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☆ GSK CEO says RSV vaccine revenue to top 1 bln pounds in first year
▼ + stars: | 2023-11-30 | by ( Michele Gershberg | ) www.reuters.com time to read: +4 min

GSK had previously forecast 2023 sales for Arexvy between 900 million pounds and 1 billion pounds ($1.26 billion) following a strong U.S. launch. "We’re delighted with the start of our RSV vaccine," Walmsley said in a Reuters Newsmaker interview. The U.S. Food and Drug Administration (FDA) approved Arexvy for adults aged 60 years or older in May and GSK launched the vaccine in the U.S. later in the year. GSK made close to two-thirds of RSV doses given in the United States since early September, according to IQVIA data earlier this month. On Tuesday, rival Pfizer (PFE.N) said it was disappointed in the performance of its RSV shot Abrysvo compared with GSK.

Persons: Walmsley, GSK's, Emma Walmsley, We’re, David Denton, AstraZeneca's, commercialise Johnson, Ludwig Burger, Michael Erman, Josephine Mason, Kirsten Donovan, Elaine Hardcastle Organizations: GSK, Reuters, U.S . Food, Drug Administration, Pfizer, U.S, Thomson Locations: British, U.S, Europe, Japan, United States

The full benefit for these Indian manufacturers will not be immediate, said Peter DeYoung, CEO of Piramal Pharma Solutions. Nimgaonkar said Indian CDMOs need to do more to ensure their reputation on quality standards matches Western and Chinese ones. The Indian CDMOs told Reuters that their facilities are routinely inspected by the FDA. Aragen counts seven of the 10 biggest pharma companies as clients, he said, declining to name them. "New biotechs are deciding to put eggs in both the Indian and China baskets from the start," Subramanian said.

Persons: Trump, Tommy Erdei, Ashish Nimgaonkar, Nimgaonkar, Sai, Peter DeYoung, Helen Chen, CDMOs, Piramal, DeYoung, Ramesh Subramanian, Subramanian, Maggie Fick, Andrew Silver, Michele Gershberg, Catherine Evans Organizations: Jefferies, Glyscend Therapeutics, Reuters, Sciences, Piramal Pharma, Sai Life Sciences, Western pharma, Piramal Pharma Solutions, L.E.K, Consulting, pharma, U.S . Food, Drug Administration, FDA, Thomson Locations: China, India, SHANGHAI, HYDERABAD, U.S, Shanghai, United States, London, Hyderabad

☆ US lawmakers ask SEC to scrutinize Musk comments on Neuralink
▼ + stars: | 2023-11-22 | by ( Marisa Taylor | ) www.reuters.com time to read: +3 min

Neuralink logo and Elon Musk photo are seen in this illustration taken, December 19, 2022. Yet Musk, Neuralink's CEO, downplayed investor concerns about the results of its animal testing, the letter said. Musk wrote that "no monkey has died as a result of a Neuralink implant," in a post to his social media site, X, on Sept. 10. Neuralink did not respond to requests for comment on the letter to the SEC. As a result, Musk's statement "may have violated" SEC rules in denying a connection, the lawmakers wrote.

Persons: Elon, Dado Ruvic, Elon Musk, Earl Blumenauer of, Jim McGovern, Barbara Lee, Tony Cardenas, Musk, Neuralink, Marisa Taylor, Michele Gershberg, Marguerita Choy Organizations: REUTERS, U.S, Securities and Exchange Commission, Democratic, Reps, Massachusetts, SEC, Reuters, U.S . Food, Drug Administration, Thomson Locations: Earl Blumenauer of Oregon, Tony Cardenas of California

More than 10,000 Palestinians, including over 4,000 children, have been killed, according to health officials in Hamas-run Gaza. “I can’t forget his image.”The WHO is pushing for the most vulnerable among the chronically ill to be allowed out for treatment. Other countries have offered to take in patients, including Egypt, Turkey and the United Arab Emirates. This is the first time there is such a comprehensive ban on movement and Gaza patients can’t make it out,” said Osama Qadoumi, the supervisor at Makassed Hospital. There are 350,000 patients with chronic conditions in Gaza, including cancer and diabetes, as well as 50,000 pregnant women, according to data from United Nations organizations.

