Wed.Dec 01, 2021

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Facing challenges, Deciphera cuts workforce by a third

Bio Pharma Dive

The Massachusetts biotech is eliminating 140 positions as it looks to cut costs following disappointing study results for its sole commercial product.

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There are instances when TV (DTC) is NOT a good idea

World of DTC Marketing

OPENING: TV is great at creating awareness, but it can also scare patients away if one of your side effects is “may lead to death.” This is one side effect that stands out when your target audience watches your spot along with “serious heart rhythm problems” and “new cancers have happened during treatment.” I understand that DTC marketers are in love with TV even though it’s becoming less effective.

Doctors 210
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Vertex, needing research spark, finds promising results in small study of kidney disease drug

Bio Pharma Dive

The biotech, which has been stung by recent clinical setbacks, plans to soon advance the medicine into late-stage testing.

Research 200
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Emmes Announces Completion of Third ACTT Clinical Trial for COVID-19

Pharma Mirror

Rockville, Emmes today announced that it conducted the data and statistical analysis for the third iteration of the Adaptive COVID-19 Treatment Trial (ACTT-3), using its proprietary Advantage eClinical system. The ACTT-3 trial assessed the efficacy and safety of interferon beta-1a plus remdesivir compared to remdesivir alone in hospitalized adults with COVID-19.

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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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All adults to be offered COVID-19 booster jabs by end of January 2022

Pharma Times

The UK government has aimed to expand their COVID-19 vaccination programme, in accordance with guidance from the Joint Committee on Vaccination and Immunisation (JCVI).

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Medinfar awarded first ever CPhI Verified Certificate

Pharma Mirror

CPhI awards the first ever CPhI Verified certificate to Medinfar – an international pharmaceutical manufacturer of Rx, cosmetics, food supplements and veterinary products. The new certification was given after a detailed evaluation by SGS – the world’s leading verification, inspection and certification company – spanning some 14 separate criteria, including the company’s approach to quality and environmental management, supply chain, health and safety and business continuity planning.

Cosmetics 130

More Trending

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Thermo Fisher, Qiagen and Others Assure Their COVID-19 PCR Tests Detect Omicron

XTalks

With all the uncertainty around the new SARS-CoV-2 variant, Omicron (B.1.1.529), diagnostic test makers are assuring people that their COVID-19 PCR tests work just fine in detecting the latest version of the coronavirus. Upon being declared a variant of concern by the World Health Organization (WHO) on Friday last week, companies like Thermo Fisher Scientific, Qiagen, Abbott, Cue Health and Co-Diagnostics have said that their current SARS-CoV-2 assays are able to detect the Omicron variant of th

Gene 105
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French biotech raises €5m, looks to restore patient response to anticancer immunotherapies

BioPharma Reporter

EverImmune, a biotech based near Paris, and specialized in the development of live biotherapeutic products in the field of microbiota oncology, has raised â5m (US$5.7m) in a Series A funding round from undisclosed private investors.

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15 traits of effective bosses and how to catalyse your team

pharmaphorum

Oliver Stohlmann’s Corporate Survival Hacks series draws on his experiences of working in local, regional and global life science communications to offer some little tips for enjoying a big business career. This post looks at people manager effectiveness and how to boost team and co-worker engagement. It’s that special time in the annual corporate lifecycle: year-end performance reviews are being conducted around the globe, employee ratings allocated, calibrated and translated into salary increa

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23andMe Ramping Up Drug Development Efforts with Key Moves

BioSpace

23andMe raised $592 million in proceeds from the IPO and, as of September 30, had about $700 million. With that cash in hand, it plans to push faster and deeper into drug development.

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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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Sanofi snaps up acne vaccine developer Origimm Bio

pharmaphorum

Sanofi has added to its vaccine pipeline with an agreement to acquire Austria’s Origimm Biotechnology and its vaccine-based immunotherapy for people with acne. The French group said that ORI-001, a vaccine based on recombinant proteins from the Cutibacterium acnes (formerly Propionibacterium acnes ) bacterium that is often found in acne lesions, could be the first ever vaccine for the condition.

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Biopharma is Tackling Misfolding Proteins in Parkinson’s Disease

BioSpace

Parkinson’s disease has been immensely challenging for biotech companies. A high rate of late-stage attrition in trials has led to a lack of approved therapies for the disease.

Protein 103
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Computer Company ASUS Launches At-Home Food Safety Gadget PureGo PD100

XTalks

ASUS — best known for its computers, laptops and phones — launched its first kitchen gadget, the PureGo PD100, designed to help ensure the cleanliness of fruits and vegetables. As its first foray into at-home food safety, ASUS says it’s bringing “laboratory-standard food safety testing equipment into your kitchen.” So, how does it work? After placing newly-bought produce into a tub of water for two to three minutes, the PD100 is added to the bath so that its filter is submerged.

