Top related persons:
Top related locs:
Top related orgs:

Search resuls for: "Healthcare Products Regulatory Agency"


23 mentions found


All four drugs are in a class of wildly popular weight loss drugs known as GLP-1s. In the United Kingdom, authorities last year seized hundreds of counterfeit Ozempic pens — insulin pens that had been relabeled as Ozempic. Counterfeit weight loss drugs have serious health risks, according to the pharmaceutical companies and federal officials. Counterfeiters are already trying to cash in on a weight loss drug that the company hasn't even put on the market yet: retatrutide. But it's also one of the epicenters of the lucrative counterfeit drug trade, according to U.S. authorities who track counterfeit drugs.
Persons: It's, , Eli Lilly's Mounjaro, they've, Laver, Andy Morling, CNBC Morling, Eli Lilly, Daniel Skovronsky, Eli Lilly's, we'll, Skovronksy, John F, Sal Ingrassia, Ingrassia, Customs isn't, we've, Yoav Keren, GLP, TikTok, Keren, BrandShield, it's, Nicole Johnson, CNBC Johnson, Johnson, Mike Doustdar, Doustdar, Direnc Bada Organizations: CNBC, U.S, Laver Beauty, DHL, Novo Nordisk, Laver, Medicines, Healthcare Products Regulatory Agency, Lilly Research Labs, Kennedy International, JFK International Mail Facility, U.S . Customs, Border Protection, JFK, CBP, Protection, CNBC CNBC, FDA, Customs, Meta, Facebook, World Health Organization, U.S ., Intellectual, Coordination Center, National, Turkish National Police, Novo Nordisk's, CNBC Counterfeiters, CNBC FDA Locations: BOULDER, COLO, Boulder, Ozempic, Shijiazhuang, China, Beijing, Englewood Cliffs , New Jersey, United Kingdom, London, New York City, U.S, Turkey, Europe, South America, United States, India, Mexico, Istanbul, Zurich
LONDON — The U.K.'s health regulator on Tuesday approved the use of Novo Nordisk 's Wegovy weight loss drug to reduce the risk of overweight and obese adults suffering from serious heart problems or strokes. The new approval from the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) makes the Danish pharmaceutical giant's GLP-1 obesity drug the first in the country to be prescribed for prevention of cardiovascular events in people with obesity. It follows similar label expansion by the U.S. Food and Drug Administration in March. Shares of Novo Nordisk were up after the announcement, trading 1.46% higher by 4:10 p.m. London time after pushing higher for much of the session. The MHRA's deputy director of innovative medicines, Shirley Hopper, said the decision marked an "important step forward" in combatting the effects of obesity.
Persons: Shirley Hopper Organizations: Novo Nordisk, Medicines, Healthcare, Agency, U.S . Food, Drug Administration Locations: London
CNN —The United Kingdom has become the first country to give regulatory approval to a medical treatment involving the revolutionary CRISPR gene editing tool. The treatment, made by Vertex Pharmaceuticals, is administered by taking stem cells out of a patient’s bone marrow and editing a gene in the cells in a lab. “Modifying the stem cells from the bone marrow of the patient avoids the problems associated with immune compatibility, i.e. The release from the MHRA did not say how much the treatment would cost, but it’s likely to be expensive. CRISPR-Cas9 has had a major impact on biomedical research, clinical medicine and agriculture and is widely used in labs around the world.
Persons: , , Julian Beach, , — Emmanuelle Charpentier, Jennifer A, Doudna —, Casgevy, Alena Pance, ” Pance, Cas9, Jiankui Organizations: CNN, country’s Medicines, Healthcare, Agency, Beta, Vertex Pharmaceuticals, US Food and Drug Administration, University of Hertfordshire, Science Media Centre Locations: United Kingdom, South Asian
CNN —Britain’s health agency is warning the public not to buy pre-filled pens claiming to contain the weight loss drugs Ozempic and Saxenda without a prescription, after a small number of people were hospitalized. Ozempic is used to treat adults with type 2 diabetes, and is used off-label for weight loss. More than 350 potentially fake Ozempic pens have been seized since January of this year, according to the MHRA. The agency has also received reports that patients have obtained fake Saxenda pens in the UK through “through non-legitimate routes.”No fake weight-loss pens were seized before January 2023, the agency says. The maker of both drugs, Novo Nordisk, told CNN Thursday that it is aware that counterfeit pens are being circulated.
