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EU countries lay out framework for combating drug shortages

After the European Commission proposed a massive overhaul to the EU’s drug legislation, a group of 19 European countries is launching an effort to reduce the bloc’s supply chain reliance on outside countries. The position paper (PDF) urges the EU to “take more drastic steps” to improve the security of Europe’s supply of medicines. Belgium is leading the charge, and 18 other countries such as France, Germany and Spain are on board. In 2019, more than 40% of global active pharmaceutical ingredients came from China, the countries point out. That, coupled with other factors such as the fact that “almost all API producers depend on China for intermediate inputs,” make Europe and the rest of the world dependent on “a few manufacturers for a large bulk of their medicines supply,” according to the paper. The proposed European Critical Medicine Act would follow in the footsteps of similar acts such as the Critical Raw Materials Act ...
- Source: drugdu
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- May 9, 2023
AI model shows promise in detecting lung cancer earlier

Lung cancer accounts for more than 20% of cancer deaths in the UK A new UK study has revealed the potential of using artificial intelligence (AI) to help doctors diagnose lung cancer earlier. LIBRA, which was led by researchers from the Royal Marsden NHS Foundation Trust, the Institute of Cancer Research, London, and Imperial College London, used data from the CT scans of nearly 500 patients with large lung nodules – abnormal growths – to develop an AI model. The Royal Marsden Cancer Charity, the National Institute for Health and Care Research, RM Partners and Cancer Research UK also supported the study. To assess how effective the new model was at predicting cancer, the team used a measure called the area under the curve (AUC). An AUC of one would indicate a perfect model, while 0.5 would be expected if the model was randomly guessing. The results, which have ...
- Source: drugdu
- 135
- May 9, 2023
Researchers evaluate the dual-therapeutic effect of gene therapy in mouse model of osteosarcoma

Reviewed by Lily Ramsey, LLM Investigators at Brigham and Women’s Hospital and collaborating institutions evaluated the dual-therapeutic effect of gene therapy in a clinically relevant model for common form of bone cancer. With a worldwide incident rate of 3.4 cases per million people per year, osteosarcoma is one of the most common bone cancers affecting children and adolescents. The current gold standard treatment option requires extensive surgical intervention and chemotherapy that leads to a poor prognosis and decreased quality of life. Due to the aggressive nature of the disease, the surgical intervention usually involves total reconstruction of the limbs or, in most cases, amputation. Researchers at Brigham and Women’s Hospital, a founding member of the Mass General Brigham healthcare system, in collaboration with investigators at University College Dublin (UCD), Massachusetts Institute of Technology (MIT), and Trinity College Dublin (TCD), have identified a potential therapeutic target and developed a unique delivery ...
- Source: drugdu
- 148
- May 9, 2023
Medicare Improperly Paid Providers $348M for Telehealth Psychotherapy Services

In the first year of Covid-19, Medicare paid providers $1 billion for psychotherapy services, and $580 million were improper payments, including $348 million that were for telehealth services, a recent audit by the Office of Inspector General (OIG) found. The OIG audit, published Tuesday, analyzed $1 billion in Part B payments for more than 13.5 million psychotherapy services from March 2020 through February 2021. Its analysis consisted of two random samples of psychotherapy services: a sample of 111 enrollee days for telehealth services and a sample of 105 enrollee days for non-telehealth services. An enrollee day includes “all claim lines for Medicare Part B psychotherapy services with the same service start date for a specific enrollee,” the OIG said. Audits from before the pandemic showed improper payments for psychotherapy services, leading the agency to examine payments during the pandemic when telehealth access was greatly expanded. “Because of the significant increase ...
- Source: drugdu
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- May 9, 2023
Treatment for uterine fibroids without surgery

A newer, more effective treatment for uterine fibroids is available that doesn’t require surgery. That’s good news for the estimated 26 million women in the U.S. who have fibroids—including the millions of Black women who are disproportionately affected by these benign tumors. Black women in the U.S. are up to three times more likely to develop fibroids than white women. Dr. Elizabeth Stewart, a Mayo Clinic gynecologist and researcher, recently published a review on these approved fibroid medications. They are called oral gonadotropin-releasing hormone (GnRH) antagonist combinations. “There are two new FDA-approved drugs for the medical treatment of uterine fibroids,” says Dr. Stewart. Dr. Stewart says the drugs are effective in treating heavy menstrual bleeding, relieving pain and reducing the need for a hysterectomy. “Because many women are pushed in the direction of surgical therapy, and we know there are big limitations to surgical therapies, this is a great treatment option for many ...
- Source: drugdu
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- May 9, 2023
Amid high demand, Novo Nordisk temporarily throttles US supply of low-dose Wegovy

