Sat.Nov 06, 2021 - Fri.Nov 12, 2021

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Moderna founder unveils new drug company focused on a different kind of RNA

Bio Pharma Dive

Encouraged by Moderna's success, Flagship Pioneering has been busy creating startups like Alltrna, which launched Tuesday. The biotech is researching how to make medicines from transfer RNA molecules.

RNA 359
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A huge gap exists between HCP medical information needs and pharma

World of DTC Marketing

SUMMARY: Quantitative and qualitative data was gained through surveys with EPG Health’s multi-stakeholder databases (HCP, pharma, and service providers) and interviews conducted with pharma execs by Impatient Health. The objective was to identify new and preferred pathways for the creation and delivery of medical information. Key Findings 1 : HCPS ARE IN CONTROL AND PHARMA KNOWS IT.

Branding 231
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Association of Self-reported COVID-19 Infection and SARS-CoV-2 Serology Results With Persistent Physical Symptoms

JAMA Internal Medicine

This cross-sectional study of individuals from the French CONSTANCES cohort assesses whether the belief in having been infected with SARS-CoV-2, having serological test–confirmed COVID-19 infection, or both are associated with persistent physical symptoms often attributed to long COVID in the general adult population.

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University of Oxford begins human trials of Ebola vaccine

Pharma Times

ChAdOxl biEBOV is being tested for safety and immunogenicity, and may protect against multiple species of the virus

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Mirati gives first look at KRAS drug combination in lung cancer

Bio Pharma Dive

Study results for Mirati's drug combined with Keytruda have been much anticipated, as the San Diego biotech aims to challenge Amgen and its rival KRAS-blocking drug Lumakras.

Drugs 341
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AI tool may help doctors select best drugs for COVID patients

pharmaphorum

Researchers in the US have developed an artificial intelligence-based tool that is able to predict COVID-19 symptoms and suggest which FDA-approved drugs might be used to treat patients. The MOATAI-VIR algorithm, developed by scientists at Emory University and Georgia Tech, was put through its paces in a study that showed it was able to predict 24 out of 26 clinical manifestations of COVID-19, including acute respiratory distress, blood clotting issues, cytokine storms, brain fog, and loss of sm

Doctors 135

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New COVID-19 vaccines could target replication proteins

Pharma Times

Researchers have said that next generation vaccines for COVID-19 should aim to induce a response against ‘replication proteins’

Protein 120
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J&J, world's largest drugmaker, plans to split in two

Bio Pharma Dive

The industry giant and mainstay of corporate America will separate its consumer health business from its drug and medical device units, which will retain the J&J brand.

Branding 344
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Neuroplast reports successful Phase 1 trial for spinal cord injury stem cell treatment

BioPharma Reporter

Dutch stem cell company Neuroplast has announced positive Phase 1 results for its Neuro-Cells investigational stem cell treatment in patients suffering from Traumatic Spinal Cord Injury (TSCI).

Trials 111
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UK sets aside £248m to “digitise” NHS diagnostics

pharmaphorum

The UK government has announced £248 million in spending over the next year for a project to make it easier for patient test results and scans to be shared between hospitals, labs and GP surgeries. The aim is to “digitise diagnostics care” across the NHS, reducing the time it takes to diagnose health problems and get treatment started earlier, helping to address the massive backlog in care caused by the pandemic, according to a Department of Health and Social Care (DHSC) statement.

Radiology 109
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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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Scientists Explore SARS-CoV-2 Mega Vaccine

BioSpace

?Scientists are conducting research into the possibility of creating a vaccine that activates T cells that targets not just SARS-CoV-2 but also its variations, even the ones that cause common colds.

Scientist 109
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Cortexyme plans path forward for Alzheimer's drug that failed study

Bio Pharma Dive

Detailed results presented Thursday show no difference between the biotech's drug and placebo on the study's main measures. But a seeming benefit in a subgroup of patients convinced the company to plan another trial.

Drugs 316
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Researchers discover the first instance of living organisms producing elemental carbon

Scienmag

Carbon is the building block of all known life on our planet. The carbon cycle regulates the release and absorption of carbon from a number of natural sources — including the ocean, soil, geochemical processes, and human emissions — to maintain a delicate balance of this crucial element in our world. Credit: Kristin Rose Jutras […].

Research 102
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Scotland is world’s first country to greenlight Tagrisso for NSCLC

pharmaphorum

Scotland has given the green light to AstraZeneca’s Tagrisso for restricted use to treat adult patients with non-small cell lung cancer (NSCLC), making it the first country in the world to approve the routine use of the therapy in this setting. The Scottish Medicines Consortium (SMC) has approved Tagrisso (osimertinib) for use within NHS Scotland as a monotherapy for adjuvant treatment after tumour removal in adult patients with stage IB-IIIA NSCLC whose tumours have epidermal growth factor (EGF

HR 104
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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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Exploring the Mystery of COVID-19 Vaccine-Linked Heart Inflammation

BioSpace

Researchers aren’t sure why the mRNA vaccines appear to, in rare cases, cause heart inflammation. The FDA said the risk appears higher within seven days of the second jab of the vaccines.

