Tue.Jan 05, 2021

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5 FDA approval decisions to watch in the 1st quarter

Bio Pharma Dive

By March, the FDA expects to conclude reviews of key drugs for heart failure, Duchenne's and multiple myeloma, as well as decide on whether to clear Biogen's controversial Alzheimer's treatment.

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Top Life Sciences Startups to Watch in 2021

BioSpace

BioSpace is proud to present its NextGen Bio “Class of 2021,” a list of up-and-coming life sciences companies in North America that recently launched.

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A new, well-connected biotech aims to fight cancer with viruses

Bio Pharma Dive

Founded by industry veteran Arie Belldegrun's venture capital firm, IconOVir Bio raised $77 million to push its lead drug — derived from the common cold — into clinical testing.

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FDA slams down any suggestion of changing COVID-19 vaccine dosage

BioPharma Reporter

The US FDA has emphasized it will not make any changes to the recommended dosing of authorized COVID-19 vaccines: saying any modifications would create a âsignificant riskâ of undermining vaccination efforts.

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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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FDA says changing coronavirus vaccine dosing could put 'public health at risk'

Bio Pharma Dive

In an unusual statement, FDA chief Stephen Hahn and top official Peter Marks opposed altering vaccination regimens without further evidence, calling proposals to do so "premature.

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Virologists Voice Growing Concern Over South African COVID-19 Variant

BioSpace

SARS-CoV-2 has mutated into several strains. Most of them are not particularly different than the primary strains, but two, B.1.1.7, which was first observed in the U.K., and now 501.V2, which originated in South Africa, have virologists watching closely.

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Akston ramps up efforts for room temperature COVID-19 vaccine: 'A vaccine for everywhere and everyone in the world'

BioPharma Reporter

Akston Biosciences has announced a strategic partnership with LakePharma to manufacture commercial quantities of its COVID-19 vaccine candidate, as the room temperature stable vaccine gears up to begin Phase 1/2 clinical trials this month.

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Facebook posts help facilitate belief that HPV vaccine is dangerous to health

Scienmag

University of Missouri health communication expert believes study could inform the ongoing COVID-19 vaccine roll out and distribution Credit: University of Missouri The human papillomavirus infection, or HPV, is the most common sexually transmitted infection in the U.S., according to the Centers for Disease Control and Prevention. HPV is associated with health problems including genital […].

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Backed by Bayer, Senti Biosciences Snags $105 Million in Series B Fundraising

BioSpace

Backed by Leaps by Bayer, Bay Area-based Senti Biosciences secured $105 million in a Series B financing round that will help the company advance its therapeutic pipeline of allogeneic chimeric antigen receptor natural killer (CAR-NK) cell therapies.

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Dungeness crab fishing industry response to climate shock

Scienmag

How do fishing communities respond when disrupted by marine heatwave-associated harmful algal bloom closures? Credit: Northwest Fisheries Science Center/NOAA Fisheries Fishermen contend with regulations, natural disasters, and the ups and downs of the stocks they fish, along with many other changes. As a result, fishing communities are quite resilient.

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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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Ribometrix and Genentech Partner in Potential $1 Billion+ RNA Deal

BioSpace

Durham, North Carolina-based Ribometrix announced a strategic collaboration deal with Genentech to identify and advance novel RNA-targeted small molecule therapeutics.

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Identifying Canada’s key conservation hot spots highlights problem

Scienmag

First of its kind mapping of most important places for freshwater, recreation and carbon storage provides tool for conservation decisions Credit: CREDIT: Jake Dyson To stop biodiversity loss, Canada recently committed to protecting 30% of its land and sea by 2030. But making conservation decisions about where to locate new protected areas is complicated.

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Rebranded Pfizer Logo Highlights Mission to Cure and Prevent Disease

BioSpace

Pfizer is giving itself a corporate facelift, dropping its traditional blue-pill company logo in favor of a double helix DNA spiral that reflects the advances in medical science that have placed the curing of multiple diseases within reach.

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Researchers regenerate deactivated catalyst in methanol-to-olefins process

Scienmag

Credit: GAO Mingbin MTO process, which was first commercialized in 2010, is a catalytic process converting methanol, which is typically made from coal, natural gas, biomass, and CO2, over SAPO-34 zeolite catalyst. It’s becoming one of the main streams for producing light olefins, including ethylene and propylene, from non-oil resources. One of the major challenges […].

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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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Research Consortium to Study If COVID-19 Increases Long-Term Risk of Dementia

BioSpace

In a recent paper published in Alzheimer’s and Dementia, a team of researchers is calling for more prospective studies that will look into the impact coronavirus disease 2019 (COVID-19) has on brain functioning.

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Syracuse researchers awarded $2.1M grant to study causes of congenital heart defects

Scienmag

Credit: Syracuse University Congenital heart defects are the most common type of birth defect, affecting nearly 1% of births in the United States each year, according to the Centers for Disease Control. Doctors have been unable to lower that number due to a lack of knowledge about their source. Thanks to a $2.1 million grant […].