Persons: Naser, Khan Younis, Mohammed Salem, Tahreer Azzam, Azzam, ”, “, Osama Qadoumi, Richard Peeperkorn, haven’t, Um Taha, Farrah, Hala, God ’, Henriette Chacar, Jennifer Rigby, Michele Gershberg, James Mackenzie, Daniel Wallis Organizations: REUTERS, Makassed, West Bank, World Health Organization, WHO, Hamas, Reuters, United, United Nations, Makassed Hospital, Thomson Locations: Khan, Gaza, Jerusalem, Israel, Egypt, Turkey, United Arab Emirates, Makassed, Hala

[1/2] Mosquitoes are seen on stagnant water on the roadside during countrywide dengue infection, in Dhaka, Bangladesh, August 24, 2023. REUTERS/Mohammad Ponir Hossain/File Photo Acquire Licensing RightsCompanies Takeda Pharmaceutical Co Ltd FollowLONDON, Oct 6 (Reuters) - Dengue fever will become a major threat in the southern United States, southern Europe and new parts of Africa this decade, the WHO's chief scientist said, as warmer temperatures create the conditions for the mosquitoes carrying the infection to spread. Many cases go unrecorded, but in 2022 4.2 million cases were reported worldwide and public health officials have warned that near-record levels of transmission are expected this year. Qdenga is also approved by the EU regulator, but Takeda withdrew its application in the United States earlier this year, citing data collection issues. Dengue is spread by infected Aedes aegypti mosquitoes, which behave differently to the malaria-carrying kind.

Persons: Mohammad Ponir Hossain, ” Jeremy Farrar, ” Farrar, Farrar, ”, “, Takeda, Jennifer Rigby, Michele Gershberg, Sharon Singleton Organizations: REUTERS, Takeda Pharmaceutical, World Health Organization, Reuters, Wellcome, WHO, Takeda Pharmaceuticals, U.S . Food, Drug Administration, Thomson Locations: Dhaka, Bangladesh, United States, Europe, Africa, Asia, Latin America, Vietnam, Saharan Africa, EU

☆ Dengue Will 'Take Off' in Southern Europe, US, Africa This Decade, WHO Scientist Says
▼ + stars: | 2023-10-06 | by ( Oct. | At A.M. | ) www.usnews.com time to read: +4 min

By Jennifer RigbyLONDON (Reuters) - Dengue fever will become a major threat in the southern United States, southern Europe and new parts of Africa this decade, the WHO's chief scientist said, as warmer temperatures create the conditions for the mosquitoes carrying the infection to spread. Many cases go unrecorded, but in 2022 4.2 million cases were reported worldwide and public health officials have warned that near-record levels of transmission are expected this year. Earlier this week, the WHO recommended Takeda Pharmaceuticals' Qdenga vaccine for children aged 6 to 16 in areas where the infection is a significant public health problem. Qdenga is also approved by the EU regulator, but Takeda withdrew its application in the United States earlier this year, citing data collection issues. Dengue is spread by infected Aedes aegypti mosquitoes, which behave differently to the malaria-carrying kind.

