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The Medicines and Healthcare products Regulatory Agency (MHRA) has warned the public to avoid buying pre-filled weight loss pens without a prescription. The warning came after 369 fake Ozempic injections have been seized since January 2023. However, Saxenda pens were obtained by members of the public in the UK through "non-legitimate routes". The health regulator has urged the public to buy the pens after consulting a healthcare professional and with a prescription. Dr Alison Cave, MHRA Chief Safety Officer shared her opinion on the matter, she said: "Buying products such as Ozempic or Saxenda without a prescription, from illegally trading suppliers, significantly increases the risk of receiving something which is either fake or not licensed for use in the UK.

Drug shortages have become a global issue, with many countries struggling to maintain a consistent supply of common medications, including antidepressants, immunosuppressants and drugs to treat type 2 diabetes and ADHD. Earlier last month, the British Generic Manufacturers Association (BGMA), the trade body for off-patent medicines, warned that 111 products were facing supply problems, the highest on record in the UK, and more than double the number recorded at the start of 2022. More than half of products affected (55) are branded generic drugs, which represent 10 per cent of prescription products used in the UK. The trade body blamed the escalating rebate rate of the government's voluntary scheme for branded medicine pricing and access (VPAS) for these shortages, but Brexit is also cited as another reason for the problem.

Britain has declined to sign the World Health Organization's (WHO) proposed pandemic accord, citing concerns over the redistribution of vaccines, as reported by The Telegraph on Tuesday. The accord aims to ensure fair distribution of resources during global health crises, including reserving 20 per cent of tests, treatments, and vaccines for distribution in poorer nations. According to media reports the Department of Health and Social Care stated that they would only support the adoption of the accord if it aligns with the national interest and respects sovereignty. However, a DHSC spokesperson refrained from detailing the specific proposals within the accord, emphasising that no agreements had been reached yet. The WHO has not yet responded to requests for comment on this matter.

The British Generic Manufacturers Association (BGMA) on Monday alerted the Health and Social Care Committee that medicines shortages have increased and are "around double what they were a year ago." BGMA chief executive Mark Samuels told the committee that they have been highlighting the medicine shortage risk to ministers since July 2021 and the association is "very concerned" about the current situation. "We've been monitoring it for several years now, and as you saw in the written evidence, shortages have increased. They're around double what they were a year ago. We have them at 101 shortages in February this year," said Samuels. Dr Rick Greville, director of distribution and supply at the Association of the British Pharmaceutical Industry (ABPI), highlighted that the problem of drug shortages in the UK is a "long-standing issue" and the scarcity of certain medications "continues to be challenging".

A recent report by the British Generic Manufacturers Association (BGMA) has shed light on ongoing supply challenges in England's generic medicines market, revealing significant issues impacting patient care. The report highlights significant challenges faced in supply of medicines as currently, 51.72 per cent of generics in short supply lack licensed alternatives, posing substantial hurdles to ensuring continuous patient care. Additionally, 39.08 per cent of affected generics are branded, indicating widespread disruptions across the market. A notable 26.44 per cent of generics experiencing shortages have been affected for over six months, highlighting persistent difficulties in supply chain management. The report indicates that 0.15 per cent of generic medicine presentations listed in the Drug Tariff are currently facing supply issues, impacting accessibility nationwide.

Prince Charles formally opened a new 1 billion pound AstraZeneca research and development (R&D) facility in Cambridge on Tuesday (November 23), as the company aims to fuel the growth of its drug pipeline. AstraZeneca has supplied two billion doses of its Covid-19 vaccine, developed at Oxford University, and is also looking to bring a preventative antibody cocktail against Covid-19 to market. Prince Charles, son of Queen Elizabeth and heir to the throne, saw an exhibit on the pandemic and a demonstration of how augmented reality headsets can help with lab work, before hearing about the company's net-zero targets. "The last two years have been some of the most difficult of a generation," Prince Charles said in a speech.