Persons: Ozempic, ” Allison Schneider, Dr, Sanjay Gupta, Alison Cave, ” Ozempic, , Meg Tirrell Organizations: CNN, Medicines, Healthcare, Agency, Novo Nordisk, , “ Novo Nordisk, General Pharmaceutical Council, Get CNN, CNN Health, European Medicines Agency, European Union Locations: Ozempic, “ Novo, Novo, Germany, Europe
Homeland Security, as well as companies that help identify counterfeit products such as Israel’s BrandShield. Fake weight-loss drugs will be a key focus in the agency’s annual counterfeit medicines report, due next year, the official said. “We have counterfeit products and stolen products,” the official said. "We will look online and if we find something that infringes (obesity drug trademarks) we'll get it taken down,” said Yoav Keren, BrandShield CEO. When a consumer buys those fakes, “what you get are expired drugs, counterfeit drugs, or nothing,” he added.
Persons: George Frey, Eli Lilly, BrandShield, Novo’s Ozempic, , Jim Mancuso, Mancuso, Europol, Novo, Lilly, , Ozempic, Yoav Keren, MHRA, Eli, Mounjaro, Patrick Wingrove, Aurora Ellis Organizations: Novo Nordisk, Pharmacy, REUTERS, Novo Nordisk’s, Pharmaceutical Security Institute, drugmakers Novo Nordisk, Europol, Interpol, U.S . Homeland Security, U.S . Food, Drug Administration, U.S . Department of Homeland, Coordination Center, PSI, Medicines, Healthcare, Agency, Health Organization, Ireland’s, Products Regulatory Authority, Reuters, Thomson Locations: Provo , Utah, U.S, America, Europe, Germany, Egypt, Russia, North America
[1/2] A vial and sryinge are seen in front of a displayed Moderna logo in this illustration taken January 11, 2021. REUTERS/Dado Ruvic/Illustration/File Photo Acquire Licensing RightsSept 6 (Reuters) - Moderna (MRNA.O) on Wednesday said clinical trial data showed its updated COVID-19 vaccine will likely be effective against the highly-mutated BA.2.86 subvariant of the coronavirus that has raised fears of a resurgence of infections. The Omicron offshoot carries more than 35 mutations in key portions of the virus compared with XBB.1.5, the dominant variant through most of 2023 and the target of the updated shots. Moderna said it had shared the new finding on its vaccine with regulators and submitted it for peer review publication. European regulators have since backed the Pfizer/BioNTech shot, with Britain's Medicines and Healthcare products Regulatory Agency approving the vaccine on Tuesday, but have yet to make any announcements on Moderna’s updated vaccine.
Persons: Dado Ruvic, Jacqueline Miller, Moderna, COVID, BioNTech, Patrick Wingrove, Bill Berkrot Organizations: REUTERS, World Health Organization, WHO, U.S . Centers for Disease Control, Prevention, ” Moderna, CDC, Omicron, U.S . Food, Drug Administration, Pfizer, Moderna, Britain's Medicines, Healthcare, Agency, Reuters, Thomson Locations: The Massachusetts, Switzerland, South Africa, Israel, Denmark, U.S, Britain, New York
Moderna said its shot generated an 8.7-fold increase in neutralizing antibodies against BA.2.86 compared with an untreated natural antibody response in clinical trials in humans. Pfizer said its updated vaccine with partner BioNTech (22UAy.DE) elicited a strong antibody response against BA.2.86 in a preclinical study in mice. Moderna, Pfizer/BioNTech and relative newcomer to the COVID vaccine market Novavax (NVAX.O) have created versions of their shots aimed at the XBB.1.5 subvariant, the dominant variant through most of 2023. Moderna shares were down 1.6% and Pfizer shares were off nearly 3% in afternoon trading. The Omicron offshoot carries more than 35 mutations in key portions of the virus compared with XBB.1.5, the target of the updated shots.
Persons: Moderna, Jacqueline Miller, BioNTech, Cowen, Tyler Van Buren, Dado Ruvic, Patrick Wingrove, Michael Erman, Bill Berkrot Organizations: Pfizer, World Health Organization, WHO, U.S . Centers for Disease Control, Prevention, ” Moderna, Moderna, REUTERS, CDC, Omicron, U.S . Food, Drug Administration, Britain's Medicines, Healthcare, Agency, Reuters, Thomson Locations: Switzerland, South Africa, Israel, Denmark, U.S, Britain, New York, New Jersey
Boxes of Tecentriq from Genentech are seen at the Huntsman Cancer Institute at the University of Utah in Salt Lake City, Utah, U.S., July 22, 2022. REUTERS/George Frey/File Photo Acquire Licensing RightsAug 29 (Reuters) - Britain's state-run national health service will be the first in the world to offer an injection that treats cancer to hundreds of patients in England which could cut treatment times by up to three quarters. The treatment is currently offered by transfusion to NHS patients with a range of cancers, including lung, breast, liver and bladder. NHS England said it expected the majority of around 3,600 patients starting the treatment of atezolizumab every year in England to switch onto the time-saving injection. But added that patients receiving intravenous chemotherapy in combination with atezolizumab may remain on the transfusion.
