Tue.Dec 21, 2021

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Sanofi to buy cancer immunotherapy biotech for $1B

Bio Pharma Dive

The French drugmaker is interested in Amunix Pharmaceuticals' technology, which could allow for more precise delivery of biologic drugs into cancerous tissue.

Drugs 337
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Cancer researchers across the UK partner in new trial to find drugs for rare cancers

Pharma Times

The DETERMINE trial aims to discover whether existing ‘licensed’ drugs could also benefit patients with rare cancer types that the drug is not currently licensed for.

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Duchenne patient dies in Pfizer gene therapy study

Bio Pharma Dive

The tragic news follows changes Pfizer recently made to the design of another study testing the therapy due to side effects seen in some participants.

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Sanofi buys US immuno-oncology biotech Amunix for $1 billion

pharmaphorum

Sanofi has bolstered its immuno-oncology pipeline with a $1 billion agreement to acquire Amunix Pharma of the US – its fourth bolt-on deal of 2021. South San Francisco-based Amunix specialises in T-cell engager and cytokine-based treatments for solid tumours, and is planning to advance its lead programme AMX-818 – a cell-based therapy which targets HER2-expressing cancers – into the clinic 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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GSK's long-acting HIV shot approved for preventive use

Bio Pharma Dive

The landmark FDA approval makes Apretude the first injectable treatment in the U.S. for HIV pre-exposure prophylaxis.

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Leveraging augmented analytics to drive better business decisions

pharmaphorum

In early 2020, health officials were cautious about forecasting a COVID-19 vaccine timeline to the public, as vaccine discovery was a historically laborious process that took years (if not decades). Yet a successful COVID-19 vaccine gained emergency approval in just 11 months, a blistering pace that likely saved millions of lives. Such a fast turnaround would not have been possible without advanced analytics and the troves of intelligence that scientists had at their disposal.

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Drug development and working with specialised Rare Disease networks

pharmaphorum

There are currently an estimated 300 million people living with one or more Rare Diseases across the world. There are over 7,000 Rare Diseases that have been identified, yet only 5% have treatments. However, despite the work still left to be done, there are now a growing number of treatments in the pipeline and 2020 proved to be a remarkable year for orphan drug approvals, with the US FDA approving more orphan designated treatments than non-orphan drugs.

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Rare dinosaur embryo exquisitely preserved inside the egg suggests bird-like pre-hatching posture

Scienmag

Over the last 100 years, many fossilized dinosaur eggs and nests have been found, but finding one with a well-preserved embryo inside is exceedingly rare. Now, researchers reporting in the journal iScience on December 21 have detailed one such specimen discovered in southern China. Credit: Lida Xing Over the last 100 years, many fossilized dinosaur […].

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Novartis taps immuno-oncology partner BeiGene for TIGIT drug

pharmaphorum

Novartis has joined the ranks of big pharma companies developing TIGIT-targeted drugs for cancer, and found its candidate in an existing partner, Chinese biotech BeiGene. The Swiss pharma group is paying BeiGene $300 million upfront for an option on ociperlimab, a TIGIT antibody in phase 3 testing for non-small cell lung cancer (NSCLC), with another $700 million on offer if that option is exercised before 2023.

Drugs 97
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Fueling the future with new perovskite-related oxide-ion conductors

Scienmag

Stable and high oxide-ion conductors based on a new hexagonal perovskite-related oxide has been reported by scientists at Tokyo Tech, Kojundo Chemical Laboratory Co. Ltd. and Australian Nuclear Science and Technology Organisation (ANSTO) in a recent study. These high-performance oxide-ion conductors could pave the way for the development of solid electrolytes for next-generation batteries and […].

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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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CHMP recommend Saphnelo for systematic lupus erythematosus

Pharma Times

With approval, Saphnelo would be the first available treatment for systematic lupus erythematosus in Europe in over ten years.

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NASA’s DAILI CubeSat to study complex atmospheric composition

Scienmag

DAILI successfully launched aboard the SpaceX Falcon 9 rocket at 5:07 a.m. EST on Dec. 21, 2021 from Launch Complex 39A at NASA’s Kennedy Space Center in Florida. Credit: NASA/ The Aerospace Corporation DAILI successfully launched aboard the SpaceX Falcon 9 rocket at 5:07 a.m. EST on Dec. 21, 2021 from Launch Complex 39A at NASA’s Kennedy […].

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Bond Digital Health raises £1m for lateral flow test software

pharmaphorum

Welsh medtech company Bond Digital health has raised £1 million ($1.3 million) in additional funding for its data capture and management system for lateral flow tests (LFTs). The Cardiff-based company said it will use the new money to expand its headcount, including hiring a new customer service team, and adding to its sales, marketing and product development departments.

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Three PNNL innovations earn FLC National Awards

Scienmag

By Allan Brettman Credit: Photo by Andrea Starr | Pacific Northwest National Laboratory By Allan Brettman RICHLAND, Wash.—Three innovations developed at the Department of Energy’s Pacific Northwest National Laboratory have been named winners in the 2022 Federal Laboratory Consortium for Technology Transfer Awards. A PNNL-developed airport security device that scans passengers’ shoes earned the Interagency […].

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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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Family in Nigeria Lost 3 Daughters to Sickle Cell. Can They Save a Fourth?

