PharmaFocus Today – Page 378 – media

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
- 435
- 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
- 195
- May 8, 2023
Rise in UK measles cases causing concern

BBC By James Gallagher Health and science correspondent A “very concerning” rise in the number of people catching measles in the UK has been reported by health officials. The virus spreads incredibly easily and a fall in vaccination rates is leaving more children vulnerable to infection. There were 54 cases of measles in the whole of last year. However, there have already been 49 in the first four months of 2023. The UK Health Security Agency (UKHSA) is encouraging parents to ensure their children’s vaccinations are up to date. The main symptoms of measles are a fever and a rash. But it can cause more serious complications including meningitis, and an infection can be fatal. That is why the measles, mumps and rubella (MMR) vaccine is part of routine childhood immunisations. Vaccination rates had been falling in the UK before the Covid pandemic. However, the disruption caused by Covid has dented vaccination ...
- Source: drugdu
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- May 8, 2023
People with Long COVID neurological symptoms found to have differences in immune cell profiles and autonomic dysfunction

Reviewed by Emily Henderson, B.Sc. Twelve people with persistent neurological symptoms after SARS-CoV-2 infection were intensely studied at the National Institutes of Health (NIH) and were found to have differences in their immune cell profiles and autonomic dysfunction. These data inform future studies to help explain persistent neurological symptoms in Long COVID. The findings, published in Neurology: Neuroimmunology & Neuroinflammation, may lead to better diagnoses and new treatments. People with post-acute sequelae of COVID-19 (PASC), which includes Long COVID, have a wide range of symptoms, including fatigue, shortness of breath, fever, headaches, sleep disturbances, and “brain fog,” or cognitive impairment. Such symptoms can last for months or longer after an initial SARS-CoV-2 infection. Fatigue and “brain fog” are among the most common and debilitating symptoms, and likely stem from nervous system dysfunction. Researchers used an approach called deep phenotyping to closely examine the clinical and biological features of Long COVID in 12 ...
- Source: drugdu
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- May 8, 2023
People with Long COVID neurological symptoms found to have differences in immune cell profiles and autonomic dysfunction

Twelve people with persistent neurological symptoms after SARS-CoV-2 infection were intensely studied at the National Institutes of Health (NIH) and were found to have differences in their immune cell profiles and autonomic dysfunction. These data inform future studies to help explain persistent neurological symptoms in Long COVID. The findings, published in Neurology: Neuroimmunology & Neuroinflammation, may lead to better diagnoses and new treatments. People with post-acute sequelae of COVID-19 (PASC), which includes Long COVID, have a wide range of symptoms, including fatigue, shortness of breath, fever, headaches, sleep disturbances, and “brain fog,” or cognitive impairment. Such symptoms can last for months or longer after an initial SARS-CoV-2 infection. Fatigue and “brain fog” are among the most common and debilitating symptoms, and likely stem from nervous system dysfunction. Researchers used an approach called deep phenotyping to closely examine the clinical and biological features of Long COVID in 12 people who ...
- Source: drugdu
- 250
- May 8, 2023
ckWomen with a history of domestic abuse may have higher risk of atopic diseases

Women who have suffered domestic abuse may have a higher risk of developing atopic diseases including asthma, new research has found. Published today in the Journal of Allergy and Clinical Immunology: In Practice, the research led by the University of Birmingham found that in analysis of patient records, there were a significantly larger percentage of women who had atopic diseases and had a history of being exposed to domestic abuse and violence compared to those who hadn’t. After adjusting for possible cofounders, our results show women with a recorded exposure to domestic violence and abuse had a 52% increased risk of developing atopic diseases. “Domestic violence and abuse is a global issue that disproportionately affects women. We set out to deepen our understanding of the health impacts of domestic violence so evidence-based public health policies can be further developed to address not only domestic violence, but secondary effects like the development ...
- Source: drugdu
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- May 8, 2023
Early smoking cessation associated with higher survival rates following a lung cancer diagnosis

Quitting smoking early was associated with higher survival rates following a lung cancer diagnosis, according to a new study led by researchers at Harvard T.H. Chan School of Public Health. Compared to those who never smoked and were being treated for non-small cell lung cancer (NSCLC), current smokers had 68% higher mortality and former smokers had 26% higher mortality. Our participants’ smoking histories varied, with some having stopped smoking a few years before their diagnosis and others having stopped several decades before. This wide range gave us confidence in our results—that the benefit of pre-diagnosis smoking cessation persists even after lung cancer is diagnosed.” David Christiani, Senior Author, Elkan Blout Professor of Environmental Genetics The study was published online in JAMA Network Open on May 5, 2023. While most similar research has compared mortality among current smokers and never smokers, the majority of the study’s participants were former smokers, ...
- Source: drugdu
- 149
- May 7, 2023
Neogap, Cellerys partner for study of multiple sclerosis therapy

Biopharmaceutical company Neogap Therapeutics has partnered with Swiss company Cellerys for a Phase II study of the latter’s RED4MS therapy for multiple sclerosis. Under the collaboration, Neogap will provide its EpiTCer technology for Cellerys’ upcoming Phase II study of an innovative cell therapy to fight multiple sclerosis. The RED4MS therapy is being studied for the induction of antigen-specific immune tolerance in multiple sclerosis patients. The Neogap EpiTCer technology will be used for the identification of rare autoreactive T cells in the patients, utilising them as biomarkers of tolerance in patients. Neogap CEO Samuel Svensson said: “We are thrilled to contribute to and be a part of Cellerys upcoming Phase II study, where EpiTCer will be a key aspect in monitoring autoreactive T cells. “The collaboration with Cellerys opens up opportunities for Neogap to use our technology platform in several disease fields, including autoimmune diseases and other immune-related conditions. “Our ...
- Source: drugdu
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- May 7, 2023

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