Persons: Jennifer Rigby LONDON, ” Jeremy Farrar, ” Farrar, Farrar, ”, “, Takeda, Jennifer Rigby, Michele Gershberg, Sharon Singleton Organizations: World Health Organization, Reuters, Wellcome, WHO, Takeda Pharmaceuticals, U.S . Food, Drug Administration Locations: United States, Europe, Africa, Asia, Latin America, Bangladesh, Vietnam, Saharan Africa, EU

☆ Novo Nordisk's Wegovy bonanza looms large in Denmark
▼ + stars: | 2023-10-05 | by ( Maggie Fick | ) www.reuters.com time to read: +6 min

COPENHAGEN, Oct 5 (Reuters) - The whirlwind success of weight-loss treatment Wegovy is providing a bonanza not just for its developer, Novo Nordisk (NOVOb.CO), but also for its home country of Denmark. Interviews with Danish economists, analysts, and executives at the Novo Nordisk Foundation which controls Novo highlight the benefits to the economy from jobs to private wealth - but also the potential pitfalls of relying on a single, outsized company. Record profits for Novo are projected to generate returns for the Foundation of more than $12 billion in coming years. Novo Nordisk added 3,500 jobs in Denmark in 2022, bringing the total in the country to 21,000 employees, out of 59,000 worldwide, a company spokesperson said. Before Wegovy, "we used to be kind of, 'Isn't Denmark the place where Stockholm is the capital?'"

Persons: Danes, Lars Skovgaard Andersen, Lars Christensen, Wegovy, Mads Krogsgaard Thomsen, " Thomsen, Moller, Thomsen, Melinda Gates, Rasmus Kristian Feldthusen, Maggie Fick, Jacob Gronholt, Alexander Smith, Josephine Mason, Michele Gershberg, Catherine Evans Organizations: Novo Nordisk, Novo Nordisk Foundation, Danske Bank, Copenhagen Business School, Novo, Foundation, Reuters, Novo Holdings, Carlsberg, Maersk, U.S, Melinda Gates Foundation, UK's Wellcome Trust, Wegovy, University of Copenhagen, Nokia, Pedersen, Thomson Locations: COPENHAGEN, Denmark, Stockholm, Copenhagen, Danish, Novo, Europe, North America, Asia, OUTGROWING DENMARK, Finland

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

☆ Cough syrup deaths overseas prompt US crackdown on toxic testing
▼ + stars: | 2023-09-26 | by ( Patrick Wingrove | ) www.reuters.com time to read: +6 min

Defendants and lawyers attend a court hearing in the case of child deaths linked to contaminated cough syrups, in Tashkent, Uzbekistan August 16, 2023. Cough syrups made in India and Indonesia have been linked to deaths of more than 300 children globally. The medicines were found to contain high levels of DEG and EG, leading to acute kidney injury and death. IMPORT ALERTSThe FDA warning letters give manufacturers an opportunity to fix quality control problems or face penalties. In addition, 13 U.S. makers of consumer products like earwax removers, nasal spray, hand soap and shampoo, including Lex, were threatened with possible seizures and injunctions by the FDA.

Persons: Stringer, Paul Hastings, Peter Lindsay, syrups, Lex, Charlene Paz, Greg Landry, Patrick Wingrove, Rishika, Joyce Lee, Michele Gershberg, Bill Berkrot Organizations: REUTERS, U.S, FDA, Drug Administration, EG, Reuters, South, South Korea's LCC, LCC, Daxal Therapeutics, Herbals, South Korea’s KM Pharmaceutical, Sangleaf Pharma, Massachusetts College of Pharmacy & Health Sciences, Thomson Locations: Tashkent, Uzbekistan, U.S, India, South Korea, Switzerland, Canada, Egypt, Washington ,, Indonesia, United States, Florida, South Korea's, South, New York, Rishika Sadam, Hyderabad, Seoul

☆ Explainer: Extreme heat may mean using a different sunscreen
▼ + stars: | 2023-08-17 | by ( Nancy Lapid | Thomson Reuters | Nancy Has Been A Health News Editor At Reuters For More Than A Decade. Previously She Was A Writer | ) www.reuters.com time to read: +4 min

Because mineral sunscreens aren't absorbed, older formulations often had a greasy feel and a white appearance. People who do not like the thicker texture of mineral sunscreens often use chemical sunscreens in creams or sprays. The ingredients form a thin protective film that absorbs UV rays and changes their structure, converting them into heat before they penetrate the skin. Extreme heat also means more sweating, and sweat can contribute to itchiness and rashes some people experience from ingredients in chemical sunscreens, Radusky added. Even in the absence of extreme heat, people with sensitive skin should opt for mineral sunscreens, the AAD advises.

