Search Results for “EC” – Page 111 – media

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
- 179
- May 8, 2023
WHO declares end to Covid-19 global public health emergency

The spread of Covid-19 is no longer a global public health emergency, the World Health Organization declared Friday. “For more than a year, the pandemic has been on a downward trend with population immunity increasing from vaccination and infection, mortality decreasing, and the pressure on health systems easing,” WHO Director-General Tedros Adhanom Ghebreyesus said at a news conference in Geneva. “This trend has allowed most countries to return to life as we knew it before Covid-19,” Tedros said. “It’s therefore with great hope that I declared Covid-19 over as a global health emergency.” Nearly 7 million people have died from the virus worldwide since the WHO first declared the emergency on Jan. 30, 2020, according to the U.N. organization’s official data. Tedros said the true death toll is at least 20 million. The WHO’s decision comes as the U.S. is set to end its national public health emergency on ...
- Source: drugdu
- 97
- May 7, 2023
Acelyrin follows Kenvue with largest IPO for a biotech startup since 2021

Acelyrin has raised $540 million in an initial public offering, the largest for a biotechnology startup since early 2021 and one of only a handful by young drugmakers this year. The company said Thursday it sold 30 million shares at $18 apiece, exceeding the projections it set earlier this week. It will start trading Friday on the Nasdaq under the ticker symbol “SLRN.” The pace of biotech IPOs has slowed considerably since 2021, when a record 104 startups flooded Wall Street, according to data compiled by BioPharma Dive. The following year, the number of new stock offerings fell by about 80%. Until this week, only five companies had priced a new offering in 2023, the sector’s slowest start in at least five years. The value of those offerings has also trended downwards. Prior to Acelyrin’s offering, nine of the last 15 biotech startups that went public raised $15 million or ...
- Source: drugdu
- 113
- May 6, 2023
FDA issues new draft guidance on decentralised clinical trials

The US Food and Drug Administration (FDA) has issued new draft guidance on the implementation of decentralised clinical trials (DCTs), in which some or all trial-related activities occur at locations other than traditional investigation sites. This could include carrying out clinical tests at a local facility rather than a research medical centre, or conducting follow-up visits in the participants’ homes using telemedicine. The 16-page document provides recommendations for sponsors, investigators and other stakeholders on the use of these trials, which the agency expects’ will play an important role in addressing public health needs’. ‘By reducing barriers to participation, we expect that DCTs will increase the breadth and diversity of participants in clinical trials and improve accessibility for those with rare diseases or mobility challenges,’ the FDA said in a statement. The guidance covers recommendations on topics such as DCT design, the use of digital health technologies for remote patient monitoring, ...
- Source: drugdu
- 120
- May 6, 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
- 147
- May 3, 2023
Excessive digital technology use is associated with reduced sleep quality regardless of environmental and genetic factors, study finds

In a recent study published in the SLEEP Journal, researchers explored the association between poor sleep and the excessive use of digital technology among adolescents after adjusting for familial factors and examining the influence of environmental and genetic factors on the association. Background Although many studies have reported that excessive use of digital technology among adolescents and young adults is linked to lower sleep quality, recent research indicates that in studies that used relevant control groups, the association was weaker or non-significant. This implied that a third unexplored factor, such as environmental or genetic influences, could be the underlying reason for these observed associations. Factors related to parental control and lack of boundaries resulting in inconsistent bedtimes and excessive use of technology could be impacting the quality of sleep. Digital technology is thought to impact sleep quality in various ways. Hyperarousal and the requirement to constantly ...
- Source: drugdu
- 127
- May 3, 2023
Kite’s CAR-T therapies recommended by NICE for certain blood cancers

The two treatments could benefit up to 600 patients each year in England via the Cancer Drugs Fund. Kite – a Gilead company – has announced that two of its CAR T-cell therapies have been recommended by the National Institute for Health and Care Excellence (NICE) as options to treat certain aggressive blood cancers. The treatments, both given as one-off infusions, have been specifically recommended for use within the Cancer Drugs Fund (CDF), which pays for cancer treatments while further data is collected on their clinical effectiveness. Kite’s Yescarta (axicabtagene ciloleucel) has been recommended for adults with diffuse large B‑cell lymphoma (DLBCL) that returns within a year of, or is resistant to, first-line chemoimmunotherapy. It can also be used with a stem cell transplant in some cases. The treatment was previously available as standard care after two or more systemic therapies, with the updated guidance now making it available after ...
- Source: drugdu
- 143
- May 2, 2023
Seres’s Bacteria in a Pill Becomes First FDA-Approved Oral Microbiome Therapy

Recurrent Clostridioides difficile infection can be treated with fecal microbiota transplants. FDA approval of Seres Therapeutics’ Vowst makes it the first oral microbiome therapy. A capsule filled with bacteria is now FDA approved for treating a serious and potentially deadly type of gut infection, making the Seres Therapeutics drug the first oral microbiome therapy to receive the regulatory go-ahead for patients. The infection is caused by Clostridioides difficile (C. difficile or C. diff), a bacterium that’s part of the diverse microbial community in the intestines. When the gut microbiome is disrupted, C. diff can proliferate, releasing toxins that cause frequent diarrhea, abdominal pain, and fever. In severe cases, the infection leads to organ failure and death. Antibiotics can treat C. diff infection, but these bacteria can develop resistance, leading to a recurrence of the infection. When that happens, patients have limited treatment options. According to Centers for Disease Control and Prevention data cited by Seres, about 156,000 cases of ...
- Source: drugdu
- 170
- May 2, 2023
Moderna says it expects up to $15 billion in sales of Covid, RSV, flu vaccines in 2027

Moderna on Tuesday said it expects to see between $8 billion and $15 billion in sales from its Covid, RSV, flu and other respiratory vaccines in 2027. The biotech company said it sees a corresponding operating profit in the range of $4 billion to $9 billion. Those respiratory product estimates are supported by additional research investments of $6 billion to $8 billion “over the next few years,” Moderna added. The announcement came ahead of Moderna’s Vaccine Day on Tuesday. At the annual event, the company presented updates on its vaccine portfolio to investors and analysts eager to see how the company will navigate its post-pandemic boom. Moderna said earlier this year it expects $5 billion in mRNA Covid vaccine sales in 2023, a steep drop from the $18 billion the shot raked in last year. The Cambridge, Massachusetts-based company’s Covid vaccine remains its only commercially available product. ...
- Source: drugdu
- 122
- 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
- 128
- May 1, 2023
pneumococcal vaccination policies

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