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☆ Novo Nordisk rivals see room to compete in $100 billion weight-loss drug market
▼ + stars: | 2023-05-04 | by ( Michael Erman | ) www.reuters.com time to read: +6 min

The company has two oral GLP-1 drugs in mid-stage trials, and aims to choose one for a late-stage trial this year. He forecasts GLP-1s or similar drugs topping $100 billion in annual sales early in the 2030s, with Lilly's product accounting for more than $50 billion in sales. Smaller biotechs are also vying for a piece of the obesity market and hope large pharmaceutical companies will pay up for partnerships. "I don't know if it's $90 billion or $80 billion or $50 billion. The current GLP-1 drugs can cause nausea and vomiting.

The membership of the panel at Musk’s company, Neuralink, raises questions about potential violations of conflict-of-interest regulations aimed at protecting research integrity, a dozen animal-research and bioethics experts told Reuters. Autumn Sorrells has chaired an oversight board approving animal experiments by Elon Musk’s brain-chip startup, Neuralink, and also run the company’s animal care program. Reuters couldn’t determine the compensation terms of the Neuralink IACUC members who are also company employees. The independence of such boards, Nicolelis said, is critical to protecting the integrity of animal research that could impact humans in future clinical trials. These institutions generally prohibit people with direct financial interests from serving on IACUCs or voting on animal experiments.

The World Health Organization said last year the syrups, made by Indian manufacturer Maiden Pharmaceuticals Ltd, contained lethal toxins ethylene glycol (EG) and diethylene glycol (DEG) – used in car brake fluid. "If you ask and you don't get informed, it's a dead end," Rutendo Kuwana, the WHO's team lead for incidents with substandard and falsified medicines, told Reuters in an interview on March 31. Drug inspectors found a dozen violations at Maiden last October related to the production of the cough syrups sold to Gambia, a government document showed. Among these, some of the COAs of raw ingredients used in making the syrups, including propylene glycol, were missing batch numbers. Kuwana said the WHO was sure of its own cough syrup test results from two separate independent laboratories, both of which showed contamination.

Its peak sales forecast is of more than $2 billion annually together from the maternal vaccine and an RSV shot for older adults. The case highlights how equitable global access will require better advance planning by drugmakers, governments and health organizations, health officials say. "They could have tried sooner," said Erin Sparrow, WHO's technical officer for the RSV vaccine, referring to Pfizer. Pfizer has yet to take a number of steps needed to make the vaccine available in developing countries, according to global health officials and the company. She still expects it to be several years before the RSV vaccine is launched in lower-income countries.

☆ As weight-loss drugs hit the U.S. market, doctors debate how to use them
▼ + stars: | 2023-03-30 | by ( Patrick Wingrove | ) www.reuters.com time to read: +6 min

[1/2] The American Medical Association logo is seen at their office in Washington, D.C., U.S., August 30, 2020. REUTERS/Andrew Kelly/March 30 (Reuters) - As powerful new obesity drugs enter the U.S. market, medical associations are keen to advise their members on how to best use them for patients. "These new compounds are game changers, there's no doubt about it," said Anthony Comuzzie, chief executive of The Obesity Society. The group last provided obesity treatment guidelines in 2013 alongside the American Heart Association and American College of Cardiology. OBESITY AS A DISEASEThe American Medical Association, the nation’s largest medical group, recognized obesity as a disease in 2013.

REUTERS/Daniel BecerrilLONDON, March 29 (Reuters) - Drugs that combat obesity could for the first time be included on the World Health Organization's "essential medicines list," used to guide government purchasing decisions in low- and middle-income countries, the U.N. agency told Reuters. A panel of advisers to the WHO will review new requests for drugs to be included next month, with an updated essential medicines list due in September. The request to consider obesity drugs was submitted by three doctors and a researcher in the United States. The majority – 70% - live in low- and middle-income countries. EXPANDING ACCESSIncluding obesity drugs among the WHO's essential medicines could have great significance for that population.

