Wed.Feb 15, 2023

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Innovation in immuno-oncology: Leading companies in cancer monoclonal antibody therapy

Pharmaceutical Technology

The pharmaceutical industry continues to be a hotbed of innovation, with activity driven by the evolution of new treatment paradigms and the gravity of unmet need, as well as the growing importance of technologies such as pharmacogenomics, digital therapeutics, and artificial intelligence. In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Immuno-oncology: Leading companies in cancer monoclonal

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With sales falling, Biogen’s new CEO says transformation is needed

Bio Pharma Dive

“There's an urgent need to restore growth to the company,” Christopher Viehbacher told investors Wednesday, on an earnings call that detailed a 7% decline in the company’s total revenue.

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Innovation in immuno-oncology: Leading companies in gene therapy delivery using viral vectors

Pharmaceutical Technology

The pharmaceutical industry continues to be a hotbed of innovation, with activity driven by the evolution of new treatment paradigms, and the gravity of unmet needs, as well as the growing importance of technologies such as pharmacogenomics, digital therapeutics, and artificial intelligence. In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Immuno-oncology in Pharmaceuticals: Gene therapy deli

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Beetroot Really Can Boost Athletic Performance, And This Is Why

AuroBlog - Aurous Healthcare Clinical Trials blog

Beetroot is gaining popularity as a performance-enhancer for athletes and those wanting to gain a competitive advantage in running and cycling. Some people juice beetroot, some eat it, others mix up a drink from the powdered form.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

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

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Leading innovators in CRISPR nucleases for the pharmaceutical industry

Pharmaceutical Technology

The pharmaceutical industry continues to be a hotbed of innovation, with activity driven by the evolution of new treatment paradigms and the gravity of unmet need, as well as the growing importance of technologies such as pharmacogenomics, digital therapeutics, and artificial intelligence. In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Innovation in Pharmaceuticals: CRISPR nucleases.

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CMS plans trio of experiments aimed at lowering drug costs

Bio Pharma Dive

The pilot programs could allow adjusted payments for drugs cleared under accelerated approval and help states manage the costs of gene therapies.

More Trending

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Brent Saunders appointed Bausch + Lomb CEO in return to pharma C-suite

Bio Pharma Dive

Saunders, who led Allergan until its sale to AbbVie, will replace turnaround CEO Joseph Papa as head of the contact lens and eye drug manufacturer.

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Leading innovators in coronavirus vaccine components

Pharmaceutical Technology

The pharmaceutical industry continues to be a hotbed of innovation, with activity driven by the evolution of new treatment paradigms, gravity of unmet need, as well as the growing importance of technologies such as pharmacogenomics, digital therapeutics, and artificial intelligence. In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Innovation in Pharmaceuticals: Coronavirus vaccine components.

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IISc & Brunel University eye long-term research & educational collaboration to strengthen scientific expertise

AuroBlog - Aurous Healthcare Clinical Trials blog

The Indian Institute of Science (IISc), Bengaluru and the Brunel University, London are looking for long-term research and educational collaboration to strengthen scientific expertise in the country. In this regard, a £100,000 (Rs 1 crore) programme for joint research projects has been launched as part of the UK–India university collaboration.

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Leading innovators in embryonic stem cell culturing for the pharmaceutical industry

Pharmaceutical Technology

The pharmaceutical industry continues to be a hotbed of innovation, with activity driven by the evolution of new treatment paradigms, and the gravity of unmet needs, as well as the growing importance of technologies such as pharmacogenomics, digital therapeutics, and artificial intelligence. In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Innovation in Pharmaceuticals: Embryonic stem cell cu

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The New Age of Decentralized Clinical Trials

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

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STAT+: In about-face, Moderna vows Americans won’t have to pay for its Covid-19 vaccine

STAT News

In an unexpected shift, Moderna has decided not to ask Americans to pay for its Covid-19 vaccine, a move that follows intense criticism over initial plans to charge $110 to $130 per dose after the company pivots from government contracts to commercial distribution. The vaccine maker released a brief statement that it “remains committed” to ensuring everyone in the U.S. has access to its Covid-19 shot, regardless of whether they have health insurance coverage.

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Leading innovators in flavivirus vaccine components

Pharmaceutical Technology

The pharmaceutical industry continues to be a hotbed of innovation, with activity driven by the evolution of new treatment paradigms and the gravity of unmet need, as well as the growing importance of technologies such as pharmacogenomics, digital therapeutics, and artificial intelligence. In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Innovation in Pharmaceuticals: Flavivirus vaccine compo

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How do pandemics begin? There's a new theory — and a new strategy to thwart them

NPR Health - Shots

Animals carry millions of pathogens. So it's a daunting task to find the one with the greatest potential to spark a pandemic. Now scientists are rethinking the way they hunt for that next new virus.

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Leading innovators in genetically modified animal models for the pharmaceutical industry

Pharmaceutical Technology

The pharmaceutical industry continues to be a hotbed of innovation, with activity driven by the evolution of new treatment paradigms, and the gravity of unmet needs, as well as the growing importance of technologies such as pharmacogenomics, digital therapeutics, and artificial intelligence. In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Innovation in Pharmaceuticals: Genetically modified a

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Roles and Responsibilities of Specialized Clinical Supply Experts

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.

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Why severe fatty liver leads to liver damage

Medical Xpress

In hepatic steatosis, hepatocytes "die," resulting in liver damage. Severe steatosis increases hepatocellular deaths, thus aggravating liver damage. The mechanism is unclear. Using mice, we show that mild steatosis causes apoptosis whereas severe steatosis predominantly causes necroptosis leading to cell rupture. This induces strong inflammation and new cell death, producing further liver damage.

