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☆ AstraZeneca withdraws Covid-19 vaccine citing low demand
▼ + stars: | 2024-05-08 | by ( Hanna Ziady | ) edition.cnn.com time to read: +1 min

London CNN —AstraZeneca is withdrawing its highly successful coronavirus vaccine, citing the availability of a plethora of new shots that has led to a decline in demand. But the vaccine has not generated revenue for AstraZeneca since April 2023, the company said. “As multiple, variant Covid-19 vaccines have … been developed, there is a surplus of available updated vaccines. “AstraZeneca has therefore taken the decision to initiate withdrawal of the marketing authorizations for Vaxzevria within Europe,” it added. AstraZeneca said it would work with regulators in other countries to “align on a clear path forward,” including withdrawing marketing authorizations for the vaccine where no future commercial demand is expected.

Persons: University of Oxford —, “, Vaxzevria, ” AstraZeneca Organizations: London CNN, AstraZeneca, University of Oxford, CNN, “ AstraZeneca, European Medicines Agency, Union Locations: United Kingdom, Vaxzevria, Europe

☆ EU probe of weight loss and diabetes drugs like Wegovy, Ozempic finds no link to suicidal thoughts
▼ + stars: | 2024-04-12 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

European Union drug regulators found no evidence that highly popular weight loss and diabetes drugs such as Wegovy and Ozempic are linked to an increased risk of suicidal thoughts and self-injury, the regulator said Friday. The review examined several drugs from Novo Nordisk , including Wegovy and Ozempic. Clinical trials from Novo Nordisk and Eli Lilly have not demonstrated a link between GLP-1s and suicidal thoughts. The probe also included other active ingredients in older weight loss and diabetes drugs, including dulaglutide, exenatide and lixisenatide. Results from another study conducted by the agency also did not support a link between GLP-1 drugs and the risk of suicidal thoughts.

Persons: Eli Lilly, couldn't, Liraglutide Organizations: Novo Nordisk, European Union, European Medicines Agency, U.S . Food, Drug Administration, EMA, Icelandic Medicines Agency Locations: London, Britain, Novo, U.S, GLP, Wegovy, Ozempic

☆ Acetaminophen use in pregnancy not linked to neurodevelopmental disorders, large study finds
▼ + stars: | 2024-04-09 | by ( Mira Cheng | ) edition.cnn.com time to read: +6 min

CNN —Using acetaminophen, the active ingredient in Tylenol, during pregnancy was not associated with increased risk of autism, ADHD or intellectual disability in children, a new study found. “This is a very extensive and well-designed study that found no association between acetaminophen use and neurodevelopmental impairment, including autism and ADHD,” he said. For example, the study found that parents who have neurodevelopmental disorders — which have strong heritability — are also more likely to use pain medications, like acetaminophen, during pregnancy. This relationship might make it seem like children who are exposed to acetaminophen during pregnancy are more likely to develop neurodevelopmental disorders, when, in fact, their increased risk is due to genetics, according to the study. The study found significant differences between birthing parents with higher acetaminophen use and those with lower or no use.

Persons: —, ” Dr, Eric Brenner, ” Brenner, ”, Brenner, Dr, Sanjay Gupta, judiciously, Yalda Afshar Organizations: CNN, Karolinska Institute, Drexel University, Duke University, Food and Drug Administration, European Medicines Agency, Get CNN, CNN Health, FDA, David Geffen School of Medicine, UCLA Locations: Sweden

Handout via REUTERS/File photo Acquire Licensing RightsSummaryCompanies Ozempic shortages expected throughout 2024Victoza shortages expected until at least Q2 2024Diabetes drug Ozempic used 'off label' to treat obesityNov 21 (Reuters) - Novo Nordisk (NOVOb.CO) will ration starter kits of Ozempic in Europe and reduce supplies of another diabetes drug, Victoza, to prioritise producing Ozempic, which has seen a surge in demand from people using it to lose weight. Ozempic contains semaglutide, an ingredient in Novo's hugely popular anti-obesity drug Wegovy. Intermittent Ozempic shortages are expected throughout 2024, while Victoza shortages are expected at least until the second quarter of 2024, according to the statement on the EMA's website. "No new patients should be started on Victoza until at least Q2 2024 when supply is expected to normalise," Novo urged doctors in the document. It also told doctors to consider other injectable GLP-1 drugs or "other suitable alternatives" where Ozempic or Victoza are not available for patients.

