DIRS.INFO The most relevant business & tech news

☆ 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

☆ 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

☆ Few patients continue weight loss drugs like Wegovy after a year — but health costs soar for all
▼ + stars: | 2023-07-11 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +4 min

A selection of injector pens for the Wegovy weight loss drug are shown in this photo illustration in Chicago, Illinois, March 31, 2023. And a group of patients in the analysis who didn't take a weight loss drug saw their health-care costs decrease by 4% on average during the same time period. Weight loss drugs are also known as GLP-1 agonists, which mimic a hormone produced in the gut to suppress a person's appetite. Prime Therapeutics' analysis does not indicate why patients stopped taking weight loss drugs. But experts say the medicines may further perpetuate a dangerous diet culture that idealizes weight loss and thinness.

Persons: Joseph Leach, Eli Lilly, Elon Musk Organizations: Novo Nordisk, CNBC, Prime Therapeutics, Food and Drug Administration, Therapeutics, Reuters, Pfizer, National Institutes of Health Locations: Chicago , Illinois, U.S, Danish

☆ Daily pill from Eli Lilly leads to 15% weight loss in midstage study, rivaling Wegovy results without the shot
▼ + stars: | 2023-06-23 | by ( Meg Tirrell | ) edition.cnn.com time to read: +4 min

Currently approved medicines for weight loss like Novo Nordisk’s Wegovy are given as once-weekly injections. Novo Nordisk’s Ozempic, which contains the same key ingredient as Wegovy, called semaglutide, and Lilly’s Mounjaro are both approved for Type 2 diabetes but used off-label for weight loss. Weight loss at 36 weeks ranged from 9.4% to 14.7%, compared with 2.3% on placebo, the results showed. Lilly’s is just one of a crop of experimental weight loss drugs seeking to join blockbusters like Wegovy on the market. Novo Nordisk reported results last month showing that a pill version of semaglutide yielded 15% weight loss over 68 weeks, similar to Wegovy’s results.

Persons: Eli Lilly’s, what’s, Lilly, Lilly’s, ”, Nadia Ahmad, orforglipron, “ you’re, Dr, Sean Wharton, White, Ahmad, it’s, Sanjay Gupta, semaglutide Organizations: CNN, New England, of Medicine, American Diabetes Association, Nordisk’s, Nordisk’s Ozempic, Wharton Medical Clinic, CNN Health, Novo Nordisk, Pfizer Locations: San Diego

☆ California, other states join FTC bid to block Amgen deal
▼ + stars: | 2023-06-22 | by ( David Shepardson | ) www.reuters.com time to read: +2 min

WASHINGTON, June 22 (Reuters) - The states of California, New York, Illinois, Minnesota, Washington and Wisconsin have joined a Federal Trade Commission (FTC) lawsuit to stop Amgen's (AMGN.O) $27.8 billion deal to buy Horizon Therapeutics (HZNP.O), according to a court filing on Thursday. Washington Attorney General Bob Ferguson said his state had joined the lawsuit because "monopolies harm consumers" and the merger could allow Amgen to "dominate" prescription drug markets. The FTC acquisition marks a change for the agency, which previously had typically flagged therapeutic overlaps in companies and waved deals through after requiring one of the medicines to be divested. Amgen said in a statement last month it was disappointed by the FTC decision and it believed it had "overwhelmingly demonstrated" that the deal had no legitimate competitive issues. The last major pharmaceutical deal approved by the FTC was AstraZeneca's (AZN.L) $39 billion acquisition of Alexion Pharma in April 2021, about two months before FTC Chair Lina Khan was appointed by the Biden administration.

Persons: Bob Ferguson, Rob Bonta, Amgen, Lina Khan, Biden, David Shepardson, Jamie Freed Organizations: Federal Trade Commission, Horizon Therapeutics, . Washington, FTC, Horizon, Alexion Pharma, Thomson Locations: California , New York , Illinois, Minnesota, Washington, Wisconsin, California

☆ The US military is so worried about generic pills that it reportedly wants to do its own testing to make sure they're safe
▼ + stars: | 2023-06-09 | by ( Lydia Ramsey Pflanzer | Zachary Tracer | ) www.businessinsider.com time to read: +4 min

The US military is planning to independently test the quality of generic drugs, Bloomberg reported. The quality of the US drug supply has come into question amid recalls of medications like metformin. The US military is reportedly planning to take extra steps to test the quality of the generic drugs it buys for servicemembers and their families. Bloomberg reported in May that the White House has assembled a team to tackle shortages and quality issues with generic medications. "I have family who take generic drugs, I take generic drugs," he said, adding, "I don't get concerned and I don't tell them to be concerned."

