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.

Bayer has said decades of studies have shown it is safe and the chemical has been widely used by farmers for decades, but EU approval was set to expire at the end of the year.

Germany's Bayer acquired Roundup through its $63 billion purchase of U.S. agrochemical group Monsanto in 2018 and has since spent billions of dollars to settle a series of U.S. lawsuits claiming it caused cancer.

The Commission's proposal will be put to a vote on Oct. 13 by the 27 European Union members, with a "qualified majority" of 15 representing at least 65% of the bloc's population required either to support or to block the proposal.

The European Food Safety Agency (EFSA) said in a report issued in July that it had not identified "critical areas of concern" to prevent renewed approval.

Bayer said it welcomed the Commission's proposal and that the decision of EU members should be based on the scientific conclusions of relevant authorities, such as EFSA, leading to re-approval.

Campaign group Pesticide Action Network Europe said that there were serious concerns about the safety assessments and that polls in six EU countries showed citizens did not support the extension of approval.

https://news.yahoo.com/european-commission-proposes-10-approval-101251163.html

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.

The potential impact on the medical industry could be even bigger. Over 40% of Americans are obese according to the Centers for Disease Control and Prevention, and that number has increased by nearly 40% over two decades. Obese people are more likely to suffer from cardiovascular disease, various cancers, arthritis and dementia. In 2016 the Milken Institute estimated the medical costs associated with obesity in the United States at nearly $500 billion a year. A 2021 study published in the BMJ projected that costs from reduced health and higher absenteeism worldwide would rise 50% by 2060.

The adoption of anti-obesity drugs remains hard to gauge. At a cost of about $1,000 per month it’s unclear whether insurers and public health authorities will fund widespread treatment. Side effects can also be harsh. Only about a third of those who started taking the drugs for obesity were still doing so a year later, according to one analysis.

Any destructive impact is therefore likely to be gradual. Even so, investors are beginning to fret. Breakingviews scanned transcripts of corporate earnings calls, presentations and other events tracked by LSEG for mentions of Wegovy, Ozempic and Mounjaro – excluding those hosted by Novo and Lilly. In 2022 there were 18 such events. So far this year, at least one of the drugs has been mentioned 71 times.

Among the potential losers are firms like ResMed and Inspire Medical Systems, which make products that treat sleep apnea, a condition where patients intermittently stop breathing while asleep. Around 70% of sufferers are obese. On a call with investors in August, ResMed CEO Michael Farrell said he thought weight-loss drugs wouldn’t have a major impact on the company’s future sales because the treatment is harsh and its cost would discourage many patients from taking it long term, while awareness of the effects of obesity could push patients towards apnea treatment. Even so, ResMed’s stock has since lost about a third of its value.

Meanwhile, companies selling joint replacements such as Zimmer Biomet and Smith+Nephew could see their $25 billion and $11 billion values slimmed. These two firms earn about two-thirds and 30% of their revenue, respectively, from hip and knee implants. One study estimated about a quarter of surgical cases involving knees could be avoided if patients weren’t overweight. Rival weight management treatments also look vulnerable. Since June 2021, when Novo Nordisk’s first obesity drug gained regulatory approval, shares of WW International, formerly Weight Watchers, have collapsed about 70%, despite the company unveiling a plan to distribute weight-loss drugs.

Economic destruction could spread further afield, too. Anecdotal reports and trials on animals suggest GLP-1 drugs may also dampen urges beyond snacking, including consuming alcohol, nicotine and possibly engaging in other addictive behaviors like gambling. These changes may have limited impact or affect only a small number of users. But any reduction in addictions could have big effects. The gambling and alcohol industries tend to display so-called Pareto distributions, where a few users provide most of the profit. In England, for example, 4% of drinkers account for 23% of the industry’s revenue, according to a study in the journal Addiction. And the top 20% most engaged gamblers using an online casino operated by the Canadian government made up 92% of revenue and 90% of losses. Widespread adoption of GLP-1 drugs could also produce corporate winners as consumers divert cash previously spent on food and medical care. Plastic surgeons may benefit if patients seek nips and tucks following weight loss. Dating services like Match and Grindr may attract newly confident users. Fashion brands and sporting goods groups could get a lift from people seeking new wardrobes or embracing athletic pursuits. Yet even as Novo, Lilly and others see their addressable markets expand, some companies will see theirs shrink. For investors, the TUM may be just as important as the TAM.

https://news.yahoo.com/anti-obesity-drugs-shrink-more-124406158.html

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.

The World Health Organization (WHO) and other health agencies linked contaminated India-made cough syrups to the deaths of 70 children in Gambia, 65 in Uzbekistan and at least six in Cameroon over the past year.

