6th Annual Pharmaceutical Microbiology USA Conference
Pharmaphorum
by ssapal@smi-online.co.uk
1y ago
  Boston, MA, USA www.microbiologyeastcoast.com Sponsored by: LONZA Chaired by: Donald Singer, USP General Chapter Committee Microbiology Chair, US Pharmacopeia Contamination Control and Microbial Methods Explored to Assure Product Quality and Prevention Microbiology remains an essential tool in reducing microbial growth in the manufacture of pharmaceuticals, to detect and eliminate microorganisms that would pose a risk to patients and jeopardise product batches. Ensuring the sterility of the finished product continues to be one of the most critical aspects of drug development, however a ..read more
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How can digital and AI optimise the delivery of patient support programs in cancer?
Pharmaphorum
by mike.hammerton@pharmaphorum.com
1y ago
How can digital and AI optimise the delivery of patient support programs in cancer? Oncology patient support programs (PSPs) hold great promise for cancer patients, clinicians, and drug makers by providing patients with literature and resources that help them cope with their disease and treatment experiences. However, these PSPs often fall short of delivering the dynamic, responsive, and personalised experience that patients have come to expect in other areas of their lives – be it banking, entertainment, travelling, or even news. This raises questions about the suitability and sustainability ..read more
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What happened to all the antibiotics?
Pharmaphorum
by Ben Hargreaves
1y ago
Across the world, there are reports of shortages of common antibiotics. Ben Hargreaves examines why these shortages are happening and what is being done in the background to return supply to normal. In many countries across the world, there are shortages of common antibiotics. The problems have been reported across many countries in Europe, in the US, Canada, and Australia. Though the shortages have been more widely reported in more economically developed countries, the reality is that supply is likely limited globally. This poses significant issues for healthcare systems in those countries ..read more
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Why we need to support healthcare’s vital acceleration
Pharmaphorum
by mike.hammerton@pharmaphorum.com
1y ago
What do I mean by vital acceleration? With the population ageing, the need for healthcare is growing fast: between 2015 and 2050, the proportion of the world’s population over 60 years old will nearly double from 12% to 22%, according to the World Health Organization. Keeping our elderly population healthy will prove a major challenge in years to come. Not only will they need new treatments, but these must also be delivered in affordable ways. That’s what is relentlessly driving industry growth, as well as spurring innovation and efficiency. And that is just one side of the story. Think about ..read more
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Lilly breaks new ground for BTK class with Jaypirca approval
Pharmaphorum
by Phil Taylor
1y ago
Eli Lilly has picked up an FDA approval for its non-covalent BTK inhibitor Jaypirca in relapsed mantle cell lymphoma (MCL) patients who relapse after treatment with current drugs in the class. The accelerated approval covers adults MCL patients who have previously been treated with at least two lines of systemic therapy, including a covalent BTK inhibitor. Jaypirca (pirtobrutinib) has been specifically designed to work in patients who develop resistance mutations to current BTK inhibitors for MCL, such as AbbVie/Johnson & Johnson’s Imbruvica (ibrutinib), AstraZeneca’s Calquence (acalabrut ..read more
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EMA reviewing Novartis’ Adakveo after phase 3 miss
Pharmaphorum
by Phil Taylor
1y ago
The EMA’s human medicines committee has started a review of Novartis’ sickle cell disease (SCD) therapy Adakveo, shortly after the company reported that it failed to show efficacy in a phase 3 trial. On Friday, Novartis said that the phase 3 STAND trial of Adakveo (crizanlizumab) found no statistically significant difference between the drug and placebo on annualised rates of vaso-occlusive crises (VOCs) – the excruciatingly painful attacks that intermittently affect patients with SCD. The EU regulator’s Committee for Medicinal Products for Human Use (CHMP) said it will “assess the impact of ..read more
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Trial sets up earlier use of J&J’s Carvykti in myeloma
Pharmaphorum
by Phil Taylor
1y ago
One of the Johnson & Johnson’s top clinical trial readouts for 2023 just generated results, which bode very well for the future prospects of multiple myeloma CAR-T Carvykti. BCMA-directed cell therapy Carvykti (ciltacabtagene autoleucel) has seen sluggish growth since it was first approved by the FDA in March 2022 as a fifth-line or later therapy for multiple myeloma, but the CARTITUDE-4 study could see it used earlier on in the treatment pathway. The study – which tested Carvykti in patients with one to three lines of prior therapy – gives J&J an opportunity to leapfrog Bristol-Myers ..read more
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Measuring the cost-effectiveness of vaccines targeting infectious diseases
Pharmaphorum
by mike.hammerton@pharmaphorum.com
1y ago
Cost-effectiveness modelling is a powerful tool in understanding the value health interventions can bring to populations. For vaccines that target infectious diseases, as Pragya Khurana and Dr Richard Pitman of ICON explain, cost-effectiveness research can power evidence generation and decision-making that helps keep people safe. As the world saw with COVID-19, infectious diseases and the pandemics they cause can put immense strain on healthcare systems, particularly with regard to labour, resources, and funding. Nearly three years after the initial outbreak began, the UK’s National Health Se ..read more
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JP Morgan 2023 – Adi Hoess
Pharmaphorum
by Jonah Comstock
1y ago
pharmaphorum editor-in-chief Jonah Comstock joins Adi Hoess, CEO of Affimed Therapeutics, at their JPM2023 headquarters at the Zeppelin Hotel, to learn about Affimed’s work and their plans for the year to come.  Affimed is using bispecific antibodies to activate the innate immune system of cancer patients to create longer-lasting and more effective results.   Hoess describes the company’s clinical programmes, including an ADC for Hodgkin’s lymphoma and a novel cell therapy approach. He describes how they are approaching some of the major hurdles in cell therapy, like manufactur ..read more
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Tackling ongoing staffing burnout rates through AI-enabled precision oncology
Pharmaphorum
by mike.hammerton@pharmaphorum.com
1y ago
The emergence of COVID-19 resulted in staffing challenges that have continued to have a sustained, negative impact on clinical trial workflows. In fact, 76% of healthcare professionals have recently cited feelings of burnout, leading to a turnover rate twice as high as before the pandemic and increased levels of vacant positions across clinical research sites. With recent fears around profitability, many hospitals and institutions have adjusted or decreased their workforce in particular areas, with some re-positioning back-office employees to handle patient-facing roles. In addition, many lai ..read more
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