Persons: Anna Edney, Riley Griffin, Valisure, David Light, Jeremy Kahn, Mike Ganio, ASHP Organizations: Bloomberg, FDA, Morning, servicemembers, Department of Defense, White, DOD, Food and Drug Administration, American Society of Health, System

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

☆ Pfizer oral weight loss drug may be as effective as, quicker than Ozempic injection by Novo Nordisk, study says
▼ + stars: | 2023-05-22 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

An oral drug made by Pfizer causes a similar amount of weight loss as, and works quicker than, rival Novo Nordisk 's blockbuster injection Ozempic, according to results from a phase two clinical trial released Monday. The results suggest danuglipron may be as effective for weight as Ozempic over a shorter period of time. New York-based Pfizer is the latest pharmaceutical company to dip into the blockbuster weight loss drug market. Novo Nordisk's Ozempic and Wegovy catapulted to the national spotlight in recent years for being weight loss "miracles." But experts say the medicines may further perpetuate a dangerous diet culture that idealizes weight loss and thinness.

☆ US FTC sues to block Amgen's $27.8 bln deal for Horizon Therapeutics
▼ + stars: | 2023-05-16 | by ( ) www.reuters.com time to read: +1 min

WASHINGTON, May 16 (Reuters) - The U.S. Federal Trade Commission said on Tuesday it would sue to stop Amgen Inc's (AMGN.O) $27.8 billion deal to buy Horizon Therapeutics Plc (HZNP.O). The agency said it was opposing the deal because it would give Amgen "monopoly positions" for medicines used to treat thyroid eye disease and chronic refractory gout. The deal, which was announced in December 2022, would give Amgen two fast-growing drugs, the thyroid eye disease treatment Tepezza and gout treatment Krystexxa. Other key drugs in Amgen's product portfolio, such as psoriasis therapy Otezla, face the loss of patent protections over the next few years. It is unusual for the agency to sue to stop a pharmaceutical deal.

☆ Amy Silverstein, Who Chronicled a Life of Three Hearts, Dies at 59
▼ + stars: | 2023-05-16 | by ( Alex Williams | ) www.nytimes.com time to read: +1 min

As her condition deteriorated, Ms. Silverstein rose to the top of the waiting list for a donor heart, which she received at Columbia-Presbyterian hospital in New York. It was only as she recovered from the operation that she began to learn the price of coronary salvation. “With the medicines that she took and the repeated infections, she felt bad at some point virtually every single day,” Mr. Silverstein said in a phone interview. To check for signs of rejection, she had to undergo frequent heart biopsies in which doctors “run a catheter down through your blood vessels and pluck pieces of your heart out,” Mr. Silverstein said. “She had over 90 of them.”After “Sick Girl” was published, Ms. Silverstein received reams of fan letters from other transplant recipients, hailing her for her courage in bringing to light the odd mix of joy and misery that can accompany life with a new organ — what she called the “gratitude paradox.”

☆ 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.

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.

☆ Fact Check-Cervical smear test sterilisation process is safe, no evidence for cancerous claims
▼ + stars: | 2023-04-24 | by ( Reuters Fact Check | ) www.reuters.com time to read: +3 min

There is no evidence that tools used for cervical cancer screenings are cancerous, despite a video circulating online warning about the sterilisation process of test utensils. A controlled amount of the gas ethylene oxide (EO), a carcinogen, is used to sterilise medical instruments, but the process is safe, experts told Reuters. There is no evidence, however, that its use in cervical screening sterilisation processes is cancerous. Guidance from the World Health Organization (WHO) shows EO is used in the sterilisation process for speculums in line with international standards (here). The use of ethylene oxide in the sterilisation process for cervical cancer screening utensils is safe and strictly regulated.

☆ GSK licenses companies to make cheap copies of HIV prevention drug
▼ + stars: | 2023-03-30 | by ( Maggie Fick | ) www.reuters.com time to read: +2 min

LONDON, March 30 (Reuters) - British drugmaker GSK (GSK.L) has signed deals with three companies allowing them to make inexpensive generic versions of its long-acting HIV preventive medicine for use in lower-income countries, where the majority of new HIV cases occur. The injected drug cabotegravir was approved by regulators in the United States in late 2021. Last July, GSK announced a program with the United Nations-backed healthcare organisation, the Medicines Patent Pool, aiming to get poor countries access to new HIV therapies far earlier than they did for previous HIV medicines. GSK said last year the new program could result in the generic form of its injection being available in lower-income countries beginning in 2026. The generic copies will be supplied in 90 countries, subject to regulatory approvals there, the statement said.