Persons: Johnson, Brian Snyder, Jacqueline, Ross Radusky, Radusky, Nancy Lapid, Michele Gershberg, Aurora Ellis Organizations: REUTERS, American Academy of Dermatology, Sun Protection, Research Center, Thomson Locations: Gloucester , Massachusetts, U.S, Scottsdale , Arizona, Dallas , Texas

☆ Focus: US psychiatrists prescribe Wegovy to battle medication-induced weight gain
▼ + stars: | 2023-08-03 | by ( Elissa Welle | ) www.reuters.com time to read: +6 min

[1/2] A selection of injector pens for the Wegovy weight loss drug are shown in this photo illustration in Chicago, Illinois, U.S., March 31, 2023. The global market for weight-loss drugs is forecast to reach as much as $100 billion within the decade. Beyond severe mental health disorders, other patients struggling with obesity tend to suffer from mental health issues like depression and anxiety at higher levels than the general population, studies show. However, psychiatrists specializing in eating disorders are wary that drugs like Wegovy could exacerbate their patients’ focus on weight loss because they are so effective. Dr. Michael Weintraub, an endocrinologist at NYU Langone Health, said ideally psychiatrists will work with endocrinologists because weight-loss drugs require careful monitoring not related to mental health issues.

Persons: Jim Vondruska, Wegovy, Novo, It's, doggedly, Joseph Goldberg, Eli Lilly, Natalia Salomao, Dost Ongur, Brigham, Roy Chengappa, New Yorker Alexander Roger, Roger, Michael Weintraub, McLean's Ongur, Elissa Welle, Michele Gershberg, Bill Berkrot Organizations: REUTERS, Icahn School of Medicine, U.S . Food, Drug Administration, Reuters, Mass, Brigham McLean Hospital, University of Pittsburgh Medical Center, New Yorker, Fordham University, Nordisk, NYU Langone Health, Thomson Locations: Chicago , Illinois, U.S, Mount Sinai, New York, Europe, Danish, Boston

☆ Insight: Wegovy weight-loss injection factory plagued by sterile-safety failures
▼ + stars: | 2023-07-27 | by ( Maggie Fick | ) www.reuters.com time to read: +10 min

Microbial contamination of drugs injected into the body, rather than swallowed, can be deadly, the people said - although the FDA inspectors didn't report any signs of this sort of contamination at the Brussels factory. In both visits, the FDA inspectors found Catalent staff had repeatedly failed to investigate why equipment was malfunctioning. BLINDSIDED BY BOOMING DEMANDWithin months of launching Wegovy, Novo Nordisk was overwhelmed by demand in America, and told shareholders that its initial supply would not keep pace. From December that year and throughout 2022, Novo repeatedly pushed out the timeline for when the supply constraints would end. In late December 2022, Novo announced all five dose strengths were available again in the United States.

Persons: Wegovy, Catalent, Eli Lilly, LLY.N, Susan Bain, Karsten Munk Knudsen, Ambre James, Brown, James, Knudsen didn't, Steven Lynn, Lynn, David Talmage, didn't, Novo, Maggie Fick, Vincent Flasseur, Michele Gershberg Organizations: U.S . Food, Drug Administration, Reuters, FDA, Novo Nordisk, University of Southern, Novo executives, Novo, U.S, Manufacturing, Parenteral Drug Association, Thomson Locations: U.S, Brussels, Danish, University of Southern California, Wegovy, Novo, America, United States

☆ Insight: The meds they bought were toxic. Now Gambian parents seek justice
▼ + stars: | 2023-07-14 | by ( Edward Mcallister | ) www.reuters.com time to read: +8 min

Three Gambian lawyers said this is the highest profile case of its kind against the nation's health ministry and the drug regulator, as well as against Maiden itself. It adds that the regulator and the health ministry failed to ensure that drugs were prescribed "with the expected standard of care." Gambia's health ministry did not respond to requests for comment. By this stage, the Gambian health ministry had sent samples of the Maiden syrups abroad for testing. The drugs regulator, the Medicines Control Agency, which is part of the health ministry, did not respond to a request for comment for this story.