India's federal drug regulator, the Central Drugs Standard Control Organisation (CDSCO), conveyed the decision on mandatory audits for raw material and packaging material suppliers in a meeting with industry representatives on Sept. 15, according to a presentation seen by Reuters.

Drugmakers will have to do an audit of their raw materials and packaging suppliers "at least once in a year", the presentation said. Currently such audits are done occasionally after events, such as a product recall, it said.

India's Health Ministry did not immediately respond to a request for comment.

Some Indian drugmakers were buying key ingredients from suppliers who did not have a license to sell pharmaceutical-grade products, Reuters has reported. The drugmakers have denied allegations that their products were responsible for deaths.

Drugmakers will also have to inform their licensing authorities, generally the drug regulator of the state where they are based, of all product recalls, the document showed.

Health experts have previously criticised the lack of data on product recalls after some Indian companies were given drug export licences by their home state, despite previous violations in other states.

The WHO says the death of 12 children in India in late 2019 after consuming contaminated cough syrup may have been the start of a wave of poisoning by the India-made medicines.

In all the cases, the syrups were found to contain high levels of the toxin diethylene glycol (DEG), and or a related chemical, ethylene glycol.

Through the new regulatory steps for pharma products, India wants to build "trust and confidence on quality" and reduce "product failure", among other things, the presentation said.

Separately, the trade ministry has been holding workshops across the country for drugmakers to "review the regulatory perspectives on DEG contamination and discuss the current regulations in place to prevent it", according to a statement from the ministry backed trade body, the Pharmaceuticals Export Promotion Council of India (Pharmexcil).

"Maintaining the quality of pharmaceutical products is crucial to guaranteeing the patient's safety, failing which could have long-term ramifications for the global public's confidence on Indian medicines," Pharmexcil said.

"The Indian pharma units, especially the MSME (small companies) sector are facing new challenges under resource-poor settings to meet global as well as domestic healthcare expectations."

https://news.yahoo.com/exclusive-india-mandate-annual-audit-130907850.html

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.

President Joe Biden had tasked HHS last year with developing a national action plan to tackle long COVID, a complex, multi-symptom condition that arises months after a COVID-19 infection and leaves many of its sufferers unable to work.

"The Biden-Harris Administration is supporting patients, doctors and caregivers by providing science-based best practices for treating long COVID, maintaining access to insurance coverage, and protecting the rights of workers as they return to jobs while coping with the uncertainties of their illness," said HHS Secretary Xavier Becerra.

The funding will be used for increasing in-person and virtual visits, establishing new satellite clinics, and an education initiative aimed at growing referrals. Limited knowledge and acceptance among clinicians has contributed to delays in diagnoses and referrals.

It will also go towards social services, hiring interpreters, group patient programs, and behavioral health support. The grants prioritize access for underserved, rural, vulnerable, and minority populations that are disproportionately impacted by long COVID.

The condition affects nearly 7% of all U.S. adults and 2.3% of the overall population and has cost an estimated $386 billion in lost wages, savings and medical bills, according to an analysis in April by the Solve Long Covid Initiative, a non-profit research and advocacy group.

More than 200 symptoms have been linked to the syndrome - including extreme fatigue, difficulty thinking, headaches, dizziness when standing, sleep problems, chest pain, blood clots, immune dysregulation, and even diabetes.

No proven treatments are available but research is underway. The National Institute of Health (NIH) is conducting a $1.15 billion effort, the RECOVER program, which launched two clinical trials in July that will evaluate at least four potential treatments. 

https://finance.yahoo.com/news/u-government-awards-45-million-130000692.html

Colorado police face trial over ketamine killing of Elijah McClain

 Opening arguments were expected to begin Wednesday afternoon in the first of three trials over the 2019 killing of Elijah McClain, a Black man who was not suspected of any crime when Colorado police confronted him, placed him in a choke hold and called paramedics who gave him a sedative overdose.

McClain, 23, was walking home from a convenience store in the Denver suburb of Aurora on Aug. 24, 2019, when he was stopped by police responding to a report he was acting suspiciously.

Police restrained the slight McClain in a choke hold. He was later injected with the powerful sedative ketamine by paramedics, then lapsed into cardiac arrest and died days later at a hospital. All the police and paramedics involved are white.

The McClain case drew national attention following the 2020 killing of George Floyd under the knee of a white Minneapolis police officer, which sparked a summer of global protests over the mistreatment of African Americans and other minorities by U.S. law enforcement.

Local prosecutors at first declined to press charges in McClain's death. But a public outcry prompted Colorado's governor to order the state attorney general to review the case. A grand jury charged three police officers and two paramedics in a 32-count indictment in September 2021, two years after the killing.