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Detailed Roche study results muddy another Alzheimer's hypothesis

Bio Pharma Dive

Data presented at an Alzheimer's meeting raised more questions about the seeming benefit of Roche and AC Immune's drug semorinemab, which they claim is the first of its kind to slow deterioration of memory.

Drugs 316
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SMC accepts oral therapy for relapsing multiple sclerosis

Pharma Times

Janssen's Ponvory accepted for use within NHS Scotland for adults RRMS patients

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One world, one health: The interconnected web of antimicrobial resistance

pharmaphorum

Tackling antimicrobial resistance (AMR) requires a one health approach that joins the dots between the human, animal, and environmental drivers, consequences, and data. AMR threatens to undermine “almost a century of health gains” and marshalling a response to such a problem “requires cooperation at many levels”. That’s according to a newly published report from the US National Academies of Sciences, Engineering, and Medicine, which calls for a One Health approach that recognises the scale of th

Medicine 104
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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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Alzheimer’s Research Shifts from Amyloid and Tau to Neuroinflammation, Other Causes

BioSpace

Research into Alzheimer’s disease is shifting from amyloid plaque and tau protein to neuroinflammation, white matter changes and insulin resistance.

Insulin 120
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Moderna, escalating dispute with NIH, claims government had no role in key vaccine patent

Bio Pharma Dive

The biotech claimed its NIH partners were involved only after a key discovery was made "by Moderna scientists using Moderna technology." The dispute could end up in court.

Scientist 306
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Positive results for GSK’s anaemia drug daprodustat

Pharma Times

Daprodustat is an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor in development for anaemia due to chronic kidney disease

Drugs 102
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Valneva gets EU deal for COVID jab, and may sue UK

pharmaphorum

Shares in France’s Valneva leaped after it got an EU order to supply 60 million doses of its COVID-19 vaccine VLA2001 over the next two years, including 27 million next year. The deal for the adjuvanted, inactivated SARS-CoV-2 vaccine still depends on authorisation of the jab by the European Medicines Agency (EMA) which is due to start a rolling review of VLA2001 shortly, but Valneva thinks it could start delivering supplies to the EU in April next year.

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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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Moderna: Vaccine mRNA Sequence Was Selected Without NIH Input

BioSpace

Moderna responded to claims that the government should be co-patent owners of the mRNA vaccine developed by the company and said its mRNA sequence was exclusively selected by Moderna scientists.

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Eye-focused gene therapy startup gets $60M cash infusion from Sanofi

Bio Pharma Dive

Shortly after postponing a $135 million IPO, Gyroscope has found another way to back a treatment for a disease that's become a top target of multiple drugmakers.

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World Chicken Day: Is Vegan Chicken Legally Allowed to be Called ‘Chicken?’

XTalks

While chicken is the most common type of poultry consumed around the world, to some, its meaning has changed considerably over the last few years thanks to the growing vegan movement. Today, on World Chicken Day, let’s explore how chicken has evolved throughout the last decade and determine whether vegan chicken can legally be called “chicken.”. Plant-based meat alternatives have helped reshape the landscape of the food industry over the last few years.

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Moderna squares off with US government over COVID jab patent

pharmaphorum

After being hailed as a triumph of public-private drug development, Moderna’s partnership with the US government on its COVID-19 vaccine looks like it may descend into acrimony. That is according to a New York Times report , which says Moderna is now in dispute with the National Institutes of Health (NIH) after it filed a US patent in the US that claims the company’s scientists invented the vaccine on their own.

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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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Why Flu Vaccines are Recommended Despite Low Efficacy

BioSpace

While some get the jab faithfully each flu season, about half of the American population declines, likely over doubts of the vaccine’s effectiveness and necessity.

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US pays $1B to nearly double supply of Merck's COVID-19 pill

Bio Pharma Dive

The new agreement raises the financial upside of molnupiravir, which Merck believes could be a $7 billion product in 2022. But Pfizer's rival drug, which has produced seemingly superior efficacy, could affect those projections.

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Students win $100,000 prize from Elon Musk’s carbon-removal competition

Scienmag

Last spring, as Laura Stieghorst watched Elon Musk’s SpaceX rocket blast off from Cape Canaveral, the University of Miami undergraduate wished the billionaire would pour as much money into saving the planet from climate change as he was enabling people to leave it. Credit: Jenny Hudak/University of Miami Last spring, as Laura Stieghorst watched Elon […].

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Germany says only Pfizer COVID jab should be used in under 30s

pharmaphorum

Germany’s vaccination advisory committee has recommended that people aged under 30 should only be offered Pfizer/BioNTech’s COVID-19 vaccine Comirnaty, saying it seems less likely to cause heart inflammation than Moderna’s rival shot Spikevax. The draft guidance from the Robert Koch Institute’s STIKO committee also says that pregnant women, regardless of their age, should get the Pfizer/BioNTech vaccine.

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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.