antiviral

Truepill preps launch of virtual COVID-19 service for oral antivirals

Telehealth, diagnostics and pharmacy business Truepill will launch a new virtual care platform in the coming weeks that it says will provide “end-to-end” care for people with COVID-19. The on-demand, online service will combine virtual consultations and next-day delivery of oral antiviral medicines – assuming those become available to patients in the US. Closest to …

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Merck’s oral COVID drug squeaks past FDA advisory committee

An FDA advisory committee voted by 13 to 10 to recommend emergency-use authorisation for Merck & Co and Ridgeback’s oral antiviral molnupiravir for mild-to-moderate COVID-19, saying it would be useful for some high-risk patients. The panel met shortly after updated results from the phase 3 MOVE-OUT trial of the drug showed it was less effective …

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Fall in efficacy of Merck’s molnupiravir puts Pfizer in driver’s seat

Merck & Co has reported new data with its oral antiviral molnupiravir that suggests it is not as effective against COVID-19 as originally hoped. An updated readout from the MOVE-OUT study of molnupiravir shows that the original 48% reduction in the risk of hospitalisation or death in people with mild or moderate COVID-19 at high …

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FDA clears Takeda drug for post-transplant CMV infections

Takeda has scored the first-ever FDA approval of a treatment for refractory cytomegalovirus (CMV) infections in organ transplant patients, which can lead to an increased risk of complications and even death. Livtencity (maribavir) has been cleared for use in transplant patients aged 12 or over with CMV infections that do not respond to first-line treatment …

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FDA hands out approvals to Takeda transplant drug, Aadi Bio cancer therapy

Takeda Pharmaceutical won FDA approval for Livtencity, an antiviral developed to treat cytomegalovirus infection in transplant patients. The agency also approved an Aadi Biosciences drug, making it the first therapy authorized for treating a rare type of soft-tissue cancer.

Pfizer gets bumper $5.3bn order from US for oral COVID drug

Already making big profits from its COVID-19 vaccine, Pfizer looks set to bolt on another big revenue stream with its oral antiviral drug Paxlovid after scoring a $5.3 billion order for the drug from the US government. The deal is dependent on Paxlovid (PF-07321332/ritonavir) being granted either emergency use authorisation (EUA) or full approval, although …

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Pfizer files oral COVID pill in US, signs access deal for 95 countries

Armed with impressive new data for its oral antiviral Paxlovid, Pfizer has filed for emergency use authorisation as a COVID-19 treatment in the US – and signed a deal to allow other manufacturers to make it in some lower-income countries. Paxlovid – based on new protease inhibitor PF-07321332 and HIV drug ritonavir – was found …

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US buys another $1 billion-worth of Merck’s COVID capsule

The US federal government has ordered another 1.4 million doses of Merck & Co and Ridgeback Biotherapeutics’ oral antiviral molnupiravir for COVID-19, adding to an earlier agreement to supply 1.7 million doses. The latest agreement – worth around $1 billion – means that the US has now called dibs on 3.1 million doses of molnupiravir, …

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Pfizer’s pill cuts COVID deaths and hospitalisations by 90%

An oral antiviral drug developed by Pfizer has been shown to dramatically cut the risk of hospitalisation or death from COVID-19 when given in the early stages of infection. The phase 3 trial found that Paxlovid – which combines new protease inhibitor PF-07321332 with already-approved HIV drug ritonavir – reduced the risk of hospitalisation or …

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UK first to authorise Merck/Ridgeback’s COVID pill molnupiravir

Merck & Co and Ridgeback’s oral antiviral molnupiravir has been approved in its first market – the UK – as a treatment for people with mild to moderate COVID-19 who are at increased risk of developing severe disease. The Medicines and Healthcare products Regulatory Agency (MHRA) said today that molnupiravir, now given the trade name …

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Generic pill could be alternative to oral antivirals in COVID-19

A generic pill has been shown to reduce hospitalisation rates in high-risk patients with early COVID-19, potentially offering a low-cost alternative to oral antivirals from Merck & Co and others, according to researchers in Brazil. The antidepressant fluvoxamine given as a twice-daily regimen for 10 days to acutely symptomatic patients with COVID-19 who also had …

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Merck takes further steps to expand access to oral COVID pill

