Fri.Jul 09, 2021

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Celldex pins its hopes for a comeback on skin disease drug

Bio Pharma Dive

After several setbacks, most notably the failure of a brain cancer vaccine, Celldex has a chance at reinvention should early drug results pan out for the 16-year-old biotech.

Drugs 363
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Pharma is big business whose goal is to maximize shareholder value

World of DTC Marketing

SUMMARY: Pfizer asks for accelerated approval for a COVID booster shot even though the FDA says it’s unnecessary. From 2016 to 2020, the 14 leading drug companies spent $577 billion on stock buybacks and dividends—$56 billion more than they spent on R&D over the same period.” From 2016 to 2020, compensation for the 14 companies’ top executives totaled $3.2 billion.

Drugs 292
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FDA, under fire for Alzheimer's drug approval, seeks investigation of review process

Bio Pharma Dive

Janet Woodcock, the agency's acting head, asked the HHS inspector general to investigate contacts between Biogen executives and FDA staff as criticism mounts of the regulator's handling of the controversial approval.

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Rare disease: industry, patients and tech join forces on diagnosis

pharmaphorum

Takeda’s Adam Zaeske discusses how cross-sector collaboration is shaping a brighter future for rare disease diagnosis. Diagnosis can sometimes be the most difficult part of a rare disease patient’s journey, and it’s with good reason that the process is often referred to as an ‘odyssey’ in these communities. “We’re dealing with very small populations of patients, on top of small populations of specialist physicians who are able to diagnose them,” says Adam Zaeske, formerly head of Rare Diseases,

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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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Bluebird resumes marketing gene therapy in Europe

Bio Pharma Dive

Zynteglo sales have been on hold since February, when a patient in a clinical trial of another, related Bluebird medicine developed leukemia.

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EMA finds possible link between mRNA COVID jabs and myocarditis

pharmaphorum

The EU medicines regulator has said that there is some evidence to suggest a possible link between mRNA-based vaccines for COVID-19 and rare cases of heart inflammation. . According to the EMA’s pharmacovigilance risk assessment committee (PRAC), labelling for Pfizer/BioNTech’s Comirnaty and Moderna’s Spikevax should be updated to reflect “very rare cases” of myocarditis and pericarditis with the shots.

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NICE rejects Orchard’s gene therapy for rare childhood disease MLD

pharmaphorum

Orchard Therapeutics’ gene therapy for rare childhood disease metachromatic leukodystrophy (MLD) Libmeldy has been rejected for NHS use by NICE in draft guidance. The agency said that while there was evidence of a short-term benefit with Libmeldy (atidarsagene autotemcel or OTL-200 ), assumptions about its long-term effects are uncertain, making it unclear whether it will offer value for money to the NHS.

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Biden Signs Order to Urge More Scrutiny of Big Business

NY Times

A new executive order reflects the administration’s growing embrace of warnings by some economists that declining competition is hobbling the economy’s vitality.

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Expanded access for Zolgensma following final NICE guidance

Pharma Times

NHS bodies in Wales and Northern Ireland are now expected to consider providing access to SMA gene therapy

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Match matters: The right combination of parents can turn a gene off indefinitely

Scienmag

UMD scientists discover that mating can cause epigenetic changes in nematode worms that last for 300 generations Credit: Antony Jose/UMD Evidence suggests that what happens in one generation–diet, toxin exposure, trauma, fear–can have lasting effects on future generations. Scientists believe these effects result from epigenetic changes that occur in response to the environment and turn […].

Gene 98
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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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Survey finds kidney cancer patients face anxiety over delayed scan results

Pharma Times

Findings revealed that 66% of patients are waiting at least three weeks after their scan for results

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Scientists observe a new type of topological defect in chiral magnets for the first time

Scienmag

Credit: Masahiro Nagao “Topological defects” are formed when the symmetry of a magnetic material is disrupted. Domain walls (DWs) are a type of topological defect that separates regions of different magnetic orientations. A widely studied phenomenon, the manipulation of these defects has potential applications in high-performance memory storage devices, energy processing devices, and quantum computing. […].

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Rare disease specialists talk resources, research and hope

Outsourcing Pharma

During the Rare/Orphan Diseases, Special Patient Population webinar, a group of industry experts discussed challenges and opportunities faced in the field.

Research 105
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Seeing with radio waves

Scienmag

Researchers at the University of Tsukuba use radio-frequency waves to image “spin-locked” defects in diamond with record-breaking resolution, which may lead to advances in material characterization and quantum computing Credit: University of Tsukuba Tsukuba, Japan – Scientists from the Division of Physics at the University of Tsukuba used the quantum effect called “spin-locking” to significantly […].

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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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Valneva’s chikungunya virus vaccine granted breakthrough designation

Pharma Times

Currently, no preventative vaccines or effective treatments are available for the chikungunya virus

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To splice or not to splice…

Scienmag

Credit: Elisabeth Paymal To splice or not to splice… In an article published in the journal RNA, Karan Bedi, a bioinformatician in Mats Ljungman’s lab, Department of Radiation Oncology at the University of Michigan Medical School, investigated the efficiency of splicing across different human cell types. The results were surprising in that the splicing process […].

