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Britain will start to roll out Merck's molnupiravir Covid-19 antiviral pill through a drug trial later this month, Susan Hopkins, chief medical adviser at the UK Health Security Agency said on Sunday (November 7). Last week Britain became the first country in the world to approve the potentially game-changing Covid-19 antiviral pill, jointly developed by US-based Merck & Co Inc and Ridgeback Biotherapeutics. The government said in October it had secured 480,000 courses of the Merck drug, as well as 250,000 courses of an antiviral pill developed by Pfizer Inc. Asked about the molnupiravir approval, Hopkins told BBC television: "That is great news and it will start to be rolled out through a drug trial in the end of this month/the beginning of December." Hopkins said all the trials so far had been done with the unvaccinated, so this would help understand how it will work in the wider vaccinated population.

Antiviral Drugs Market by Mechanism of Action (Nucleotide Polymerase Inhibitors, Reverse Transcriptase Inhibitors, and Protease Inhibitors), Type (Generic Drugs and Branded Drugs), and Application (HIV, Hepatitis, Herpes, and Influenza) - Global Opportunity Analysis and Industry Forecast, 2018-2025

Researchers from the University of Oxford today (December 8) started recruiting for a clinical trial to test novel antiviral Covid-19 treatments for early use in the illness by people in the community and those who are at higher risk of complications. Partnering with the National Institute for Health Research (NIHR), colleagues in several UK universities, and the NHS UK-wide, the Platform Adaptive trial of NOvel antiviRals for eArly treatMent of Covid-19 In the Community (PANORAMIC), is a national priority trial, and will be open to participants from across the UK. The first treatment to be tested by the UK Antiviral Taskforce will be molnupiravir, a Covid antiviral pill already licensed by the MHRA. Britain became the first country in the world to approve molnupiravir, which was jointly developed by U.S.-based Merck & Co Inc and Ridgeback Biotherapeutics, in November.

UK regulator has approved a second oral antiviral for early treatment of Covid-19 in high-risk adults, after molnupiravir. The Medicines and Healthcare products Regulatory Agency (MHRA) gave its nod for a new treatment called Paxlovid (PF-07321332 and ritonavir), after finding it safe and effective at reducing the risk of hospitalisation and death in people diagnosed with mild Covid-19 infection. Developed by Pfizer, Paxlovid prevents the multiplying of virus, helping the body to overcome the infection. A clinical trial for the treatment in high risk individuals revealed that a five-days course of Paxlovid reduces the risk of hospitalisation and death by 89 per cent. It further revealed that Paxlovid is most effective when taken in the early stage of infection. Dr June Raine, MHRA chief executive, said: "We now have a further antiviral medicine for the treatment of Covid-19 that can be taken by mouth rather than administered intravenously. This means it can be administered outside a hospital setting, before Covid-19 has progressed to a severe stage."

More than 1.5 million courses of Pfizer's COVID-19 antiviral drug Paxlovid have expired unused in European countries by the end of November, the health analytics firm Airfinty has revealed. It is predicted that the figure could surge to 3.1 million, at a value of $2.2 billion (around £1.73 billion), by the end of Feb 2024. According to Airfinty analysis, Britain has the highest unused stock, with an estimated one million expired drug courses worth $700 million (over £550 million). With 2.2 million courses estimated to expire unused by the end of June 2024 due to the low prescription of the antiviral in the country, the total drug value wasted in the UK could reach $1.5 billion (£1.1 billion), the report added.

The Pharmacists' Defence Association (PDA) has issued an advisory information to community pharmacy contractors about Paxlovid antiviral treatment for non-hospitalised patients. "Patients will be assessed to see if they meet the criteria for inclusion and will need careful checking to see if Paxlovid therapy is safe due to the significant number of drug interactions. Assessment and prescribing are provided via dedicated services with dispensing and supply arranged by the central supply service or via participating community pharmacies," said the PDA. Every pharmacist can support this service by making themselves familiar with the service set up in their area. This is so that they can provide advice and signpost to healthcare colleagues and patients. Pharmacists working in general practice may also be able to help with identifying newly diagnosed highest risk patients. Whilst most of this group should have already been identified and contacted, no system is entirely foolproof. The PDA's advisory note provides information around indemnity and links to information about the prescribing and administration of Paxlovid since it is being provided under a temporary authorisation, and is subject to numerous drug-drug interactions, and is a recommended first-line treatment.

