PharmaFocus Today – Page 349 – media

ImmunityBio gets manufacturing-related FDA snub on cancer drug, shares crash

ImmunityBio was hit with a complete response letter from the FDA for its bladder cancer prospect, sending the California-based company’s stock into a steep slide Thursday. The company’s stock fell more than 50% in overnight trading after it announced in a Securities and Exchange Commission filing Wednesday that it received a CRL from the agency on its application for its drug Anktiva in combination with a vaccine mainly used against tuberculosis, Bacillus Calmette-Guérin. The treatment is designed for patients with BCG-unresponsive, non-muscle invasive bladder cancer. Shares in the overnight session tumbled to $3.39 from Wednesday’s closing price of $6.22. “The deficiencies relate to the FDA’s pre-license inspection of the company’s third-party contract manufacturing organizations,” ImmunityBio said in the filing. “Satisfactory resolution of the observations noted at the pre-license inspection is required before the [application] may be approved.” ImmunityBio said it has requested a meeting with the FDA to address the agency’s concerns. The ...
- Source: https://seekingalpha.com/news/3969942-immunitybio-stock-crashes-after-fda-snub-cancer-therapy
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Cytiva and Pall Life Sciences complete integration

Cytiva and the life sciences business of Pall Corporation have completed their integration and are now united as one business under the Cytiva brand. With nearly 16 000 associates in 40 countries, and more than 300 years’ heritage of trusted expertise, the new Cytiva supports customers in solving major biotechnology challenges and plays a critical role in advancing and accelerating therapeutics for the benefit of patients everywhere. In January 2023, the life sciences business of Pall separated from Pall Corporation. Pall’s biotech portfolio is now a product family in Cytiva’s bioprocess business. The Pall medical portfolio will remain a market brand and part of Cytiva. Pall Corporation continues to operate as a Danaher operating company serving customers across a wide range of industrial applications. “The biotechnology industry is at the start of a new era. New modalities are emerging, there is greater emphasis on local manufacturing, and we are accelerating ...
- Source: https://www.news-medical.net/news/20230512/Cytiva-and-Pall-Life-Sciences-complete-integration-to-create-a-global-innovation-and-solutions-leader-in-biotechnology.aspx
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Despite rough quarter, Bayer’s duo of Nubeqa and Kerendia continue to excel

As Bayer presented its first-quarter earnings, much of the focus centered on the company’s struggling agricultural sector, which has been hindered by the poor performance of its glyphosate-based weedkillers. Somewhat under the radar is Bayer’s pharma business, which could use a boost as well. On the company’s list of best-selling medicines, seven of the top 10 posted a sales decline from the first quarter of last year. That list doesn’t include the aging eye treatment Eylea, which was up 2% on the quarter. Still, the drug posted a sequential (PDF) sales decline of 4% from the fourth quarter of last year. It all adds up to lots of pressure to perform for Bayer’s most promising new treatments—prostate cancer drug Nubeqa and kidney disease therapy Kerendia. Bayer’s small dose of good news on Thursday is that both are progressing nicely. The company has projected the drugs will generate 3 billion euros ($3.2 billion) each at peak. During the ...
- Source: https://www.fiercepharma.com/pharma/rough-quarter-bayers-duo-nubeqa-kerendia-continue-excel
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Sobi to acquire CTI BioPharma for approximately $1.7bn

Swedish Orphan Biovitrum (Sobi) has said it will acquire CTI BioPharma for approximately $1.7bn, marking a notable expansion to the Swedish drugmaker’s rare haematology pipeline. The deal will grant Sobi access to the US biopharma’s recently-approved Vonjo (pacritinib), a novel oral kinase inhibitor for patients with myelofibrosis and severe thrombocytopenia. The drug was granted accelerated approval by the US Food and Drug Administration (FDA) in February last year to treat adults with intermediate or high-risk primary or secondary myelofibrosis with low platelet counts. This was based on positive results from a phase 3 trial of Vonjo in patients with myelofibrosis. Results showed that 29% of patients receiving Vonjo had a reduction in spleen volume of at least 35% compared to 3% of patients receiving best available therapy. Sobi said Vonjo will be ‘highly complementary’ to Doptelet (avatrombopag), its oral thrombopoietin receptor agonist which also addresses rare haematological platelet disorders. Guido ...
- Source: https://www.pmlive.com/pharma_news/sobi_to_acquire_cti_biopharma_for_approximately_$1.7bn_1491454
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- May 14, 2023
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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