Thu.Sep 24, 2020

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AstraZeneca turns to Samsung Biologics to help fuel Asia drugs push

Bio Pharma Dive

The British drugmaker struck a manufacturing deal with Samsung to expand its ability to supply drugs to the Asia Pacific region, an area that's been key to its recent growth.

Drugs 246
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Ageism within pharma

World of DTC Marketing

WHAT”S HAPPENING? As more and more pharma companies merge and the industry consolidates good jobs are going to shrink, Unfortunately, what I’m hearing and seeing is that the industry is passing on older candidates with experience in favor of younger candidates who may be perceived as more technology literate. Kathy was someone who impressed me from the first time I met her.

HR 143
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Drugmakers push forward on large-scale production of coronavirus vaccines

Bio Pharma Dive

HHS Secretary Alex Azar said six vaccine developers involved with Operation Warp Speed had begun commercial manufacturing of their experimental shots.

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Could a COVID-19 breath test help UK out of lockdown?

pharmaphorum

A potential COVID-19 breath test has been unveiled in the UK, as the country desperately searches for alternatives to crippling lockdown measures to prevent the disease from spreading. The breath test has been developed by Integumen in collaboration with Modern Water, Avacta and Aptamer Group, which had been working on test that identifies the SARS-CoV-2 coronavirus in waste water.

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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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Gene therapy company Taysha completes sprint from first funding to IPO

Bio Pharma Dive

Led by alumni of Zolgensma developer AveXis, the university spinout could have four experimental therapies in the clinic by the end of 2021.

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Cognoa preps FDA filing for digital autism diagnostic

pharmaphorum

An artificial intelligence-powered diagnostic for autism spectrum disorder (ASD), developed by Cognoa, has met all its objectives in a pivotal trial and will be filed for approval with the FDA. The ASD diagnostic app is designed to serve as a tool that can be used by paediatricians in primary care to detect autism traits early on and start treatment sooner.

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Life in phase III: How effective data management can support NHS Trusts to hit their targets

pharmaphorum

Although life for the general public is (slowly) starting to edge back towards normality, healthcare providers are still on a heightened state of alert. In the UK, the 1 August step down from EPRR incident level four may have meant we’re no longer in a state of national incident, but at a regional level NHS Trusts and private sector providers are still very much working flat out to manage and contain COVID-19 and its associated fallout.

Doctors 111
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Is the FDA Doing Enough to Regulate Added Chemicals in Foods?

XTalks

Despite our best efforts to avoid added chemicals, the food and beverages we consume likely contain one or more of some 10,000 chemicals allowed to be added to foods. Some of these chemicals are known endocrine (hormone) disruptors linked to developmental, cognitive and other health problems in babies and adults. Yet the US Food and Drug Administration (FDA), the agency charged with protecting our food from unsafe chemicals, hasn’t been doing the job Congress intended when it passed th

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Gilead pays $97m to resolve US illegal kickback claims

pharmaphorum

Gilead has paid $97 million to resolve claims by US authorities that it acted illegally by using a charitable foundation as a conduit to fund co-payments of thousands of Medicare patients taking its pulmonary arterial hypertension drug, Letairis. While this may sound innocuous, the US Department of Justice is cracking down on this activity as it undermines US laws that aim to place a check on drug prices on the federally-funded Medicare scheme.

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AZ vaccine still on hold in the US, lawmakers hear majority of Americans remain susceptible to COVID-19

BioPharma Reporter

AstraZeneca's phase 3 COVID-19 vaccine trial remains on hold in the US as the FDA probe into a patient illness in the UK trial that initiated the global pause continues, the US Department of Health and Human Services Secretary, Alex Azar, told US media yesterday [September 23].

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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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GSK’s Journey to Accelerated Study Delivery

XTalks

In a recent webinar , Jess Robinson, Director of Study Start-up at GSK, highlighted the importance of aligning people, processes, and technology when embarking on a study start-up transformation journey. A deep dive into cycle time metrics for key start-up milestones was the catalyst for change at GSK. After benchmarking their performance against industry standards, they realized they needed to change how they work to optimize clinical delivery.

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New patent for Optinose Us drug XHANCE

Drug Patent Watch

Annual Drug Patent Expirations for XHANCE Xhance is a drug marketed by Optinose Us Inc and is included in one NDA. There are sixteen patents protecting this drug. XHANCE drug…. The post New patent for Optinose Us drug XHANCE appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 90
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Oncimmune partners with Genentech to profile samples from rheumatology trials

Pharma Times

UK-headquartered company will characterise autoantibody profiles of clinical trial patients

Trials 123
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Emails Show How Pesticide Industry Influenced U.S. Position in Health Talks

NY Times

The U.S. insisted that new international guidelines on combating drug resistance omit any mention of fungicides — a demand that the industry made but that ran counter to science.

