EUA for Baricitinib + Remdesivir to Treat Hospitalized Patients with COVID-19

Shots: The EUA is based on ACCT-2 study assessing baricitinib (4mg, qd for 14 days or until hospital discharge) in combination with remdesivir vs PBO with remdesivir in hospitalized patients with/ out oxygen requirements Result: Median time to recovery from 8-7days (12.5% improvement), patients who progressed to ventilation (23% vs 28%), patients who died @day29 …

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Gilead Q3 revenue rise bolstered by $873m Veklury sales

Gilead Sciences is the first and so far only company to claim FDA approval for a COVID-19 treatment with its Veklury antiviral, and its latest financial results reveal the benefit of that achievement. The US drugmaker sold $873 million-worth of Veklury (remdesivir) in the three months to the end of September, helping it to a …

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Gilead’s remdesivir finally gets US approval

Gilead’s Veklury (remdesivir) has become the first COVID-19 drug approved in the US following a nod from the FDA. As an antiviral drug, remdesivir works to stop replication of SARS-CoV-2, the virus that causes COVID-19. Originally intended as a treatment for Ebola virus, remdesivir made headlines early on in the pandemic as the first drug …

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Gilead’s Veklury (remdesivir) Receives the US FDA’s Approval as the First Treatment for COVID-19

Shots: The approval is based on three studies including P-lll ACTT-1 study assessing the efficacy and safety of a 10-day treatment course of Veklury vs PBO in 1063 hospitalized patients with confirmed SARS-CoV-2 infection and mild, moderate or severe COVID-19 receiving the treatment with SOC. The other two studies include two P-II OLE studies (SIMPLE-Severe …

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Gilead’s COVID-19 drug Veklury falls short in WHO’s global trial

Gilead’s Veklury (remdesivir) has failed to produce an effect on hospital stay and mortality in COVID-19 patients in a large global trial, casting doubt on previous supportive study findings. The results from the World Health Organization’s large Solidarity trial are yet to be peer reviewed but were posted online on a preprint server. Interim findings …

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EU ramps up supply of COVID-19 vaccine, drugs

The European Commission has taken its advance orders for potential COVID-19 vaccines to more than 1.1 billion, after signing a supply deal for up to 400 million doses of Johnson & Johnson’s experimental candidate. The agreement is the third for coronavirus vaccine supply for the EU, coming after earlier deals with AstraZeneca and Sanofi/GlaxoSmithKline, and …

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Amid mixed messages about his Covid-19 diagnosis, Trump looks like a one-man clinical trial

While the White House and doctors at Walter Reed have sought to reassure the public that Trump’s condition is improving, he has received numerous drugs for Covid-19, including the steroid dexamethasone, which is typically administered only to those who are critically ill.

Timing of Remdesivir for COVID-19

Date:  October 19, 2020 Issue #:  1609 Summary:  Remdesivir (Veklury – Gilead), an investigational antiviral drug administered by IV infusion, is now available through an FDA Emergency Use Authorization (EUA) for treatment of COVID-19 in all hospitalized patients. An earlier EUA limited use of the drug to patients hospitalized with severe disease.

Is COVID the Rx for the Pharmaceutical Industry’s Reputation?

Darlene Dobry, Strategic Advisor, Medical Devices and Pharmaceuticals As the COVID-19 pandemic continues to bring the world’s economies, healthcare systems, and communities to their knees, the Pharma industry appears to be the shining hope to help us return to a new normal. Could the industry’s response to this global public health crisis be the Rx …

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Zydus Launches Cheapest Version of Remdesivir at $37.41 per Vial in India

Shots: The company has launched Remdec at a price of $37.41 (Rs. 2800) for a 100mg lyophilized injection. The generic version is the most economical Remdesivir brand in India In Jun’2020, Zydus signed a non-exclusive agreement with Gilead to manufacture and commercialize Remdesivir for severe COVID-19 in India. The API of the therapy has been …

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Trials of Gilead’s remdesivir in Covid-19 not diverse enough, experts write

In a commentary, physicians and pharmacists wrote that percentages of Black, Latino and Native American patients in two Phase III studies of the drug that the company is using for FDA approval were disproportionate to Covid-19’s incidence in those communities.

Gilead Reports NDA Submission to the US FDA for Veklury (Remdesivir) to Treat COVID-19

Shots: The NDA filing is based on P-III studies evaluating Veklury vs PBO, conducted by NIAID. The studies demonstrated that Veklury led to faster time to recovery and that a 5-day or 10-day treatment duration led to similar clinical improvement Across multiple studies, Veklury was generally well-tolerated in both the 5-day and 10-day treatment groups, …

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Gilead files COVID-19 drug remdesivir with FDA

Gilead has filed its COVID-19 drug remdesivir with the FDA, to treat patients with severe disease, under the brand name Veklury. The drug is currently available to US patients under an Emergency Use Authorisation for treatment of hospitalised patients with severe COVID-19. This filing is the last part of a rolling submission with the FDA …

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Big Pharma plays CMO as Pfizer signs on to produce Covid-19 drug remdesivir for Gilead

Gilead Sciences had said in its second-quarter earnings that it would partner with companies in North America, Europe and Asia to manufacture the antiviral drug, which received an emergency use authorization from the FDA in May.

Pfizer signs deal with Gilead to manufacture COVID-19 antiviral remdesivir

Pfizer has signed a multi-year agreement with Gilead to manufacture and supply the COVID-19 antiviral remdesivir, which is also being tested in combination with other drugs in an effort to fight the pandemic. Under the terms of the agreement Pfizer will become one of several external partners who manufacture the investigational treatment for the disease. …

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Mylan Launches Remdesivir Under the Brand Name Desrem for COVID-19 in India

Shots: Mylan launches Desrem (remdesivir) addressing the unmet needs amid COVID-19. The drug is approved for the treatment of suspected or laboratory-confirmed incidences of COVID-19 in adults and children hospitalized with severe symptoms Mylan will manufacture Desrem in its state-of-the-art injectable facility in Bangalore, India, and other export markets where Mylan has received a license …

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