Persons: syrups, Maiden, vomited, Amie Jammeh, Mafugi Jassey, Mafugi, Jammeh, Loubna Farage, Jude Nwokike, Markieu Janneh Kaira, Kaira, Edward McAllister, Michele Gershberg, Sara Ledwith Organizations: Suit, Reuters, World Health Organization, WHO, Pharmaceuticals, EG, World Bank, Medicines, Pharmacopeia, Medicines Control Agency, Thomson Locations: Serekunda, Gambia, India, DAKAR, Indonesia, Uzbekistan, Senegal, Africa

Reuters reported last month that the cancer research arm of the World Health Organization (WHO), known as the International Agency for Research on Cancer (IARC), was set to make that declaration on July 14, according to two sources with knowledge of the process. The designation as "possibly carcinogenic to humans" will provide an incentive to fund more rigorous research into the safety question, toxicology and cancer experts say. "We have been pushing for an IARC review for many years now." But no action was taken until 2022, after aspartame was again nominated for review by CSPI and Melnick in 2019. The research body has said "new evidence" prompted its aspartame review, without giving any details.

Persons: Andy Smith, Smith, Coke, Peter Lurie, Lurie, James Huff, Ron Melnick, CSPI, There's, Samuel Cohen, Erik Millstone, Millstone, Jennifer Rigby, Michele Gershberg, Catherine Evans Organizations: Reuters, World Health Organization, WHO, International Agency for Research, Cancer, MRC, Unit, University of Cambridge, Cola's, Regulators, for Science, Joint Food and Agriculture Organization, U.S . National Institutes of Health, University of Nebraska Medical Center, University of Paris, Britain's University of Sussex, Thomson Locations: United States, U.S, France

☆ Exclusive: Most patients using weight-loss drugs like Wegovy stop within a year, data show
▼ + stars: | 2023-07-11 | by ( Chad Terhune | ) www.reuters.com time to read: +4 min

The annual cost of overall care for patients prior to taking Wegovy or a similar drug was $12,371, on average, according to the analysis. The costs for a similar control group of patients not taking the drugs decreased by 4% over the same period. The analysis by Prime Therapeutics, a pharmacy benefits manager (PBM), reviewed pharmacy and medical claims data for 4,255 people with commercial health plans. For the analysis, Prime Therapeutics excluded patients with type 2 diabetes to focus on obesity treatment. In trials with adults, Novo found that 6.8% of patients taking Wegovy discontinued treatment due to gastrointestinal problems and other adverse events.

Persons: Wegovy, Khrysta Baig, Patrick Gleason, Novo, aren't, Gleason, David Lassen, Lassen, Chad Terhune, Michele Gershberg, Bill Berkrot Organizations: Reuters, Vanderbilt University, Novo Nordisk, Prime Therapeutics, Therapeutics, U.S, Blue, Thomson Locations: Danish

[1/4] Diet Coke is seen on display at a store in New York City, U.S., June 28, 2023. Aspartame, used in products from Coca-Cola diet sodas to Mars' Extra chewing gum and some Snapple drinks, will be listed in July as "possibly carcinogenic to humans" for the first time by the International Agency for Research on Cancer (IARC), the World Health Organization's (WHO) cancer research arm, the sources said. Pepsico removed aspartame from sodas in 2015, bringing it back a year later, only to remove it again in 2020. Listing aspartame as a possible carcinogen is intended to motivate more research, said the sources close to the IARC, which will help agencies, consumers and manufacturers draw firmer conclusions. But it will also likely ignite debate once again over the IARC's role, as well as the safety of sweeteners more generally.

