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Amylyx’s ALS drug again surpasses Wall Street expectations

Amylyx Pharmaceuticals has again impressed Wall Street, disclosing Thursday a new earnings report in which product revenue was significantly higher than many analyst forecasts. The Cambridge, Massachusetts-based biotechnology company said product revenue from January through the end of March totaled $71.4 million, up from the nearly $22 million generated during the final three months of last year. Amylyx has one product, an ALS medicine sold as Relyvrio in the U.S. and Albrioza in Canada. The company is now profitable less than a year into the drug’s launch, having posted nearly $1.6 million in net income during its latest quarter. In March, Amylyx executives told investors Relyvrio’s launch was going better than expected. They estimated that more than 1,300 U.S. patients with ALS, or amyotrophic lateral sclerosis, were taking the drug at the end of last year, and that the company was on pace to double this ...
- Source: https://www.biopharmadive.com/news/amylyx-als-relyvrio-sales-first-quarter/650139/
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A machine-learning approach for the early diagnosis of Parkinson’s disease

By Dr. Priyom Bose, Ph.D.May 11 2023Reviewed by Benedette Cuffari, M.Sc. Among all neurological diseases, the incidence of Parkinson’s disease (PD) has increased significantly. PD is typically diagnosed on the basis of motor nerve symptoms, such as resting tremors, rigidity, and bradykinesia. However, the detection of non-motor symptoms, such as constipation, apathy, loss of smell, and sleep disorders, could help in the early diagnosis of PD by several years to decades. In a recent ACS Central Science study, scientists from the University of New South Wales (UNSW) discuss a machine learning (ML)-based tool that can detect PD years before the first onset of symptoms. Study: Interpretable Machine Learning on Metabolomics Data Reveals Biomarkers for Parkinson’s Disease. Image Credit: SomYuZu / Shutterstock.com Background At present, the overall diagnostic accuracy for PD based on motor symptoms is 80%. This accuracy could be increased if PD was diagnosed based on biomarkers rather than primarily depending on physical symptoms. Several ...
- Source: https://www.news-medical.net/news/20230511/A-machine-learning-approach-for-the-early-diagnosis-of-Parkinsons-disease.aspx
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Maximizing the Value of AI in Cancer Care

Real-time patient experiences is the missing element to most electronic health records, artificial intelligence, and machine learning models today. Anish Patankar, SVP, GM, Oncology Informatics Software, Elekta Cancer treatment has come a long way in recent years and is now evolving more rapidly through the integration of artificial intelligence (AI) tools, such as machine learning (ML). Currently, health data exists in many forms, including electronic health records (EHR), diagnostic images, genomic and molecular data, pharmacological data, and patient-reported data. The creation of state-of-the-art cancer treatments can be enhanced by the ways clinicians leverage data to optimize care, and there’s no better way to achieve this than through the use of AI. Completing the picture There is a missing element to most EHR, AI, and ML models today – real-time patient-reported outcomes. This type of data refers to information regarding patients’ experiences with their medical conditions, treatments, and healthcare providers, ...
- Source: drugdu
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COVID-19 that occurs after vaccination carries a much lower risk of severe illness

Scientists have developed several vaccines to prevent infection by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causal agent of the ongoing coronavirus disease 2019 (COVID-19) pandemic. Previous studies have shown that although vaccine-induced immunity declines over time, vaccine effectiveness (VE) against severe COVID-19 persists for extended periods. Background Several studies have indicated that COVID-19 vaccines were less effective in preventing severe illness in older adults and otherwise immunocompromised patients. Nevertheless, COVID-19 vaccination has reduced disease severity among patients hospitalized due to SARS-CoV-2 infection. Fully vaccinated people who were hospitalized due to symptomatic COVID-19 were less likely to require mechanical ventilation, intensive care unit (ICU) admission, or die as compared to unvaccinated individuals. However, there remains a lack of studies that have evaluated the relationship between COVID-19 booster vaccination and disease severity using large samples infected with different SARS-CoV-2 variants. About the study A recent Journal of ...
- Source: https://www.news-medical.net/news/20230511/COVID-19-that-occurs-after-vaccination-carries-a-much-lower-risk-of-severe-illness.aspx
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AI used to build a 3D model of the Commander complex

University of Queensland researchers have used artificial intelligence to build a 3D map of key cell components to better understand dementia and infectious diseases including COVID-19. Professor Brett Collins from UQ’s Institute for Molecular Bioscience and Professor Pete Cullen from the University of Bristol led a team that modeled the 16 subunit Commander complex, a bundle of proteins that act as ‘postal workers’ in cells. Just as the postal system has processes to transport and sort cargo, cells in our bodies have molecular machines that transport and sort proteins. This protein transport system is implicated in many diseases including heart disease, Alzheimer’s disease and infections. “Knowing the 3D shape of these proteins helps us understand how they function, why mutations cause disease, and how to design drugs to target them in the future,” Professor Collins said. “Viruses such as SARS-CoV-2 – which causes COVID-19 – and human papilloma virus ...
- Source: drugdu
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- May 13, 2023
Research pinpoints the time of year and hour when people have the strongest suicidal thoughts