☆ Vaccine makers prep bird flu shot for humans 'just in case'; rich nations lock in supplies
▼ + stars: | 2023-03-20 | by ( Jennifer Rigby | Thomson Reuters | Jen Reports On Health Issues Affecting People Around The World | ) www.reuters.com time to read: +5 min

There has also been a push among companies to develop a bird flu vaccine for poultry, a market potentially far larger than that for humans. Many countries' pandemic plans say flu shots should go first to the most vulnerable while supply is limited. The agreements include six of the largest seasonal flu manufacturers, such as GSK, Sanofi and CSL Seqirus, the WHO said. NEW APPROACHESIn a pandemic, vaccine manufacturers would shift production of seasonal flu vaccines and instead make shots tailored to the new outbreak when needed. The results will be closely watched, as the data on Moderna’s seasonal flu candidate was mixed.

☆ WHO, advisors urge China to release all COVID-related data after new research
▼ + stars: | 2023-03-18 | by ( ) www.reuters.com time to read: +3 min

Access to the information was subsequently restricted “apparently to allow further data updates” by the Chinese Center for Disease Control and Prevention (CDC). WHO officials discussed the matter with Chinese colleagues, who explained that the new data were intended to be used to update a preprint study from 2022. "We continue to call on China to be transparent in sharing data, and to conduct the necessary investigations and share the results," he said. The Huanan Seafood Wholesale Market in Wuhan was shut down by Chinese authorities after the novel coronavirus emerged in the city in late 2019. The market has since been a focus of study of whether the virus had infected several other species before jumping to humans.

☆ How cough syrup gets poisoned
▼ + stars: | 2023-03-10 | by ( ) www.reuters.com time to read: +3 min

These medicines combine active ingredients such as paracetamol (known as acetaminophen in the United States) to reduce fever with a syrup made from glycerin or propylene glycol that is safe, sweet and easy to swallow. In Gambia, imported cough syrup for children was found by global health officials to be contaminated with two highly toxic substances: ethylene glycol (EG) and diethylene glycol (DEG). Manufacturers making propylene glycol for pharmaceutical use must purify it to remove any toxins, Kumar Koduri said. Mix-ups can happen due to human error, said Kumar Koduri. EG and DEG can cost less than half the price of propylene glycol, according to two websites selling the chemicals.

☆ Exclusive: WHO investigating links between cough syrup deaths, considers advice for parents
▼ + stars: | 2023-01-24 | by ( Jennifer Rigby | ) www.reuters.com time to read: +6 min

The deaths of children from acute kidney injury began in July 2022 in Gambia, followed by cases in Indonesia and Uzbekistan. The WHO has said the deaths are linked to over-the-counter cough syrups the children took for common illnesses and which contained a known toxin, either diethylene glycol or ethylene glycol. The WHO, working with Indonesia’s drugs regulator, also issued an alert in October about cough syrups made by four Indonesian manufacturers and sold domestically. The manufacturers are: PT Yarindo Farmatama, PT Universal Pharmaceutical, PT Konimex, PT AFI Farma. PT Universal Pharmaceutical Industries’ lawyer, Hermansyah Hutagalung, said it had pulled from the market all cough syrups deemed dangerous.

The methods for counting COVID deaths have varied across countries in the nearly three years since the pandemic began. CAN CHINA'S COVID DATA BE TRUSTED? With one of the lowest COVID death tolls in the world, China has been routinely accused of downplaying infections and deaths for political reasons. Globally, the study estimated 18.2 million excess deaths in 2021-2022, compared with reported COVID deaths of 5.94 million. China actually cut its accumulated death toll by one on Dec. 20, bringing the total to 5,241.