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Build Back Better Act Would Patch Holes in Health Coverage

NY Times

Taken together, the provisions in the social policy bill represent the biggest step toward universal coverage since the passage of the Affordable Care Act.

Drugs 105
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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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10 Ways to Combat Stressful Work Situations

BioSpace

Are you looking for ways to combat a stressful work environment? Here are 10 ways that can help you improve your day at work.

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MRI reveals altered brain structure in fetuses exposed to alcohol

Scienmag

CHICAGO – In the first MRI-based study to investigate pre-natal alcohol exposure, researchers found significant changes in the brain structure of fetuses exposed to alcohol compared to healthy controls. Results of the study are being presented today at the annual meeting of the Radiological Society of North America (RSNA). Credit: RSNA and Marlene Stuempflen, M.D. […].

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BMS Faces Heat from Employees Over Vaccine Mandate

BioSpace

Four BMS employees have filed a lawsuit against BMS after claiming the company would not grant them a religious exemption and threatened their employment.

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Build Back Better Act Would Patch Holes in Health Coverage

NY Times

Taken together, the provisions in the social policy bill represent the biggest step toward universal coverage since the passage of the Affordable Care Act.

Drugs 98
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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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The Norwegian wolf is extinct

Scienmag

There’ s no longer any doubt — the wolves found in Norway and Sweden today are actually Finnish, according to extensive studies done on their genetic make-up. Humans wiped out Norway’s original wolf population in the wild around 1970. Credit: Per-Harald Olsen, NTNU There’ s no longer any doubt — the wolves found in Norway […].

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Study: Survivors of Severe COVID-19 at Higher Mortality Risk and More Research

BioSpace

Research continues to reveal how COVID-19 affects different people with different health issues, both short-term and long-term.

Research 107
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CT uncovers bone disease in Tyrannosaurus rex jaw

Scienmag

Credit: RSNA and Charlie Hamm, M.D. CHICAGO – Researchers in Germany identified bone disease in the fossilized jaw of a Tyrannosaurus rex using a CT-based, nondestructive imaging approach, according to a study being presented today at the annual meeting of the Radiological Society of North America (RSNA). The imaging method could have significant applications in […].

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GSK Shares Positive Omicron Update, New Oxford Partnership

BioSpace

GlaxoSmithKline said early research shows its monoclonal antibody is demonstrating efficacy against the newest strain of COVID-19.

Antibody 103
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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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Scientists may have solved an important part of the mystery of ultra-rare blood clots linked to adenovirus-based COVID-19 vaccines

Scienmag

An international team of scientists believe they may have found a molecular mechanism behind the extremely rare blood clots linked to adenovirus COVID-19 vaccines. Credit: Chun Kit Chan, Arizona State University An international team of scientists believe they may have found a molecular mechanism behind the extremely rare blood clots linked to adenovirus COVID-19 vaccines. […].

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Tune Therapeutics Debuts with $40 Million to Fine-Tune the Human Genome

BioSpace

Tune claims TEMPO can rapidly target and adjust the epigenomic machinery, controlling gene expression and dictating how the DNA will be molded.

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Cell wall remodeling enables fungal network development in grasses

Scienmag

Scientists now have a deeper understanding of how a fungus develops a symbiotic lifestyle inside grass leaf and why the grass leaf fails to defend itself against the intruder, thanks to research coming from Massey University in New Zealand and the University of Münster in Germany. Fungal endophytes of the Epichloë species are known to […].

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Sanofi to acquire Origimm Biotechnology, gaining therapeutic acne vaccine candidate

BioPharma Reporter

Sanofi will acquire Origimm Biotechnology GmbH, an Austrian privately-owned biotech developing a therapeutic vaccine for acne.

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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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New computational approach predicts chemical reactions at high temperatures

Scienmag

New York, NY—December 1, 2021— Extracting metals from oxides at high temperatures is essential not only for producing metals such as steel but also for recycling. Because current extraction processes are very carbon-intensive, emitting large quantities of greenhouse gases, researchers have been exploring new approaches to developing “greener” processes.

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Astellas Hopes to Improve Gene Therapy Safety with $1.6 Billion Dyno Deal

BioSpace

With this new collaboration, Astellas will take advantage of Dynos' next-gen AAV vectors to deliver its gene therapy.

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Story tips: For the birds, fresh twist on heat, upcycling plastics and probing for COVID particles

Scienmag

Bioenergy – For the birds Credit: Chris Lituma/West Virginia University Bioenergy – For the birds An analysis by Oak Ridge National Laboratory showed that using less-profitable farmland to grow bioenergy crops such as switchgrass could fuel not only clean energy, but also gains in biodiversity. Researchers examined segments of land in the Midwest responsible for […].

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Decentralized format can help elevate trial inclusivity: Science 37

Outsourcing Pharma

An expert from the decentralized clinical trial solutions provider discusses how the virtual format and technology can help improve study representation.

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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.