PharmaFocus Today – Page 354 – media

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
- 118
- 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
- 129
- 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
After FDA rejection, Gilead’s Hepcludex looks set for full EU nod

Six months after Gilead got a smackdown in the United States for its drug to treat hepatitis delta virus (HDV), bulevirtide has scored a regulatory win in Europe. The Committee for Medicinal Products for Human Use (CHMP) has given bulevirtide a thumbs up for patients with HDV and compensated liver disease. If the European Commission signs off on the entry inhibitor, it will become the only authorized treatment for HDV in Europe. Known commercially as Hepcludex, the drug received conditional approval in Europe three years ago. Since then, a phase 3 trial has demonstrated the effectiveness and safety of the treatment. Gilead hoped the results of the MYR301 study—which were released in June of last year and showed significant viral declines after 48 weeks of treatment—would pave the way for approval in the U.S. But the FDA sent Gilead a complete response letter (CRL) citing manufacturing and delivery concerns. The regulator did not ask Gilead to conduct another ...
- Source: drugdu
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- May 8, 2023
Biogen chalks up a Tecfidera patent win in Europe after losing US protections

While Biogen’s attempts to resurrect a crucial Tecfidera patent in the U.S. floundered, the company is chalking up a win in Europe. The European Commission has ruled that Biogen’s multiple sclerosis drug Tecfidera will have market protections until February 2025, Biogen revealed in a filing. This comes after a March decision from the European Union’s Court of Justice that went in Biogen’s favor and blocked generic versions of Tecfidera. The appeal ruling made the drug entitled to European market protections through at least February 2024, which Biogen swiftly sought to enforce against would-be generic rivals. Meanwhile in the U.S., Biogen took its Tecfidera patent case all the way to the Supreme Court after a court ruled the patent invalid in 2020. The patent was originally slated to expire in 2028 until a district judge decided in Viatris’ favor, agreeing with the argument that Biogen didn’t adequately describe its invention. With that, Viatris’ generic was cleared ...
- Source: drugdu
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- May 8, 2023
Protalix, Chiesi challenge Sanofi with EU approval for Fabry disease med as FDA decision looms

Protalix BioTherapeutics and Chiesi Farmaceutici have endured a rejection from the FDA and conducted multiple readouts of a phase 3 trial of their Fabry disease candidate. After many stops and starts, the companies have finally scored a marketing approval in Europe for PRX-102 (pegunigalsidase alfa), an enzyme replacement therapy for the rare, genetic, progressive disorder, which causes an accumulation of fatty deposits in the lysosomes and strikes roughly 1 in 50,000 people. The authorization is based on results from a clinical program that has tested PRX-102 in more than 140 patients with up to 7.5 years of treatment. A head-to-head trial pitting PRX-102 against Sanofi’s Fabrazyme (agalsidase beta) demonstrated noninferior efficacy in controlling the kidney disease that accompanies the disorder. Fabrazyme, which was approved 20 years ago, is the longtime dominant drug in the Fabry disease market, generating sales of 938 million euros ($986 million) last year. Amicus Therapeutics of Philadelphia, which earned an FDA approval for its ...
- Source: drugdu
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- May 8, 2023

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