A revised autopsy report in September 2022 concluded McClain died from a ketamine overdose. The forensic pathologist who had initially concluded McClain's cause of death was "undetermined," wrote in the later report that he had had “insufficient information” during his 2019 autopsy.

In a video recording of the encounter from a police-worn body camera, a sobbing McClain could be heard pleading: "I can't breathe, please stop. I was just going home."

The Colorado attorney general also determined that Aurora's police department routinely violated the law by engaging in racially biased policing and excessive use of force.

The first trial involves city of Aurora police officer Randy Roedema and former officer Jason Rosenblatt, who are both charged with manslaughter, criminally negligent homicide and other charges, and are facing a joint jury trial. Both men have pleaded innocent.

Aurora police officer Nathan Woodyard, who is accused of putting McClain in a chokehold, will stand trial alone on the same charges in October. He has pleaded innocent.

Two paramedics who injected McClain with a high dose of ketamine are scheduled for a joint trial on the same charges in November. The pair have pleaded innocent.

Rosenblatt was fired in 2020 after responding "haha" in a text in response to a mocking photo that three police officers had taken at the site of McClain's killing. The other two officers and the paramedics have been suspended without pay pending the outcome of the trial. Two of the officers who posed for the photo were fired, and the third resigned before any disciplinary action was taken.

The city of Aurora agreed in November 2021 to pay McClain's family $15 million to settle a civil rights lawsuit.

An independent panel hired by Aurora's City Council found the officers who stopped McClain had no apparent reason to suspect a crime was being committed and that an initial internal police investigation of the matter was flawed.

https://news.yahoo.com/colorado-police-face-trial-over-143531904.html

US appeals judge, 96, suspended in rare clash over fitness

 The U.S. Court of Appeals for the Federal Circuit on Wednesday suspended Judge Pauline Newman from hearing new cases amid a deepening clash over the 96-year-old jurist's mental competence to serve on the bench.

A council of judges on the Washington, D.C., court unanimously said Newman had failed to cooperate with an investigation into her fitness and barred her from hearing new cases for at least one year or until she sits for court-ordered medical examinations.

"We are acutely aware that this is not a fitting capstone to Judge Newman's exemplary and storied career," the council said, but added it had no choice when "a judge of this Court is no longer capable of performing the duties of her judicial office."

Such a public and contentious internal dispute over competency is highly unusual in the federal judiciary. Newman has defended her fitness, citing the opinions of two doctors, and filed a lawsuit in a separate Washington court seeking to move or halt the investigation.

Newman's attorney Greg Dolin said on Wednesday that the council was "ignoring data or information or opinions that are inconsistent with its predetermined goals and outcomes," and that the judge would challenge the order and continue to press her claims in court.

A representative for the Federal Circuit declined to comment.

Newman, a highly-respected figure in patent law and a prominent dissenter, was appointed to the patent-focused Federal Circuit by President Ronald Reagan in 1984. The court's chief judge said in orders made public in April that Newman showed signs of cognitive and physical impairment and accused her of refusing to cooperate with inquiries into her mental health.

Court employees also described "memory loss, confusion, paranoia and angry rants" by Newman, according to documents released in August.

Newman's attorneys said in a response to the council made public on Wednesday that the committee investigating her fitness was "interested in one thing and one thing only - keeping Judge Newman off the bench via the exercise of raw power."

https://www.aol.com/us-appeals-judge-96-suspended-140539559.html

Ford unhappy at UK's potential EV shift

 Some auto industry leaders are not happy with Britain's potential rethink on plans for electric vehicles.

This week, British Prime Minister Rishi Sunak is expected to water down some measures meant to help the country hit a target of net zero emissions by 2050.

That includes pushing back its current plan to ban new petrol and diesel car sales by 2030 to five years later.

Sunak is expected to argue the response to climate change should be more "proportionate."

But that has drawn the anger of Ford UK, which said Britain risked undermining the transition to EVs.

Ford said dropping the 2030 deadline would be a mistake, and hinted it could put further investments in the country at risk.

Ford said it had already invested over $530 million in its UK facilities, and had been planning to spend even more to fit with the 2030 timeline.

The U.S. auto giant said Britain's policy should focus on helping the EV market grow in the short term.

There was further criticism of the possible change from a leading auto industry trade body.

The Society of Motor Manufacturers and Traders said the auto industry had already invested billions in new EVs.

But it said the transition to clean energy could be put in danger without a clear and consistent message from government.

https://news.yahoo.com/ford-unhappy-uks-potential-ev-110347797.html