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The National Institute for Health and Care Excellence (NICE) has released conclusive draft guidance, suggesting Pfizer's Vydura (rimegepant) as a choice for treating acute migraines in adults with or without aura. However, there is a caveat. This recommendation applies exclusively to individuals with a prior history of migraines, meeting one of the following criteria: At least 2 triptans were tried and they did not work well enough or Triptans were contraindicated or not tolerated, and nonsteroidal anti-inflammatory drugs (NSAIDs) and paracetamol were tried but did not work well enough. This drug was developed by the US-based Biohaven Pharmaceuticals, acquired by Pfizer in 2022, in an $11.6 billion deal. Nurtec ODT is the commercial name for the drug in the US, while the European Union approved the drug under the name Vydura in April 2022. NICE recommended rimegepant, an oral lyophilisate (dissolving wafer) and the first oral calcitonin gene-related peptide (CGRP) receptor antagonist for acute migraine treatment, to be taken at the onset of a migraine attack. Migraine affects one in seven people in the UK, often with a debilitating impact, Pfizer UK said in a statement. The condition entails symptoms such as head pain, vomiting, nausea, altered vision, fatigue, and heightened sensitivity to light, sound, and odours.

Instability in the supply chain network is frequently undermining the profit margins in community pharmacies, former Pharmacy Minister and Chair of the Health and Social Care Committee Steve Brine has said. Brine emphasised that community pharmacies often lack information about the prices wholesalers charge for essential generic medications. "They lack visibility into scarcity, and the pricing of these products is often significantly higher compared to other European countries," the former minister remarked during a parliamentary debate focused on the future of community pharmacies on September 14. From financial pressures to workforce crisis and pharmacy closures, the debate delved into critical challenges faced by pharmacies, aiming to propose tangible solutions for a sustainable future in the sector. Chaired by Sir Mark Hendrik, the debate was initiated by Conservative MP Peter Aldous and featured contributions from a host of participants including Labour MPs Taiwo Owatemi and George Howarth among others.

Essential Pharma, an international speciality pharma group, has procured an establishment and manufacturing licences in Switzerland and Malta. Following a successful inspection by Swissmedic, the company has been granted an establishment licence in Switzerland, which will allow the company to significantly enhance its supply chain efficiency for a wide range of important medicinal products. It will apply to transactions for both finished and unfinished pharmaceuticals, allowing importing, exporting, wholesaling and trading abroad. Essential Pharma has also received a manufacturing and importation authorisation (MIA) in Malta, following a successful Good Manufacturing Practice (GMP) inspection by the Malta Medicines Authority. The MIA will allow the company to import medicinal products into the European Union where manufacturing has taken place in a third country. This will allow greater flexibility in how the business manages the flow of medicines across its territories. These approvals strengthen the company's geographical expansion, improve its operational efficiencies, and enhance its offering as a global business partner. They will also provide new strategic opportunities for the company and will play a fundamental role in driving value creation through functional improvements to scale and productivity.

In a mutual agreement with the STADA board, Roger Scarlett-Smith has stepped down from his role as head of UK. The company has assigned the responsibility of UK operation to Rudolf Bär with current responsibilities as cluster head for Mid-Sized European Markets. Scarlett-Smith joined STADA in October 2018 to lead the UK operation upon the retirement of Dieno George. Prior to this, he had enjoyed an illustrious career in the Consumer Healthcare sector, largely with GlaxoSmithKline, for which he held positions including as President North America, President EMEA and Head of Global Categories. Under his leadership, the STADA UK business has grown sales by 50 per cent and profitability has more than doubled. He has reshaped the business to improve efficiency. There has been a marked acceleration of product innovation including key line extensions to the Zoflora disinfectant range as well as the introduction of a salmeterol and fluticasone inhaler in the Rx respiratory sector. Meanwhile, T+R has developed a fine reputation regionally, being voted number 1 regional company last year and winning many national industry awards.

