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☆ 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

Asia's hydropower output fell 17.9% during the seven months through July, data from energy think tank Ember showed, while fossil fuel-fired power rose 4.5%. In India, hydropower generation fell 6.2% during the eight months ended August in the sharpest decline since 2016. In some cases, the hydropower output plunge was a result of efforts to conserve water and alter supply patterns. "This trend of rapidly increasing wind or solar power generation in China could push for hydropower playing this critical regulating function, instead of operating whenever there is water," he added. However, unlike hydro, wind power is harder to forecast and control, as it varies by local weather conditions.

Persons: Carlos Torres Diaz, Rystad, Lauri Myllyvirta, Myllyvirta, Ember, Victor Vanya, Sudarshan Varadhan, Jamie Freed Organizations: REUTERS, Rights, National Bureau, International Energy Agency, Centre for Research, Clean Energy, Air, Thomson Locations: Qiaojia, Yunnan province, Ningnan, Sichuan province, China, Rights SINGAPORE, Asia, India, Vietnam, India's, Philippines, Malaysia, Ember

REUTERS/Adnan Abidi/File Photo Acquire Licensing RightsCompanies Coal India Ltd FollowSINGAPORE, Sept 4 (Reuters) - India has stepped up the use of coal to generate electricity in a bid to stop outages caused by lower hydroelectricity output, and as an increase in renewables is struggling to keep pace with record power demand. Demand typically peaks in May, when Indians crank up air-conditioners to beat the heat, and industries operate without rain-related disruptions. Coal's share in power output rose to 66.7% in August - the highest for the month in six years, according to a Reuters analysis of government data. The government has repeatedly defended the use of coal citing lower per capita emissions compared with richer nations, and rising renewable energy output. India's peak demand - the maximum capacity required during any time of the day - rose to a record 243.9 gigawatts (GW) on Aug. 31, the Grid India data showed, exceeding available capacity by 7.3 GW.

Persons: Adnan Abidi, Sudarshan, Robert Birsel Organizations: REUTERS, Companies Coal India, India, Grid, Thomson Locations: Delhi, India, China

☆ 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

☆ The 'Bitcoin Family' has a special algorithm that tracks moon cycles — and it's helped them gain 50% since the bear market bottom
▼ + stars: | 2023-07-11 | by ( Mackenzie Sigalos | ) www.cnbc.com time to read: +13 min

Didi Taihuttu in Lagos, Portugal MacKenzie SigalosTaihuttu's indicator considers a mix of inputs, including directional trading data and moon cycles. Moving Average Convergence Divergence (MACD) compares two moving averages of a cryptocurrency's price by subtracting the 26-period exponential moving average (EMA) from the 12-period EMA. When the 50-day moving average crosses below a falling 200-day moving average, it is known as the Death Cross , signaling a bear market may be imminent. When the 50-day moving average crosses below a falling 200-day moving average, it is known as the , signaling a bear market may be imminent. Price chart showing the 'Didi BAM BAM' market indicator Didi TaihuttuAnd then there are the intangible price influencers — like moon phases.

Persons: Thailand Didi Taihuttu LAGOS, Didi Taihuttu, Portugal MacKenzie Sigalos Taihuttu's, Bitcoin, Taihuttu, DAI —, Didi, Portugal MacKenzie, Portugal —, Portugal Didi Taihuttu, Mayer, It's, Price, —, I'm, Didi Bam Bam, Thailand Didi, ChatGPT, Goldman Sachs, Marco Argenti, Goldman, Louisa, David Solomon, Morgan Stanley, Morgan, Jeff McMillan, — CNBC's Ryan Browne Organizations: CNBC, Didi BAM, BAM, Bollinger Bands, Bollinger, Lightning Networks Locations: Phuket, Thailand, PORTUGAL, Lagos, Algarve, Taihuttu, bitcoin, Portugal, cryptocurrency, ChatGPT

☆ 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

☆ Taylor Swift changes controversial lyrics for ‘Better Than Revenge’
▼ + stars: | 2023-07-07 | by ( Lisa Respers France | ) edition.cnn.com time to read: +8 min

From Taylor Swift On her birthday in 2019, Swift shared this photo of herself as a child. From Taylor Swift A 13-year-old Swift sings the National Anthem before an NBA game in Philadelphia in 2002. Kevin Winter/ACMA/Getty Images Swift sings the National Anthem before Game 3 of the 2008 World Series in Philadelphia. John Mabangalo/Pool/Getty Images Swift performs during a sold-out show at New York's Madison Square Garden in 2009. Jeff Kravitz/Getty Images Swift performs on stage during an "Eras Tour" concert in Atlanta in April 2023.