Persons: Ozempic, hasn't, Novo, Eli Lilly's, tirzepatide, Ludwig Burger, Eva Mathews, Emelia Sithole, Mark Potter Organizations: Handout, REUTERS, Diabetes, Novo Nordisk, European Medicines Agency, EU, Thomson Locations: Novo, London, Britain, Europe, Danish, United States, France, Austria, Belgium, Germany, Wegovy, Norway, Denmark, EU

☆ British health agency warns of fake Ozempic pens linked to hospitalizations
▼ + stars: | 2023-10-26 | by ( Amanda Musa | ) edition.cnn.com time to read: +3 min

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

REUTERS/George Frey Acquire Licensing RightsBERLIN, Oct 24 (Reuters) - Several people were hospitalised in Austria after using suspected fake versions of the diabetes drug Ozempic, the country's health safety body said, the first report of harm to users in a widening European hunt for counterfeiters. Regional regulator, the European Medicines Agency (EMA), last week warned about pre-filled injection pens falsely labelled as Ozempic, which has seen surging demand for its weight-loss benefits. The maker of the drug, Novo Nordisk (NOVOb.CO), has flagged a surge in online offers of fake versions of Ozempic as well as its weight-loss drug Wegovy, both based on semaglutide. The BASG did not provide an exact number of people harmed by the fake Ozempic, or say how long-lasting the adverse effects would be on their health. That person likely did not procure the fakes from an official pharmacy, it said, warning that fake injection pens may still be in circulation.

Persons: George Frey, Ozempic, BASG, Wegovy, Miranda Murray, Ludwig Burger, Alexandra Schwarz, Angus MacSwan, Bernadette Baum Organizations: Novo Nordisk, Pharmacy, REUTERS, Rights, European Medicines Agency, EMA, Thomson Locations: Provo , Utah, U.S, Austria, Danish, Germany, Britain, British, Berlin, Frankfurt, Vienna

☆ European regulators warn of fake Ozempic pens found at wholesalers in EU, UK amid shortage
▼ + stars: | 2023-10-18 | by ( Meg Tirrell | ) edition.cnn.com time to read: +2 min

There’s no evidence fake Ozempic pens have been dispensed to patients from legal pharmacies and no indication any patients have been harmed, the EMA said in a statement. The fake pens were caught because they were packaged with real serial numbers that were flagged as inactive when the packs were scanned. “Check the patient information leaflet for Ozempic to see what the genuine Ozempic pens should look like,” the EMA said in its warning for patients. The fake pens were detected as Ozempic and similar medicines used for both diabetes and weight loss are in shortage in both the US and Europe. Both Novo Nordisk and Eli Lilly have filed lawsuits against medical spas, wellness centers and compounding pharmacies to stop them from selling what they call “unlawful” copycats.

Persons: ”, Dr, Sanjay Gupta, “, Eli Lilly, it’s Organizations: CNN, European Union, European Medicines Agency, EMA, CNN Health, Novo Nordisk, ”, Nordisk Locations: United Kingdom, Germany, Europe

Accounts of suicidal thoughts linked to this class of drugs are drawing increasing scrutiny, including an investigation by European regulators announced in July. More than half of the narrative summaries describe suicidal thoughts appearing shortly after the person started the medicine or increased the dose. Wegovy’s U.S. prescribing label, produced with FDA approval, says suicidal thoughts or attempts have been reported in clinical trials for other weight-loss medicines. Sanofi's Acomplia, which never won U.S. approval, was withdrawn in Europe in 2008 after being linked to suicidal thoughts. She said she has not experienced any suicidal thoughts on that drug.

Persons: Dawn Heidlebaugh, Megan Jelinger, ”, Heidlebaugh, Eli Lilly, Thomas J, Moore, aren't, It’s, Novo, Dr, Erick Turner, Turner, Novo’s, drugmakers, Sanofi's, Sanofi, Contrave, John Amos, Lilly, Reuters weren’t, Lisa Wood, ” Wood, Sarah Sobol, you’re, Sobol, ’ ” Katherine, Jayson Chesnutt, Chesnutt, Robin Respaut, Chad Terhune, Maggie Fick, Ludwig Burger, Michele Gershberg, Brian Thevenot Organizations: REUTERS, Novo, U.S . Food, Drug Administration, Reuters, FDA, Johns Hopkins Bloomberg School of Public Health, Oregon Health & Science University, Novo Nordisk, U.S ., European Union, European Medicines Agency, U.S, Currax Pharmaceuticals, Vivus, Facebook, Thomson Locations: Findlay , Ohio, U.S, Ohio, Novo, Canada, Europe, Carolina, Buffalo , New York, North Carolina, Indiana