The NHS is on track to miss out on savings of over a billion pounds as patents for a new lineup of 85 biologics are set to expire within the next five years, the British Generic Manufacturers Association has revealed in its new study. The government's Voluntary Scheme for Branded Medicines Pricing and Access is expected to lead to a cost of more than £1 billion for the NHS in the coming years. The BGMA research found that more than 85 biological medicines will experience loss of exclusivity during the upcoming VPAS Scheme period from 2024 to 2028. "This includes blockbuster products like the cancer medicine Keytruda and wet macular product Eylea, which together generate approximately $25 billion in global sales," BGMA said. "The molecules coming off-patent also cover other disease areas including oncology, diabetes, arthritis, and asthma." While biological medicines dominate the medicines budget, constituting the largest cost and cost growth sectors, NHS England aims to expedite biosimilar availability, yielding substantial savings and expanding patient access to vital treatments. Yet, the report found that "this is jeopardised by the influence of the VPAS Scheme".

The National Health Service will begin its autumn Covid vaccine program next week, a month earlier than planned in response to the spread of a new variant dubbed Pirola. Covid vaccines will be administered to care home residents and housebound individuals from Monday onwards, while over-65s and other vulnerable groups will receive their appointments the week after. On Aug. 30, NHS England shifted the autumn vaccination drive to start on September 11 in response to the new Covid-19 variant, BA.2.86, detected on August 18. The primary groups can book through a national system upon receiving an invitation from the NHS. Some people may get an earlier call from their GP, and a few have already scheduled Covid vaccinations alongside their flu jabs. The NHS will begin inviting other eligible groups from Sept. 18. However, it is important to note that not everyone will receive a call at the same time. These groups will include individuals aged 65 and over, those aged six months to 64 years in a clinical risk category, frontline health and social care workers, and individuals aged 12 to 64 who are carers or household contacts of those with immunosuppression.

The Department of Health and Social Care (DHSC) has added further 28 new products to the list of 'Drugs for which Discount is Not Deducted' (DND) in Part II of the Drug Tariff from 1 August 2022. PSNC said, "It will continue its work to assess whether other drugs and appliances fulfil the current DND entry requirements under either the 'Group' and 'Individual item' criteria and make applications to NHSBSA and DHSC, accordingly." A total of 529 products have been granted DND status following checks made by PSNC within the past 26 months.

Pfizer said on Tuesday it will pay $11.6 billion to buy Biohaven Pharmaceuticals, making a big bet on its ability to boost sales of the top-selling pill in a new class of migraine drugs. The boards of both companies have approved the deal, they said. Biohaven shares jumped 70 per cent to $141.31, while Pfizer was up slightly at $48.83. Pfizer is flush with cash from a once-in-a-lifetime surge in revenue from Covid-19 vaccines and therapeutics and has said it is looking to buy companies or drugs that could add at least $25 billion in annual sales by the end of the decade. "The CGRP oral medications, though still somewhat newer entrants in a deeply entrenched space, continue to make steady inroads in disrupting the broader migraine market in the U.S.," said BioHaven chief executive Vlad Coric. Biohaven forecast Nurtec sales of $825 million to $900 million in 2022. Pfizer said it expects the pills to eventually overtake the shots.

The National Institute for Health and Care Excellence (NICE) has recommended abemaciclib also called Verzenios, made by Eli Lilly, for people with hormone receptor-positive, HER2-negative, node-positive early breast cancer at high risk of recurrence who have had surgery to remove their tumour. The clinical trial result showed that people having abemaciclib with hormone therapy had a more than 30 per cent better chance of their cancer not coming back following surgery compared with people having hormone therapy alone. Helen Knight, interim director of medicines evaluation at NICE, said: "Today's positive draft recommendation, which comes less than a month after abemaciclib received its licence, is fantastic news. The fact that we have been able to produce draft recommendations so quickly is testament to the success of our ambition to support patient access to clinically and cost effective treatments as early as possible. "Until now there have been no targeted treatments for people with this type of breast cancer. Abemaciclib with hormone therapy represents a significant improvement in how it is treated because being able to have a targeted treatment earlier after surgery will increase the chance of curing the disease and reduce the likelihood of developing incurable advanced disease."