Persons: CNN — Taylor Swift, ” Swift, “, Swift, ” Taylor, shaming, ” Taylor Swift, Christopher Polk, Scott, Andrea Swift, Taylor Swift, Jesse D, Tim McGraw, Kevin Winter, John Mabangalo, Chad Batka, Bryan Bedder, Larry Busacca, Miley Cyrus, Lucas Till, Hannah Montana, Sam Emerson, Everett, Jonas, Frank Masi, Taylor, I'm, West, Beyonce, Jeff Kravitz, Lucy Nicholson, Christopher Morris, Josh Haner, Kevin Mazur, James Taylor, Charles Sykes, Matt Sayles, Mark J, Terrill, Invision, Jimmy Fallon, Douglas Gorenstein, Nicholas Harvey, Kanye West, Kim Kardashian, Laraine Newman, Bill Hader, Taran Killam, Kristen Wiig, Keenan Thompson, Fred Armisen, Kerry Washington, Betty White, Bradley Cooper, Dana Edelson, Andrea, Ethan Miller, Tim Boyles, Selena Gomez, Jordan Strauss, Mike Coppola, John Shearer, Andrew Lloyd Webber, Brandon Urie, Katy Perry, Republic Records Jack Antonoff, Aaron Dessner, Will Heath, Seth Wenig, Terence Rushin, didn’t, It’s, –, Scooter Braun, Braun Organizations: CNN, Staples Center, NBA, of Country, Garden, New York Times, New York's Rockefeller Center, Walt Disney Co, Kanye, Madison, MTV, NBC, ACM, Academy of Country, Getty, New York's Metropolitan Museum of Art, Universal Pictures, Coachella, Republic Records, New York University, Machine Locations: Los Angeles, West Reading , Pennsylvania, Philadelphia, Las Vegas, New York, Auburn Hills , Michigan, Newark , New Jersey, Pennsylvania, Frankfurt, Germany, London, Arlington , Texas, Tampa, Chicago, Atlanta

☆ California, truck manufacturers strike deal on emissions rules
▼ + stars: | 2023-07-06 | by ( David Shepardson | ) www.reuters.com time to read: +3 min

[1/2] Tesla's new electric semi truck is unveiled during a presentation in Hawthorne, California, U.S., November 16, 2017. REUTERS/Alexandria Sage/File PhotoWASHINGTON, July 6 (Reuters) - California state air regulators and truck and engine manufacturers said on Thursday they had reached an agreement on state emissions rules that will give companies more flexibility to meet requirements. The California Air Resources Board (CARB) said the "Clean Truck Partnership" with the Truck and Engine Manufacturers Association (EMA) includes new flexibility for manufacturers to meet emissions requirements while reaching state goals for reducing emissions. Newsom said "today truck manufacturers join our urgent efforts to slash air pollution, showing the rest of the country that we can both cut dangerous pollution and build the economy of the future." California said Thursday it agreed to modify elements of the 2024 NOx emission regulations for which manufacturers will provide offsets to maintain California emission targets.

Persons: Gavin Newsom, Newsom, Jed Mandel, David Shepardson, David Gregorio Our Organizations: REUTERS, WASHINGTON, California Air Resources Board, Manufacturers Association, U.S . Environmental Protection Agency, Twitter, Cummins, Daimler Truck North, Ford Motor, General Motors, Hino Motors, Volvo Group North America, EPA, Thomson Locations: Hawthorne , California, U.S, Alexandria, California, CA

☆ Cybersecurity experts have become targets for board seats
▼ + stars: | 2023-07-03 | by ( Bob Violino | ) www.cnbc.com time to read: +6 min

The research also showed that 90% of public companies lack even one qualified cyber expert, showing a significant cyber board supply-demand gap. A recently released report on CISO board readiness conducted by IANS Research in collaboration with Artico Search and The CAP Group, found that less than half of the CISOs stand out as board candidates. So, what skills do CISOs need — aside from cybersecurity expertise — to be considered credible board members? CISOs also need to understand risk to speak to a board. In addition, CISOs must understand business risk.

Persons: Kakolowski, Nick Kakolowski, Steffen, Chris Steffen, Larry Whiteside, CISO, Ember, Whiteside, CISOs Organizations: IANS Research, CAP Group, Enterprise Management Associates, Cloud Security Alliance, University of South Locations: RegScale, University of South Florida

☆ 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

☆ 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.

☆ Exclusive: China plans $500 million subsea internet cable to rival US-backed project
▼ + stars: | 2023-04-06 | by ( Joe Brock | ) www.reuters.com time to read: +10 min

China's three main carriers – China Telecommunications Corporation (China Telecom), China Mobile Limited and China United Network Communications Group Co Ltd(China Unicom) – are mapping out one of the world’s most advanced and far-reaching subsea cable networks, according to the four people, who have direct knowledge of the plan. They said HMN Tech, which is majority-owned by Shanghai-listed Hengtong Optic-Electric Co Ltd, would receive subsidies from the Chinese state to build the cable. China Mobile, China Telecom, China Unicom, HMN Tech, and Hengtong did not respond to requests for comment. The consortium on the SeaMeWe-6 cable – which originally had included China Mobile, China Telecom, China Unicom and telecom carriers from several other nations – initially picked HMN Tech to build that cable. China Telecom and China Mobile pulled out of the project after SubCom won the contract last year and, along with China Unicom, began planning the EMA cable, the four people involved said.