Persons: Coke, Shannon Stapleton, Health Organization's, JECFA, Nozomi Tomita, Zsuzsanna, Germany’s Bayer, Frances Hunt, Wood, Mars Wrigley, Kate Loatman, –, Jennifer Rigby, Richa Naidu, Michele Gershberg, Mark Potter Organizations: REUTERS, International Agency for Research, Cancer, Health, Joint WHO, Food, Agriculture Organization's, WHO, Reuters, Japan's Ministry of Health, Labour, Welfare, Food Safety Authority, U.S, International, Association, Cargill, International Council of Beverages Associations, Ramazzini Institute, EFSA, Pepsico, Thomson Locations: New York City, U.S, United States, Europe, Geneva, France, Italy, sodas

JECFA, the WHO committee on additives, is also reviewing aspartame use this year. The first group includes substances from processed meat to asbestos, which all have convincing evidence showing they cause cancer, IARC says. Like aspartame, this means there is either limited evidence they can cause cancer in humans, sufficient evidence in animals, or strong evidence about the characteristics. Pepsico removed aspartame from sodas in 2015, bringing it back a year later, only to remove it again in 2020. Listing aspartame as a possible carcinogen is intended to motivate more research, said the sources close to the IARC, which will help agencies, consumers and manufacturers draw firmer conclusions.

Persons: Coke, Shannon Stapleton, Health Organization's, JECFA, Nozomi Tomita, Zsuzsanna, Germany’s Bayer, IARC, Frances Hunt, Wood, Mars Wrigley, Kate Loatman, –, Jennifer Rigby, Richa Naidu, Michele Gershberg, Mark Potter, Susan Fenton Organizations: REUTERS, International Agency for Research, Cancer, Health, Reuters, Joint WHO, Food, Agriculture Organization's, WHO, Japan's Ministry of Health, Labour, Welfare, Food Safety Authority, U.S, International, Association, Cargill, International Council of Beverages Associations, Ramazzini Institute, EFSA, Pepsico, Thomson Locations: New York City, U.S, United States, Europe, Geneva, France, Italy, sodas

The company, Marion Biotech, bought the ingredient — propylene glycol (PG) — from trader Maya Chemtech India, as reported by Reuters. "Marion bought commercial-grade propylene glycol," said a second source, an investigator, who declined to be named while the inquiry is ongoing. International standards allow only trace amounts of EG and DEG in pharmaceutical-grade propylene glycol. The toxins were found in cough syrups exported to Gambia by the other Indian company, Maiden Pharmaceuticals. India made it mandatory for companies to have their cough syrups tested before export from June.

Persons: Marion, Deepak Sharma, Max, Vijay Kumar, Tuhin Bhattacharya, Mool Singh, Atul Rawat, Jaya Jain, Sachin Jain, Rohan Gupta, syrups, Maiden, Saurabh Sharma, Krishna, Jennifer Rigby, Olzhas, Sara Ledwith, Michele Gershberg, Deepa Babington Organizations: Reuters, Marion Biotech, Indian, EG, World Health Organization, Authorities, . Police, Marion, Court, Maya, Maiden Pharmaceuticals, WHO, Thomson Locations: DELHI, Uzbekistan, India, Delhi, Marion, Uttar Pradesh, Allahabad, Gambia, Indonesia, London, Almaty

☆ Analysis: Weight loss drug candidates multiply, spurring hopes of better outcomes, lower costs
▼ + stars: | 2023-06-27 | by ( Deena Beasley | ) www.reuters.com time to read: +5 min

More than 40% of Americans are obese, according to the U.S. Centers for Disease Control and Prevention, and demand is strong for treatments to reduce body weight as well as maintain weight loss. The company said it would continue to develop its twice-daily weight loss drug candidate. Structure Therapeutics (GPCR.O) is developing oral obesity drugs that it says are simpler to manufacture than the current injectables. "We define weight loss quality as the percentage of weight loss attributed to fat loss," said Versanis Chief Scientific Officer Lloyd Klickstein. "With diets, bariatric surgery, incretin drugs or other weight loss drugs, two-thirds to three-quarters of the weight loss is fat, but one-quarter to one-third is lean."