AstraZeneca on Wednesday (April 5) said a combination of its cancer drugs Imfinzi and Lynparza met the main goal in a late-stage trial in patients with advanced ovarian cancer. The drugmaker said treatment with a combination of those drugs, along with chemotherapy and bevacizumab - the existing standard of care - improved progression-free survival in newly diagnosed patients with advanced ovarian cancer without certain mutations. Lynparza is jointly developed with U.S.-based Merck & Co as a treatment for breast cancer in early stage with certain mutations. Imfinzi alone, along with chemotherapy and bevacizumab, did not reach statistical significance in its interim analysis, the drugmaker added. Philipp Harter, director, Department of Gynaecology and Gynaecologic Oncology, Evangelische Kliniken Essen-Mitte, Germany and principal investigator for the trial, said: "DUO-O showcases the power of academia and industry collaboration in advancing new treatment combinations for patients with ovarian cancer. I'm grateful for the academic cooperative study groups and patients around the world that made this trial possible and look forward to sharing the results with the clinical community." Susan Galbraith, executive vice president, Oncology R&D, AstraZeneca, said: "While there has been significant progress for patients with advanced ovarian cancer, an unmet need still remains. These data from the DUO-O trial provide encouraging evidence for this this Lynparza and Imfinzi combination in patients without tumour BRCA mutations and reinforce our continued commitment to finding new treatment approaches for these patients. It will be important to understand the key secondary endpoints as well as data for relevant subgroups."

Modulator therapies, manufactured by Vertex Pharmaceuticals (VRTX.O), may no longer be available for new cystic fibrosis (CF) patients in the UK. A draft guidance recently published by the National Institute for Health and Care Excellence (NICE) stated that it would not recommend the use of Kaftrio, Symkevi and Orkambi on new CF patients. Kaftrio and Symkevi are currently recommended for the treatment of cystic fibrosis in patients aged 6 years and older, while Orkambi is used for patients aged 1 and older. The NICE draft guidance highlighted medicine costs and the strain on resources and finances faced by the National Health Service (NHS) as reasons for removing these drugs.

The latest formulation of XGEVA (denosumab) is now available to patients in the UK, offering a more convenient treatment option for bone metastasis. It is the first product to be authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) via the new International Recognition Procedure (IRP). Denosumab (XGEVA) is used to prevent serious bone-related complications resulting from bone metastasis in adults and to treat giant cell tumour of bone in both adults and adolescents. The medicine was authorised on 29 February 2024 as a 120 mg solution for injection in a prefilled syringe. In contrast to the current vial presentation, this simplifies the administration process, reducing the volume of liquid injected and lowering the risk of dosing errors. The product was authorised in 30 days by the MHRA, thanks to the new IRP that facilitated a rapid approval process.

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A daily medication for high blood pressure could be replaced by an injection twice a year, if Queen Mary University and Barts Health NHS Trust succeed in their trail to investigate if an injection-based drug - Zilebesiran - could inhibit the production of a protein called angiotensinogen (AGT). Scientists are to trial a world-first drug to treat high blood pressure that can be given by injection twice a year. Professor Sir Nilesh Samani, medical director, British Heart Foundation, said: "This exciting trial could lead to good news for the millions of people across the UK with high blood pressure, many of whom need to take daily medication to lower their risk of heart attacks and strokes. "The study will determine whether an injection given twice a year lowers blood pressure sufficiently over a prolonged period. "If this proves to be the case, it may provide an alternative to taking daily pills for some patients."

Britain's biotech firm Avacta Group on Monday (January 10) announced halting sales of its Covid-19 rapid antigen lateral flow test AffiDX to replace antibodies in the device and increase its ability to diagnose the Omicron variant. The company stated that AffiDX is capable of detecting Omicron when the virus is present in high numbers in samples, but the sensitivity of the test reduces at lower viral loads. The performance of all rapid antigen tests came under scanner in wake of a large number of mutations in the Omicron variant. AffiDX contains both a proprietary Affimer reagent and a commercially available antibody. The Affimer reagent detects the Omicron variant with the same sensitivity as the Delta variant, and performance of the antibody is paired with the Affimer reagent in the test. This has been affected by the additional Omicron mutations, the firm said. Alastair Smith, chief executive of Avacta Group, said: "Our determination to only provide high quality, high performance diagnostic tests has led us to the correct decision to pause all marketing of the AffiDX® lateral flow antigen test. We have, of course, been unable to market the product in the UK since October 2021, as the product continues to await approval under the new CTDA regulatory process.

It is not sustainable to give Covid-19 booster shots every three to six in the long term, Britain's chief scientific adviser said on Tuesday (January 4), even though the booster rollout is needed in the short term to combat the Omicron variant. "It would be a situation that isn't tenable to say everyone's going to need to be having another vaccine every three or six months. "That's not the long-term view of where this goes to," Patrick Vallance said at a news conference, adding that annual booster shots against Covid-19 might be necessary, similar to flu shots.

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.