Glenmark, a multinational pharmaceutical company, has partnered with AI data-driven supply chain management platform 7bridges. Initially focusing on their European business, where they have operations in 15 markets, the supply chain and logistics function is a big focus area for this cost reduction. The partnership with 7bridges will allow Glenmark to baseline their supply chain data giving them visibility of data, cost and service performance across their network of logistics service providers. This exercise will identify areas where invoices from their logistics service providers are being incorrectly or overcharged. With automatic dispute raising, savings will be quickly achieved. The platform will then enable Glenmark to benchmark their data, so they can compare the performance and cost of their LSPs to the wider industry. With Glenmark's global vision to emerge as a leading integrated research-based global pharmaceutical company, this investment in their supply chain will be integral to achieving this. The next step in the partnership will be to run simulations to optimise road freight services and 3PL operations, with the aim to then roll out globally.

Alphega Pharmacy Oncology Support Programme allows community pharmacists from six European countries to enhance support and guidance they provide to cancer patients. The programme aims to help upskill pharmacists and their teams to provide more expert advice to patients living with cancer, raising their profile in the community as key healthcare providers. Enhancing knowledge amongst community pharmacists about cancer treatment and its side effects is vital as cancer cases are set to increase if current trends continue. The programme covers practical help topics, such as oral care, nutrition advice and skin, hair and nail care among others, helping patients to get more of the support they need because community pharmacists are easily accessible, rather than needing to book a GP or consultant appointment. With rates of cancer forecast to rise throughout Europe , and cancer patients likely on average to visit hospital less often, community pharmacists are well-placed to look to support cancer patients with managing the side-effects of their treatment.

The European Union's population shrank for a second year running last year, the bloc's statistics office said on Monday, as the region reels from over two million deaths from the coronavirus. According to Eurostat, the population of the 27 countries that make up the bloc fell by close to 172,000 from the previous year and over 656,000 from January 2020. "In 2020 and 2021 the positive net migration no longer compensated for the negative natural change in the EU and, as a consequence, the EU total population has been decreasing," it said, pointing to impacts from the pandemic. The number of deaths began outstripping births in the EU a decade ago, but immigration from outside the bloc helped offset the gap until the first year of the pandemic. The previous time the EU had registered a fall in population was in 2011 - the only other time since 1960 - but this rapidly picked up due to net migration.

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.

The Swiss competition commission (COMCO) has opened an investigation of Novartis over possible unlawful use of a patent to reduce competitive pressure, the Swiss drugmaker confirmed on Thursday, September 15. COMCO conducted an early morning raid on the company on Sept. 13, it said in a statement that did not name Novartis, which subsequently said in its own statement that it was the group under investigation. "The company allegedly attempted to protect its drug for the treatment of skin diseases against competing products by using one of its patents to initiate litigation proceedings," COMCO said in a statement. Novartis said COMCO had started an investigation in collaboration with the European Commission into the assertion of a patent in the broader field of dermatology treatments. "In connection with this investigation, COMCO representatives visited the company headquarters in Basel," it said.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approving an oral therapy to treat myelofibrosis patients with moderate to severe anaemia. Myelofibrosis is a rare blood cancer that affects the body's normal production of blood cells, and the affected patients are likely to develop anaemia over the course of the disease. British drugmaker GSK, the manufacturer of the oral therapy known as momelotinib, said that it can be used to treat "both newly diagnosed and previously treated myelofibrosis patients." The medicine helps address disease-related splenomegaly (enlarged spleen) or symptoms in adult patients who are Janus kinase (JAK) inhibitor naïve or have been treated with ruxolitinib, as stated by the company. Nina Mojas, Senior Vice President of Oncology Global Product Strategy at GSK, said that receiving the positive CHMP opinion "is a significant step in bringing momelotinib to patients in the EU with this difficult-to-treat blood cancer."

