Group items matching

in title, tags, annotations or url

Director of the Mayo Clinic's Vaccine Research Group suffered from fever for five hours straight after receiving the second dose of the Moderna vaccine.

Even as the UK agrees deals for 14 million additional vaccine doses from Moderna and Pfizer, the Royal Pharmaceutical Society has renewed its calls for community pharmacies in England to play an increased role in delivering booster jabs for Covid-19. "Pharmacists and pharmacy teams across the health service in England have been crucial to the success of the flu and Covids-19 vaccination programmes from the outset," said Thorrun Govind, chair of the RPS in England, who has been making a case on national television for an increased role of the profession. She added: "They continue to go above and beyond to support patient care, engaging with local communities and helping to overcome vaccine hesitancy. "They've already done so much this year to look after patients in really difficult circumstances, but many will be ready to rise to the challenge of this new national effort."

Oxford Cannabinoid Technologies Holdings plc, which specialises in developing cannabis-derived medicines with pain-relieving properties, has successfully administered the first-in-human dose of its lead pharmaceutical drug compound, OCT461201, in its phase 1 clinical trial. The company holds a portfolio of four drug candidates intended for use as licensed pain medications. The drug is a selective cannabinoid receptor type 2 agonist with the potential to treat chemotherapy-induced peripheral neuropathy and irritable bowel syndrome. The UK trial, conducted by Simbec Research Limited, part of Simbec-Orion Group Ltd., is progressing with healthy volunteers, OCTP said in a statement. Using a single ascending dose protocol, the primary objective is to demonstrate OCT461201's safety and tolerability, while providing information on its pharmacokinetic profile, to confirm its value as a potential drug. Results from the trial, funded entirely by OCTP's existing resources, are expected in the third quarter of 2023, the statement added.

The Medicines and Healthcare Products Regulatory Agency (MHRA) has approved the marketing authorisation of Adtralza, a dermatological solution developed by Danish specialist LEO Pharma. This injectable solution contains 300 mg of tralokinumab in a 2 mL pre-filled pen and will be available for tralokinumab patients in the UK from early 2024. Tralokinumab is indicated for treating moderate-to-severe atopic dermatitis in adult and adolescent patients aged 12 and older who require systemic therapy, Leo Pharma said in a statement. It is a fully human monoclonal antibody developed to specifically bind to and inhibit the IL-13 cytokine. Previously, it was available in a 150 mg in 1 mL pre-filled syringe. According to Leo Pharma, the 300 mg tralokinumab in a 2 mL pre-filled pen offers a streamlined administration for both patients and prescribers. It begins with an initial 600 mg dose in two injections, followed by a single 300 mg maintenance dose administered every other week. "We're pleased that this simplified administration method for tralokinumab will soon benefit eligible atopic dermatitis patients in the UK. It aligns with our commitment to elevate the standard of care and support for individuals with skin conditions," said Leanne Walsh, Vice President and General Manager of UK and Ireland at LEO Pharma.

Recent uptake of COVID-19 vaccine booster doses in Europe has been "rather disappointing," an official said on Thursday (November 24), amid concerns that protection against severe cases of the disease could weaken during the winter. The European average rate of re-vaccination, or receiving booster doses, was only 29 per cent in the groups of people considered to be at highest risk, such as the elderly and immunocompromised. "It is of concern that those most at risk of hospitalisation or severe COVID are not adequately protected," the European Medicines Agency's head of health threats and vaccines strategy, Marco Cavaleri, told a news briefing. Though there have not been major increases in COVID-19 case rates in recent weeks, Cavaleri said that could change during the colder winter months.

The Department of Health and Social Care (DHSC) is encouraging people to come forward for their first and/ or second dose of the Covid vaccine before the free offer ends on Friday (30 June). The NHS's world-leading vaccination programme has so far delivered over 146 million Covid jabs. Building on the success of autumn and spring booster programmes, a seasonal, targeted vaccination offer will remain open for those most at risk, in line with advice from the Joint Committee on Vaccination and Immunisation (JCVI). Health Minister Maria Caulfield said: "As we live with Covid without restrictions on our freedoms, it is right that we move towards a more targeted vaccination offer that prioritises those most at risk, so we can focus our efforts on cutting waiting lists for NHS treatment - one of the Prime Minister's top five priorities. As the offer for any adult to get a Covid vaccine comes to an end on 30 June, I would urge those who have not yet come forward to choose to have the first and second Covid vaccine. It takes minutes to get your jab and thousands of sites are open across England." This year's spring booster programme continues to gather pace, with over two million eligible people receiving their vital top-up dose.

The Department of Health and Social Care (DHSC) has notified pharmacies over the shortage of Buserelin (Suprefact) 5.5mg/5.5ml solution for injection vials is out of stock until mid-August 2022. Limited supply of Buserelin (Suprefact) 5.5mg/5.5ml solution for injection vials remains available in NHS Trusts and health boards. Buserelin (Suprecur) 5.5mg/5.5ml solution for injection vials are currently available, however, this stock is short dated (expires end of July) and further stock is expected mid-August 2022. Buserelin (Suprecur)150microgram/dose nasal spray is out of stock until late-December 2022. Limited supply remains available in NHS Trusts and Health Boards. Nafarelin (Synarel) 200microgram/dose nasal spray remains available but is currently unable to support an uplift in demand (until mid-August 2022 when it can support a partial uplift in demand).

