Group items tagged

Proposed changes to a European Union pharmaceuticals law will include stronger obligations for the supply of medicines and earlier notifications of shortages, EU Health Commissioner Stella Kyriakides said last week (January 17). Kyriakides told a session of the European Parliament that shortages of antibiotics are a growing problem for many European countries. She said the European Commission's proposal to revise the pharmaceuticals legislation is planned for March. "Our objective is and remains to secure access to medicines for all patients in need and to avoid any market disruption of medicines in the EU," Kyriakides said. Shortages of antibiotics have been reported in 26 European countries, the European Medicines Agency says. The unseasonably early upsurge in respiratory infections in Europe this winter and insufficient production capacity are the root causes of the shortages, Kyriakides said. Numerous EU lawmakers speaking at the session said the shortages needed to be tackled urgently. But experts say shortages of essential generic medicines like antibiotics are likely to be recurrent in Europe due to problems in the sector such as the gradual migration of generic manufacturing to Asia.

The European Commission launched an initiative to deal with the ongoing supply crisis on Tuesday (24 October). The following announcement comes after the shortage of key antibiotics last winter identified by the European Health Emergency Preparedness and Response Authority (HERA) and the European Medicines Agency (EMA). The "European Voluntary Solidarity Mechanism" is a proposed short-term measure that involves a Member State's need for a given medicine to other Member States to redistribute medicines from their available stock. Additionally, the Commission intends to cooperate with member states to improve components of pharmaceutical reform with an aim to strengthen supply security. They are setting up a few actions apart from the launch, a list of critical medicines to analyse the supply chain by early 2024; regulatory flexibilities; strengthening security of supply; and availability of antibiotics and treatments for respiratory viruses by next winter.

The European Commission said on Wednesday it would allocate 1.23 billion euros ($1.3 billion) to mental health initiatives across the 27-member European Union and make mental health a pillar of health policy. "Today marks a new beginning for a comprehensive, prevention-oriented and multi-stakeholder approach to mental health at EU level," Stella Kyriakides, EU Commissioner for health and food safety, said in a statement. "We need to break down stigma and discrimination so that those in need can reach out and receive the support they need. It is OK not to be OK, and it is our duty to ensure that everyone asking for help has access to it." The Commission said mental health problems already impacted around 84 million people before the COVID-19 pandemic with an economic cost of about 600 billion euro a year, or 4% of the bloc's GDP. The situation has deteriorated since the pandemic with the war in Ukraine, climate change anxiety and the rising cost of living due to soaring inflation. At a press conference, Commission vice-president Margaritis Schinas called it a "silent epidemic" and said the topic was the last piece in the European Health Union "puzzle".

The European Union's health regulator on Friday said it had recommended granting a conditional marketing authorisation for a gene therapy by Australian drugmaker CSL Ltd and partner uniQure N.V. , to treat haemophilia B, a rare bleeding disorder which is caused by genetic anomalies. About one in 40,000 people are affected by the inherited disorder, caused by a gene mutation that hampers the body's ability to make clotting protein factor IX. If approved, the treatment, branded Hemgenix, will be the first gene therapy in the European Union for the condition that is usually treated by regular injections of factor IX, the European Medicines Agency said. CSL had acquired exclusive global rights to Hemgenix in May last year from uniQure N.V.

The European Commission is prepared to rewrite European Union law on medicines to ensure stable supply of generic and life-saving medicines in Northern Ireland. In a press statement issued on Friday (Dec 17), the commission said it put forward a package of measures to ensure the continued long-term supply of medicines from Great Britain to Northern Ireland. In the context of the Northern Ireland Protocol, this means that the same medicines will continue to be available at the same time across the United Kingdom. Commenting on the news, policy manager at the National Pharmacy Association (NPA) Helga Mangion said: "We are encouraged by the EU's statement on medicines availability in Northern Ireland, though of course we await the final outcome of the negotiations. We have been talking to the government, the MHRA and other stakeholders about these issues for months, highlighting the concerns of our members in Northern Ireland."

Adding to the growing evidence of global medicine shortages, a new study has revealed that the European generic medicines market is "not in shape" to help Europe meet its public health priorities. In the past decade, the rate of generic medicines withdrawals has risen by 12 per cent, while there has been a three per cent decrease in the launch of generic products, as per Teva Pharmaceuticals' recent analysis of IQVIA data. Within the mental therapeutic area, seven per cent of generic products disappeared between 2013 and 2023, while there was a seven per cent decrease in the availability of generic cancer medicines in just six years (2017-2022). These medicines were listed on the Union List of Critical Medicines to help avoid potential shortages, as the European Commission (EC) said this could cause "significant harm to patients and pose important challenges to health systems." While mature generic products constitute the majority of the List, they remain susceptible to withdrawals, despite containing products crucial for safeguarding Europe's public health, the Teva analysis report noted. Since 2013, the number of generic products for the treatment of schizophrenia and bipolar disorder has declined by 25 per cent, with Hungary and Bulgaria experiencing the biggest loss at 83 per cent and 58 per cent respectively.