The global company in information and data analytics, Elsevier launched a platform, PharmaPendium for drug candidates. It is an effective tool that provides data including complete Food and Drug Administration (FDA) and European Medicines Agency (EMA) approval packages for drug development. The platform is supported by the FDA, the Medical Devices Agency (PMDA) and the top 20 global pharma companies. Olivier Barberan, Director of Translational Medicine Solutions spoke about how "improved access to highly relevant data plus predictive tools enhances regulatory success, safeguarding the massive investments of pharma companies." "Translation of preclinical research findings to humans in an efficient but safe way is one of the greatest challenges facing drug developers. We designed the new PharmaPendium to solve this," he added.

Two new subvariants of Omicron - BA.4 and BA.5 - are spreading much faster than other corovanirus variants in Europe, which could lead to more hospitalisations and deaths as they become dominant, the EU's disease prevention agency said on Monday (June 13). Most EU countries have so far detected low rates of the two subgroups. But in countries where the proportion has risen - such as Portugal, where BA.5 accounted for 87 per cent of cases by May 30 - there have been surges in overall cases, according to the European Centre for Disease Prevention and Control (ECDC). The two sublineages were added to the World Health Organization's monitoring list in March and have also been designated as variants of concern by the ECDC. Variants BA.4 and BA.5 do not appear to carry a higher risk of severe disease than other forms of Omicron.But an increase in case numbers from higher transmission rates risks leading to an increase in hospitalisations and deaths, the agency said. "The growth advantage reported for BA.4 and BA.5 suggest that these variants will become dominant," ECDC said in a statement on its website.

French drugmaker Sanofi said on Monday (June 13) an upgraded version of the Covid-19 vaccine candidate it is developing with GSK showed potential in two trials to protect against the virus's main variants of concern, including the Omicron BA.1 and BA.2 strains, when used as a booster shot. While the two companies' first experimental Covid shot is undergoing review by the European Medicines Agency, Sanofi and GSK have continued work on a vaccine that is moulded on the now-supplanted Beta variant, hoping still that it will confer broad protection against future viral mutations. Sanofi said this new vaccine candidate was shown to significantly boost antibody levels against a number of variants of concern, when given to trial participants who had an initial course of mRNA vaccines, a type made by BioNTech-Pfizer and Moderna. In a separate trial conducted by a French hospitals network, Sanofi's Beta-adapted booster shot triggered a higher immune response than Sanofi's first-generation shot or Pfizer-BioNTech's established vaccine in previously vaccinated volunteers.

When Ignasi Biosca-Reig heard there were shortages of amoxicillin in Spain, he quickly added shifts at his drug company's factories to boost production of the popular antibiotic. But a few extra shifts was as far as he could go. Much as he would have liked to significantly increase supplies, Biosca-Reig said he couldn't justify investing millions of euros in new production lines unless he was paid more for the generic drug to cover sharply rising costs. But, like many other European countries, Spain set the price manufacturers are paid for paediatric amoxicillin when the generic version of the drug was first launched in the country two decades ago, and it has barely budged since. "It's a non-business," said Biosca-Reig, chief executive of Spanish drugmaker Reig Jofre. "We wanted to react, but we had a problem," he said. "The costs go up, the price remains the same."

Northern Ireland will see changes in the regulatory landscape following the issuance of the Windsor Framework on 27th Feb 2023 and the corresponding EU Commission proposal. An agreement, in principle, has been reached by the UK and EU. The new path forward of the Windsor Framework marks a turning point in how both the UK and the EU will work together collaboratively and constructively to ensure that the same medicines are available in Northern Ireland at the same time as they are in the rest of the United Kingdom. Whilst this is a successful result for Northern Ireland patients, this is major change for companies that have made specific provisions in their supply chains for Northern Ireland. The supply chains of companies where provisions and changes were made such as introduction of GB specific pack may be impacted as a result. However, the burden on the UK Pharma supply chain will be eased. Prime Minister Rishi Sunak walks with European Commission chief Ursula von der Leyen in Windsor on February 27, 2023 Pharma companies will need to carefully consider making changes within their processes and supply chains pending the issuance of clear guidance from the MHRA on the regulation changes resulting from the Windsor Agreement and the corresponding EU Commission proposed regulatory changes associated with medicinal products within the Northern Ireland market. Smooth access to the EU market for Northern Ireland pharmaceutical and medical technology firms has been safeguarded within the constraints of the agreement. The pragmatic dual-regulatory system protects business, patients and healthcare services, and reflects that it is an essential state function to maintain and oversee the supply of medicines within the whole United Kingdom.