Persons: George Frey, Dr Alexander Martin, atezolizumab, Marius Scholtz, Genentech, Roche, Farouq Suleiman, Sandra Maler Organizations: Huntsman Cancer Institute, University of Utah, REUTERS, Medicines, Healthcare, Agency, Foundation Trust, Roche Products, Thomson Locations: Genentech, Salt Lake City , Utah, U.S, England, West Suffolk
Saxenda is Novo's older GLP-1 drug and has lower effectiveness than its newer obesity treatment Wegovy, which contains semaglutide. Novo told Reuters it had received a request on Monday from the MHRA about the agency's review of potential suicidal and self-harming thoughts related to GLP-1 drugs. The MHRA said AstraZeneca's GLP-1 drug for type 2 diabetes, called exenatide and marketed as Bydureon, was also included in the review. The MHRA said that two other GLP-1 drugs, Sanofi's (SASY.PA) lixisenatide and Eli Lilly's (LLY.N) dulaglutide, were also included. It is also investigating GLP-1 drugs for possible risk of thyroid cancer.
Persons: Novo, AstraZeneca's GLP, lixisenatide, Eli Lilly's, Sanofi, Eli Lilly, liraglutide, Alison Cave, Novo's, MHRA, Ozempic, GLP, Maggie Fick, Josephine Mason, Mark Potter, Jane Merriman Organizations: Novo Nordisk, European Union, The Medicines, Healthcare, Agency, Reuters, AstraZeneca, European Medicines Agency, Thomson Locations: Britain, Europe, United States
Packages of the weight-loss drug Wegovy from the pharmaceutical company Novo Nordisk lie on the sales counter in a Danish pharmacy. U.K. health authorities on Wednesday said they are reviewing obesity and diabetes drugs like Novo Nordisk 's Wegovy and Ozempic after some patients who took the treatments reported thoughts of suicide or self-harm. The MHRA said the review includes all obesity and diabetes drugs available in the U.K. Aside from Ozempic and Wegovy, it includes Novo Nordisk's other weight loss drug Saxenda. Other diabetes drugs like AstraZeneca 's Bydureon, Eli Lilly 's Trulicity and Sanofi 's Lyxumia are also included in the probe. Novo Nordisk said in a statement that it received a review request from the MHRA on Monday.
Persons: MHRA, Eli Lilly, Sanofi Organizations: Novo Nordisk, Nordisk, Medicines, Healthcare, Agency, CNBC, European Union, AstraZeneca, Reuters Locations: Danish, U.S, Novo
A South Korean COVID-19 vaccine recently authorised in Britain is administered by injection, not sprayed into the sky from aircraft, as social media posts falsely claim. Some social media users have since been saying that SKYCovion will be sprayed on people from aircraft in a possible misinterpretation of the vaccine’s name (here). However, the vaccine is not based on mRNA and is administered through intramuscular injection, according to the MHRA and SK bioscience. SKYCovion is not an mRNA vaccine but has a traditional protein-antigen design. The SKYCovion vaccine authorised in Britain is injected intramuscularly, not sprayed from the sky.
Persons: chemtrails, Read Organizations: South, SK bioscience, GlaxoSmithKline, GSK, SK Chemicals, Britain’s Medicines, Healthcare, Agency, Twitter, ” SK bioscience, Reuters Locations: Britain, South Korean
The offer of COVID vaccination for very young children is voluntary and specifically targeted to children who are most at risk from COVID, according to the government’s April announcement of the new policy. After Britain’s Joint Committee on Vaccination and Immunisation (JCVI) recommended that young children in clinical risk groups should be offered COVID vaccination, some social media users responded with outrage. JCVI ADVICEThe UK advice does not include all young children. In fact, the prioritisation of COVID-19 vaccination for clinically vulnerable children explains higher mortality rates seen during the pandemic among vaccinated children as compared with unvaccinated children (here and here). There is no evidence the vaccine is unsafe for infants and young children, according to experts and health regulators.
Women who got pregnant during Pfizer’s COVID vaccine trials did not have an unusual rate of miscarriage, experts said as they responded to an online video. This is a miscarriage rate of 14%, which is within the “normal” or expected rate of miscarriage per pregnancy, Male said. They also said there is no evidence of impact from COVID-19 vaccines on fertility. Pfizer started a global trial of pregnant women in February 2021. There is no evidence that COVID-19 vaccines affect fertility and pregnancies during Pfizer’s COVID vaccine trials did not have an unusual rate of miscarriage.