Healthcare workers, including community pharmacy staff, can book their Covid-19 booster vaccination through the National Booking Service from Wednesday (September 7) onwards. NHS England has announced that around seven million people, including those aged 75 and over, people who are immunosuppressed and health and care workers will be able to book an appointment for their Covid-19 booster vaccinations online or by calling 119. Eligible staff are encouraged to book an appointment for a booster dose as soon as possible, provided it has been at least three months since their last dose of the vaccine. "For other eligible patients (not health and care workers), invitations are being sent out and will be landing on their doormats from Wednesday 7th September inviting people to book their appointment for the following week without delay. The NHS will contact people when it is their turn to book in for the vaccine - there will be no need for patients to contact the NHS," said PSNC.

The Pharmaceutical Services Negotiating Committee (PSNC) has issued a revised guidance for the dispensing of controlled drugs in instalments on 19 September that has been declared as a bank holiday for Her Majesty The Queen's state funeral. PSNC said: "Many instalment prescriptions have already been issued in advance of the upcoming Bank Holiday. Where they contain the Home Office approved wording "Please dispense instalments due on pharmacy closed days on a prior suitable day" then you will need to plan to make these supplies at an appropriate time. This wording would also permit the supply of the initial dose of a prescription starting on the Bank Holiday Monday where the date of the signature is before this." However, PSNC is aware that not all prescriptions will contain such a direction to support the supply, in advance, of a dose for Monday 19 September where the supplying pharmacy is closed. "We recognise that this client group are often vulnerable with multi-morbidities and that the risk to them may be significant. You should therefore exercise your professional discretion in determining when to make an instalment supply for the Bank Holiday Monday. Make the care of the patient your first priority and consider the potential impact of both making the supply in advance and of not making the supply in your decision making process. The exceptional circumstances that led to the Bank Holiday and its short notice may inform your decision."

The National Institute for Health and Care Excellence (NICE) has recommended faricimab as treatment option for adults with wet age-related macular degeneration or diabetic macular oedema. Thousands of people in England could benefit from the recommendation of a new drug that helps to treat two leading causes of sight loss and visual impairment. Faricimab is administered as an eye injection and is being recommended as an option for treating some adults with wet age-related macular degeneration (AMD) or with diabetic macular oedema (DMO). In the key clinical trials, aflibercept, another eye injection drug used to treat AMD and DMO, was administered every 8 weeks, while faricimab dosing, based on assessments of the disease activity, allowed for an interval of up to 16 weeks between doses, and was found to be equally effective. Up to 300,000 people in England with wet age-related macular degeneration (AMD) could be eligible to receive faricimab as part of their treatment alongside just over 28,000 people with diabetic macular oedema.

Health secretary Sajid Javid urged people to book a Covid-19 booster shot on Wednesday (December 1) as he said there were 22 confirmed cases of the Omicron virus variant in the country. Javid said the government believed a booster campaign would help protect against severe disease from Omicron, even if it turns out that vaccines are not as effective against the variant as previous strains of the disease. He said he hoped to know more about Omicron within two weeks, as scientists work to understand what impact the new variant will have on transmissibility and serious disease. "At this point in time the case numbers are very low," Javid told Sky News. "For the UK we've got 22 confirmed cases at the moment and that will go up, it will certainly go up." Britain plans to offer all adults a Covid-19 booster shot by the end of January. Government data shows 81 per cent of the population aged over 12 have had two doses of the vaccine while 32 per cent have had a booster shot or third dose.

GlaxoSmithKline and Sanofi said on Wednesday (December 15) they expect data from late-stage clinical trials of its booster dose of their Covid-19 vaccine candidate in the first quarter, instead of this year, another delay for the potential shot. The news came as two companies said preliminary data from trials showed the single-dose booster provided strong immune responses. They added that they need more time to test the booster on more people who have not been infected by the virus before they can submit data to regulators. The Phase III trial for the recombinant adjuvanted Covid-19 vaccine recruited most participants in the third quarter, coinciding with a significant increase in the number of people infected globally due to the Delta variant, it said. "To provide the necessary data to regulatory authorities for the booster vaccine submission, the trial will continue to accrue the number of events needed for analysis, with results expected in Q1, 2022." No safety concerns were identified. This is the latest delay for the vaccine's development, putting the companies further behind rivals in the race for Covid-19 shots.

American biotechnology company Novavax said on Monday (February 28) it would pursue full approval of its Covid-19 vaccine in the second half of this year and forecast total revenue of between $4 billion and $5 billion for 2022. "We expect to gain additional authorizations where we have already filed, including in the US. We will pursue full approval of our vaccine including filing our BLA (biologics license application), in the second half of 2022," CEO Stanley Erck said during a post-earnings call. Novavax late last month filed for emergency use authorization of the shot in U.S. adults, a much-awaited step following months of struggles with development and manufacturing problems. Novavax said it has completed delivery of around nine million vaccine doses to Indonesia, 6 million to Australia and two million to South Korea and expects to supply 69 million doses to Europe in the first half of this year.

