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Indian pharmaceutical companies are gearing up to become global suppliers of repurposed Covid-19 drugs. With the launch of new innovative Covid-19 oral drugs, Indian companies are again expected to grab opportunities in the global supply of oral Covid-19 drugs, according to data and analytics company GlobalData. As several countries witness increasing cases of Covid-19 despite vaccination, they have started booking supply orders for innovative Covid-19 treatments like antibody cocktails, monoclonal antibodies and the latest addition such Merck's the oral Covid-19 drug 'molnupiravir'. Prashant Khadayate, pharma analyst at GlobalData, comments: "Oral treatment for Covid-19 would be the most convenient option for the patients ranging from mild to moderate Covid-19 and would not require a hospital setting. Currently, a majority of the Covid-19 treatments require a hospital setting." According to GlobalData's Pharma Intelligence Center, the UK is the first country to approve molnupiravir which is in pre-registration stage in the US, EU and Japan.

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.

The NHS on Thursday (May 5) said it has rolled out the arthritis drug baricitinib for seriously ill Covid patients. The Recovery trial, conducted by the NHS and University of Oxford, found that 13 per cent fewer severely ill patients died of Covid when treated with the drug compared to existing treatment options. Typically used to treat arthritis to reduce pain and inflammation, baricitinib can now be given to hospitalised Covid patients in addition to current treatments, and clinical studies show that this can provide benefits on top of existing treatment. The NHS has led the rollout of Covid medicines, from the discovery of dexamethasone as the world's first effective treatment, to the first vaccination outside of a clinical trial in December 2020. The NHS said baricitinib works by reducing inflammation caused by Covid-19 by blocking signals to the immune system that are causing it to attack the body.

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."

The National Institute for Health and Care Excellence (NICE) has issued draft guidance on 'Evusheld' which is not recommended for vulnerable adult with high risk of severe Covid-19 on Thursday (16 February). The draft guidance is open for public consultation until 9 March 2023. The committee will consider any comments received at a meeting currently due to take place on 4 April 2023. It comes after last month's decision by the US drug regulator to withdraw its emergency use authorisation for Evusheld as a preventative treatment for Covid-19, which said there was insufficient evidence that Evusheld is effective against the dominant variants of Covid-19 in the US. NICE's independent appraisal committee has reached the same conclusion having considered evidence which shows Evusheld is unlikely to prevent infection with most of the variants circulating in the UK now and in the near future. It has also announced that it is developing a new review process to update recommendations on the cost-effectiveness of Covid-19 treatments so they can be made available more quickly to patients if they show promise against new variants and are found to be cost-effective.

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.

British drugmaker AstraZeneca says it's confident that its new version of COVID-19 antibody treatment could protect immunocompromised patients against all known virus variants. Laboratory studies show the antibody, called AZD3152, neutralises all known variants of COVID-19 and AstraZeneca has support from regulators to make the treatment available by the end of this year, the company's vaccines head Iskra Reic said on Tuesday (April 18). AstraZeneca plans, pending more positive data and regulatory approval, to make the antibody available by the end of 2023. These types of therapies are most needed for people with compromised immune systems, either because of underlying conditions or because they are undergoing immune suppressing treatments. They account for nearly 2% of the global population. AstraZeneca's AZD3152, it new COVID-19 antibody, was acquired through a $157 million deal last year with British biotech start-up RQ Bio. The British drugmaker will likely make future investments like its current partnerships with RQ Bio but did not have any deals to announce, said Reic, a long-time AstraZeneca executive who has led the company's vaccines and immune therapies unit since it was formed in late 2021, during the pandemic.

The British scientists behind one of the major therapeutic Covid-19 trials have turned their focus to treatments for monkeypox, a viral disease that has been labelled a global health emergency by the World Health Organization. The team from Oxford University behind the so-called RECOVERY trial - which honed in on four effective Covid treatments - on Tuesday unveiled a new trial, dubbed PLATINUM, to confirm whether Siga Technologies' tecovirimat is an effective treatment for monkeypox. Although there are vaccines developed for the closely related smallpox that can reduce the risk of catching monkeypox, there are currently no treatments that have been proven to help hasten recovery in those who develop the disease. The UK has over 3,000 confirmed cases of monkeypox. The virus is transmitted chiefly through close contact with an infected person. It typically causes mild symptoms including fever, rash, swollen lymph nodes and pus-filled skin lesions. Severe cases can occur, though people tend to recover within two to four weeks. Siga's drug, branded Tpoxx, has been cleared to treat diseases caused by the family of orthopoxvirus that includes smallpox, monkeypox and cowpox by the European Union and United Kingdom, but due to limited trial data it is generally only used in severe cases in Britain.

