Category: antiviral

  • Enanta lawsuit claims Pfizer’s Paxlovid infringes its patent

    US biotech Enanta Pharma has filed a lawsuit against Pfizer, claiming that its oral antiviral for COVID-19 Paxlovid infringes one of its patents and seeking damages from the pharma giant. The suit – filed in a Massachusetts district court – claims that Paxlovid (nirmatrelvir and ritonavir) infringes its 11,358,953 patent which covers “compounds and pharmaceutically […]

  • As cases rise, WHO says monkeypox risk is “moderate”

    The World Health organisation’s latest assessment of the monkeypox outbreak is that it poses a moderate threat to public health, as cases of the infection continue to rise. In an update posted yesterday, the WHO said it had received reports of 257 confirmed cases of monkeypox from 23 countries, 106 of them from the UK […]

  • Monkeypox cases are rising. Should we be worried?

    The World Health Organization has said the current outbreak of monkeypox is the largest ever recorded outside sub-Saharan Africa, with cases rising above the 100-mark a few days ago and the UK top of the table with 56 as of yesterday. Top of the list of concerns is how the virus – which does not […]

  • Enanta RSV drug fails a Phase 2 test, but studies continue in higher-risk patients

    An antiviral that Enanta Pharmaceuticals is developing for respiratory syncytial virus infection failed to beat a placebo in its first Phase 2 test. But the biotech notes that these study participants weren’t very sick and may have recovered on their own, so it’s now pinning its hopes on ongoing studies in higher-risk groups, such as […]

  • Merck makes $3.2bn from COVID-19 drug Lagevrio in Q1

    Orders for Merck & Co’s oral antiviral for COVID-19 helped to swell the drugmaker’s first quarter revenues by a massive 50%, although underlying growth was also strong. Lagevrio (molnupiravir) added $3.2 billion to Merck’s top line of $15.9 billion, but even without the drug sales would have risen 19% thanks to a strong performance from […]

  • Pfizer bulks up in RSV with $525m takeover of ReViral

    Pfizer is looking to follow its vaccine/oral antiviral combination that has proved so profitable in COVID-19 with a similar approach in respiratory syncytial virus (RSV). The drugmaker is in the latter stages of development for its RSV vaccine with phase 3 results due shortly, and has just snapped up an oral antiviral for the disease […]

  • Synairgen slumps as inhaled COVID drug fails pivotal test

    UK biotech Synairgen saw the value of its shares crater after its inhaled interferon beta therapy SNG001 was found to provide no benefit to people hospitalised with COVID-19. The drug – originally developed for asthma – missed both primary and secondary efficacy measures in the 623-patient SPRINTER trial, including a failure to reduce the time […]

  • FDA clears Gilead’s Veklury for COVID outpatients

    The FDA has extended the emergency use authorisation for Gilead Sciences’ antiviral Veklury to include non-hospitalised patients with COVID-19, extending the uses of the drug. The green light means that intravenously-administered Veklury (remdesivir) is another option for non-hospitalised patients with mild-to-moderate COVID-19 who are at high risk of progression to severe disease, alongside oral antivirals […]

  • The power of similarities to accelerate antiviral development for COVID-19

    In April 2020, I wrote a blog post entitled “Exploiting similarities between SARS-CoV-2 and other viruses to accelerate vaccine and therapy development,” where I described research areas leveraging genetic and phenotypic similarities between SARS-CoV-2 and other known viruses. In my quest to find relevant data, I used Reaxys Medicinal Chemistry to generate a list of […]

  • After trial win, Novartis nabs COVID drug from Molecular Partners

    There are still licensing deals to be done in the COVID-19 category it seems, after Novartis paid around $163 million to license rights to an antiviral drug developed by Molecular Partners. The opt-in has been prompted by the results of a phase 2 trial of ensovibep (MPO420), which showed that a single intravenous dose of […]

  • Pfizer pips Merck to first oral COVID antiviral okay in US

    Pfizer’s Paxlovid has become the first oral antiviral for COVID-19 to be authorised for emergency use by the FDA, as the US braces itself for a surge in Omicron cases over the holiday period. The green light means that Paxlovid – based on nirmatrelvir (formerly PF-07321332) and ritonavir – has been cleared for use in […]

  • As Omicron cases rise, EMA backs early use of Pfizer’s Paxlovid

    The EMA’s human medicines committee has said that EU member states can start to offer Pfizer’s oral antiviral Paxlovid as a treatment for people with COVID-19 outside hospital, ahead of a formal approval for the drug. The decision comes amid rising rates of infection and deaths due to COVID-19 across the EU, and with 529 […]

  • Merck halts more trials of HIV candidate islatravir

    Merck & Co has halted enrolment in a pair of phase 3 trials of its experimental HIV drug islatravir, raising another warning flag about the highly-touted therapy. The two studies – IMPOWER 22 and IMPOWER 24 – are testing islatravir as a once-monthly, oral therapy for pre-exposure prophylaxis or PrEP, which accounts for a sizeable […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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, […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]