PharmaFocus Today – Page 341 – media

Medicare holds firm on Alzheimer’s drug coverage policy

By Rachel Cohrs CMS Administrator Chiquita Brooks-LasureCHIP SOMODEVILLA/GETTY IMAGES WASHINGTON — Despite pressure from Congress and advocates, Medicare isn’t changing its coverage plan for new Alzheimer’s drugs anytime soon. Medicare on Thursday issued a statement reiterating its intent to require patient registries to collect data about how medications perform even after they gain full Food and Drug Administration approval. Eisai’s Leqembi could gain full approval within the next month, so time is running short for the agency to solidify details. Right now, Leqembi and Biogen’s Aduhelm only have accelerated approval from the FDA, and are subject to even more restrictive coverage limits that require patients to be enrolled in a clinical trial to receive the medications. If Leqembi wins full approval, those restrictions will relax slightly, but providers would still need to collect data about all patients who receive the drugs in a patient registry. Medicare had previously announced ...
- Source: drugdu
- 105
- June 3, 2023
Recurrent cases of ocular toxoplasmosis more likely to occur in women

Women are more likely to experience recurrent cases of the Toxoplasma parasite, according to new Flinders University research. With the condition putting people at risk of further attacks of toxoplasmosis that can progressively damage the retina and lead to vision loss, international experts have demonstrated that women are also more likely to have more than one lesion in their eyes. The new study, which analyzed the impact of toxoplasmosis on 262 participants at an eye clinic in Brazil, aims to address differences in the way dangerous infections like toxoplasmosis impact people because of their gender to develop targeted treatments. Closely associated with cats, Toxoplasma is a parasite that causes the infectious disease known as toxoplasmosis. For humans, while domestic cat feces can be a carrier, the most common route of infection is by eating undercooked or raw meat sourced from infected livestock. Professor Justine Smith (Study Senior Author, Strategic Professor ...
- Source: drugdu
- 103
- June 3, 2023
MedTech Europe sets out position on cybersecurity, making case for reliance on MDR

Dive Brief MedTech Europe has set out its vision for cybersecurity in the medical technology ecosystem in a paper that argues for industry-specific legislation. The trade group outlines three areas of discussion, starting with its belief that medtech security should be regulated under sectoral legislation such as the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR). Other parts of the paper address MedTech Europe’s preferred approach for tackling ransomware and support for actions to improve digital literacy in general and cybersecurity skills in particular. Dive Insight More connected medical devices have increased the risk that hackers will access confidential data or gain the ability to modify technologies in ways that put patients at risk. As the risks increase, medical device manufacturers “continue to invest significant resources in guaranteeing state of the art cybersecurity for all their products and services,” the trade group wrote. Other groups including ...
- Source: drugdu
- 152
- June 2, 2023
Personalized video exercises may be useful to support rehabilitation for people with RMD

Apps have become ubiquitous in many parts of life, including for health. For people with an RMD, personalized video exercises (PEV) may be useful to support rehabilitation and physical exercise. In an abstract shared at the 2023 EULAR annual congress, Davergne and colleagues explore the effectiveness of PEV provided through Apps in supporting rehabilitation for people with disability. The impact was measured in terms of a range of outcomes, including the effect on functional capacity, confidence in exercise performance, use of care, health-related quality of life, adherence, and adverse events. Data were collected in a systematic review of randomized controlled trials which evaluated the effect of Apps providing PEV to support physical rehabilitation for any RMD. The primary outcome was functional capacity at the end of the intervention. In total, 7 articles were included, representing data from 906 participants, 93% of whom were adults. The Apps used in these studies ...
- Source: drugdu
- 144
- June 2, 2023
FDA warns patients about compounded versions of Novo Nordisk’s Ozempic, Wegovy

In the rush to supply prescriptions of Novo Nordisk’s popular diabetes and weight loss meds, some pharmacies are making unauthorized versions of Ozempic and Wegovy, the FDA warned on Tuesday. Some compounding pharmacies, which are permitted to make drugs during times of shortage, are using unauthorized versions of semaglutide—the key active ingredient in the GLP-1 drugs. Compounding pharmacies are currently allowed to make Ozempic and Wegovy because they are in short supply. But they must use approved ingredients, the FDA points out. The agency has received adverse event reports after patients have used compounded semaglutide. In some cases, compounders may be using salt forms of semaglutide, called semaglutide sodium or semaglutide acetate, which have not been proven to be safe or effective. The FDA asks users of Ozempic and Wegovy to get a prescription from a licensed provider and only obtain drugs from state-licensed pharmacies or outsourcing facilities registered with ...
- Source: drugdu
- 174
- June 2, 2023
US appeal in high-stakes Gilead patent case garners support from patient advocates