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.

An alliance of companies has pledged to ensure equitable access to vaccines and treatments for pandemics, as the friction around intellectual property rights for Covid-19 interventions between the pharmaceutical industry and developing nations endures. At the heart of the plan is a commitment to set aside part of the production of vaccines and treatments upfront for vulnerable populations in low-income countries when the next pandemic arises, given how fragmented access to Covid tools has left many populations unprotected. In order to do better next time - and without knowing which companies will develop the first drugs and vaccines for the next pandemic - having the industry collectively make this commitment is potentially transformative, said Thomas Cueni, head of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA). The pledge, called the Berlin Declaration, was made on July 19 by members of the global pharmaceutical industry group that include many of the companies involved in developing Covid interventions, such as AstraZeneca, GSK, Moderna, Pfizer and Merck. The declaration is not legally binding. However, if a company that signed on reneges on its vow, it would face grave consequences in the court of public opinion, said Cueni.

Pharmacy teams are being encouraged to support the ground-breaking Platform Adaptive trial of Novel antivirals for early treatment of Covid-19 In the Community (PANORAMIC) study by raising awareness among patients. The study aims to find out whether new antiviral treatments can help Covid-19 patients avoid hospital admission and support a quicker recovery. The PANORAMIC trial will allow researchers to gather data on the potential benefits of treatments to patients and will help the NHS to develop plans for rolling out the products to further patients in 2022. Anyone over the age of 50 or between 18 to 49 with certain underlying health conditions can participate in the trial after receiving a positive PCR or lateral flow test result for Covid-19. People who wish to participate in the trial can sign up themselves through the study's website and may be contacted by a member of the clinical team in a general practice that has been set up to deliver the PANORAMIC trial.

GlaxoSmithKline (GSK) says initial tests of the antibody-based Covid-19 therapy it is developing with US partner Vir suggest the drug is effective against the Omicron variant. A GSK statement on Thursday (December 2) said that lab tests and a study on hamsters have demonstrated the sotrovimab antibody cocktail to work against viruses that were bio-engineered to carry a number of hallmark mutations of the new variant. The tests are continuing to confirm the results against all of the Omicron mutations, with an update expected by the end of the year, it added. The antibody is designed to latch on to the spike protein on the surface of the coronavirus, but Omicron has been found to have an unusually high amount of mutations on that protein. "Sotrovimab was deliberately designed with a mutating virus in mind," said Vir chief executive George Scangos, adding that the drug was targeting a region of the spike protein that was highly unlikely to mutate.

British drugmaker GSK said on Tuesday (December 7) its antibody-based Covid-19 therapy with US partner Vir Biotechnology is effective against all mutations of the new Omicron coronavirus variant, citing new data from early-stage studies. The data, yet to be published in a peer-reviewed medical journal, shows that the companies' treatment, sotrovimab, is effective against all 37 identified mutations to date in the spike protein, GSK said in a statement. Last week, another pre-clinical data showed that the drug had worked against key mutations of the Omicron variant. Sotrovimab is designed to latch on to the spike protein on the surface of the coronavirus, but Omicron has been found to have an unusually high number of mutations on that protein. "These pre-clinical data demonstrate the potential for our monoclonal antibody to be effective against the latest variant, Omicron, plus all other variants of concern defined to date by the WHO," GSK chief scientific officer Hal Barron said.

Genomic sequencing allowed the world to track new coronavirus variants throughout the pandemic. Now British researchers plan to use it to better understand a host of other respiratory pathogens, from influenza to respiratory syncytial virus (RSV). The work is aimed at shedding more light on known threats and, potentially, emerging ones, the team at the Wellcome Sanger Institute, working with the UK Health Security Agency, said. The world has never had access to the kind of real-time information for these viruses that scientists obtained on SARS-CoV-2 through sequencing millions of genomes, Ewan Harrison, head of the new Respiratory Virus and Microbiome Initiative, told reporters on Monday. That includes granular detail on how they transmit as well as how they evolve in the face of the human immune response. "We hope that by expanding our ability to sequence these viruses routinely, we can build upon the work that's going on COVID, and hopefully supercharge research efforts to understand the transmission of these viruses, but also to help develop new treatments and vaccines," Harrison said.

