Pharmaceutical Technology

MAY 11, 2023

Results published in Nature for a personalised pancreatic cancer vaccine that uses neoantigens from patients’ tumours have lent further support to early positive signals. The vaccine, developed by BioNTech, led to half of the patients with pancreatic cancer in the Phase I trial remaining cancer-free 18 months later. In the study, 16 patients were treated with a vaccine called autogene cevumeran that contained a maximum of 20 neoantigens, alongside Roche’s anti-PD-L1 immunotherapy Tecentriq (atez

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RNA Vaccination Vaccine Trials 345

Bio Pharma Dive

MAY 11, 2023

Revenue from the biotech’s ALS therapy Relyvrio totaled $71.4 million in the first quarter, well above analyst estimates and helping the company turn a profit only months into the drug’s launch.

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Drugs 239

Pharmaceutical Technology

MAY 11, 2023

Bayer has entered a strategic collaboration agreement with biotechnology company Bicycle Therapeutics to discover, develop, manufacture and commercialise Bicycle’s radioconjugates for a number of oncology targets. The collaboration will see Bicycle use its phage platform to discover and develop bicyclic peptides while Bayer will fully fund and manage further preclinical and clinical development, manufacturing and commercialisation aspects.

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Development Manufacturing Protein Clinical Development 162

Rethinking Clinical Trials

MAY 11, 2023

A new article from the NIH Pragmatic Trials Collaboratory outlines stakeholder insights and ethical considerations related to sharing deidentified, participant-level data in pragmatic clinical trials. While there are numerous arguments for and against data sharing in the context of pragmatic trials, the report aims to address the gap in documented stakeholder perspectives.

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Trials Clinical Trials Clinical Trials 130

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Pharmaceutical Technology

MAY 11, 2023

Otsuka Pharmaceutical and H Lundbeck have received approval for the supplemental new drug application (sNDA) from the US Food and Drug Administration for Rexulti (brexpiprazole) to treat agitation associated with dementia due to Alzheimer’s disease. Rexulti has become the first and only pharmacological treatment to receive approval for this indication in the US.

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FDA Approval Trials Regulation Drugs 147

Bio Pharma Dive

MAY 11, 2023

The committee members urged the agency to move quickly to improve access to Perrigo’s contraception pill.

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Medical Xpress

MAY 11, 2023

Blood plasma is collected from people routinely during clinical care and for research. It is potentially a rich source of protein biomarkers for diagnostic and prognostic purposes, for measuring response to treatment, and for revealing disease biology. Yet identifying such biomarkers in plasma with proteomics, our best available tool, has been a challenge: 99% of plasma consists of everyday proteins like albumin, globulins, and coagulants that essentially crowd out the needle-in-a-haystack prote

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Protein Research 139

Pharmaceutical Technology

MAY 11, 2023

The global pharma industry experienced a 20% drop in social media posts on covid-19 in Q1 2023 compared with the previous quarter, with the highest share accounted for Pfizer, according to GlobalData’s analysis of social media posts. GlobalData’s COVID-19 Cross-Sector Impact – Thematic Research report helps understand how the effect of covid-19 on pharmaceutical sector compares with 17 other key sectors, in terms of equity indices, M&A volumes, jobs index, and filings.

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Research 130

Medical Xpress

MAY 11, 2023

Using new genetic tools to study statins in human cells and mice, Stanford Medicine researchers and collaborators have uncovered how the cholesterol-lowering drugs protect the cells that line blood vessels.

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Research Genetics Medicine Drugs 137

Pharmaceutical Technology

MAY 11, 2023

The global pharma industry experienced a 32% rise in social media posts on artificial intelligence in Q1 2023 compared with the previous quarter, with the highest share accounted for Healthcare Information and Management Systems Society, according to GlobalData’s analysis of social media posts. Artificial intelligence is among the top emerging technologies being employed for drug discovery and development and has demonstrated strong potential in the Pharmaceutical sector.

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Marketing Drugs Research Development 130

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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

Clinical Trials

Medical Xpress

MAY 11, 2023

Ischemic stroke, caused by a blockage of blood flow to the brain, is a common cause of death and disability. Treatments are urgently needed to improve patient outcomes, because recovery currently depends largely on the timely injection of a blood clot-dissolving drug. Priorities for therapy include limiting inflammation at the ischemic site and rebuilding neuronal connections damaged by the stroke.

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Drugs Research 131

Pharmaceutical Technology

MAY 11, 2023

Deerfield Management-founded biotechnology company Aviko Radiopharmaceuticals has announced plans to advance precision boron neutron capture therapy (BNCT) to treat cancers and other diseases. BNCT is a precision medical approach which destroys cancerous cells and reduces the impact on surrounding healthy tissues. The company has an innovative boron medicines pipeline.

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Medicine Business Development Clinical Research Development 130

Medical Xpress

MAY 11, 2023

Genomic studies of cancer patients have revealed thousands of mutations linked to tumor development. However, for the vast majority of those mutations, researchers are unsure of how they contribute to cancer because there's no easy way to study them in animal models.

Gene Editing 130

Gene Editing Gene Genome Genomics 130

Pharmaceutical Technology

MAY 11, 2023

The European Commission (EC) has granted approval for AstraZeneca ’s Ultomiris (ravulizumab) to treat neuromyelitis optica spectrum disorder (NMOSD) in adult patients. Approved as the first and only long-acting C5 complement inhibitor, Ultomiris is indicated to treat adults with anti-aquaporin-4 (AQP4) antibody-positive (Ab+) NMOSD in the European Union (EU).