From over-the-counter flu tablets to crucial antibiotics and antidepressants, medicines are running scarce in UK pharmacies this year, causing concerns among patients, the government, and the wider pharma industry. Drug shortages have accelerated over the past year due to a clutch of problems including the after-effects of the pandemic on supply chains, the war in Ukraine, and soaring input costs weighing on manufacturers. More recently, a sudden spike in respiratory infections - another by-product of Covid-19 that neither pharma companies nor the government were able to predict - has deepened the crisis, with 70 commonly taken drugs out of stock in Britain as of February. The problem is not unique to the UK. In a recent survey of groups representing pharmacies in 29 European countries, three quarters said shortages were worse this winter than a year ago, with a quarter reporting more than 600 drugs in short supply. The US is also facing significant shortages of popular prescription drugs like amoxicillin and Adderall, an ADHD medication. To some extent, the current disruption is laying bare wider challenges facing the industry for several years that were only exacerbated by the pandemic. The over-reliance on foreign suppliers for most active pharmaceutical ingredients (APIs) is one of them. This model has left companies more susceptible to supply shocks, which have in turn increased in frequency and severity due to pandemic lockdowns, the war in Ukraine and other issues such as the shortage of shipping containers. Pharma's long and opaque supply chains, alongside regulatory complexities, also mean it is taking longer for drugmakers to reconfigure manufacturing and distribution in times of additional need.

At the European Conference of Clinical Microbiology & Infectious Diseases (ECCMID) this year in Copenhagen, Denmark, data on a test that may detect HIV, hepatitis B, and hepatitis C from a single drop of blood are being presented. Hepatitis B or C claim the lives of over a million people each year. Every year, 1.5 million individuals contract HIV, and 650,000 people pass away from HIV-related causes. The World Health Organisation has made the elimination of all three viruses by 2030 one of its global health strategies but new tests are necessary if case numbers are to be reduced. The most common test for hepatitis B, hepatitis C and HIV involves taking a blood sample from a vein using a needle. While this method works extremely well, there is a potentially large reservoir of the three conditions in places where this method is not suitable. This could be prisons, drug rehabilitation centres and homeless shelters, where the taking of venous blood samples isn't always suitable or countries in which the shipping and refrigerated storage of blood samples can be challenging. Alternatives include dried blood spot tests, in which a single spot of blood is tested for nucleic acid from the three viruses.

The Medicines and Healthcare products Regulatory Agency (MHRA) made its new International Recognition procedure (IRP) fully operational from 1 January 2024, inviting developers of new medicines to submit their applications for marketing authorisation. Beginning this year, the EC Decision Reliance Procedure (ECDRP) has been replaced by IRP, and the Mutual Recognition/Decentralised Reliance Procedure (MRDCRP) has come under its umbrella. The move is expected to further improve access to life-saving medicines for UK patients following the UK's departure from the European Union.

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 Medicine and Healthcare products Regulatory Agency (MHRA) has cautioned men on valproate to talk to their healthcare professional about their treatment, if they want to start a family in the next year. The warning came after a new study, commissioned by the European Medicines Agency, suggested that children fathered by men who took the anti-seizure medicine in the three months prior to conception may be at higher risk of developing neurodevelopmental disorders. Around five in 100 children born to fathers treated with valproate around conception were diagnosed with a neurodevelopmental disorder, compared to three in 100 children whose fathers were taking other antiseizure medicines (lamotrigine or levetiracetam). However, the risk is believed to be much smaller than the risk associated with valproate in pregnancy.