PharmaFocus Today – Page 333 – media

Argentina allows morning-after pill to be bought over counter

IMAGE SOURCE,REUTERS Image caption, An Argentine feminist at a protest (file image) By Oliver Slow BBC News Women in Argentina will no longer require a prescription to get emergency contraception. The government said making the morning-after pill more easily available removed an “important barrier” for those seeking terminations. The move was welcomed by feminist groups, who see it as a sign of progress in the Catholic-majority country. However critics said the move displayed a “failure of pregnancy prevention”. The health ministry said the measure would help avoid unintentional pregnancies by overcoming “difficulties of access to health services, contraception supplies, and education” faced by some. “This removes an important barrier to access,” Valeria Isla, director of sexual and reproductive health at the ministry, told Reuters news agency. “People can have this method of contraception as support before an emergency happens.” Vanessa Gagliardi, leader of the feminist group Juntas y a ...
- Source: drugdu
- 215
- June 3, 2023
EULAR announces the launch of new survey targeted directly at RMD patients

The European Alliance of Associations for Rheumatology (EULAR) has announced the launch of the EULAR Impact of RMDs Survey, an online questionnaire targeted directly at RMD patients. The data collected through this survey will be an important resource for researchers, healthcare professionals, and patients alike, providing a comprehensive database of patient-reported outcomes on their healthcare situation, and how the illness affects their social and occupational lives. By collecting and analysing data from a large number of patients with RMDs on a recurring basis, the survey will provide valuable insights into the burden of disease and help improve the overall care for people living with these conditions. “EULAR is committed to improving the lives of people with rheumatic diseases,” said Dr Anna Molto, chair of the EULAR Research sub-committee of epidemiology and public health and lead of the project. “The launch of this survey is a significant step forward in our ...
- Source: drugdu
- 105
- June 3, 2023
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
- 103
- 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
- 99
- 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
- 144
- 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
- 139
- 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
- 169
- 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
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- 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
- 172
- 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
- 117
- June 2, 2023

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