March 21 (Reuters) - Britain's health regulator said on Tuesday it would introduce new measures for faster and easier approval and execution of clinical trials in the country. The move comes months after an industry report showed that the number of annual clinical trials started in Britain dropped by 41% between 2017 and 2021, posing a "clear and serious threat" to its reputation as a clinical research destination. "This overhaul of the clinical trials legislation will ... help to streamline approvals by removing granular and duplicative regulatory requirements," Marc Bailey, Chief Science and Innovation Officer at the Medicines and Healthcare products Regulatory Agency (MHRA) said. An application review will need to be completed within 30 days, while a maximum of 10 days will be given for a decision to be granted, the regulator said. Reporting by Radhika Anilkumar in Bengaluru; Editing by Vinay DwivediOur Standards: The Thomson Reuters Trust Principles.
A poster masked as an advert and featuring a photo of a man’s head shattering falsely alleges that COVID-19 vaccines have been officially recognized as the cause of 31,570 psychiatric disorders in the UK. However, no association between COVID-19 vaccines and any psychiatric disorder has been found, an MHRA spokesperson told Reuters. The spokesperson added: “We have closely monitored the safety of the COVID-19 vaccines since the beginning of the UK vaccination programme. Reuters previously addressed claims that the UK’s Yellow Card scheme shows confirmed side effects of COVID vaccines here, here and here . No link has been found between COVID-19 vaccines and psychiatric disorders, according to the MHRA.
Millions of people have viewed a BBC News interview with a British cardiologist who used the broadcast to spread misinformation about COVID-19 vaccines. Malhotra cites the British Heart Foundation (BHF) for reporting 30,000 excess cardiovascular deaths “during the pandemic or since the pandemic”. A BHF spokesperson told Reuters that there were indeed 30,000 excess deaths involving ischaemic heart disease (IHD) in England between March 2020 and August 2022. Reuters has addressed similar claims linking COVID-19 vaccines with excess mortality (here, here and here), cardiac arrests (here, here and here), and other heart issues. Experts say the 30,000 excess cardiovascular deaths reported since the beginning of the pandemic are due to COVID-19 infection and issues with healthcare services.
He suffered a cardiac arrest moments after making a tackle and had to have his heartbeat restored on the field (here). In the UK, Dr Steven Cox, chief executive of charity Cardiac Risk on the Young (CRY), also told Reuters via email that sudden cardiac death in young people “is sadly not a new phenomenon”. The authors also noted that this was “likely... a significant underestimate” of the true incidence of cardiac death in the young. Another study published in 2022 by PLOS medicine found acute COVID-19 was associated with a 5.8x increased risk of cardiovascular disease, including a 6.4x increased risk of atrial arrythmias in the month after infection. Experts say there is no research that shows a link between COVID-19 vaccines and athletes collapsing or dying from sudden cardiac arrest.
Group A Streptococcus (GAS) is the name for bacteria that can cause infections like strep throat, scarlet fever and impetigo. However, the 2014 study examined different bacteria and found that while their numbers increased following the nasal flu vaccine, that did not lead to increased bacterial disease. A recent UK study has also found that while infections of influenza itself be linked to increased cases of Group A Strep, the nasal vaccine is associated with a reduction in bacterial infections. But it did not investigate group A strep bacteria; rather, the study investigated Streptococcus pneumoniae and Staphylococcus aureus, which Mina said in an email, are “very different” pathogens to group A strep. A 2014 study does not show the nasal spray flu vaccine causes Group A Strep.
“The LAIV vaccine used in the UK does not contain Streptococcus A,” an MHRA spokesperson told Reuters via email. The bacteria are not listed in the ingredients for Fluenz Tetra (bit.ly/3HesXo4), which is also marketed in the U.S. as fluMist. “Group A strep is not used at any stage of the development of the nasal flu vaccine. The vaccine does not contain Group A strep,” Pollard said via email. The MHRA and AstraZeneca told Reuters that group A strep is not an ingredient in the Fluenz Tetra vaccine, and two independent experts said there are no reports of contamination.
REUTERS/Clodagh Kilcoyne/File PhotoLONDON, Dec 6 (Reuters) - Britain's health regulator on Tuesday authorised a COVID-19 vaccine for infants as young as six months, opening the door for vaccinating the country's youngest children once the UK's Joint Committee on Vaccination and Immunisation (JCVI) agrees. Whether the vaccine is eventually deployed in this age group depends on a recommendation from the JCVI, which advises UK health departments on which shots should be used as part of the national vaccination programme. The vaccine is tailored for use in this age group - it is a lower dose version than the one used in children aged five to 11 years. U.S. officials rolled out this version of the Pfizer-BioNTech shot for the same age group earlier this year. Months ago, EU regulators also endorsed the use of COVID vaccines made by Pfizer-BioNTech and Moderna (MRNA.O) for under-fives.