The European Parliament on Thursday adopted a proposal from Brussels to ensure the continued supply of medicines from Britain to Northern Ireland - an issue that had dogged the bloc since London left it. "Great news from the @Europarl_EN today with the overwhelmingly positive vote to ensure the continued supply of medicines to Northern Ireland," tweeted Maros Sefcovic, European Commission vice president who had been leading discussions with London. "The EU is delivering on this lasting solution for Northern Ireland in record time," he added, though the EU Council must give final approval. Britain itself has yet to give formal approval on a move that would avoid potential disruption of supplies as London wants an overall accord for matters pertaining to the Northern Ireland protocol governing post-Brexit trade.

Aspen has committed not to charge more for its six generic cancer drugs for the next 10 years in the UK, according to the Competition and Markets Authority (CMA). The CMA also clarified that "although these commitments were offered while the UK was a part of the European Union" they remain "legally binding". It added: "The CMA has now assisted the NHS to secure binding undertakings from Aspen, under the law of England and Wales, which enshrine the UK elements of the commitments and are enforceable by UK courts, including in relation to the supply of these drugs in Northern Ireland and Scotland." This allows NHS to monitor and ensure compliance by Aspen following the UK's exit from the EU. In 2017, the European Commission began an investigation into Aspen over concerns that the company had engaged in excessive pricing for 6 off-patent cancer medicines.

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.

AstraZeneca said on Monday (June 27) two of its existing therapies were recommended for treating patients with some forms of high-risk breast cancers in the European Union, in a boost to the company's oncology portfolio. Lynparza, a cancer drug developed jointly with U.S.-based Merck, was backed for standalone use or in combination with endocrine therapy in adults with a form of genetically mutated early-stage breast cancer. The drug, which has received a similar recommendation in the United States in March, is a key asset for AstraZeneca. It was recommended in patients with low-to-normal levels of a protein known as HER2 that is the target of several new therapies. Enhertu - developed jointly with Japan's Daiichi Sankyo (4568.T) - was the other drug that was endorsed by the European Medicines Agency for treating an aggressive form of breast cancer characterised by a high rate of HER2.

The drug, alpelisib, which is the 100th cancer drug that has being fast-tracked to patients under the NHS Cancer Drugs Fund (CDF) will be used in combination with the hormone therapy, fulvestrant, to target the gene that causes fast-growing tumours. Up to 3,000 people a year with a certain type of secondary breast cancer will benefit from the treatment. The approach has contributed to people in England having access to nearly one third more cancer drugs compared to the European average. The drug which is manufactured by pharmaceutical company Novartis, is part of a growing number of precision treatments that target a tumour based on mutations in its DNA and that the NHS is rolling out. John Stewart, NHS National Director for Specialised Commissioning said, "In just over five years, more than 80,000 people have benefitted from earlier access to a range of cancer drugs, with people in England having access to nearly one third more cancer drugs compared to the European average, and this latest innovative new treatment will help up to 3,000 more to live a better quality of life.

Japanese drugmaker Eisai said on Tuesday (January 10) it had submitted a marketing application to the European health regulator for review of its Alzheimer's drug lecanemab, which was recently granted accelerated approval in the United States. The drug, developed in partnership with Biogen, is an antibody that has been shown to remove sticky deposits of a protein called amyloid beta from the brains of those in the early stages of the mind-wasting disease. Nearly all previous experimental drugs using the same approach have failed. The company's application to the European Medicines Agency is based on results from a late-stage study in which the drug was shown to slow down the rate of cognitive decline in patients with early Alzheimer's by 27 per cent, compared with a placebo. Eisai also reiterated its plans to apply for marketing authorization of the drug in Japan by the end of its business year on March 31.

The European Association of Hospital Pharmacists (EAHP) published a shortage supply report on 17 October. They have officially stated that the shortage has resulted in care delays affecting 58 countries in their recent survey. It has been found in the report that 59 per cent of pharmacists said medicines shortage had delayed patient care, whereas 43 per cent confirmed it resulted in suboptimal treatment and 35 per cent said that it had led to the cancellation of care. András Süle, president of the EAHP spoke on the findings of the report, saying: "Problems caused by medicine shortages remain serious, threaten patient care in hospitals and require urgent action".