A few compounds picked by AI are now in development, but those bets will take years to play out. Reuters interviews with more than a dozen pharmaceutical company executives, drug regulators, public health experts and AI firms show, however, that the technology is playing a sizeable and growing role in human drug trials. The U.S. Food and Drug Administration (FDA) said it had received about 300 applications that incorporate AI or machine learning in drug development from 2016 through 2022. Without AI, Bayer said it would have spent millions more, and taken up to nine months longer to recruit volunteers. Finding real-world patients by mining electronic patient data can be done manually, but using AI speeds up the process dramatically.

Persons: Dado Ruvic, Jeffrey Morgan, Amgen, Badhri Srinivasan, Sameer Pujari, drugmaker Bayer, Bayer, Blythe Adamson, Roche, Richard Pazdur, Gen Li, John Concato, Natalie Grover, Martin Coulter, Julie Steenhuysen, Josephine Mason, David Clarke Organizations: Pharmaceutical Research, REUTERS, Pharmaceutical, Bayer, Novartis, Deloitte, U.S . Food, Drug Administration, Reuters, World Health, Flatiron Health, FDA, European Medicines Agency, FDA's Oncology, Excellence, Medical, FDA's Center, Drug, Research, Thomson Locations: U.S, Johannesburg, Texas, Finland, United States, London, Chicago

☆ Europe to decide on Novavax's COVID vaccine in October
▼ + stars: | 2023-09-21 | by ( ) www.reuters.com time to read: +1 min

Four vials with the "Nuvaxovid" COVID-19 vaccine from Novavax are pictured in Saabruecken, Germany, February 26, 2022. REUTERS/Frank Simon/File photo Acquire Licensing RightsSept 21 (Reuters) - The European Medicines Agency (EMA) expects to decide on the use of Novavax's (NVAX.O) updated COVID-19 vaccine in October, its director Emer Cooke said on Thursday. The agency had started the evaluation process for the protein-based shot on Aug. 24, Cooke said at a press conference. EU regulators recently gave the green light for an updated COVID-19 vaccine from Pfizer (PFE.N) and its German partner BioNTech (22UAy.DE), which targets the XBB.1.5 variant of Omicron. Moderna's (MRNA.O) updated shot is also on track to win approval.

Persons: Frank Simon, Emer Cooke, Cooke, BioNTech, Novavax, Bhanvi, Michael Erman, Saumyadeb Chakrabarty Organizations: REUTERS, European Medicines Agency, Pfizer, U.S . Food, Drug Administration, FDA, Moderna, Thomson Locations: Saabruecken, Germany, United States, Bengaluru, New York

☆ Stocks making the biggest moves midday: General Motors, Stellantis, Planet Fitness, Adobe and more
▼ + stars: | 2023-09-15 | by ( Alex Harring | ) www.cnbc.com time to read: +4 min

Nucor — The steelmaker fell 6.1% after offering worse-than-expected guidance for third-quarter earnings, with the company pointing to pricing and volume challenges. Core & Main — The infrastructure stock retreated 4.1% a day after it announced a secondary stock offering. The bank said Apellis has a favorable risk/reward ahead of third-quarter earnings. The Wall Street firm said the resumption of loan repayments introduce bookings risk to food delivery. The Wall Street firm said its pessimistic outlook was changing despite recent underperformance in the reinsurance space.

Persons: Stellantis, Chris Rondeau, Rondeau, Craig Benson, Nucor, Raymond James, Needham, Charles Shi, Lam, Goldman Sachs, Apellis, MoffettNathanson, Estée Lauder, Goldman, Yun Li, Jesse Pound, Samantha Subin, Pia Singh, Brian Evans, Lisa Kailai Han Organizations: UAW, General Motors Wentzville, General Motors, Ford, United Auto Workers began, Workers, CNBC, LSEG, PTC Therapeutics, Medicines Agency's, Medicinal Products, Arm, Investment, Bloomberg News, Apple, Dexcom, ASML Holding, Lam Research, Taiwan Semiconductor, Adobe, Bank of America, JPMorgan, Apellis Pharmaceuticals, Waste Systems Locations: Wentzville , Missouri, New Hampshire, Wells, underperform

☆ Europe to face shortage of Lilly's diabetes drug through September
▼ + stars: | 2023-08-28 | by ( ) www.reuters.com time to read: +1 min