RNA 98
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Pharma SAAS solutions must balance safety, efficiency: IQVIA

Outsourcing Pharma

A leader from IQVIA suggests what to look for when seeking ways to automate drug safety processes, while maintaining security and customer satisfaction.

Drugs 105
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Turn off the blue light!

Scienmag

Researchers from University of Tsukuba in collaboration with Yamagata University scientists find that exposure to light with less blue before sleep is better for energy metabolism Credit: University of Tsukuba Tsukuba, Japan – Extended exposure to light during nighttime can have negative consequences for human health. But now, researchers from Japan have identified a new […].

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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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Biden to Urge More Scrutiny of Big Business

NY Times

An order reflects the administration’s growing embrace of warnings by some economists that declining competition is hobbling the economy’s vitality.

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Normal brain growth curves for children developed childhood brain disorders, infections and injuries

Scienmag

Credit: humonia/Image compilation: College of Engineering In the United States, nearly every pediatric doctor’s visit begins with three measurements: weight, height and head circumference. Compared to average growth charts of children across the country, established in the 1970s, a child’s numbers can confirm typical development or provide a diagnostic baseline to assess deviations from the […].

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MHRA approves over-the-counter contraceptive pill

Pharma Times

First ever contraceptive pill to gain a license for over-the-counter sale in the UK

Licensing 123
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How robots and brain-computer interfaces could transform stroke patients’ recovery

Scienmag

Credit: BrainCo, Ltd. Strokes, which occur when the blood supply to part of our brain is interrupted or reduced, are the leading cause of death and disability in the adult population. Among the patients who survive, 75% will experience difficulties carrying out daily activities independently and need long-term functional exercises and rehabilitation.

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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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Performance.io appoints Jason Brown as global chief commercial officer

pharmaphorum

UK-based online marketing agency Performance.io (PIO) has appointed Jason Brown as it’s global chief commercial officer. Brown has held several senior leadership positions at pharma companies including Sanofi and Novartis, before joining sales force benchmarking organisation, STEM where he was promoted to President of EU5 and global COO. His most recent role was as chief commercial officer at Pharmaspectra, where he was responsible for the company’s international growth.

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Study model explores impact of police action on population health

Scienmag

Credit: University of Washington A specific police action, an arrest or a shooting, has an immediate and direct effect on the individuals involved, but how far and wide do the reverberations of that action spread through the community? What are the health consequences for a specific, though not necessarily geographically defined, population? The authors of […].

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F.D.A. Requests Investigation of Its Own Alzheimer’s Drug Approval

NY Times

The agency’s acting head said a federal review should look into whether any interactions between agency staff and the drug developer, Biogen, broke F.D.A. rules.

Drugs 65
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With $3M grant, UArizona-led center to advance at-home health care technology

Scienmag

A multi-institution team led by the University of Arizona aims to develop clinically validated wearable technologies to remotely monitor patient health Credit: University of Arizona The last two decades have seen an uptick in people choosing to monitor their health using wearable technologies such as Fitbits and Apple Watches. The wearable technology market is valued […].

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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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Sonde Health partners with Qualcomm on vocal biomarker tech

pharmaphorum

Sonde Health has joined forces with chipmaker Qualcomm to develop a technology platform that could diagnose human health conditions from a short sample of speech. . The two companies will make sure that Sonde Health’s vocal biomarker platform is optimised for use with Qualcomm chips used to power 5G mobile devices, saying this could unlock a number of health screening and monitoring applications.

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How otters’ muscles enable their cold, aquatic life

Scienmag

Texas A&M researchers found that the small mammals are internally warmed by thermogenic leak from their skeletal muscle, which elevates their metabolic rate Credit: Tray Wright/Texas A&M University (Image obtained under USFWS Marine Mammal Permit No. MA-043219 to R. Davis) Sea otters are the smallest marine mammal. As cold-water dwellers, staying warm is a top […].

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Performance.io appoints Jason Brown as global chief commercial officer

pharmaphorum

UK-based online marketing agency Performance.io (PIO) has appointed Jason Brown as it’s global chief commercial officer. Brown has held several senior leadership positions at pharma companies including Sanofi and Novartis, before joining sales force benchmarking organisation, STEM where he was promoted to President of EU5 and global COO. His most recent role was as chief commercial officer at Pharmaspectra, where he was responsible for the company’s international growth.

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New 3D printable phase-changing composites can regulate temperatures inside buildings

Scienmag

Materials could be used to reduce excess energy usage Credit: Texas A&M University College of Engineering Changing climate patterns have left millions of people vulnerable to weather extremes. As temperature fluctuations become more commonplace around the world, conventional power-guzzling cooling and heating systems need a more innovative, energy-efficient alternative, and in turn, lessen the burden […].

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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.