Tue.Mar 30, 2021

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A biotech shelves its Huntington's drugs after trial failures

Bio Pharma Dive

Two drugs developed by Wave Life Sciences didn't appear to have an effect on disease-causing proteins, another setback for Huntington's research after disappointing results last week from Roche and Ionis.

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Allocating DTC budgets

World of DTC Marketing

I N BRIEF : DTC managers usually have a tough time allocating DTC budgets, but once you layout your brand objectives and better understand your audience, the choices become clearer. Learn everything you can about your audience, such as “where are they online and what are they really looking for in treatment options?” The budgeting process is over, and as a DTC manager, you need to decide how much of your budget goes in each bucket.

Branding 165
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FDA turns back Keytruda, delaying immunotherapy's arrival in early cancer

Bio Pharma Dive

Merck & Co.'s drug could've been the first immunotherapy approved in the so-called neoadjuvant setting. Its rejection might indicate a higher bar for others with similar ambitions.

Drugs 286
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Lilly and GSK/Vir antibody pairing offers resistant COVID-19 hope

pharmaphorum

Two antibodies targeting different parts of the COVID-19 virus spike protein, from Eli Lilly and GlaxoSmithKline/Vir Biotech, can cut viral load dramatically within a week. . The BLAZE-4 trial found that co-administration of Lilly’s bamlanivimab – already granted emergency approval as a COVID-19 treatment – and GSK/Vir’s experimental antibody VIR-7831 reduced virus levels by 70% after seven days compared to placebo in people with mild or moderate COVID-19 symptoms.

Antibody 118
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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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Akebia tries for FDA approval of anemia drug after mixed data

Bio Pharma Dive

The drugmaker's pill fell short on a critical safety measure in two large trials last fall. That result, and the surprisingly close FDA scrutiny of a rival medicine from FibroGen, makes the approval prospects of both treatments uncertain.

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Global Vaccine Passports Edge Closer, Speeding Arrival of the Next “Normal”

BioSpace

Vaccine passports are an interim step that can speed the return of some semblance of normality by allowing the rapidly growing numbers of vaccinated people to travel more easily and to attend typically crowded sporting events, concerts and religious services.

More Trending

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FDA rebuff for Keytruda in breast cancer indication

BioPharma Reporter

A couple of new developments to report in relation to Merck, known as MSD outside the US and Canada: the first being the rejection by the US FDA of the companyâs application to use its anti-PD-1 therapy, Keytruda, in certain breast cancer patients.

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ALS Patients Fight for the Right to Try Patient-Centric Trial Design

BioSpace

Lisa Stockman Mauriello was diagnosed with ALS in January and is seeking access to Biogen’s tofersen (BIIB067) through the Right to Try Act. Her case has reinvigorated the ALS community and its fight for expanded access to investigational therapies for this cruel, always fatal disease.

Trials 105
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AI algorithm automates analysis of cystic fibrosis scans

Outsourcing Pharma

Artificial intelligence software company Thirona has released PRAGMA-AI, technology that automates and accelerates CT scans in cystic fibrosis analysis.

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Alzheimer Europe outlines state-of-play of dementia policy in Europe

Scienmag

Alzheimer Europe has launched a new report, ‘Dementia Monitor 2020’, providing a high-level overview of how countries across Europe have responded to the challenges posed by dementia Credit: Alzheimer Europe Luxembourg, 30 March 2021 – Alzheimer Europe has launched a new report, “Dementia Monitor 2020”, providing a high-level overview of how countries across Europe have […].

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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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Pharma Hones in on its Patient Engagement in 2021

Pharma Marketing Network

Until the COVID-19 pandemic struck the world in early 2020, pharma had been pretty resistant to the idea of involving the end-customer, or the patient, into their business models. COVID-19 not only left pharma no choice but to take this challenge head on, it also paved the way for pharma to build extensive awareness of their brands, as several big names have been in the spotlight in the fight against COVID-19.

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In Second Acquisition this Month, Amgen Buys Rodeo for $721 Million

BioSpace

Under the terms of the deal, Amgen is buying all outstanding shares of Rodeo with a $55 million upfront payment. In addition, there are potential milestone payments that could hit $666 million in cash.

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The ‘one who causes fear’ – new meat-eating predator discovered

Scienmag

Ruling in the Late Cretaceous, Llukalkan aliocranianus could be as long as an elephant, had extremely powerful bites, very sharp teeth, and huge claws in their feet Credit: Jorge Blanco and Journal of Vertebrate Paleontology Research published today in the peer-reviewed Journal of Vertebrate Paleontology describes a newly discovered species of dinosaur – named the […].

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Russia Authorizes COVID-19 Vaccine for Some Furry Friends

BioSpace

Citing Russia’s agricultural regulatory agency, Reuters reported the new vaccine called Carnivac-Cov will be used against the virus in dogs, cats, foxes and mink.

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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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‘Mop up’ malaria vaccine advances to trials in people

Scienmag

When mosquitos ingest the blood of a person who has malaria but who has received the vaccine, they can no longer infect other people Credit: University of Florida University of Florida researcher Rhoel Dinglasan, Ph.D., was awarded $6 million today by the Global Health Innovative Technology Fund to test a new malaria vaccine in people. […].