Merck & Co has signed a licensing deal with the UN-backed Medicines Patent Pool (MPP) that could pave the way for generic companies to manufacture its much-anticipated oral antiviral for COVID-19. The agreement would provide royalty-free licenses to companies manufacturing molnupiravir – originally developed by Ridgeback Biotherapeutics – for distribution in 105 low- and middle-income …

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EU starts review of Merck’s oral COVID drug molnupiravir

The EMA has started a rolling review of Merck & Co and Ridgeback Biotherapeutics’ much-anticipated oral antiviral molnupiravir as a treatment for COVID-19 in adults. Molnupiravir is already filed for approval in the US and Canada – where Merck is known as MSD – amid hopes that the drug could be used to protect vulnerable …

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Merck files pill for milder COVID, as AZ showcases its antibody data

As expected, Merck & Co has moved ahead swiftly with an emergency use application for its oral antiviral molnupiravir, aiming to protect people with mild or moderate COVID-19 from developing severe disease with a drug that can be delivered outside hospital. Merck & partner Ridgeback Therapeutics have filed for approval to use molnupiravir in adults …

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FDA panel backs Takeda’s CMV drug for transplant patients

Takeda is closing on a first FDA approval in the treatment of refractory cytomegalovirus (CMV) infections in organ transplant patients, after agency advisors voted unanimously in favour of its antiviral maribavir. Maribavir (TAK-620) should be approved for refractory CMV infections in people with solid organ transplants as well as haematopoietic stem cell transplants (HSCT), regardless …

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Merck preps filings for oral COVID drug, but is it really a game changer?

Merck & Co is on the brink of plugging a gap in the coronavirus treatment armamentarium after its oral drug molnupiravir cut deaths and hospitalisations in mild or moderate COVID-19 in a phase 3 trial. Merck and partner Ridgeback Therapeutics have said they will see emergency use authorisation from the FDA for molnupiravir on the …

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Gates Foundation ramps up funding to Exscientia in COVID project

The Bill & Melinda Gates Foundation must have liked what it saw in an initial collaboration with Exscientia to find new antivirals for COVID-19 and related diseases. Two months after providing initial funding of $1.5 million to get the ball rolling, the philanthropic organisation has now pledged $35 million in funding to a four-year project …

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Merck kicks off oral COVID-19 antiviral filing in Canada

Health Canada has started a rolling review of Merck & Co’s molnupiravir, an oral antiviral therapy treatment for COVID-19 partnered with Ridgeback Biotherapeutics. The Canadian regulator will start reviewing early safety, quality and efficacy data for the drug while late-stage clinical trials are still underway, in the hope of approving the drug quickly of results …

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White House pledges $3 billion war chest for COVID antivirals

The Biden Administration has said it will allocate $3 billion of its pandemic rescue plan to the development of a new generation of antiviral therapies for COVID-19, as well as future viral threats. The plan was announced today by National Institute of Allergy and Infectious Diseases (NIAID) director and chief medical advisor Anthony Fauci, who …

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Merck nabs $1.2 billion order for oral COVID antiviral from US

The US government has placed an order with Merck & Co to buy 1.7 million courses of its antiviral therapy molnupiravir for COVID-19, assuming it gets approved for use by the FDA. The $1.2 billion deal is among the largest placed by the federal government for a COVID-19 medicine, reflecting molnupiravir’s potential as an orally-active …

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New UK biotech Inspira uncloaks with deal to develop inhaled COVID therapy

UK biotech Inspira Pharmaceuticals has emerged from stealth mode with a deal with Vectura to develop an inhaled therapy for COVID-19 that could be ready for human testing within 12 months.  The start-up is focusing on processed and purified extracts from an undisclosed plant source that have been shown in lab studies to kill the …

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Tetra Bio-Pharma Initiates Additional Studies of ARDS-003 in Neuroinflammation and Antiviral Diseases

Shots: Tetra and Targeted Pharmaceuticals collaborated with George Mason University NCBID to examine the potential benefits of ARDS-003 in neuroinflammation and other antiviral applications The collaboration with Targeted provides expertise into the areas of drug development to expand the potential Return on Investment of ARDS-003 The agreement will advance the antiviral CNS program, which is …

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ViiV’s Rukobia cleared in EU as rescue HIV therapy

The European Commission has given a green light to the use of ViiV Healthcare’s Rukobia as a treatment for people with HIV that has developed resistance to other antiretroviral therapy (ART).  The first-in-class HIV attachment inhibitor is cleared for use as an add-on therapy to other ARTs in adults “for whom it is otherwise not …

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