Drugs 83
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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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UK government launches COVID-19 app as cases soar

pharmaphorum

The UK government has finally launched its COVID-19 test and trace app months behind schedule as the country faces a second wave of the potentially deadly virus. There have already been hundreds of thousands of downloads of the app, which was seen as a key part of the government’s strategy to fight the virus when it was announced in May. But a pilot scheme of the app in the Isle of Wight hit problems almost immediately because of the government’s decision to use a centralised database, instead o

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Antibodies protect against wide range of influenza B virus strains

Scienmag

Findings point the way to developing a broad-spectrum flu drug Credit: Yanan Dai Researchers have identified two antibodies that protect mice against lethal infections of influenza B virus, report scientists at Washington University School of Medicine in St. Louis and Icahn School of Medicine at Mount Sinai. Together with an antibody that targets the other […].

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NY Gov. Cuomo Plans to Vet Any COVID-19 Vaccine Approved Ahead of the Election

BioSpace

New York’s governor hinted he would delay distribution of a quickly approved vaccine until its safety and efficacy could be vetted by a panel of state scientists and researchers.

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Genome of Alexander Fleming’s original penicillin-producing mould sequenced

Scienmag

Credit: CABI Researchers have sequenced the genome of Alexander Fleming’s penicillin mould for the first time and compared it to later versions. Alexander Fleming famously discovered the first antibiotic, penicillin, in 1928 while working at St Mary’s Hospital Medical School, which is now part of Imperial College London. The antibiotic was produced by a mould […].

Genome 81
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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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What Next-Generation COVID-19 Antibody Therapeutics Need to Succeed

BioSpace

First-generation therapeutics have been largely ineffective against the SARS-CoV-2 virus, resulting in significant challenges and opportunities for the second-generation therapeutics that are being designed now.

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Researchers demonstrate how deep learning can advance study of neural degeneration

Scienmag

Credit: Adriana San Miguel, NC State University Researchers from North Carolina State University have demonstrated the utility of artificial intelligence (AI) in identifying and categorizing neural degeneration in the model organism C. elegans. The tool uses deep learning, a form of AI, and should facilitate and expedite research into neural degeneration. “Researchers want to study […].

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Detailed Map of Human Heart Could Be Key to Treating Cardiovascular Disease

BioSpace

A new study published in Nature on Sept. 24 suggests that with a cellular and molecular map of the healthy human heart, experts may be able to better understand what goes wrong in cardiovascular disease.

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High-performance single-atom catalysts for high-temperature fuel cells

Scienmag

Individual Pt atoms participate in catalytic reaction to faciitate the electrode process by up to 10 times. Single-atom Pt catalysts are stable at 700 degrees Celsius and expected to stimulate the commercialization of next-gen reversible fuel cells. Credit: Korea Institue of Science and Technology(KIST) Unlike secondary batteries that need to be recharged, fuel cells are […].

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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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Sanofi’s Toujeo Improves Diabetes Control, Giving Patients More Time in Range

BioSpace

For diabetic patients, achieving a certain “time in range” is a more realistic glucose control strategy than striving for a particular daily target, according to researchers working with Sanofi who spoke during the 56th Annual Meeting of the European Association for the Study of Diabetes.

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Air pollution leads to increase in electricity usage, study suggests

Scienmag

Scientists say unclean air triggers change in behavior that drives people indoors to use more electricity High levels of air pollution are forcing people inside to consume more electricity, subsequently causing even greater environmental problems by increasing greenhouse gas emissions. This is according to a new study from researchers at Cardiff University who have shown […].

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Biopharma Update on the Novel Coronavirus: September 25

BioSpace

Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 25, 2020.

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How to bounce back from stretched out stretchable sensors

Scienmag

Credit: Hiroki Ota, Yokohama National University Elastic can stretch too far and that could be problematic in wearable sensors. A team of researchers at Yokohama National University has proposed a fix to prevent too much stretching while improving the sensing ability of electronics. This could lead to advanced prosthetics or disaster recovery robotics.

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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.

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FDA and EMA accept regulatory submissions for UCB’s bimekizumab

Pharma Times

UCB is seeking approval for treatment in moderate-to-severe plaque psoriasis

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Secondary variant of Photorhabdus luminescens interacts with plant roots

Scienmag

New form of insect-pathogenic bacterium extends the options for sustainable crop protection and biological pest control in agriculture Credit: ill./©: Nazzareno Dominelli, Ralf Heermann One of the basic approaches in organic farming is to use organisms beneficial to the system to combat pests. The bacterium Photorhabdus luminescens is one such beneficial organism.

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How Pharma Can Use Anthropology to Help New Patients

Intouch Solutions

More and more, the principles of anthropology are being used in business -- but how can the study of human cultures help pharma marketers connect with patients and make sure they're getting the treatments they need? Read on to find out. The post How Pharma Can Use Anthropology to Help New Patients appeared first on Intouch Solutions.

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Blood-based test accurately identifies viral infection before symptoms develop

Scienmag

The study, conducted prior to COVID-19, has broad potential for pandemic responses DURHAM, N.C. – A team of Duke Health scientists have identified biomarkers that accurately identify numerous viral infections across the clinical stages of disease, advancing a potential new way to guide treatment, quarantine decisions, and other clinical and public health interventions in the […].

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.