Community pharmacies must be involved in future planning for public health emergencies, especially in cases where a quick response is needed such as the Covid-19 pandemic, a European-wide research has recommended. The project, co-led by the University of Huddersfield professor Zaheer-Ud-Din Babar in medicines and healthcare, focuses on how community pharmacies dealt with the pandemic, covering 31 pharmacy interventions on Covid-19 in 32 countries in Europe. The interventions include prevention, response, and recovery measures. It also covers improved access to medicines, expanded powers granted to pharmacies, rapid antigen testing, along with Covid-19 vaccination. Community pharmacists in the US, Canada, and Australia have been engaged in pandemic prevention, preparedness, and response strategic guidance after the 2009 flu pandemic. The aim of the research is to map the current reported practice and trends and review the pharmacies' intervention in Europe.

Tynor Foot Drop Splint Right/Left Applications Prevention and correction of foot drop. Peripheral nerve paralysis. Nerve/Muscle damage. Ankle or Plantar flexion contracture. Functional Alignment of the foot. Post operative care. Burn patients. Tynor Foot Drop Splint Right/Left Features Effective foot lift. Strong leaf spring action. Customizable. Thin walled, worn in a shoe. Tynor Foot Drop Splint Right/Left Measurements Measure shoe size Size Chart - Sizes European American Small 34-36 2.8-4.4 Medium 37-39 5.3-6.8 Large 40-42 7.5-9.0

The history of surrogate motherhood goes back to biblical times. In fact, some people say it dates back to Sarah and Abraham. Certain people say that it started even before them, and that it is only recorded about Abraham because he was written about in the Bible. In many countries, surrogacy has been around since before records. Many cultures have belief systems that abide with the rules of surrogacy and those that do not agree can be thrown out of their families. Numerous religions and civilizations will actually celebrate the surrogate mothers, for their good deeds and service to others. During the 1980's surrogate mothers were used by the gay community to build their families, then, it was frowned upon by society. The American Indians were the first ones to truly begin the surrogate mother history in this part of the world. So we are looking back to the 1899's for the beginning of this part of the story. If an Indian woman was found to be infertile, then her husband would go to the chief of his tribe and ask for help. He would then be sent to see the medicine man, who would give the wife certain herbal concoctions. Then, after the witch doctor said nothing could be done to help his wife, the husband would go to see the chief. He would be allowed to take another woman and make her pregnant, hopefully, so that he would be able to father a son to carry on his tribe. The barren wife would have no relations with the child. He would stay with his birth mother. The American Indians were not the only civilization to use surrogate mothers to carry on the family name and bloodline. Back in recent European history it has been heard of, especially in Spain for kings to take in several surrogate mothers until he was born a son. The surrogate mother of the child would then become nanny to all of the royal children. The children would believe themselves to be genetically related to the king and queen. Never knowing the truth. Obviously, things like this were kept secret, bec

Medical tourism is growing by leaps and bounds as people realize the benefits of cost saving and excellent treatment they receive in countries other than their own. People from the CIS, for instance, had to look to European countries like Germany, France and the UK for treatment and in all these countries the treatment is expensive not to speak of stay and travel. Asian countries like India, Thailand and Sri Lanka are proving to be the better alternatives. The deterrent is how to find the best facility at the best cost and proceed. This is where a healthcare facilitator steps in and takes care of everything much to the relief of the patient and his family. The vital bridge Healthcare facilitators act as the vital bridge between the patient and the treatment facility that matches their needs. If you are in the US, UK, Australia, the CIS countries or in any African country and wish to find the best facility in India, for instance, the facilitator is the one to get in touch with. They maintain database of hospitals and surgeons across the country, know their specialization and how much treatment can cost. Healthcare facilitators put you in touch with a medical institution that will give the best in terms of quality of treatment and cost. They do this by first going through your medical records and getting their panel of medical experts to match the ailment with a hospital. Patients get the benefit of expertise and save time and a great deal of money in the process. Patients receive invaluable assistance in: * Travel to the hospital * Scheduling appointments * Recommendations so that they receive personalized care * Supervision by the facilitator's own doctor to ensure that everything is being done right and, if not, patients may be switched to another hospital * Assistance with documentation and paper work * Assistance with procurement of medications * Negotiating the best rate with discount for stay and treatment * Assistance to family members

A large-scale European trial has indicated that frozen embryo transfers fail to deliver any improvement over fresh transfers during the in vitro fertilisation (IVF) process.

ImmunoGen has presented full data from the Phase III Forward I study of mirvetuximab soravtansine in ovarian cancer at the European Society for Medical Oncology (ESMO) 2019 Congress in Barcelona, Spain, saying that it failed to meet the primary endpoint of progression-free survival (PFS).