Wed.Sep 30, 2020

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Pfizer pushes deeper into China with stake in cancer biotech

Bio Pharma Dive

The $200 million investment in CStone Pharmaceuticals puts Pfizer in charge of selling a cancer immunotherapy in the world's second largest drug market.

Marketing 358
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Launching a new drug: How much to spend on DTC?

World of DTC Marketing

HERE”S THE DEAL: Determining how much to spend for the launch of a new drug is a challenge we all face and you have to be ready to shift funds from channels that are failing to provide the lift in brand awareness to channels that hit the bullseye on your objectives. The biggest request we get from clients is guiding them through the process of allocating total DTC spend along with channel allocation.

Drugs 180
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Arranta Bio set to boost manufacturing for growing pipeline of microbiome drugs

Bio Pharma Dive

The contract manufacturer aims to capitalize on progress for microbiome-based therapies, a field that's been buoyed by some recent clinical successes.

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Life science leaders sign new ‘Biotech Social Pact’ for Europe

pharmaphorum

The signatories of a new Biotech Social Pact with Europe and patients explain why healthcare calls for a new social contract, not a pharmaceutical strategy. As Europe continues its efforts to battle the Covid-19 pandemic, it is rightfully focusing its attention on the longer-term implications of this crisis. One common thread is clearly emerging from EU and national discussions: to reinforce Europe’s “strategic autonomy” and “technological sovereignty” in key industrial sectors.

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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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Researchers Discover Genetic Errors and Rogue Antibodies in Cases of Severe COVID-19 Infection

XTalks

While it remains unclear why some people become more gravely ill than others when infected with the SARS-CoV-2 virus that causes COVID-19, researchers have found that an immune deficiency may be part of it. Two recent studies have shown that individuals who lack an important immune factor may have reduced ability to fight the virus. The two studies were recently published online in the journal Science, both of which were led by Jean-Laurent Casanova, an infectious disease geneticist at Rockefell

Antibody 135
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Regeneron’s antibody cocktail active against coronavirus, cuts symptoms

pharmaphorum

Regeneron’s antibody cocktail seems to reduce levels of coronavirus and improve symptoms in patients, according to early test results. This first data comes from a descriptive analysis from the seamless phase 1/2/3 trial that Regeneron hopes will hurry the medicine dubbed REGN-COV2 to market. The ongoing double-blind trial measures the effect of adding REGN-COV2 to usual standard of care, compared with usual standard of care.

Antibody 135

More Trending

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CRISPR Technology Edges Closer to Commercial Use

BioSpace

While CRISPR has been used as a research tool for the most part, the technology is moving toward commercial applications.

Research 130
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FSD Pharma Phase II COVID-19 trial gets go-ahead

Outsourcing Pharma

The companyâs Phase II trial of ultramicronized PEA has received FDA approval and expects to begin dosing patientparticipants as early as next month.

Trials 115
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Alnylam Posts Positive Results of Groundbreaking Phase III PH1 Trial

BioSpace

Alnilam – the bright center star in the middle of Orion’s belt – has navigated its namesake Alnylam to positive results in their ILLUMINATE-B Phase III clinical trial evaluating RNAi therapeutic, lumasiran, in young children with Primary hyperoxaluria Type 1 (PH1).

Trials 103
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CPhI calls on pharma companies to put sustainability at the top of their agenda

BioPharma Reporter

The pandemic has required a rethink of how we do business: and CPhI Festival of Pharma is encouraging companies to prioritize sustainability efforts moving forward.

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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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What to Consider When Choosing a Reference

BioSpace

Whose contact information do you provide? What if they ask for multiple people? Can you ask a current co-worker? Below we answer common questions when it comes to selecting references.

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Buscopan vs Mebeverine | OTC IBS treatment

Druggist

Buscopan and mebeverine are two common drugs used for symptomatic treatment of irritable bowel syndrome (IBS). Both drugs can be prescribed by a doctor or purchased over the counter from pharmacies and in case of Bucopa IBS relief from supermarkets. Buscopan vs Mebeverine lists similarities and differences between both drugs. I will review their role in the management of IBS in accordance with the treatment guidelines on irritable bowel syndrome.

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HPV vaccine effective against cervical cancer

Scienmag

Credit: Stefan Zimmerman Women vaccinated against HPV have a significantly lower risk of developing cervical cancer, and the positive effect is most pronounced for women vaccinated at a young age. That is according to a large study by researchers at Karolinska Institutet in Sweden published in New England Journal of Medicine. “This is the first […].