New research has identified the month when people have the strongest suicidal thoughts, and that these thoughts occur a few months before the peak of suicide behaviors in spring/early summer. It also showed the daily peak in suicidal thought is between 4-5 a.m. Most people assume suicide rates will be highest in winter, yet spring/early summer is when suicidal behaviors peak and this finding has baffled researchers since first identified. Research from the University of Nottingham’s School of Psychology, led in collaboration with the University of Amsterdam and Harvard University, has examined the seasonal paths of suicidal thoughts and identified when suicidal thoughts peak during the year and also what time of day these thoughts are the worst. The findings have been published in Translational Psychiatry. Over a period of six years, responses were collected from over 10,000 people in the UK, US and Canada who completed questionnaires and tasks ...
- Source: drugdu
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Otsuka, Lundbeck’s Rexulti nabs new use in Alzheimer’s disease agitation

After Lundbeck and Otsuka’s Rexulti cleared a key advisory committee hurdle, the FDA has given the drug the go-ahead to treat dementia-associated agitation in Alzheimer’s disease patients With the approval, Rexulti becomes the first drug approved for this use in the United States. The FDA granted the nod based on data from two 12-week studies in which patients showered statistically significant and clinically meaningful improvements on the Cohen-Mansfield Agitation Inventory scale, according to the FDA. The metric looks at the frequency and intensity of dementia-related agitation. In the studies, Rexulti demonstrated a 31% improvement from baseline agitation symptoms compared with placebo. Agitation symptoms cover a wide group of behaviors including pacing, gesturing, profanity, shouting, and physical outbursts, Otsuka said in a release. The symptoms are the leading causes of assisted living or nursing room placement and have been known to be associated with accelerated disease progression, Tiffany Farchione, director ...
- Source: drugdu
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Sobi Emerges as Savior for CTI Biopharma Cash Crunch With $1.7B M&A Deal

CTI Biopharma has something many biotech companies aspire to achieve—revenue. Sales of its approved cancer drug are growing, but commercialization comes with costs as does development of the molecule for additional indications. CTI expects it will need to raise money, but the dismal financial conditions mean fundraising prospects for any biotech company could remain challenging for the foreseeable future. Enter Swedish Orphan Biovitrum (Sobi), the Stockholm-based rare diseases biopharmaceutical company. Sobi has agreed to acquire CTI in a cash deal that values the Seattle-based biotech at $1.7 billion. According to the terms of the deal, Sobi will pay $9.10 for each share of CTI, which represents an 89% premium to the stock’s price before the deal was announced Wednesday. The heart of the acquisition is Vonjo, a drug for myelofibrosis, a rare bone marrow cancer that impairs the production of red blood cells. Last year, the FDA granted accelerated approved ...
- Source: drugdu
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Pfizer CEO says Medicare will likely face legal action over drug price negotiations

Pfizer CEO Albert Bourla on Thursday said pharmaceutical companies will likely take legal action against Medicare drug price negotiations, which aim to cut costs for older Americans, but will likely reduce company profits. “I think that there will be legal action, but I’m not sure if we’ll be able to stop anything before 2026 or not,” Bourla said during a live-streamed interview with Reuters. Bourla referred to a provision in the Biden administration’s Inflation Reduction Act that will allow the Medicare program to negotiate prices on the costliest prescription drugs each year. The first negotiations start in September and new prices will go into effect in 2026. He said the most “certain way” to stop negotiations would be to call on Congress to introduce legislation that will revise the federal government’s plan. But Bourla noted he is “not optimistic” about that happening. Democrats control the Senate and President Joe ...
- Source: drugdu
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- May 13, 2023
European Commission green lights Servier’s Tibsovo

Treatment concerns patients with IDH1-mutated acute myeloid leukaemia and IDH1-mutated cholangiocarcinoma Servier has revealed that the European Commission (EC) has approved Tibsovo – also known as ivosidenib tablets – as a therapy in two vital indications. The first is in combination with azacitidine for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) with an isocitrate dehydrogenase-1 (IDH1) R132 mutation. These individuals will not have been eligible to receive standard induction chemotherapy. The second is as a monotherapy among adult patients with locally advanced or metastatic cholangiocarcinoma in addition to a IDH1 R132 mutation who have previously undergone treatment using at least one prior line of systemic therapy. Tibsovo remains the only IDH1 inhibitor approved across Europe, while it has also received orphan medicine designation recognising the significant benefit brought to patients by the drug. Philippe Gonnard, executive vice president, global product strategy at Servier, explained: “IDH1 ...
- Source: drugdu
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