Eli Lilly logo is shown on one of the company's offices in San Diego, California, U.S., September 17, 2020. REUTERS/Mike Blake/File photo Acquire Licensing RightsAug 28 (Reuters) - Europe will continue to face a shortage of Eli Lilly & Co's (LLY.N) blockbuster diabetes drug Trulicity through September, the European Medicines Agency (EMA) said on Monday. Like rival Novo Nordisk (NOVOb.CO), Eli Lilly has also been struggling to meet high demand for its diabetes drugs including Trulicity, which treats type 2 diabetes in people older than 10. Novo's diabetes drug Ozempic was in short supply for months in the U.S., partly driven by prescriptions to non-diabetic patients seeking to lose weight. The EMA said on Monday Austria, Finland, Greece, Poland and Sweden are currently affected by the Trulicity shortage, while temporary shortfalls are also expected in Denmark and Norway.

Persons: Eli Lilly, Mike Blake, Co's, Ozempic, Khushi, Devika Organizations: REUTERS, European Medicines Agency, Novo Nordisk, Monday Austria, Thomson Locations: San Diego , California, U.S, Europe, Finland, Greece, Poland, Sweden, Denmark, Norway, North Carolina, Bengaluru

☆ Exclusive: UK probes Novo's Ozempic, weight-loss drug Saxenda over suicidal, self-harming thoughts
▼ + stars: | 2023-07-26 | by ( Maggie Fick | ) www.reuters.com time to read: +4 min

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

☆ What investors need to know about weight loss medicines and suicide risk
▼ + stars: | 2023-07-16 | by ( Christina Cheddar Berk | ) www.cnbc.com time to read: +7 min

Investors would be forgiven if talk of a potential suicide risk associated with a new class of diabetes and weight loss drugs led to skittishness last week. Prior attempts to treat overweight or obese patients with medications were often plagued with side effects and drug recalls. The first is that most obesity drugs, including GLP-1s, are "centrally acting," which means they work on a patient's brain. The second is that prior obesity drugs have been withdrawn because of high rates of psychiatric disorders, he said, citing Sanofi's Acomplia as one of the more recent examples. This was not the case for the GLP-1 medications.

Persons: skittishness, Eli Lilly's Trulicity, Lilly's, Wolfe, Tim Anderson, Anderson, Sanofi's Acomplia, Eli Lilly, Wolfe's Anderson, Colin Bristow, Lilly, LLY's, Peter Verdult, Wegovy, Verdult, Bristow, Emmanuel Papadakis, Papadakis, — CNBC's Michael Bloom Organizations: Nordisk's Ozempic, Wall Street, European Medicines Agency, EMA, Wolfe Research, FDA, UBS, Citi, Novo Nordisk, Deutsche Bank, Prevention Locations: United States, U.S

☆ EU expands Wegovy, Ozempic probe over suicide risks to include other weight loss, diabetes drugs
▼ + stars: | 2023-07-11 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +4 min

In this photo illustration, boxes of the diabetes drug Ozempic rest on a pharmacy counter on April 17, 2023 in Los Angeles, California. But it could potentially include Eli Lilly 's diabetes drug Mounjaro, which is approved in the EU. Liraglutide is the active ingredient in Novo Nordisk's weight loss drug Saxenda. Semaglutide is the active ingredient in the Danish company's weight loss injection, Wegovy, and its diabetes counterpart, Ozempic. They mimic a hormone produced in the gut called GLP-1 to suppress a person's appetite and ultimately aid with weight loss.

Persons: Eli Lilly, It's, Liraglutide, Semaglutide, ideation Organizations: Novo Nordisk, European Medicines Agency, Pfizer, EMA, CNBC, Icelandic Medicines Agency, Novo Nordisk's Saxenda, Food and Drug Administration Locations: Los Angeles , California, Danish, Wegovy's, U.S

☆ European drugs regulator to review Wegovy, Ozempic following reports of suicidal thoughts
▼ + stars: | 2023-07-10 | by ( Anmar Frangoul | ) www.cnbc.com time to read: +1 min

The European Medicines Agency said Monday it would undertake a review into a number of drugs used to treat obesity and diabetes after it was reported some patients experienced thoughts of suicide or self-harm. "The review is being carried out in the context of a signal procedure raised by the Icelandic Medicines Agency following three case reports," the EMA said. The EMA said the case reports "included 2 cases of suicidal thoughts, one following the use of Saxenda and one after Ozempic. "The semaglutide-containing medicine Wegovy and the liraglutide-containing medicine Saxenda are authorised for weight loss, together with diet and physical activity," the EMA said. "Suicidal behaviour is not currently listed as a side effect in the EU product information of these medicines," the EMA said.