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Cancer Research UK calls on government to address cancer inequality

Pharma Times

New report finds 60 cancer cases per day could be avoided in less wealthy areas

Research 129
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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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New global research network to explore wonders of bats

Scienmag

Credit: Jon Flanders STONY BROOK, NY, September 30, 2020 – Bats are nature’s solution to control insect pests like mosquitos and earworms, they play crucial roles in pollinating plant so they set seed, and they can survive or ward off many viruses. With all these astonishing characteristics of bats that impact earth’s ecology and the […].

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NeuroRx and Relief Therapeutics sign new supply agreements for COVID-19 drug

Pharma Times

Supply chain agreements come before upcoming data readout

Drugs 137
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Nights warming faster than days across much of the planet

Scienmag

Credit: University of Exeter Global warming is affecting daytime and night-time temperatures differently – and greater night-time warming is more common than greater daytime warming worldwide – new research shows. University of Exeter scientists studied warming from 1983 to 2017 and found a difference in mean annual temperature of more than 0.25°C between daytime and […].

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MHRA deems Sanofi’s avalglucosidase alfa ‘promising’ for Pompe disease

Pharma Times

New therapy granted a Promising Innovative Medicine designation by UK agency

Medicine 125
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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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Study links low immunity to poor outcomes in patients with HIV who contract COVID-19

Scienmag

Age and underlying health conditions also associated with decreased survival Credit: Justin Kelley Clinical trials are testing whether medications that treat human immunodeficiency virus (HIV) can also treat COVID-19, leading some patients with HIV to believe they might be protected against the coronavirus. But a researcher from the MU School of Medicine not only found […].

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Flame Bioscience to Ignite Pipeline with $100M Common Stock Financing

BioSpace

Proceeds from common stock financing will be used to progress clinical trials for inflammation-driven lung cancer and inflammatory diseases.

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Cardiac arrest, poor survival rates common in sickest patients with COVID-19

Scienmag

Credit: Stephanie King/ Michigan Medicine Even when a sudden cardiac arrest happens inside a top hospital, where a code blue team is readily available, most people won’t survive. This year, while researchers continued exploring how to improve dismal cardiac arrest survival rates, clinicians started noticing a new population of patients who seemed to be experiencing […].

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Fujifilm Irvine Scientific takes on distribution of substrate that supports cell therapy research

BioPharma Reporter

Fujifilm Irvine Scientific has become the exclusive, worldwide distributor of cellnest, a recombinant peptide attachment substrate that is said to provide optimal adhesion and proliferation of stem cells in chemically defined, animal component-free conditions.

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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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Mosquitos lost an essential gene with no ill effects

Scienmag

UMD study suggests caution is needed for research that presumes closely related species use the same genes for similar functions Credit: Image credit: Alys Jarvela/University of Maryland. University of Maryland entomologists discovered that a gene critical for survival in other insects is missing in mosquitos–the gene responsible for properly arranging the insects’ segmented bodies.

Gene 90
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$21 Million Investment Expands Aphena’s Bottling, Cold Chain Storage Capabilities

BioSpace

The expansion is part of the company’s acquisition of a 500,000-square-foot property that Aphena will renovate “into a state-of-the-art pharmaceutical and packaging and distribution facility.

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NASA confirms, heavy rainfall, strengthening of tropical storm Marie

Scienmag

Credit: Credit: NASA/NOAA/NRL Tropical Storm Marie has formed in the Eastern Pacific Ocean and NASA satellite data helped confirm the strengthening of the storm. In addition, using a NASA satellite rainfall product that incorporates data from satellites and observations, NASA estimated Marie’s rainfall rates the provided more clues about intensification.

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BioSpace Global Roundup, Oct. 1

BioSpace

Biopharma and life sciences companies from across the globe provide updates on their pipelines and business practices.

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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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Cannabinoids associated with negative respiratory health effects in older adults with COPD

Scienmag

Researchers publish first data on the impact of cannabinoids on the respiratory health of individuals with COPD Credit: Unity Health Toronto Cannabinoids, a class of prescription pills that contain synthetically-made chemicals found in marijuana, are associated with a 64 per cent increase in death among older adults with chronic obstructive pulmonary disease (COPD), according to […].

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FDA Lifts Clinical Hold on Solid Biosciences’ DMD Gene Therapy Trial

BioSpace

The trial was initially placed on hold in November 2019 due to safety concerns.

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Can organic plant protection products damage crops?

Scienmag

Researchers at Göttingen University discover new disease affecting maize Credit: A Pfordt, University of Göttingen Protecting crops against pests and diseases is essential to ensure a secure food supply. Around 95 percent of food comes from conventional agriculture, which uses chemical pesticides to keep crops healthy. Increasingly, however, organic pesticides are also being sought as […].

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After NASH Failures, Genfit Restructures and Cuts Staff by 40%

BioSpace

As part of its half-year 2020 financial report, the company announced significant restructuring that will include cutting 40% of its staff.

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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.