☆ 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.

☆ Britain to overhaul clinical trial regulation to fast-track approvals
▼ + stars: | 2023-03-21 | by ( ) www.reuters.com time to read: +1 min

March 21 (Reuters) - Britain's health regulator said on Tuesday it would introduce new measures for faster and easier approval and execution of clinical trials in the country. The move comes months after an industry report showed that the number of annual clinical trials started in Britain dropped by 41% between 2017 and 2021, posing a "clear and serious threat" to its reputation as a clinical research destination. "This overhaul of the clinical trials legislation will ... help to streamline approvals by removing granular and duplicative regulatory requirements," Marc Bailey, Chief Science and Innovation Officer at the Medicines and Healthcare products Regulatory Agency (MHRA) said. An application review will need to be completed within 30 days, while a maximum of 10 days will be given for a decision to be granted, the regulator said. Reporting by Radhika Anilkumar in Bengaluru; Editing by Vinay DwivediOur Standards: The Thomson Reuters Trust Principles.

☆ Exclusive: India may issue alert on Marion cough syrup exports after toxins found
▼ + stars: | 2023-03-04 | by ( Krishna N. Das | ) www.reuters.com time to read: +3 min

[1/2] Logo of Marion Biotech, a healthcare and pharmaceutical company is seen on a gate outside their office in Noida, India, December 29, 2022. REUTERS/Anushree FadnavisNEW DELHI, March 4 (Reuters) - India may issue an alert on cough syrup exported by Marion Biotech, whose products have been linked to deaths in Uzbekistan, after tests showed many of the company's drug samples contained toxins, a drug inspector said on Saturday. "The health ministry could issue an alert. Babbar has been part of a team that inspected Marion's plant four times after Uzbekistan said in December the children died after consuming the company's cough syrups. India in October suspended production at Maiden for violating manufacturing standards after the WHO said four of its cough syrups may have killed dozens of children in Gambia.

☆ US CDC concludes cough syrups likely to blame for children's deaths in Gambia -report
▼ + stars: | 2023-03-02 | by ( Jennifer Rigby | ) www.reuters.com time to read: +2 min

The links between the children's deaths and contaminated medicines first came to light in October, when the World Health Organization sent out an alert saying four cough syrups made by India's Maiden Pharmaceuticals Ltd contained toxic levels of diethylene and ethylene glycol and should be withdrawn. The new investigation "strongly suggests" that medicines contaminated with the toxins, imported into Gambia, led to the cluster of acute kidney injury among 78 children. Maiden has denied its drugs were at fault for the deaths in Gambia, and the Indian government has said the syrups showed no contamination when it tested them. "This likely poisoning event highlights the potential public health risks posed by the inadequate quality management of pharmaceutical exports," the report said. Since the deaths in Gambia, 201 children have also died in Indonesia, and 19 in Uzbekistan, linked to different manufacturers' contaminated cough syrups.

☆ Ozempic Runs Low for Diabetes Patients as Weight-Loss Use Surges
▼ + stars: | 2023-02-22 | by ( Peter Loftus | ) www.wsj.com time to read: 1 min

Jerrod Balzer takes Ozempic to manage his Type 2 diabetes and is concerned about receiving his medication refill due to a shortage. Drugs like Ozempic have become so popular among people seeking to lose weight that they are now in short supply for patients with diabetes who depend on the medicines. Diabetes patients said they are spending hours trying to find nearby pharmacies that have their prescriptions in stock. If they don’t, some patients have had to reduce dosing of Ozempic and similar drugs to stretch out their supplies, or switch to alternative drugs.

☆ These cofounders are giving parents-to-be an alternative option to traditional hospital care by addressing the system inadequacies for people of color
▼ + stars: | 2023-02-22 | by ( Alexandra York | ) www.businessinsider.com time to read: +5 min

Allegra Hill and Kimberly Durdin launched Kindred Space LA, a birth-support center, in 2018. They shared their experiences launching Kindred Space LA and their hopes for the future. Today, Kindred Space LA offers in-clinic births, home births, support groups, sessions with mental-health professionals, and collaborative care with ob-gyns and midwives who work in hospitals. Insider spoke with Hill and Durdin about their experiences launching Kindred Space LA and their hopes for the future. Kindred Space LA ultimately raised around $50,000, enough to open the birth clinic that year.