UK approves Pfizer-BioNTech's COVID booster targeting BA.4/5
  + stars: | 2022-11-09 | by ( ) www.reuters.com   time to read: +1 min
Nov 9 (Reuters) - Britain's health regulator on Wednesday approved a COVID-19 booster from Pfizer Inc (PFE.N) and partner BioNTech SE (22UAy.DE) targeting the Omicron BA.4 and BA.5 sub-variants and the original coronavirus strain. The UK's Medicines and Healthcare products Regulatory Agency (MHRA) said the vaccine was approved for use as a booster dose in people aged 12 years and older after it was found to meet safety, quality and effectiveness standards. "All approved COVID booster vaccines help to improve the protection obtained from earlier doses of the vaccine and help give longer-term protection against getting seriously ill from COVID-19," according to the MHRA. Pfizer and BioNTech last week said their so-called bivalent COVID-19 vaccine tailored for BA.4/5 produced a strong antibody response in older adults than the original shot after one month, and in October said it generated a strong immune response. Reporting by Pushkala Aripaka in Bengaluru; Editing by Shinjini Ganguli and Shounak DasguptaOur Standards: The Thomson Reuters Trust Principles.
Testarea clinică a acestui vaccin a stârnit confuzie după ce rezultate preliminare anunţate la sfârşitul lunii noiembrie au relevat efecte diferite în cazul unor doze diferite. AstraZeneca continuă testele, dar MHRA precizează că evaluarea sa pe baza căreia a autorizat vaccinul nu a avut în vedere rezultatele administrării unei singure jumătăţi de doză. Deşi eficacitatea vaccinului AstraZeneca este mai redusă faţă de cea a vaccinului Pfizer-BioNTech, în condiţiile numărului insuficient de doze disponibile acest vaccin poate juca un rol semnificativ în combaterea pandemiei. Mai mult, vaccinul AstraZeneca nu necesită transportul şi stocarea la temperaturi de -70 de grade Celsius, cum este cazul vaccinului Pfizer-BioNTech, putând fi păstrat într-un frigider obişnuit timp de şase luni. Vaccinul Pfizer-BioNTech foloseşte noua tehnologie a ARN-ului mesager, care transmite celulelor umane informaţia genetică pentru a produce proteina Spike, ce va declanşa răspunsul imun care produce anticorpi.
Organizations: Healthcare products, Moderna Locations: SUA, UE, Totuşi
Aceasta se sprijină pe codul genetic al virusului SARS-CoV-2 pentru a antrena sistemul imunitar al organismului să creeze anticorpi împotriva lui, scrie agerpres.ro Vaccinul Pfizer-BioNTec implică însă restricţii şi măsuri severe de transport şi stocare. După ce sunt condiţionate la linia de producţia a Pfizer din Belgia, vaccinurile sunt plasate în cutii cu temperatură controlată, fiecare cu o capacitate între 1.000 şi 5.000 de doze, şi transportate cu camioane sau avioane. Cutiile sunt prevăzute cu un termometru care arată temperatura ce trebuie menţinută la aproximativ -70 de grade Celsius pentru ca vaccinul să-şi păstreze eficacitatea optimă. După sosirea la centrul de vaccinare, fiecare fiolă este diluată cu soluţie salină.Potrivit companiilor Pfizer şi BioNTec, peste 900 de persoane au lucrat la acest vaccin şi au fost testate peste 20 de mutaţii ale noului coronavirus, iar vaccinul a reuşit să le neutralizeze cu succes. Prin urmare, cele două companii farmaceutice, americană şi germană, sunt încrezătoare că acesta va oferi protecţie pentru mutaţiile virusului SARS-CoV-2 care există până acum şi pentru cele care ar putea să apară în următoarele 12 luni.Totuşi, nu este cunoscută durata protecţiei oferite de vaccinarea împotriva acestui virus, pentru determinarea acesteia voluntarii participanţi la testele clinice urmând să fie monitorizaţi şi în lunile următoare.De asemenea, în următoarele trei până la şase luni va continua evaluarea asupra capacităţii vaccinului Pfizer-BioNTec de a preveni transmiterea virusului de la o persoană la alta.
Organizations: Healthcare products Locations: Regatul Unit, Belgia
Total: 23