Community pharmacy is at the heart of one of the most ambitious clinical trials ever undertaken by the UK's primary care network, says senior academic pharmacist Professor Mahendra Patel. The PANORAMIC trial has been designed to rapidly evaluate several antiviral treatments over time that could help people at high risk of Covid-19 recover sooner, prevent the need for hospital admission and so ease the burden on the NHS. The Platform Adaptive trial of NOvel antiviRals for eArly treatMent of Covid-19 In the Community (PANORAMIC) is a national priority trial led by Oxford University's Primary Care Clinical Trials Unit. Lead investigators say the study will enable early and rapid testing of novel antiviral agents and help repurpose existing drugs against Covid-19. As soon as the trial is set up for delivery, it will be open to eligible participants from across the UK. Prof Patel, a key member of the trial's core team, said: "I'm really excited with this news and also by the prospect that there is a huge potential for pharmacy teams to help play a vital role in supporting this highly ambitious trial, as they have with the PRINCIPLE trial, now the world's largest community based clinical trial for Covid19."

With growing concerns over the spread of Omicron variant, the UK has signed two contracts with drug majors Pfizer Inc. and Merck & Co to buy 4.25 million courses of antivirals for the NHS patients. The move is aimed at reducing hospitalisations and easing pressures on the NHS. The two new contracts are for 1.75 million additional courses of Merck Sharp and Dohme's (MSD) molnupiravir (Lagevrio®) and 2.5 million additional courses of PF-07321332/ritonavir (Paxlovid™) from Pfizer. The ordered drugs will be available from early next year and both are expected to be effective against Omicron. The recent order is in addition to the 480,000 courses of molnupiravir and 250,000 courses of PF-07321332/ritonavir procurement announced in October.

Global demand for Pfizer's oral Covid-19 antiviral treatment Paxlovid has been unexpectedly low due to complicated eligibility requirements, reduced testing, and potential for drug interactions, according to a media report. Demand also has been hampered by the perception that Omicron infections are not that severe. Paxlovid was expected to be a major tool in the fight against Covid after it reduced hospitalizations or deaths in high-risk patients by around 90 per cent in a clinical trial. Thousands of people still die from Covid-19 every week, even as global infections are far off their peak. And there are only a few proven antiviral treatments, of which Paxlovid is the most attractive. The others are Merck & Co's far less effective rival pill molnupiravir, and Gilead Sciences' intravenous remdesivir.

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Pfizer's oral Covid-19 therapy will be evaluated as a potential treatment for patients hospitalised with the illness in a major British trial, scientists said on Monday, as cases rise in some parts of the world. The world's largest randomised study of potential medicines for Covid-19, dubbed the RECOVERY trial, will assess Paxlovid across hospitals in Britain, which has already approved the drug for early-stage treatment. "Paxlovid is a promising oral antiviral drug but we don't know if it can improve survival of patients with severe Covid-19," said Peter Horby, a professor at the University of Oxford and joint chief investigator of the RECOVERY trial. The scientists said they aim to mainly find whether Pfizer's Paxlovid reduces the risk of death among patients admitted to hospitals with Covid-19.

The UK government on Thursday (8 May) launched a new plan to tackle antimicrobial resistance (AMR), a global issue that makes infections difficult or impossible to treat. This is the second phase of a series of 5-year national action plans, aimed at supporting the government's 20-year vision to contain and control AMR by 2040. With the launch of this new national action plan, the UK commits to reducing its use of antimicrobials - such as antibiotics, antifungals and antivirals - in humans and animals. Additionally, it aims to strengthen surveillance of drug-resistant infections before they emerge and incentivise industry to develop the next generation of treatments. There are also plans to expand initiatives such as the world-first 'subscription model' for antimicrobials, launched in 2019 as a pilot.

Indian drugmaker Dr Reddy's Laboratories will launch its generic version of Merck's antiviral Covid-19 pill, molnupiravir, and price it at 35 rupees ($0.4693) per capsule, a company spokesperson said on Tuesday (January 4). The overall cost for a patient treated with a 5-day course of 40 capsules of the generic drug, to be sold under brand name 'Molflu', will come up to 1,400 rupees ($18.77). In comparison, the treatment with Merck's pill in the United States costs $700. "Molflu is expected to be available from early next week in pharmacies throughout (India) with particular focus on states with high caseload of Covid-19," the company spokesperson said. India last week gave emergency use approval to along with two vaccines, as the country braces for a possible spike in coronavirus cases due to the rapidly spreading Omicron variant.

The drug controller issued emergency use authorization to pharmaceutical businesses in India to produce generic versions of molnupiravir.