Persons: Robert Gabbay, Eli Lilly, Lilly's, Wegovy, Mico Guevarra, Lilly, Jeff Emmick, Ray Stevens, Boehringer Ingelheim, Versanis, Lloyd Klickstein, Chaguturu, Deena Beasley, Michele Gershberg, Jamie Freed Organizations: DIEGO, Novo Nordisk's, American Diabetes Association, Novo, U.S . Centers for Disease Control, ADA, Pfizer, Therapeutics, Zealand Pharma, Novartis, CVS Health, Aetna, Thomson Locations: San Diego, GLP

☆ Obesity drug Wegovy's popularity has US employers rethinking insurance coverage
▼ + stars: | 2023-06-27 | by ( Patrick Wingrove | ) www.reuters.com time to read: +6 min

[1/2] A selection of injector pens for the Saxenda weight loss drug are shown in this photo illustration in Chicago, Illinois, U.S., March 31, 2023. A new and more expensive version of the drug specifically for weight loss, called Wegovy, had been approved in 2021 by U.S. health regulators. Employers that cover weight-loss drugs have required medical practices to document patients’ need for Wegovy since it was approved. The federal Medicare healthcare program for Americans aged 65 and older cannot cover weight loss treatments by law. Only 16 states – the most populous being California, Pennsylvania and Michigan – cover Wegovy and other obesity drugs under their Medicaid plans for low-income patients.

Persons: Jim Vondruska, Shawnte, Aon, Mercer, Willis Towers Watson, Eli Lilly, Jeff Levin, Levin, Scherz, Michael Manolakis, William Yancy, Manolakis, Patrick Wingrove, Michele Gershberg, Suzanne Goldenberg Organizations: REUTERS, New, Warner Bros, Warner Bros Discovery Inc, Reuters, Marsh & McLennan, Employers, Barclays Research, Novo Nordisk, Duke University, Thomson Locations: Chicago , Illinois, U.S, New York, Marsh, Wegovy, California, Pennsylvania, Michigan

The World Health Organization is working with countries to investigate the global pharmaceutical supply chain for such syrups. Andika Urrasyidin, lead police investigator of the case, told Reuters police have called in "many" BPOM officials for questioning, and the investigation is still underway. Hersadwi Rusdiyono, the director of Indonesia's national police's crimes detection unit, said BPOM officials were brought in as witnesses, but investigators are now checking if any wrongdoing was committed by drug regulators. "We asked them according to their functions, as regulators, whether they've conducted supervision and what kind of supervision," he told Reuters. Hersadwi said the probe so far has focused on staff at lower levels and not included BPOM'S chief, Penny Lukito.

Persons: Urrasyidin, Hersadwi Rusdiyono, they've, Hersadwi, Penny Lukito, Penny, BPOM, Tirta Buana Kemindo, Stanley Widianto, Miyoung Kim, Sara Ledwith, Michele Gershberg Organizations: Reuters, World Health Organization, Police, Afi, Thomson Locations: JAKARTA, Gambia, Uzbekistan, BPOM

He warned that contaminated medicines could still be found for several years, because adulterated barrels of an essential ingredient may remain in warehouses. Cough syrups and the ingredient, propylene glycol, both have shelf-lives of around two years. Unscrupulous actors sometimes substitute propylene glycol with toxic alternatives, ethylene glycol and diethylene glycol, because they are cheaper, several pharmaceutical manufacturing experts told Reuters. The WHO said it has also offered help to Liberia and Cameroon – which recently signalled that it too may have contaminated cough syrups for sale. The contaminated syrups in Liberia were made by India's Synercare Mumbai, according to the Nigerian regulator.

