Health News Roundup: Nasal spray alternative to EpiPen suffers setback as FDA seeks fresh study; Exclusive-U.S. FDA found lapses at Novo's main U.S. factory in May 2022 -report and more
The inspection by the U.S. Food and Drug Administration (FDA) was at Novo's facility in Clayton, North Carolina, which the company says produces the active pharmaceutical ingredient (API), semaglutide, used in its hugely popular weight-loss drug Wegovy and type 2 diabetes drug Ozempic. Australia to hold independent inquiry into handling of COVID pandemic Australia's centre-left Labor government on Thursday said it would hold an independent inquiry into the handling of the COVID-19 pandemic to better prepare for future health crises.
Following is a summary of current health news briefs.
Nasal spray alternative to EpiPen suffers setback as FDA seeks fresh study
The U.S. health regulator has declined to approve a nasal spray that would have been the first needle-free emergency treatment for allergic reactions, a surprise decision that sent shares of its developer ARS Pharmaceuticals down 47% premarket. The rejection and request for additional testing sharply contrasts the backing from the U.S. Food and Drug Administration's (FDA) independent experts for the spray, neffy, in May.
Exclusive-U.S. FDA found lapses at Novo's main U.S. factory in May 2022 -report
U.S. drug regulators issued a report detailing quality control lapses at Novo Nordisk's main factory in North America as early as May last year, according to the report obtained by Reuters via a Freedom of Information Act request. The inspection by the U.S. Food and Drug Administration (FDA) was at Novo's facility in Clayton, North Carolina, which the company says produces the active pharmaceutical ingredient (API), semaglutide, used in its hugely popular weight-loss drug Wegovy and type 2 diabetes drug Ozempic.
Australia to hold independent inquiry into handling of COVID pandemic
Australia's centre-left Labor government on Thursday said it would hold an independent inquiry into the handling of the COVID-19 pandemic to better prepare for future health crises. Australia closed its international borders and locked down cities among other pandemic restrictions that helped keep infections and deaths far below levels in other comparable developed economies such as the United States and Britain.
Ypsomed signs autoinjector supply deal with Novo Nordisk
Swiss medical technology company Ypsomed announced on Wednesday a long-term supply deal with Novo Nordisk for autoinjectors, the latest sign of how the Danish drugmaker's weight-loss drug business is a boon for pharmaceutical services companies. Ypsomed said it would expand its manufacturing capacities over the coming years, with Novo Nordisk contributing a significant part of the investment for the additional production infrastructure.
US government restarts delivery of free COVID tests
The U.S. Department of Health and Human Services (HHS) said on Wednesday it will deliver COVID-19 tests for free to households across the country. Beginning Sept. 25, households will again be able to order four free tests through COVIDTests.gov, the health agency said, adding that the tests can detect currently circulating COVID-19 variants and are intended for use through the end of 2023.
Exclusive-India to mandate annual audit of pharma suppliers by drugmakers
India will make it mandatory for drugmakers to audit their raw material suppliers at least once a year, according to a government document, tightening rules after India-made cough syrups were linked to 141 children's deaths worldwide. The new mandate, along with additional testing rules for cough syrup exports implemented in June, shows that India is seeking to reassure buyers about the safety of its $42 billion pharmaceuticals industry, one of the world's largest.
Appeals court tosses order requiring Mississippi to change mental health system
A U.S. appeals court on Wednesday threw out a lower court order that required the state of Mississippi to make changes to its mental health system to avoid the risk of unnecessarily institutionalizing people with mental illness. In a unanimous opinion, a three-judge panel of the 5th U.S. Circuit Court of Appeals found that the 2021 order, which came in response to a lawsuit by the U.S. Justice Department, went too far in requiring "sweeping modifications" of state policy.
Anti-obesity drugs can shrink more than patients
Starry-eyed venture capitalists love to talk about how promising startups might capture a chunk of a giant total addressable market (TAM). This concept can also work in reverse, though. New anti-obesity drugs have the potential to transform public health, while obliterating demand for products and services from the medical, food and fitness industries. Think of them as total unaddressable markets (TUM). Drugs developed by Novo Nordisk and Eli Lilly appear to be the first truly effective diet treatments. They work by targeting receptors in the brain that reduce appetite and help people feel fuller for longer. Originally developed to tackle diabetes, they’re gaining traction as treatments for obesity. In one clinical trial, patients taking Eli Lilly’s soon-to-be-launched weight-loss drug lost about 50 pounds (23 kg). The benefits for public health are potentially huge. In August, Novo said Wegovy, its obesity drug, reduced the incidence of serious cardiovascular events like strokes and heart attacks by 20% in overweight patients who have a history of heart disease but don’t have diabetes. Sales are already soaring. Last year, Novo sold nearly $2.5 billion worth of Wegovy and Ozempic, its treatment for people with diabetes. Analysts expect that figure to balloon to $16 billion by 2027, according to forecasts compiled by Visible Alpha. Demand for the medicines, collectively known as GLP-1 drugs, far exceeds what manufacturers can currently produce. Yet excitement has lifted Novo’s market capitalisation to $420 billion, making it Europe’s most valuable company. Lilly, whose diabetes treatment is called Mounjaro, has seen its market value nearly double to more than $500 billion in under 18 months. Such a dramatic revolution in public health will also produce losers, though. The drugs are designed to suppress appetite, mimicking a gut hormone which is released after eating. During trials, patients showed reduced appetite and even an aversion towards food generally. This has the potential to affect giant groups such as Switzerland’s Nestlé, Cadbury and Oreo maker Mondelez International, and Kraft Heinz. These companies dominate a global market for snacks which is currently worth more than half a trillion dollars in revenue per year and is expected by Fortune Business Insights to expand to nearly $840 billion by 2029. Fast food groups like McDonald’s, Burger King and KFC owner Yum Brands could also face shrinking or shifting demand.
U.S. government awards $45 million for long COVID clinics
The U.S. government is awarding $45 million in grants to help clinics treating long COVID develop new models of care and expand access, the Department of Health and Human Services (HHS) said on Wednesday. Nine clinics will receive $1 million grants annually over the next five years through the Agency for Healthcare Research and Quality (AHRQ) within HHS, the department said.
EU executive proposes 10-year glyphosate approval extension
The European Commission proposed on Wednesday extending EU approval for use of glyphosate, the active ingredient in Bayer AG's Roundup weed killer, by 10 years. The World Health Organization's cancer research agency concluded in 2015 that glyphosate was probably carcinogenic to humans, but other agencies around the world, including the U.S. Environmental Protection Agency (EPA) and the European Chemicals Agency, have classified glyphosate as non-carcinogenic.
(With inputs from agencies.)
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