☆ Exclusive: China plans $500 mln subsea internet cable to rival U.S.-backed project
▼ + stars: | 2023-04-06 | by ( Joe Brock | ) www.reuters.com time to read: +10 min

China's three main carriers – China Telecommunications Corporation (China Telecom), China Mobile Limited and China United Network Communications Group Co Ltd(China Unicom) – are mapping out one of the world’s most advanced and far-reaching subsea cable networks, according to the four people, who have direct knowledge of the plan. They said HMN Tech, which is majority-owned by Shanghai-listed Hengtong Optic-Electric Co Ltd, would receive subsidies from the Chinese state to build the cable. China Mobile, China Telecom, China Unicom, HMN Tech, Hengtong and China’s Foreign Ministry did not respond to requests for comment. The consortium on the SeaMeWe-6 cable – which originally had included China Mobile, China Telecom, China Unicom and telecom carriers from several other nations – initially picked HMN Tech to build that cable. China Telecom and China Mobile pulled out of the project after SubCom won the contract last year and, along with China Unicom, began planning the EMA cable, the four people involved said.

☆ Explainer: After COVID and drug shortages, EU revamps drug laws
▼ + stars: | 2023-04-03 | by ( Maggie Fick | ) www.reuters.com time to read: +5 min

The Commission aims to publish a draft - the biggest overhaul of existing medical laws in two decades - on April 26. A Commission spokesperson said: "The Commission will put forward a balanced and patient-centred proposal, whilst fully supporting an innovative and competitive industry." If the EU health regulator approves a new use for the medicine, they get another year, bringing the total to 11. Fourteen member states have written to the Commission, criticising the idea as costly and harmful for consumers as it could disrupt the generic drugs market. Once the Commission publishes the draft, the European Parliament, Commission and member states will thrash out final details.

☆ Fact Check-Experts say Pfizer COVID vaccine trials did not cause more miscarriages and there is no evidence of COVID-19 vaccine impact on fertility
▼ + stars: | 2023-03-31 | by ( Reuters Fact Check | ) www.reuters.com time to read: +4 min

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.

☆ Pfizer/BioNTech seeks U.S. nod for updated COVID vaccine as booster in kids under 5
▼ + stars: | 2023-03-01 | by ( ) www.reuters.com time to read: +1 min

March 1 (Reuters) - Pfizer Inc (PFE.N) and its German partner BioNTech SE (22UAy.DE) have applied for emergency use authorization of their Omicron-adapted COVID-19 vaccine in the United States as a booster dose for children aged six months through four years, the companies said on Wednesday. The Omicron-adapted vaccine is currently authorized by the U.S. health regulator as the third dose of the three-dose primary course of vaccination in the country for children in this age group. If the Food and Drug Administration (FDA) authorizes the vaccine as a booster dose, children who have completed their primary series - either with three doses of the Pfizer-BioNTech's original vaccine or with two doses of their original and one dose of the adapted vaccine - would be eligible to receive the booster dose at least two months after the completion of their primary series. Last week, the companies also filed an application to the FDA for a full approval of their Omicron-adapted COVID vaccine as a primary course and a booster dose for individuals 12 years of age and above. Reporting by Sriparna Roy in Bengaluru; Editing by Shailesh KuberOur Standards: The Thomson Reuters Trust Principles.

☆ EU regulator recommends against approval for Merck's COVID pill for adults
▼ + stars: | 2023-02-24 | by ( ) www.reuters.com time to read: +1 min

Companies Merck & Co Inc FollowFeb 24 (Reuters) - The European Union's drug regulator said on Friday its Committee for Medicinal Products for Human Use has advised against market authorisation of the COVID-19 pill from Merck & Co Inc (MRK.N) for treatment in adults. Merck and its partner Ridgeback Biotherapeutics said they will appeal the decision and request a re-examination of the committee's opinion. "The CHMP's recommendation does not reflect the compelling data" from one of the company's late-stage trial and real-world studies, Dean Li, head of Merck's research division, said. In December, a large study had shown that the drug sped up recovery but did not reduce hospitalisation or death rate in higher-risk vaccinated adults. The regulator's recommendation against Merck's COVID-19 pill comes days after the company said Lagevrio was not effective at cutting the risk of coronavirus infections in people living with someone infected with the virus.

☆ EU regulator expects eventually to introduce annual COVID shots
▼ + stars: | 2023-02-15 | by ( ) www.reuters.com time to read: +1 min

LONDON, Feb 15 (Reuters) - The European Medicines Agency (EMA) expects COVID vaccination campaigns to be conducted once a year, similar to the approach with flu inoculation, it said on Wednesday. In Europe, there is a marked decline in new COVID cases, hospitalisations and deaths - the lowest levels observed in the European Union in the past twelve months, he said, citing data from the European Centre for Disease Prevention and Control (ECDC). Still, the virus continues to evolve, and an organised approach is needed to maintain the range of vaccines to confer an adequate breadth of protection to emerging variants, he said. The EMA is currently in discussions with the World Health Organization and other regulatory agencies about the criteria and process that will lead to the potential update of the vaccines in view of future vaccination campaigns, he added. Reporting by Natalie Grover in London Editing by David Goodman and Jane MerrimanOur Standards: The Thomson Reuters Trust Principles.

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