☆ Potential China wave is 'wild card' for ending COVID emergency - WHO advisors
▼ + stars: | 2022-12-20 | by ( Jennifer Rigby | ) www.reuters.com time to read: +5 min

"It's clear that we are in a very different phase [of the pandemic], but in my mind, that pending wave in China is a wild card." Last week, he told reporters in Geneva that he was "hopeful" of an end to the emergency some time next year. Tedros's earlier comments spurred hopes that the United Nations agency could soon remove the Public Health Emergency of International Concern (PHEIC) designation for COVID, which has been in place since January 2020. Some global health experts had expected China to wait for the WHO to lift the emergency status before easing its own pandemic response measures. WHO member states are currently working on re-designing the rules that govern global health emergencies to potentially address issues like this.

The UK government has promised to overhaul the youth gender care system, after it was deemed inadequate by England’s regulator of health and social care. They described a deeply flawed system that is now hobbled by a toxic political climate around gender care. The letter said a decision would be made at some point from early 2022 on whether the child “is likely to meet the access criteria” for gender care. The family has received no NHS gender care or mental health support since the referral, she said. These recommended supporting “identity exploration” and mental health treatment as the first steps to ensure that any psychological issues are addressed.

These psychiatric drugs are regulated by the federal government as controlled substances that have high potential for abuse and addiction but are not opioids. The impact on independent pharmacies' prescriptions of psychiatric drugs from the widening crackdown on opioids has not been previously reported. It is dedicated to mitigating the abuse of controlled substances without interfering in good-faith clinical decisions made by doctors, she said. "Pharmaceutical distributors must walk a legal and ethical tightrope between providing access to necessary medications and acting to prevent diversion of controlled substances," Esposito said in a written statement. The FDA, the HHS agency that administers the list of controlled substances, did not respond to a request for comment.

☆ Emerging from the COVID pandemic, again
▼ + stars: | 2022-12-07 | by ( Michele Gershberg | ) www.reuters.com time to read: +4 min

Dec 7 (Reuters) - For much of the world, 2022 marked the beginning of the end of the COVID-19 pandemic. Emerging variations of the coronavirus so far remain closely related to Omicron, without radically altering its impact. "The pandemic is over," U.S. President Joe Biden said in September, referring to the changing behavior of Americans. The World Health Organization (WHO) has yet to declare an end to the COVID public health emergency introduced in January 2020. Data show that the pandemic has disrupted all kinds of healthcare, from childhood immunizations to cancer screenings read more read more .

☆ Rare success for Alzheimer's research unlocks hope for future therapies
▼ + stars: | 2022-11-29 | by ( Julie Steenhuysen | ) www.reuters.com time to read: +6 min

Eisai and Biogen are scheduled to present full data from their lecanemab study on Tuesday at the Clinical Trials on Alzheimer's Disease conference in San Francisco. Lecanemab’s success rests on years of research into the causes of Alzheimer’s as well as advances in measuring amyloid deposits through brain scans and spinal fluids. At least 16 treatments are being tested in clinical trials, with results expected over the next three years, according to a Reuters review of the clinicaltrials.gov registry. The drugmaker has been largely absent from the Alzheimer's space after the high-profile failure of its drug verubecestat five years ago. But several antibody therapies from Lilly, Biogen and AbbVie(ABBV.N) that were designed to slow the rate of tau accumulations failed outright last year.

One of the biggest makers of generic drugs, Israeli-based Teva said it aims eventually to secure a 10% global market share of biosimilars. A division of Novartis (NOVN.S), Sandoz is currently the second biggest player after Pfizer Inc (PFE.N) in the biosimilar market by gross sales globally, per IQVIA data, cited by Sandoz. Sandoz launched eight biosimilar drugs between 2017 and 2021, including a version of Bristol-Myers’ multiple myeloma drug Revlimid. The analysis projected the value of the global biosimilar market could more than triple to an estimated $74 billion by 2030. Sandoz and Teva are both working on biosimilars for Humira.