Weeks after Gilead Sciences prevailed over the U.S. government in a high-stakes HIV patent case, patient advocates are backing the U.S.’ push to appeal. In a letter to Attorney General Merrick Garland and Department of Health and Human Services (HHS) Secretary Xavier Becerra, more than 30 organizations said they “commend the decision” by the Department of Justice (DOJ) to keep fighting in the case. After the recent trial went in Gilead’s favor on May 9, the DOJ is seeking a new trial, according to the letter. The groups said they “strongly support HHS’s and DOJ’s decision to contest the surprising verdict,” arguing that the government’s case remains “fundamentally strong.” The U.S. first sued Gilead in 2019, saying that taxpayers funded research in the early 2000s that eventually went into the company’s lucrative HIV prevention medicines. U.S. officials said they sought to license the patented technology to Gilead for many years ...
- Source: drugdu
- 165
- June 2, 2023
Amgen reports positive results for Otezla in psoriatic arthritis

Amgen has announced positive new research evaluating the use of its inflammatory disease medication Otezla (apremilast) in psoriatic arthritis. Psoriatic arthritis is a chronic, inflammatory form of arthritis estimated to affect nearly 38 million people worldwide. The condition can cause swelling, stiffness and pain in and around the joints that worsens over time and can decrease physical function. Otezla regulates inflammation by inhibiting an enzyme known as phosphodiesterase 4. This enzyme controls much of the inflammatory action within cells, which can affect the level of inflammation associated with psoriatic disease. The new data for the drug, being presented at the 2023 European Congress of Rheumatology (EULAR), includes results from the phase 4 MOSAIC study, which evaluated its effect on joint inflammation and structural progression of psoriatic arthritis using MRI. Results showed that patients treated with Otezla had improvements in both clinical and MRI measures of inflammation up to week 48, ...
- Source: drugdu
- 178
- June 2, 2023
FDA warns about compounded semaglutide-based drugs

Tyler Patchen The FDA has warned the public that compounded versions of popular GLP-1 drugs Ozempic and Wegovy may not include the same ingredients as the prescription medications, and that has raised questions about their safety and effectiveness. The regulator said Tuesday it has received reports of adverse events related to compounded versions of semaglutide, the active ingredient in Ozempic and Wegovy. Some products being marketed as semaglutide contain the salt formation of semaglutide, which is not considered safe or effective. Novo Nordisk’s Ozempic and Wegovy, both of which contain semaglutide, are approved to treat type 2 diabetes and obesity, and demand for the drugs has soared over the last two years, given the ability of both therapies to help people lose weight. That demand has created a supply crunch, with both medications on the FDA’s shortages list. Though compounding medications is legal when drug shortages occur, the compounded versions ...
- Source: drugdu
- 121
- June 2, 2023
FDA’s cancer chief weighs in on common chemo shortages — report

Tyler Patchen Richard Pazdur, director of the FDA’s Oncology Center of Excellence, attributes the current shortage of two cancer drugs to drug companies that haven’t invested in building out their production capacity. In an interview with The Cancer Letter, a weekly cancer publication, Pazdur said that the current shortages of cisplatin and carboplatin, a pair of drugs used to treat a wide range of cancer patients, are the result of two problems: manufacturers not investing in enhancing production capacity, and drug companies being dependent on one supplier of raw ingredients. The cisplatin shortage followed an inspection that revealed quality issues at a manufacturing facility, which then led to the shutdown of production. This led to a surge in carboplatin demand, creating a secondary shortage. The shortages are causing oncologists across the US to ration platinum-based drugs, according to The Cancer Letter. To restore the supply of cisplatin, the FDA is ...
- Source: drugdu
- 122
- June 2, 2023
Cats can play a role in transmitting COVID-19, finds new study

Cats can play a role in the transmission of SARS-CoV-2 and their contaminated environment (pens in this study) can be infectious, according to new research. The study is published in Microbiology Spectrum. “In practice, after the introduction of SARS-CoV-2 in our household, we should see our cat as part of the family regarding virus transmission,” said study co-author Wim van der Poel DVM, Ph.D., Professor of Emerging and Zoonotic Viruses, Wageningen University and Research, in the Netherlands. Dr. van der Poel and colleagues conducted the study to gain better insight into the risk of COVID-19 infection that could arise from cats infected with SARS-CoV-2. In the study, 16 cats were either directly exposed to SARS-CoV-2 virus obtained from a naturally infected human patient, exposed indirectly from a directly exposed cat, or exposed from the pen in which an infected cat was housed. All cats were regularly sampled during the whole ...
- Source: drugdu
- 138
- June 1, 2023

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