The Medicines and Healthcare products Regulatory Agency (MHRA) on Monday (29 January 2024) approved the medicine Rezzayo (rezafungin) to treat invasive candidiasis, an infection caused by a yeast called Candida. Invasive candidiasis can pose a serious health risk as it can affect the blood, heart, brain, eyes, bones and other parts of the body. Napp Pharmaceuticals Ltd was granted the marketing authorisation for the medicine based on phase 3 clinical trial data. In the randomised, double-blind, controlled study, more than half of the invasive candidiasis patients who were given a weekly dose of rezafungin were cured at day 14. Among 94 patients who were given a daily dose of caspofungin (another antifungal treatment), 57 of them were cured during the same time.

Eli Lilly's weight-loss medicine Mounjaro, also known as tirzepatide, will be available in the UK within weeks as a four-dose pre-filled injection pen. The Medicines and Healthcare products Regulatory Agency (MHRA) has approved the drug to treat adults with type 2 diabetes and for weight management in obese patients. Branded as Mounjaro KwikPen, the injection is to be used together with a reduced-calorie diet and increased physical activity, the regulator said. "The public health importance of safe and effective treatments to help manage diabetes and obesity, which can have a significant impact on people's health, is clear. "This approval enables access to the approved Mounjaro pen in a more convenient presentation of a month's treatment, of one dose per week," said Julian Beach, MHRA Interim Executive Director, Healthcare Quality and Access.

Amid the rapid rise in semaglutide usage, a study has suggested a potential risk of a rare eye condition associated with the weight loss drug. Semaglutide, a glucagon-like peptide 1 receptor agonist (GLP-1 RA), is available under the brand name Ozempic (by Novo Nordisk) in a lower-dose form for managing type 2 diabetes mellitus (T2DM), and as Wegovy (also by Novo Nordisk) in a higher-dose form for weight management in patients with high body mass indexes. Anecdotal evidence has indicated that semaglutide might be linked to nonarteritic anterior ischemic optic neuropathy (NAION). To investigate this potential connection, researchers in the United States analysed data over a six-year period from nearly 17,000 neuro-ophthalmology patients at Massachusetts Eye and Ear Hospital in Boston, Massachusetts, all of whom had no prior history of NAION.

Dose the eardoc work? treatment for ear infections - ventilating the eustation tube http://www.eardoc.info

Kate Bingham, the former head of the UK's Covid-19 Vaccine Taskforce who secured millions of doses for the country, said scientists should know within a week whether existing shots are effective against the Omicron variant of the coronavirus. Bingham, a venture capitalist who backed multiple vaccines at the start of the pandemic to secure early access for Britain, said she currently expected that the leading shots would still show efficacy. "The question is do they have the same level of efficacy?" she said on Wednesday. Bingham, who has returned to her role as managing partner at SV Health Investors, said Britain had built up the capability to quickly test existing vaccines against new variants. "It's not something you can do overnight, but we will get data, I would have thought within a week as to whether or not the vaccines work or don't," she said.

Department of Health and Social Care (DHSC) has issued a supply notification for Varicella vaccine (live) powder and solvent for suspension/solution for injection 0.5ml vials (Varivax and Varilrix) until mid-October. AAH have put quotas in place for GPs to limit the ordering of Varilrix and safeguard supplies during this shortage. To override this quota or obtain stock in any other primary care setting (including community pharmacy) a prescription will be required. To obtain stock through the prescription validation system pharmacy will have to contact AAH Quota Management Customer Care team: Online https://www.aah.co.uk/s/quotarequest or by logging into AAH Point https://www.aah.co.uk/s/signin then choose Additional Services and select Quotas. The pharmacy should follow the steps and fill in the required information including their email address. The pharmacy can also call: 0344 561 8899 and select option 3 (quota) The pharmacy will need to have the prescription details available The AAH team will review the request and follow the guidance provided below to validate the prescription and approve the order.

The Pharmacists' Defence Association (PDA) has urged pharmacists working in Covid-19 vaccination role to report any concerns about the needles and syringes supplied with the Moderna Spikevax Bivalent vaccine. The association has heard reports of bending when vaccinators pierce the top of the vial containing the Covid-19 vaccine doses, needles falling out during manipulation and appearing to be bent even before removal from the packaging. PDA has advised its members who are working in a Covid-19 vaccination role "to report any concerns via the Yellow Card medical device reporting system, and to keep up to date with NHS clinical updates for ongoing information and guidance." Current advice from the NHS includes sharing of video and poster resources (available on FutureNHS) which have been produced by the supplier to support the introduction of the new administration needles and syringes for Spikevax Bivalent. This is following a switch from BD Flu+ 23G x 25mm 1ml syringe combined needle and syringe (CNS) to the Owen Mumford Unifine Safety Retractable Needle 25G x 25mm & 1ml Syringe.