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Leading innovators in IgG gene expressing animal models for the pharmaceutical industry

Pharmaceutical Technology

The pharmaceutical industry continues to be a hotbed of innovation, with activity driven by the evolution of new treatment paradigms, and the gravity of unmet needs, as well as the growing importance of technologies such as pharmacogenomics, digital therapeutics, and artificial intelligence. In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Innovation in Pharmaceuticals: IgG gene expressing an

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GSK was warned repeatedly about Zantac impurity but played down risks: Bloomberg

Fierce Pharma

GSK was warned repeatedly about Zantac impurity but played down risks: Bloomberg esagonowsky Wed, 02/15/2023 - 09:02

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Kinnate Biopharma’s CCA therapy KIN-3248 receives FDA Fast Track status

Pharmaceutical Technology

Kinnate Biopharma has received Fast Track designation from the US Food and Drug Administration (FDA) for its pan-FGFR inhibitor, KIN-3248, to treat unresectable, locally advanced or metastatic cholangiocarcinoma (CCA). KIN-3248 is indicated to treat CCA harbouring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other alterations in people who previously received a minimum of one systemic therapy.

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The New Age of Decentralized Clinical Trials

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.

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For many older breast cancer patients, study finds radiation doesn’t affect survival

STAT News

Radiation has long been a mainstay of breast cancer treatment, and following surgery up with the therapy can reduce the risk of recurrence. The drawback of radiation, though, is a fistful of unpleasant potential side effects including pain, a slight risk of organ damage, a very small risk of secondary cancer, and the time and money needed for the procedures.

Medicine 111
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Clover introduces Covid-19 subunit vaccine in China

Pharmaceutical Technology

Clover Biopharmaceuticals has launched its recombinant SARS-CoV-2 subunit vaccine , a protein-based Covid-19 vaccine, in China. The first recombinant SARS-CoV-2 subunit vaccine doses have been delivered and given in Changxing, Zhejiang, as part of the country’s second booster dose (fourth vaccination dose) campaign targeting immuno-compromised people, older adults and those with comorbidities.

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Opinion: How ‘empathetic engagement’ can increase access to mental health care

STAT News

The United States is in the midst of a mental health crisis , with increasing rates of anxiety, depression, and other mental health disorders. At the same time, there is a drastic shortage of mental health professionals to address the growing need for care, from psychiatrists to social workers. Put the two together, and the crisis becomes a catastrophe.

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A new imaging technique for a clearer picture of the 'brain in the gut'

Medical Xpress

University of Calgary researchers designed a novel imaging and experimental preparation system, allowing them to record the activity of the enteric nervous system in mice. The new technique allows researchers to record what is sometimes referred to as the gut's brain during the complex processes of digestion and waste elimination.

Research 105
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Accelerating Clinical Supply Through Integrated Drug Development

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.

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FDA advisers recommend approval of over-the-counter naloxone to fight opioid overdose

STAT News

A government advisory committee voted unanimously on Wednesday to recommend that naloxone nasal spray, a medication used to reverse opioid overdoses, be sold and distributed without a prescription. The vote serves as a recommendation to the Food and Drug Administration as the agency considers whether to make the product, commonly known as Narcan, available over the counter.

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New childhood obesity guidance raises worries over the risk of eating disorders

NPR Health - Shots

Many eating disorder specialists oppose the new guidance's focus on weight loss and BMI, and say it minimizes the risk of disordered eating and will perpetuate deep-rooted, damaging stigmas.

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Development of a low-power, long-term sweat sensor patch that imitates sensory neurons

Medical Xpress

Human sweat contains chemical information including blood metabolites, ion concentrations, and nutrients. Monitoring this information using a wearable sensor can allow non-invasive (i.e., without blood sampling), real time health status tracking. For example, knowing sweat volume and ion concentrations can help people maintain adequate water and sodium levels during physical activities, and can prevent hypoglycemic shock by identifying symptomatic excessive sweating.

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Diversity in Clinical Trials: Advances and Areas for Improvement

ACRP blog

A Q&A with ACRP Diversity Advisory Council member Otis Johnson, PhD, MPA, Chief Diversity, Inclusion, and Sustainability Officer at Clario. As we mark Black History Month, what are your thoughts on overall efforts to improve diversity within the clinical trials ecosystem? I am encouraged by how focused we are as an industry on addressing the serious underrepresentation of diverse populations in clinical trials.

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How Machine Learning Drives Clinical Trial Efficiency

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.

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Multiple sclerosis discovery could end disease's chronic inflammation

Medical Xpress

University of Virginia Health neuroscientists have discovered a potential way to disrupt the chronic inflammation responsible for multiple sclerosis.

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Interview with Polarean Imaging CTO Dr. Bastiaan Driehuys on the FDA Approval of Lung Imaging Drug Device Combo Xenoview – Xtalks Life Science Podcast Ep. 97

XTalks

Bastiaan Driehuys, PhD Founder and Chief Technology Officer Polarean Imaging plc In this week’s Xtalks Life Science podcast episode, Ayesha and the editorial team spoke with Dr. Bastiaan Driehuys, Founder and Chief Technology Officer at Polarean Imaging plc. Polarean is a medical imaging company focused on improving the state of lung imaging that recently received FDA approval for its drug-device combination product, Xenoview.

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How financial counseling at the pediatrician's office can help families thrive

NPR Health - Shots

Researchers paired new parents with financial coaches in a pediatric clinic. They found the families were more likely to come for well-child visits and vaccinations — and they got ahead financially.

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Study finds chronically disrupted sleep may increase the risk for heart disease

Medical Xpress

Sleep irregularity—chronically disrupted sleep and highly variable sleep durations night after night—may increase the risk for atherosclerosis, according to a study led by Kelsie Full, Ph.D., MPH, of Vanderbilt University Medical Center.

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.