Persons: Rutendo Kuwana, Kuwana, –, syrups, Naresh Kumar Goyal, QP Pharmachem, India's Synercare, Synercare, It's, Jennifer Rigby, Krishna N.Das, Edward McAllister, Stanley Widianto, Sumit Khanna, Sophie Yu, Sara Ledwith, Michele Gershberg Organizations: World Health Organization, WHO, Reuters, Pharmaceutical, Marshall, Indonesian, –, PT Universal Pharmaceutical Industries, AFI, Pharmaceuticals, Marion Biotech, Maiden Pharmaceuticals, Thomson Locations: LIBERIA, CAMEROON, Liberia, Nigeria, Gambia, Uzbekistan, Micronesia, Indonesian, – Timor Leste, Cambodia, Senegal, Philippines, Cameroon, syrups, Marshall Islands, India's Synercare Mumbai, Nigerian, Liberian, India, Panama, Delhi, Dakar, Jakarta, Ahmedabad, Beijing

The Additional Chief Secretary, G. Anupama, said in a text message, "Enquiry is underway" and directed Reuters to the health minister for Haryana state, Anil Vij, for further details. Its chief minister and health minister, to whom Yashpal also sent his complaint, did not respond to requests for comment. Naresh Kumar Goyal, the founder of Maiden Pharmaceuticals, told Reuters in December his company did nothing wrong in the production of the cough syrup. The bribery allegation was one of about half a dozen claims of corruption by Yashpal against Taneja in the letter. Yashpal told Reuters he did not comply, because he did not feel comfortable bringing such details to the deputy of someone he had accused of corruption.

Persons: Sagnia, Edward McAllister, Yashpal, Manmohan Taneja, Taneja, Maiden, Yashpal –, –, Shatrujeet Kapur, Kapur, Anupama, Anil Vij, Vij, Naresh Kumar Goyal, Goyal, Narendra Modi, Taneja's, Lalit Kumar Goel, Goel, Krishna N, Jennifer Rigby, Sara Ledwith, Michele Gershberg Organizations: REUTERS, World Health Organization, WHO, Reuters, Corruption Bureau, Maiden Pharmaceuticals, pharma, Corruption, Taneja, EG, Thomson Locations: Yundum, Gambia, DELHI, Haryana, New Delhi, Vietnam, India, London

At least 70 children in Gambia, most under 5 years old, died from acute kidney injury between June and October. Tests by the WHO found that the Maiden cough syrups contained the lethal toxins diethylene glycol (DEG) and ethylene glycol (EG), used in car brake fluid. Indian officials have said the WHO failed to prove a causal link to the Gambia deaths, accusing the agency of denigrating its $41 billion pharmaceutical industry. However, cough syrups made by a second Indian drugmaker have been linked to the deaths of 19 children in Uzbekistan. India has since made drug testing mandatory for cough syrups before export.

Persons: Sagnia, Lamin, Edward McAllister, Dawda Jallow, Jallow, syrups, Maiden, Adama Barrow, Dawda, Shilpa Jamkhandikar, Sara Ledwith, Michele Gershberg, Bill Berkrot Organizations: Reuters, World Health Organization, WHO, Maiden Pharmaceuticals, EG, World Bank, Thomson Locations: Serekunda, Gambia, BANJUL, India, Uzbekistan

Health Minister Mansukh Mandaviya and federal and state regulators attended the session in February, according to a statement from the health ministry that did not mention cough syrups. A source with knowledge of the matter said the policy change could mean increased oversight of India's $41 billion pharmaceutical industry, which is the world's largest supplier of generic medicines. Increased testing of cough syrups as well as of raw materials for drugs in general is one of the steps being considered, said the source. India has acted against a second Indian company whose cough syrups were linked to the deaths of 19 kids in Uzbekistan, including the arrest of three of its employees. Indian health officials have expressed concern that the incidents of contaminated syrups will harm its pharmaceutical industry.

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