NY Times

About 150,000 babies are born each year in Nigeria with sickle cell, a deadly disease. Tens of thousands of them die annually before their fifth birthdays.

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Wise old elephants keep the young calm

Scienmag

Male elephants are more aggressive when fewer older males are present, new research suggests. Credit: Connie Allen Male elephants are more aggressive when fewer older males are present, new research suggests. The research, by the University of Exeter, suggests that the removal of old male elephants, which are often the targets of trophy hunting, could […].

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Why social media is critical to any digital patient recruitment strategy

Clairnes

The post Why social media is critical to any digital patient recruitment strategy appeared first on Clinical Trial Recruitment & Management Services.

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Bringing cells closer to form new tissues

Scienmag

Watch video on YouTube: [link] Credit: Professor Nobuhiko Yui, TMDU Watch video on YouTube: [link] Tokyo, Japan – The field of tissue engineering is constantly exploring the possibility of using different properties of various biomaterials to achieve tissue regeneration. However, a key factor in creating effective tissues that can ameliorate and act as physical barriers […].

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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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Sandoz submits BLA for breast and gastric cancer targeted biosimilar drug

BioPharma Reporter

Sandoz has submitted its Biologics License Application (BLA) for a proposed biosimilar trastuzumab developed by EirGenix, Inc to the US Food and Drug Administration (FDA).

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Birds’ dazzling iridescence tied to nanoscale tweak of feather structure

Scienmag

The iridescent shimmer that makes birds such as peacocks and hummingbirds so striking is rooted in a natural nanostructure so complex that people are only just beginning to replicate it technologically. The secret to how birds produce these brilliant colors lies in a key feature of the feather’s nanoscale design, according to a study led […].

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Severity of Illness in Persons Infected With the SARS-CoV-2 Delta Variant vs Beta Variant in Qatar

JAMA Internal Medicine

This cohort study assesses the severity of clinical outcomes in persons infected with the SARS-CoV-2 Delta variant vs the Beta variant in Qatar.

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Arctic birds connect the world: Biologging tech tracking of nearctic seabirds surprise scientists with diverse migratory paths from shared breeding site

Scienmag

Credit: Amy Scarpignato, Smithsonian Conservation Biology Institute As the Arctic and the oceans warm due to climate change, understanding how a rapidly changing environment may affect birds making annual journeys between the Arctic and the high seas is vital to international conservation efforts. However, for some Arctic species, there are still many unknowns about their […].

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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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New patent for Abbvie Inc drug MAVYRET

Drug Patent Watch

Annual Drug Patent Expirations for MAVYRET Mavyret is a drug marketed by Abbvie Inc and is included in two NDAs. It is available from one supplier. There are seven patents…. The post New patent for Abbvie Inc drug MAVYRET appeared first on DrugPatentWatch - Make Better Decisions.

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Measures to improve gender balance are working

Scienmag

Many technology studies are strongly male-dominated, which shows up in the labour market afterwards and is one of several reasons why women on average earn less than men. Credit: NTNU Many technology studies are strongly male-dominated, which shows up in the labour market afterwards and is one of several reasons why women on average earn less than […].

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Biogen halves price of Aduhelm in the US

BioPharma Reporter

As of January 1, 2022, Biogen will cut the price of its Alzheimerâs drug Aduhelm (aducanumab-avwa) in half: saying too many patients are not currently being offered the choice of the drug due to financial considerations.

Drugs 52
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Botox Injections May Reduce Anxiety

Scienmag

Botox, or Botulinum toxin, a medication derived from a bacterial toxin, is commonly injected to ease wrinkles, migraines, muscle spasms, excessive sweating and incontinence. Researchers at Skaggs School of Pharmacy and Pharmaceutical Sciences at University of California San Diego, in collaboration with two physicians from Germany, may have found a new use thanks to the […].

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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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EVERSANA Completes Acquisition of Intouch Group

Intouch Solutions

Adds The Premiere Digital-First Agency Network to the Market Leader in Next G eneration Commercialization. CHICAGO and KANSAS CITY, Mo. — December 21, 2021 — EVERSANA ™, the pioneer of next generation commercial services to the global life sciences industry, today announced it has completed its acquisition of Intouch Group®, a full-service global agency network serving the pharmaceutical industry.

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Toxoplasma parasites manipulate brain cells to survive

Scienmag

WEHI researchers have discovered how dormant Toxoplasma parasites in the brain manipulate their host cells to ensure their own survival. Credit: WEHI WEHI researchers have discovered how dormant Toxoplasma parasites in the brain manipulate their host cells to ensure their own survival. The researchers showed that the parasites were able to lay dormant and undetected […].

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Free Resources for the Cancer Community

Triage Cancer

For nearly a decade, Triage Cancer has been providing free resources for the cancer community – including people diagnosed, health care professionals, and caregivers. Since our founding in 2012, we’ve reached more than 2 million people through free educational events, materials, and resources. Here is a breakdown of the resources that are not only free, but could help you save money and avoid financial toxicity.

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Sensor based on quantum physics could detect SARS-CoV-2 virus

Scienmag

A novel approach to testing for the presence of the virus that causes Covid-19 may lead to tests that are faster, less expensive, and potentially less prone to erroneous results than existing detection methods. Though the work, based on quantum effects, is still theoretical, these detectors could potentially be adapted to detect virtually any virus, […].

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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.