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EMA launches review of BMS’ Opdivo for oesophageal cancer

Pharma Times

Company is aiming for approval in the adjuvant setting

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On the road to invisible solar panels: How tomorrow’s windows will generate electricity

Scienmag

A new study led by scientists from Incheon National University in Korea shows how to make a fully transparent solar cell Credit: Joondong Kim from Incheon National University Five years after the Paris climate agreement, all eyes are on the world’s progress on the road to a carbon-free future. A crucial part of this goal […].

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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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Six Life Sciences Successes and Failures To Kick Off 2021

BioSpace

2021 is off to a hopeful start for some companies, executives and scientists, while others are forced to fold programs and recalibrate.

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Mechanophores: Making polymer crystallization processes crystal clear

Scienmag

Credit: Tokyo Tech In modern times, manufacturers produce highly specialized materials for a wide array of uses, called polymers. Polymers have a variety of purposes owing to their versatile properties, ranging from being used in construction due to their high tensile strength and resistance to manufacturing plastic bags that require more lightweight, flexible materials, such […].

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People on the Move: January 2021

Outsourcing Pharma

Industry organizations with hires, promotions, acquisitions and other news to share this month include Parexel, Novartis, WCG, Idifarma and more top firms.

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Climate change caused mangrove collapse in Oman

Scienmag

Study points to sudden decrease of precipitation as cause Credit: © Valeska Decker/University of Bonn Most of the mangrove forests on the coasts of Oman disappeared about 6,000 years ago. Until now, the reason for this was not entirely clear. A current study of the University of Bonn (Germany) now sheds light on this: It […].

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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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Angelini Pharma acquires CNS specialist Arvelle Therapeutics

Pharma Times

Key focus of the deal is focal-onset seizure treatment cenobamate

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Binghamton University awarded SUNY Prepare Innovation Grants to pursue COVID-19 research

Scienmag

Credit: Binghamton University, State University of New York BINGHAMTON, NY–The State University of New York has awarded grants of up to $10,000 to three teams at Binghamton University to pursue research projects related to COVID-19. “It is a great privilege for our students and faculty to have the opportunity to pursue these projects, which could […].

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Clene goes public with gold-based neurology nanotechnology

pharmaphorum

Biotech Clene Nanomedicine has gone public with a mission to use nanotherapeutics that will use gold to treat devastating neurological diseases including Parkinson’s disease. Over the Christmas period Clene closed a reverse merger with Tottenham Acquisition I Limited, allowing shares to be publicly traded on the Nasdaq stock exchange. The US-based company says it aims to revolutionise treatment of diseases including multiple sclerosis and amyotrophic lateral sclerosis with a new class of drugs t

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New drug form may help treat osteoporosis, calcium-related disorders

Scienmag

Credit: Chris Adam/Purdue University WEST LAFAYETTE, Ind. – A novel form of a drug used to treat osteoporosis that comes with the potential for fewer side effects may provide a new option for patients. The work is supported by the National Institutes of Health and is published in Biophysical Journal. Purdue University innovators developed a […].

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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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Ex-Resolute co-founder Blackburn starts hybrid agency Certain Health

pharmaphorum

Former joint founder and owner of Resolute Communications and Real Science Paul Blackburn has launched a new hybrid agency, Certain Health. Blackburn made the move after Resolute and Real Science were absorbed into Publicis Langland. The company said its hybrid model has the benefits of both the traditional and virtual agency models, with expertise in health PR, medical education and the creative space.

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Some English bulldogs thought to have cancer may have newly identified syndrome

Scienmag

Credit: Colorado State University DENVER/January 5, 2020 – Some English bulldogs diagnosed with a common cancer may instead have a newly described, non-cancerous syndrome called polyclonal B?cell lymphocytosis. The discovery was made by Morris Animal Foundation-funded researchers at Colorado State University during a study to better understand B-cell chronic lymphocytic leukemia (BCLL).

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Amazon’s health venture Haven to cease trading

pharmaphorum

Haven, the healthcare venture launched by Amazon, Berkshire Hathaway and JP Morgan Chase is to cease trading next month after failing to achieve its goal of pushing down health insurance costs for US workers. The joint venture had been billed by many as Amazon’s big move into healthcare when it was launched three years ago with great fanfare. But since then there has been little news from the secretive venture sparked by an idea from JPMorgan CEO Jamie Dillion, with support from Amazon’s Jeff Be

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NSF funds a robot teleoperation system that could transform the manufacturing workforce

Scienmag

Profs Shuran Song, Steve Feiner, and Matei Ciocarlie are developing a novel platform to enable factory workers to work remotely Credit: Shuran Song/Columbia Engineering Remote work has long been a hotly discussed topic and is even more so now, as the COVID pandemic accelerates the adoption of remote working in many industries around the world. […].

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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.