Organizations: Novo Nordisk, European Medicines Agency, Icelandic Medicines Agency, Saxenda Locations: Danish

☆ EU probes Novo Nordisk drugs after reports of suicidal thoughts
▼ + stars: | 2023-07-10 | by ( ) www.reuters.com time to read: +2 min

Suicidal thoughts are not currently listed as a side effect in the EU product information of these treatments. Side effects have hobbled several previous attempts by the drug industry to develop lucrative weight-loss drugs. Sanofi's (SASY.PA) Acomplia, which never won a U.S. approval, was withdrawn in Europe in 2008 after being linked to suicidal thoughts. New weight-loss drugs such as Wegovy, however, regulate appetite by mimicking a gut hormone, and not directly interfere with brain chemistry. Safety data did not show any "causal association" between the suicidal or self-harming thoughts and the drugs, it added.

Persons: Acomplia, Bhanvi, Ludwig Burger, Savio D'Souza, Nivedita Organizations: European Medicines Agency, EMA, Icelandic Medicines Agency, Novo Nordisk, Thomson Locations: Danish, United States, Europe, Novo, Bengaluru, Frankfurt

☆ Novo Nordisk shares slip on EMA drug safety signal
▼ + stars: | 2023-06-22 | by ( ) www.reuters.com time to read: +2 min

reported that the European Medicines Agency (EMA) had raised the safety signal, which is a way to monitor potential adverse events from the use of approved drugs. "Novo Nordisk is aware of the signal and the request by EMA and will deliver a thorough assessment of all relevant data to elucidate this topic," Lars Otto Andersen-Lange, media relations director at Novo Nordisk, told Reuters. report referred to a May 8 statement from EMA, which raised a thyroid cancer safety signal for several drugs in the GLP-1 class, including semaglutide. But a "causal association" between semaglutide and thyroid cancer had not been demonstrated in large-scale clinical trials and post-marketing surveillance, he said. EMA's safety signal had also included GLP-1 drugs from competitors Eli Lilly (LLY.N), Astrazeneca (AZN.L) and Sanofi (SASY.PA).

Persons: Lars Otto Andersen, Lange, Andersen, " Andersen, Eli Lilly, Soren Lontoft Hansen, Nikolaj Skydsgaard, Maggie Fick, Alexander Smith Organizations: Novo Nordisk, European Medicines Agency, EMA, Nordisk, Reuters, Astrazeneca, Sanofi, Thomson Locations: COPENHAGEN, Novo, Denmark's Novo, Copenhagen

☆ Novo Nordisk says EMA raised safety signal on drugs, shares fall
▼ + stars: | 2023-06-22 | by ( Nikolaj Skydsgaard | ) www.reuters.com time to read: +3 min

The European Medicines Agency (EMA) raised the safety signal, which is a way to monitor potential adverse events from the use of approved drugs. "Novo Nordisk is aware of the signal and the request by EMA and will deliver a thorough assessment of all relevant data to elucidate this topic," Lars Otto Andersen-Lange, media relations director at Novo Nordisk, told Reuters. reported the EMA safety signal. report referred to a May 8 statement from EMA, which raised a thyroid cancer safety signal for several drugs in the GLP-1 class, including semaglutide. EMA's safety signal also included GLP-1 drugs from competitors Eli Lilly (LLY.N), Astrazeneca (AZN.L) and Sanofi (SASY.PA).

Persons: Eli Lilly, Ozempic, Lars Otto Andersen, Lange, Andersen, " Andersen, Soren Lontoft Hansen, semaglutide, Nikolaj Skydsgaard, Maggie Fick, Alexander Smith Organizations: Sanofi, Novo Nordisk, European Medicines Agency, EMA, Nordisk, Reuters, Astrazeneca, FDA, Thomson Locations: Astrazeneca, COPENHAGEN, Denmark's Novo, Copenhagen

HAMBURG, June 11 (Reuters) - BioNTech (22UAy.DE) will go to court on Monday to defend itself against a lawsuit from a German woman who is seeking damages for alleged side effects of its COVID-19 vaccine, the first of potentially hundreds of cases in the country. The plaintiff claims she suffered upper-body pain, swollen extremities, fatigue and sleeping disorder due to the vaccine. Tobias Ulbrich, a lawyer at Rogert & Ulbrich, told Reuters he aimed to challenge in court the assessment made by European Union regulators and German vaccine assessment bodies that the BioNTech shot has a positive risk-benefit profile. Almost 768 million vaccine doses have been administered in the European Economic Area (EEA), which includes the 27 EU member states plus Iceland, Liechtenstein and Norway. Rogert & Ulbrich says it has filed about 250 cases for clients seeking damages for alleged side-effects of COVID-19 vaccines.