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Trials Clinical Trials Clinical Trials Medicine 130

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Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

Clinical Research

Medical Xpress

MAY 11, 2023

Situated at the intersection of the human immune system and the brain are microglia, specialized brain immune cells that play a crucial role in development and disease. Although the importance of microglia is undisputed, modeling and studying them has remained a difficult task.

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Development 126

Pharmaceutical Technology

MAY 11, 2023

Pharmaceutical company Veeva Systems has announced that Sanofi is implementing its solutions to improve the latter’s quality management process. The move includes the deployment of Veeva Vault QMS and Veeva Vault QualityDocs into Sanofi’s operations. Sanofi’s consumer healthcare (CHC) division has already gone live with the implementation. CHC division has also chosen Veeva Vault Training to consolidate its content management and GxP [good practice] training.

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Development 130

Medical Xpress

MAY 11, 2023

A University of Queensland study has found skin with few visible freckles or blemishes may still carry sun-damaged DNA mutations that can trigger cancer. Researchers from UQ's Frazer Institute Dermatology Research Center investigated the relationship between the number of mutations found in 'normal looking' skin and the number of a person's past skin cancers.

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Dermatology DNA Research 126

Pharmaceutical Technology

MAY 11, 2023

Servier has received marketing authorisation from the European Commission (EC) for Tibsovo (ivosidenib tablets) to treat isocitrate dehydrogenase-1 (IDH1)-mutated acute myeloid leukaemia (AML) and IDH1-mutated cholangiocarcinoma. Tibsovo is an isocitrate dehydrogenase-1 inhibitor indicated to treat IDH1 R132-mutated locally advanced or metastatic cholangiocarcinoma in adult patients who have previously received a minimum of one line of systemic therapy.

Marketing 130

Marketing Trials Production Development 130

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This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

Clinical Trials

Medical Xpress

MAY 11, 2023

Postmenopausal women with clogged arteries are at higher risk of heart attacks than men of similar age, according to research presented at EACVI 2023, a scientific congress of the European Society of Cardiology (ESC), and published in European Heart Journal—Cardiovascular Imaging. The study in nearly 25,000 adults used imaging techniques to examine the arteries and followed patients for heart attacks and death.

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Cardiology Research 117

XTalks

MAY 11, 2023

Cronobacter sakazakii , the bacteria linked to recent baby formula shortages and the Abbott infant formula recall, could soon join the federal disease watchlist. In June, the Council of State and Territorial Epidemiologists (CSTE) will vote to decide if it will officially recommend adding Cronobacter infections to the list of nationally notifiable diseases to the US Centers for Disease Control and Prevention (CDC).

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Bacteria Doctors Doctor Contamination 98

Medical Xpress

MAY 11, 2023

A large team of medical researchers at Memorial Sloan Kettering Cancer Center, in New York, working with colleagues from the Icahn School of Medicine at Mount Sinai and German firm BioNTech has developed a personalized mRNA vaccine that shows promise against an aggressive form of pancreatic cancer in clinical trial results.

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Clinical Trials Clinical Trials Vaccination Vaccine 105

BioPharma Reporter

MAY 11, 2023

Cellular Origins has partnered with ScaleReady, to automate portions of its cell and gene therapies (CGT) manufacturing workflow using a robotics system for sterile liquid transfer.

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Manufacturing Gene Therapy Gene Development 98

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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

Clinical Supply

Medical Xpress

MAY 11, 2023

Frequent users of YouTube have higher levels of loneliness, anxiety, and depression according to researchers from the Australian Institute for Suicide Research and Prevention (AISRAP).

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Research 105

XTalks

MAY 11, 2023

According to a report produced by the World Health Organization (WHO), around 1.3 billion people – or 16 percent of the world’s population – are living with significant disabilities. This makes it crucial that we adopt systems that make our webinars accessible to the greatest proportion of the population. Webinar hosts dedicate a lot of time and effort when creating webinar content, marketing it to potential attendees and practicing the delivery to ensure they convey their message to the audienc

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Marketing Production Life Science Regulation 98

Medical Xpress

MAY 11, 2023

The leading cause of vision loss in Western countries is age-related macular degeneration (AMD), a deterioration of central vision that begins when droplets of lipids and proteins called lipofuscin accumulate in the retina and damage cells. Effective treatments for AMD are not available, and it remains unclear how healthy eyes prevent this accumulation.

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Protein 104

Drug Discovery World

MAY 11, 2023

Bayer and Bicycle Therapeutics have entered into a strategic collaboration agreement to discover, develop, manufacture, and commercialise Bicycle radioconjugates for multiple oncology targets. Bicyclic peptides are peptides consisting of 9-20 amino acids that can be synthetically manufactured and bind to targets with high affinity and selectivity, affording high tumour penetration and fast excretion from healthy organs.

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Manufacturing Protein Clinical Development Development 97

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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

Clinical Trials

Medical Xpress

MAY 11, 2023

Researchers at University of Galway studying cell interactions in bowel cancer have identified innovative strategies to enhance how the body and drug treatments fight the disease.

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Research Drugs 98

XTalks

MAY 11, 2023

Clinical trials are essential for the development of new treatments for rare diseases, but they can be complex and challenging to execute. Patient input is a crucial component of rare disease clinical trials, as it can provide valuable insights into the patient experience and inform decisions about study design and implementation. However, simply collecting patient input is not enough – it must be translated into actionable insights that can drive meaningful change.

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Clinical Trials Clinical Trials Trials Development 97

Medical Xpress

MAY 11, 2023

Life has changed forever because of COVID-19, and the virus is still spreading, and still causing serious illness or significant disruption of 'normal' life.

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Pharma Times

MAY 11, 2023

Treatment concerns patients with IDH1-mutated acute myeloid leukaemia and IDH1-mutated cholangiocarcinoma

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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.

Clinical Supply