Search Results for “EU” – Page 43 – media

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
- 411
- 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
- 140
- 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
- 185
- 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
- 159
- 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
- 239
- May 8, 2023
A high proportion of adults in Europe do not have protective antibody concentrations against diphtheria

In a recent study published in the Eurosurveillance Journal, researchers conducted a retrospective analysis of seroprotection against tetanus and diphtheria among residents in Austria following an increase in diphtheria cases since 2022 in Europe. Background Diphtheria is an infection caused by Corynebacterium diphtheriae resulting in the inflammation of mucous membranes in the throat and nose. While an increase in the incidence of diphtheria among migrants in Europe was observed beginning in August 2022, recent studies also found that the concentrations of antibodies against diphtheria in adults in approximately 18 countries in the European Union were negligible. Although no diphtheria outbreaks have been reported among the general population of European Union countries, the low seroprotection increases the risk of disease outbreaks. Estimating the seroprevalence among the population could help determine the risk of a diphtheria outbreak and increase awareness about the importance of vaccines to ensure ...
- Source: drugdu
- 153
- May 3, 2023
European paediatricians sound alarm over medicine shortage

Paediatricians from European countries have raised the alarm over a shortage of medicines for children including antibiotics and asthma treatment, warning it was endangering health. In a letter addressed to health ministers and seen by AFP on Saturday, the doctors stressed it was “urgent to find a fast, reliable and lasting solution” to the problems facing stocks in Europe. “The health of our children and our youngsters is in danger because of the lack of medicines throughout Europe,” they wrote. The letter was addressed to the health ministers of Austria, France, Germany, the Italian region of South Tyrol and Switzerland. It was co-signed notably by Andreas Werner, president of the French Association of Ambulatory Pediatrics, his German counterpart Thomas Fischbach and Laura Reali, head of the European Confederation of Primary Care Paediatricians. The doctors said it was the responsibility of political decision-makers to ...
- Source: drugdu
- 172
- May 2, 2023
Pfizer CEO’s texts with European Commission chief trigger new NYT lawsuit

Twenty-two months after European Commission President Ursula von der Leyen admitted to The New York Times that she negotiated a COVID-19 vaccine deal with Pfizer CEO Albert Bourla, Ph.D., through text messages, the newspaper is suing the commission over its refusal to make the texts public. While the lawsuit was filed on Jan. 25 and listed on the European Court of Justice’s public website Monday, Feb. 13, none of the documents related to the case are available to the public. Two people familiar with the suit confirmed it to Politico. The NYT argues that the EC is required legally to turn over the messages. Last year—in response to a public information request—the commission wrote that text messages do not need to be stored because they are treated as “short-lived ephemeral documents.” Reference: https://www.politico.eu/article/new-york-times-sue-european-union-ursula-von-der-leyen-pfizer-texts/
- Source: drugdu
- 141
- May 2, 2023
Addressing the much-needed development of effective pneumococcal vaccination policies for long-term care settings

The International Federation on Ageing (IFA) is proud to release findings from a recent study entitled Driving the Agenda of Pneumococcal Pneumonia Vaccination in At-risk Populations in Community and Long-term Care. The COVID-19 pandemic has exposed the brutal nature and impact of respiratory infections on people of all ages and particularly amongst those at-risk of serious complications, such as older adults in long-term care (LTC) settings. Though several respiratory infections and other vaccine-preventable diseases (VPDs) can be prevented, or their severe symptoms reduced through receiving vaccines, current vaccination uptake rates for pneumococcal disease among older adults in LTC are below national targets. This study conducted by the IFA looked at the status of existing public health policies and campaigns on pneumococcal disease in Canadian LTC settings and investigated the policy gaps that have resulted in poor vaccine uptake. One of the main findings from this study is that within LTC ...
- Source: https://www.news-medical.net/news/20230429/Addressing-the-much-needed-development-of-effective-pneumococcal-vaccination-policies-for-long-term-care-settings.aspx
- 131
- May 1, 2023
pneumococcal vaccination policies
FDA clears Pfizer’s pneumococcal vaccine for infants and children

Pfizer on Thursday gained U.S. approval of its newest pneumococcal conjugate vaccine for use in children and infants, helping it compete with a rival shot from Merck & Co. that won a similar OK last year. Pfizer’s vaccine, called Prevnar 20, is designed to protect against infection by 20 strains of the bacteria — seven more than the company’s prior Prevnar 13 version. It has been approved in adults since 2021. Last July, Merck won approval in children of its Vaxneuvance vaccine, which protects against 15 strains. Both companies could soon face more competition as the market has sparked interest from other drugmakers. While vaccines for the bacterial infection are widely available, thousands of cases still lead to hospitalization and death in the U.S. each year. In response, Pfizer, Merck and others have worked to develop new shots that offer better protection, particularly against strains that weren’t ...
- Source: drugdu
- 232
- May 1, 2023

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