☆ Britain's NICE to speed up reviews of COVID-19 treatments
▼ + stars: | 2023-02-16 | by ( Maggie Fick | ) www.reuters.com time to read: +3 min

LONDON, Feb 16 (Reuters) - Britain's agency that determines if medicines should be used in the National Health Service (NHS) said on Thursday it is speeding up how it decides if COVID-19 therapies are still effective against circulating variants. The new review process will enable the agency to update its recommendations on the cost-effectiveness of COVID treatments so they can be made available more swiftly to patients, it said. "The rapidly evolving nature of COVID-19 means we need to have a way of establishing the cost effectiveness of existing medicines against current variants in an agile way," the National Institute for Health and Care Excellence (NICE) said. It said there is no evidence of Evusheld's clinicial effectiveness against current variants and those likely to be circulating in the next 6 months. The announcement comes as demand for COVID treatments appears set to drop this year, due to population immunity from high rates of vaccination and previous infections.

☆ Novartis says operating profit to grow again ahead of Sandoz spin off
▼ + stars: | 2023-02-01 | by ( ) www.cnbc.com time to read: +3 min

Novartis on Wednesday predicted that core operating income would grow in a "mid single digit" percentage range in 2023 following stagnation last year, as the Swiss drugmaker prepares to spin off its Sandoz generics business. Full-year core operating income was broadly flat at $16.7 billion, it said in a statement, coming in slightly below market expectations of $16.8 billion. We're seeing health care systems stabilize a bit more, we're seeing China start to stabilize, and we see a second-half rebound in China. All of those are important tailwinds for a business like ours," he said during an interview in Basel, Switzerland. MS drug Kesimpta, requiring fewer injections than standard therapies, is expected to become Novartis' second largest growth driver in 2023, after Entresto.

☆ Fact Check-No evidence COVID-19 mRNA vaccines are significant contributing factor to UK’s 30,000 excess cardiovascular deaths
▼ + stars: | 2023-01-24 | by ( Reuters Fact Check | ) www.reuters.com time to read: +5 min

Millions of people have viewed a BBC News interview with a British cardiologist who used the broadcast to spread misinformation about COVID-19 vaccines. Malhotra cites the British Heart Foundation (BHF) for reporting 30,000 excess cardiovascular deaths “during the pandemic or since the pandemic”. A BHF spokesperson told Reuters that there were indeed 30,000 excess deaths involving ischaemic heart disease (IHD) in England between March 2020 and August 2022. Reuters has addressed similar claims linking COVID-19 vaccines with excess mortality (here, here and here), cardiac arrests (here, here and here), and other heart issues. Experts say the 30,000 excess cardiovascular deaths reported since the beginning of the pandemic are due to COVID-19 infection and issues with healthcare services.

☆ WHO urges 'immediate action' after cough syrup deaths
▼ + stars: | 2023-01-23 | by ( Jennifer Rigby | ) www.reuters.com time to read: +3 min

REUTERS/Anushree FadnavisLONDON, Jan 23 (Reuters) - The World Health Organization has called for "immediate and concerted action" to protect children from contaminated medicines after a spate of child deaths linked to cough syrups last year. The medicines, over-the-counter cough syrups, had high levels of diethylene glycol and ethylene glycol. It called for action across its 194 member states to prevent more deaths. It also issued a warning last year for cough syrups made by four Indonesian manufacturers, PT Yarindo Farmatama, PT Universal Pharmaceutical, PT Konimex and PT AFI Pharma, that were sold domestically. It also asked governments and regulators to assign resources to inspect manufacturers, increase market surveillance and take action where required.

☆ Nursing Homes’ Use of Schizophrenia Drugs to Be Audited by U.S. Government
▼ + stars: | 2023-01-19 | by ( Liz Essley Whyte | ) www.wsj.com time to read: 1 min

The Centers for Medicare and Medicaid Services said it would factor in use of antipsychotic medicines in nursing-home ratings. Federal health officials said they would take steps to increase oversight of nursing homes that prescribe powerful antipsychotic drugs, and prevent abuse of the medicines. The Centers for Medicare and Medicaid Services said Wednesday it would begin auditing nursing homes to see if they are accurately diagnosing their residents as schizophrenic, and would factor in use of antipsychotic medicines in nursing-home ratings.

Search resuls for: "The Medicines"

25 mentions found