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After About 50 Years, the mRNA Revolution is Here

BioSpace

Between the Moderna and Pfizer-BioNTech COVID-19 vaccines, there are two mRNA therapeutics on the market … the only two.

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Creation of 3D organoid models to fine-tune radiation dose for nasopharyngeal cancer

Scienmag

First of its kind 3D organoid models of nasopharyngeal cancer help to fine-tune radiation doses, and lower the chances of Nasopharyngeal Cancer recurrence and reduce mortality rate. Credit: Agency for Science, Technology and Research (A*STAR), Institute of Bioengineering and Nanotechnology (IBN), Singapore Institute of Advanced Medicine Holdings Pte Ltd A*STAR’s Institute of Bioengineering and Nanotechnology […].

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Novartis expands targeted radioligand therapy pipeline

BioPharma Reporter

Novartis has obtained exclusive worldwide rights to develop and commercialize therapeutic applications for a library of Fibroblast Activation Protein (FAP) targeting agents.

Protein 85
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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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Scientists discover unique Cornish ‘falgae’

Scienmag

Credit: Mark Milburn/Atlantic Scuba Red algae that grow in Cornwall’s Fal Estuary are genetically unique, new research shows. University of Exeter scientists studied the population genetics of Phymatolithon calcareum, a coralline red algal species that forms maerl beds in shallow coastal seas from Portugal to Norway. Large maerl beds fulfil a similar role to tropical […].

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Transformational therapies demand a new mindset

pharmaphorum

Pharma is moving to a new era of radically new therapies, presenting unexpected and difficult challenges. Such interventions take the need for robust value claims to a completely different level, with important implications for the evidence companies need to collect, and how they collect and communicate it. Chris Gray leads Innovation and Ventures for Adelphi’s Healthcare Communications agencies, whose long-running Renaissance series has been discussing the implications of ‘ transformational va

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Russian biologists discover a transmissible cancer lineage in the Far Eastern mussels

Scienmag

The disease can have an adverse effect on the populations of these molluscs, which are extensively farmed in Russia. Credit: SPbU ‘A transmissible cancer was first discovered in dogs in the middle of the 19th century. It is transmitted sexually from a sick dog to a healthy one, the cancer cells themselves being the infective […].

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Why You Don’t Need to Be Perfect in an Interview

BioSpace

Going into an interview knowing that it’s OK to be yourself and perfection isn’t the goal can help alleviate that self-imposed pressure.

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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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Inctye’s Pemazyre authorised in the EU for bile duct cancer

Pharma Times

Kinase inhibitor authorised to treat advanced bile duct cancer patients with a FGFR2 fusion or rearrangement

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OnQuality Pharma Raises $20 Million to Support Ongoing Oncodermatology Trial

BioSpace

The trial assesses the safety and efficacy of a targeted supportive care agent that addresses the specific side effects of vascular endothelial growth factor receptor (VEGFR) inhibitors among cancer patients.

Trials 92
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EMA approves new storage conditions for Pfizer/BioNTech COVID-19 vaccine

BioPharma Reporter

The EU has approved new storage conditions for Pfizer/BioNTechâs vaccine: allowing the ultra-cold storage vaccine to now be kept at standard pharmaceutical freezer temperatures for a total of two weeks.

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Topological protection of entangled two-photon light in photonic topological insulators

Scienmag

Credit: MBI/HU In a joint effort, researchers from the Humboldt-Universität (Berlin), the Max Born Institute (Berlin) and the University of Central Florida (USA), have revealed the necessary conditions for the robust transport of entangled states of two-photon light in photonic topological insulators, paving the way the towards noise-resistant transport of quantum information.

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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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Tokyo airport trials CommonPass digital health passport

pharmaphorum

All Nippon Airways (ANA) has begun a trial of its CommonPass app showing a traveller’s COVID-19 status at Tokyo’s Haneda Airport. It’s part of efforts by the global travel industry to make cross-border travel easier and safer and is one of several digital health passports being trialled around the world. The idea is to provide an accurate but fast way of ensuring passengers are safe to travel and prevent the spread of COVID-19 and potential variants.

Trials 72
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Decellularized spinach serves as an edible platform for laboratory-grown meat

Scienmag

The veiny skeleton of a spinach leaf shows for the first time it can support the growth of artificial meat, a Boston College researcher reports Credit: Food Bioscience Chestnut Hill, Mass. (3/31/21) — Spinach, a cost-efficient and environmentally friendly scaffold, provided an edible platform upon which a team of researchers led by a Boston College […].

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Portable Neuromodulation Stimulator Gets FDA Authorization for MS Treatment

XTalks

An innovative new non-surgical medical device called the portable neuromodulation stimulator (PoNS) has received marketing authorization from the US Food and Drug Administration (FDA) as a treatment to help improve gait in patients with multiple sclerosis (MS). The device delivers neuromodulatory electrical impulses to the brain via a cranial nerve.

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GSK to help manufacture Novavax COVID-19 vaccine

BioPharma Reporter

GSK will help manufacture up to 60 million doses of Novavaxâs COVID-19 vaccine from its facility at Barnard Castle in the UK, with doses to be distributed in the country.

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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.