Persons: Tobias Ulbrich, Caesar, Preller, Ludwig Burger, Patricia Weiss, Emilio Parodi, Natalie Grover, Sam Tobin, Josephine Mason, Mark Potter Organizations: Reuters, European Union, Pfizer, European Medicines Agency, EMA, Economic, BioNTech, United, Thomson Locations: HAMBURG, Hamburg, Germany, Iceland, Liechtenstein, Norway, United States, Italy, Milan, London

☆ Fact Check-EMA recommends COVID vaccine during pregnancy
▼ + stars: | 2023-06-07 | by ( Reuters Fact Check | ) www.reuters.com time to read: +2 min

The EMA said it found evidence showing heavy menstrual bleeding can occur after COVID vaccination, concluding there was a “reasonable possibility” the vaccines may cause it (here). The EMA in fact encourages pregnant women to get vaccinated (here). Reuters previously addressed false claims that COVID-19 vaccines impact fertility and cause miscarriage, including (here), (here), (here) and (here). The European Medicines Agency (EMA) did not say COVID-19 vaccines cause infertility, nor advise pregnant women not to get vaccinated. The EMA, in fact, advises vaccination during pregnancy.

Persons: “, Read Organizations: European Medicines Agency, COVID, EMA, Moderna, Pfizer, Victoria, Imperial College London, Reuters

June 7 (Reuters) - European regulators have approved the region's first vaccine for respiratory syncytial virus (RSV), which causes thousands of hospitalisations and deaths annually. The shot, called Arexvy, is made by British drugmaker GSK (GSK.L) and is designed to protect people aged 60 and over. The complex molecular structure of the virus and safety concerns with previous vaccine attempts had stymied efforts to successfully develop a shot since the virus was first discovered in 1956. Given the different definitions of the trial endpoints across the GSK and Pfizer trials, a direct comparison of efficacy is difficult. In Europe, RSV leads to over 270,000 hospitalisations and about 20,000 in-hospital deaths in adults over 60 each year.

Persons: Luke Miels, Peter Welford, TD Cowen, Steve Scala, Natalie Grover, Eva Mathews, Maggie Fick, Savio D'Souza, Mark Potter Organizations: GSK, European Commission, European Medicines Agency, Reuters, U.S . Food, Drug Administration, Pfizer, Jefferies, Thomson Locations: British, Europe, U.S, London, Bengaluru

☆ Fact Check-UK COVID vaccine offer for vulnerable young children not mandatory
▼ + stars: | 2023-05-10 | by ( Reuters Fact Check | ) www.reuters.com time to read: +4 min

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.

☆ R.S.V. Vaccine Approved for Older Adults
▼ + stars: | 2023-05-03 | by ( Christina Jewett | ) www.nytimes.com time to read: +3 min

advisory panel reviewed data from trials for two vaccines aimed at older adults, one from GSK and one from Pfizer. The virus can lead to pneumonia, which is far more worrisome for older adults and especially for those with underlying medical conditions like heart and lung disease or diabetes. vaccine for older adults is also expected to receive F.D.A. in older adults and said it expected authorization in the first half of this year. Last week, the European Medicines Agency did recommend approval of GSK’s vaccine for adults 60 and older.

☆ FDA approves GSK's RSV vaccine for older adults, world's first shot against virus
▼ + stars: | 2023-05-03 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +4 min

The Food and Drug Administration on Wednesday approved an RSV vaccine produced by GlaxoSmithKline for use on adults ages 60 and older. London-based GSK during an earnings presentation last week said it has "millions" of doses of the RSV vaccine ready to ship. In March, an independent panel of advisors to the FDA recommended GSK's RSV vaccine based on data from a phase three trial on older adults. A 78-year-old woman in Japan was diagnosed with Guillain-Barre syndrome nine days after receiving GSK's vaccine, according to an FDA briefing document. The FDA flagged the disorder as a potential safety issue with Pfizer's RSV vaccine for older adults.

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