Just last week, GLP-1 giant Novo Nordisk promised a supply boost of its in-demand obesity med Wegovy after lining up a second contract manufacturer. Now, though, the company is “temporarily” reducing U.S. supply of lower dosage strengths to “safeguard continuity of care,” the company said in a statement. The company sees a “short-term need” to cut back on starter doses of the drug,” CEO Lars Fruergaard Jørgensen said on the company’s first-quarter earnings call Thursday. The CEO added that manufacturing is “running well” and that the reduction will play out over a “limited period.” “We’re not out of the market with the low dose strengths. We’re just reducing supply,” Jørgensen said, noting that patients will still be able to get the product, just possibly with a longer wait time. Meanwhile, the Danish drugmaker posted huge obesity revenue gains of 124% versus last year’s first quarter, rising to 7.8 billion ...
- Source: drugdu
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- May 9, 2023
The safety and efficacy of FINLAY-FR-2/1A, a new protein-based COVID-19 vaccine

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), responsible for the coronavirus disease 2019 (COVID-19) pandemic, has claimed more than 6.92 million lives and infected over 765 million individuals. Most COVID-19 vaccines target the SARS-CoV-2 spike glycoprotein receptor-binding domain (RBD) to prevent the binding of SARS-CoV-2 to the host angiotensin-converting enzyme 2 (ACE-2) receptor. Background Preclinical studies associated with FINLAY-FR-2 (Soberana 02), a protein subunit vaccine conjugated with the tetanus toxoid carrier protein, have confirmed its effectiveness, with similar results obtained in Phases I, II, and III clinical trials. These trials have shown that FINLAY-FR-1A (Soberana Plus), an RBD dimer without conjugation, has increased neutralization capacity in COVID-19 convalescent individuals. Additionally, when this protein-based vaccine was introduced as the third dose to FINLAY-FR-2, it induced the production of anti-RBD immunoglobulin G (IgG) antibodies. Several countries, including Iran, Cuba, Venezuela, Belarus, Mexico, and Nicaragua, have approved FINLAY-FR-2 and FINLAY-FR-1A vaccines ...
- Source: drugdu
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- May 9, 2023
Positive opinion for Gilead’s Hepcludex

The vital recommendation ensures marketing authorisation for treating the hepatitis delta virus Gilead Sciences has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has provided a positive opinion for Hepcludex. Also known as bulevirtide, the therapy concerns adults with chronic hepatitis delta virus (HDV) and compensated liver disease. Meanwhile, the recommendation grants full marketing authorisation (MA) which will no longer be subject to certain obligations. Initially, Bulevirtide was granted conditional marketing authorisation in 2020 in order to treat particular HDV patients who required urgent access to treatment. The CHMP recommendation for full MA of bulevirtide arrives after the submission of phase 3 MYR301 week 48 study data, which reinforces its safety and efficacy profile. HDV remains the most severe form of viral hepatitis and impacts around 5% of people living with hepatitis B (HBV). Furthermore, there is a prevalence of ...
- Source: drugdu
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- May 9, 2023
World-First Smartphone-Powered 5 Marker Lipid Test Aids in Early Detection of Cardiovascular Diseases

By LabMedica International staff writers Image: PocDoc offers the world’s first app based five marker lipid test (Photo courtesy of PocDoc) Cardiovascular disease (CVD), accountable for 32% of global deaths annually, is the world’s leading cause of death. These largely preventable fatalities highlight the urgent need for improved access to CVD testing and subsequent treatment, a pressing concern worldwide. Now, an innovative diagnostic tool for CVD enables early detection by facilitating accurate blood testing via a smartphone or tablet, with results accessible through an app. PocDoc (Cambridge, UK) has pioneered a groundbreaking smartphone-based lipid test capable of delivering a 5 marker lipid panel via the PocDoc app in under six minutes, with results instantaneously shared with the healthcare system. This technology allows lipid testing to extend beyond the confines of general practice surgeries, thereby drastically enhancing accessibility to testing and subsequently preventing more individuals from developing CVD. Despite its ...
- Source: drugdu
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- May 9, 2023
Manufacturing operations for Eli Lilly, Rentschler reprimanded by FDA

After FDA inspectors visited Eli Lilly and Rentschler Biopharma production sites in October 2022 and early 2023, respectively, the U.S.’ drug regulator is making concerns about the facilities public. In Form 483 filings posted this week, the FDA flagged Lilly’s site in Indianapolis for three manufacturing-related shortfalls and Rentschler’s Baden-Wurttemberg, Germany, site for five deficiencies. At Lilly’s site, the regulator said the company’s aseptic technique for an undisclosed drug’s filling operation was “deficient.” Specifically, operators “handled unprotected sterile components” in a way that “may introduce contaminants onto sterile surfaces” in certain areas, the FDA said. Aside from that observation, the FDA flagged “processing areas” for two filling lines as substandard. Again, the FDA flagged sanitization procedures as not meeting its standards. Inspectors visited Lilly’s Indianapolis site from Oct. 17-21, 2022. In parallel to the Indianapolis site inspection and filing, the FDA in April rejected Eli Lilly’s ulcerative colitis prospect mirikizumab over manufacturing-related shortfalls. It isn’t immediately clear whether the ...
- Source: drugdu
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- May 8, 2023

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