Clinical trials for BioNTech's cancer vaccines should start this year in Britain, marking an important step towards their possible sale on the open market, the German company's top executive Ugur Sahin told magazine Der Spiegel. BioNTech, known for its COVID vaccine with U.S. partner Pfizer, is currently deciding which types of cancer it wants to test its personalized cancer immunotherapies on and the locations where it will conduct the trials, Sahin said. The company wants these therapies, which are based on messenger RNA (mRNA) technology similar to the one that underpins its COVID-19 vaccine, to soon become a regular treatment for cancer patients. "We believe that this should be possible for large amounts of patients before 2030," Sahin said.

Three leading pharmacists - professor Mahendra Patel, Asif Aziz and Ade Williams - have been recognised in Queen Elizabeth's annual New Year's honours list. Professor Patel, an academic pharmacist from West Yorkshire, was awarded an OBE for his "services to pharmacy." He told Pharmacy Business: "I am truly honoured and deeply humbled by this highly prestigious award that I have always believed was more deserving for others. "That's not to say I'm not proud of it - far from it, although for me it's not necessarily about rewards and recognition but more the intricacies of the journey I embark on and the learning and joy that those encounters bring with it. Most recently, Professor Patel - who has had a broad ranging portfolio career spanning community pharmacy, health education and health promotion, academia, and research - has been involved in promoting clinical trials across community pharmacies in the UK. His latest work has seen him act as one of the national leads for the PRINCIPLE and PANORAMIC trials, run by Oxford University - both trials seek to pioneer repurposed and new drug treatments in the community to prevent hospitalisation due to Covid-19.

Prostate cancer is the most common cancer among men in the United Kingdom, affecting nearly 50,000 men yearly. Combined with the challenges faced across healthcare during COVID-19, new figures show that prostate cancer accounts for a third of cancers not treated due to the pandemic, with 14,000 'missing patients' believed to have not undergone treatment since April 2020. It is more urgent than ever that men are encouraged to get checked, as any set-backs in diagnosis can reduce the pathways available, in turn affecting health outcomes. Community pharmacy teams play a crucial role in signposting the help available for men who may be concerned about their health. Therefore, it is vital that pharmacy teams have access to the information they need to correctly direct men to seek prostate cancer guidance. By maximising the trusted relationship between patients and their pharmacists, more can be done to identify the warning signs, helping men to get an earlier diagnosis.

To support NHS, clear the backlog created by the Covid-19 pandemic and help community pharmacies support more people, the Welsh government has announced an allocation of further £12.5 million funding. Of the total amount, £10mn will be distributed across the 22 local authorities to buy equipment to help people to live independently in their own homes post hospital stay. The remainder, £2.5mn, will be used to support community pharmacists and patients to improve access to treatment and advice for a range of common ailments. The move is aimed at alleviating waiting times and reducing winter pressures on the NHS. Commenting on the announcement, Elen Jones, Royal Pharmaceutical Society director for Wales said: "We are delighted that the Welsh government continue to recognise the value of pharmacists in patient care and we welcome this additional investment and support for Community Pharmacy teams across Wales.

Reacting to recommendations from a UK-first independent review, the Department of Health and Social Care (DHSC) has outlined action to tackle potential bias in the design and use of medical devices. Professor Dame Margaret Whitehead, professor of public health at the University of Liverpool, was appointed to lead the review, which focused on three areas - optical devices such as pulse oximeters, AI-enabled devices, and polygenic risk scores (PRS) in genomics. The DHSC commissioned the medical devices review after concerns were raised that pulse oximeters - widely used during the COVID-19 pandemic to monitor blood oxygen levels - were not as accurate for patients with darker skin tones. There were worries that this could cause delays in treatment if dangerously low oxygen levels in such patients were missed. However, no evidence was found from NHS studies indicating that this differing performance had an impact on patient care. Accepting the report's conclusions, the DHSC has committed to several actions, such as ensuring the safe use of pulse oximeter devices across a range of skin tones within the NHS and eliminating racial bias from data sets employed in clinical studies.