☆ Analysis: Wanted: an oxygen monitor reliable for all races
▼ + stars: | 2022-11-02 | by ( Nancy Lapid | ) www.reuters.com time to read: +6 min

Expert advisers to the U.S. Food and Drug Administration met virtually on Tuesday to discuss improvements in standards for pulse oximeters. Imarc Group market research firm forecast the global pulse oximeter market reaching $3.25 billion by 2027. Pulse oximeter problems "suddenly became enormous" during the pandemic, said Dr. Philip Bickler, director of the University of California, San Francisco's (UCSF) Hypoxia Research & Pulse Oximeter Test Facility. Current rules require that pulse oximeters be tested in a minimum of just 10 subjects, only two of whom must be "darkly-pigmented." While the devices are still useful, UCSF's Bickler said, doctors "should not base patient care only on pulse oximeter findings."

☆ Explainer: COVID, flu and RSV this U.S. winter: Why experts are worried
▼ + stars: | 2022-10-26 | by ( Nancy Lapid | ) www.reuters.com time to read: +3 min

REUTERS/Carlo Allegri/File PhotoOct 26 (Reuters) - U.S. doctors are warning that a surge in cases of respiratory syncytial virus (RSV) is coinciding with an increase in COVID transmission and an earlier-than-normal flu season, raising the specter of a "tripledemic" of respiratory illness this winter. In particular, RSV infections among young children are reportedly filling some U.S. hospitals to capacity. Older children and most adults typically experience mild, cold-like symptoms. In the meantime, it is important "for everyone to get up to date on their COVID and flu vaccines," Varma said. Part of the increase in RSV cases is due to the relaxation of COVID-precautions, such as masking and social distancing, which reduced rates of both RSV and flu during the pandemic, Varma said.

☆ Lower prostate cancer screening rates linked with more advanced cancers
▼ + stars: | 2022-10-24 | by ( Nancy Lapid | ) www.reuters.com time to read: +3 min

Register now for FREE unlimited access to Reuters.com RegisterThe benefits of screening for prostate cancer have been controversial. At individual facilities, higher rates of screening were linked with lower rates of subsequent diagnoses of advanced cancers. But for every 10% decrease in screening, there was a corresponding 10% increase in metastatic prostate cancer incidence five years later, the researchers said. Rose noted that while the USPSTF advice to limit prostate cancer screening has resulted in lower rates of prostate cancer diagnoses, rates of metastatic prostate cancer have increased "more dramatically." A spokesperson for the USPSTF said an update to its prostate cancer screening recommendation is not currently underway.

Dozens of measles cases have cropped up in Gambia this year, a spike over previous years. The measles campaign was rescheduled for 2021, but in July of that year polio was detected in a water sample. Over the years, the success of the measles vaccine has numbed many to these risks, health experts say. At the time, 86% of children had at least the first dose of the measles vaccine worldwide, according to WHO estimates. FUNDS REJECTEDThe U.S. CDC has identified 12 African countries as having no clear plans or secured resources for their next measles vaccination drive.

☆ Exclusive: NHS drafts stricter oversight of trans youth care
▼ + stars: | 2022-10-14 | by ( Jennifer Rigby | ) www.reuters.com time to read: +5 min

The guidelines are part of a wide-ranging review of treatment for young transgender people seeking NHS care. It was briefly uploaded to the NHS England website at the end of September, with plans for a 45-day public comment period, but later removed. "No-one should be purchasing illegal, unknown and potentially life-threatening drugs online," said NHS England medical director Dr Stephen Powis in a statement earlier this week. The drugs used in the UK are prescribed "off-label," which means they are not licensed for gender care. A lack of long-term scientific evidence around how to help transgender youth has contributed to a highly politicised fight in many countries.

The U.S. Food and Drug Administration findings come nearly three years after the agency's inspectors began documenting quality-control issues at the same Lilly plant in Branchburg, New Jersey. FDA inspectors returned to the plant this past July, spending 12 days there. Lilly did not directly respond to questions about the FDA inspectors' findings. The FDA report did not say whether the medicines in question were ultimately shipped to customers or discarded. In November 2019, FDA inspectors found that quality-control data had been deleted and not appropriately audited at the New Jersey plant.

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