Mon.Apr 05, 2021

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Takeda, CSL to end alliance as plasma-based COVID-19 drug fails key test

Bio Pharma Dive

An unusual partnership to develop a standardized plasma therapy for COVID-19 didn't succeed, but could be a model for collaborations should another public health crisis arise, the drugmakers said.

Drugs 278
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Healthcare is about profits, not patients

World of DTC Marketing

QUICK READ: The nation’s largest for-profit hospital chains saw higher profits , and some more than tripled their net income compared to last year. Some are also increasing their profit margins by forcing out healthcare staff who have seniority and earn more. As bigger corporations acquire smaller hospitals, this trend is accelerating. Maria has been an ER nurse in Southern California for almost 22 years.

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J&J to oversee vaccine production at Emergent factory that ruined doses

Bio Pharma Dive

The change, which follows the contractor's costly manufacturing mix-up, will displace production of AstraZeneca's unauthorized shot at the Baltimore site.

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FDA Approves Novel Non-Stimulant Treatment for ADHD

BioSpace

Shares of Supernus Pharmaceuticals were climbing in premarket trading this morning after Friday’s announcement the U.S. FDA approved the company’s non-stimulant treatment for ADHD in pediatric patients 6 to 17 years of age.

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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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Acadia, with drug application rejected, calls out FDA for backtracking

Bio Pharma Dive

According to Acadia, the FDA took issue with the main study used in its drug approval submission. That surprised the company, since regulators had never seemed concerned with the study's design.

Drugs 214
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GenomeFrontier, Ziopharm Non-Viral Vectors Could Transform CAR-T Cell Therapy

BioSpace

Chimeric antigen receptor (CAR-T) therapy is one of the biggest cancer therapy breakthroughs of our time, but as with any precise science, there is still some fine-tuning to be done to overcome safety risks, limited payload capacity, and the prohibitive cost of manufacturing.

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Life Sciences Incubator Gets Major Renovation to Provide More Space for Startups

BioSpace

The San Jose BioCube life sciences incubator project has undergone a significant renovation that includes a major expansion of its headquarter facilities and also provides housing for new life sciences startups.

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Researchers Are Hatching a Low-Cost Covid-19 Vaccine

NY Times

A new formulation entering clinical trials in Brazil, Mexico, Thailand and Vietnam could change how the world fights the pandemic.

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Current COVID-19 Vaccines are Great. Can They be Better?

BioSpace

Can they be better? Or perhaps, cheaper and easier to make, especially for developing companies? Researchers at the University of Texas and the PATH Center for Vaccine Innovation and Access think so.

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Dive into advanced data, ethical issues at free online event

Outsourcing Pharma

The April 6 webinar, Clinical Development Innovations, will touch upon artificial intelligence, machine learning, ethics and other impactful issues.

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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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HIV Research is at an Inflection Point, Offering Hope for a Cure

BioSpace

Recent advances are giving researchers hope that a functional cure or possibly even complete eradication of the virus is possible.

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Lessons From the Success of COVID-19 Control in Taiwan

JAMA Internal Medicine

Taiwan, an island nation of about 24 million people, has been extraordinarily successful in containing COVID-19. As of March 2021, there had been only 10 deaths and slightly more than 1000 cases. People live without fear of SARS-CoV-2.

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Valence Discovery Deal Brings Purpose-Built AI/ML to Charles River Labs’ Clients

BioSpace

Valence Discovery just announced a strategic alliance with Charles River Laboratories to make its artificial intelligence (AI) and machine learning (ML) platform available to Charles River’s clients.

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COVID-19 pandemic threatens to reverse gains made on Sustainable Development Goal 1 and 2

Scienmag

Researchers studying the impact of COVID-19 restrictions on food production among smallholder bean farmers in 11 countries found multiple food security threats Credit: Georgina Smith A new study analyzing bean production and food security across 11 countries in sub-Saharan Africa, found COVID-19 pandemic-related restrictions to significantly impact bean production.

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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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Gilead CEO Got $19 Million Pay in Blockbuster Year for Company

BioSpace

Gilead CEO Daniel O’Day navigated the company through the turbulent waters of COVID-19 last year, pushing out the very first approved treatment for treatment of the virus. His reward? A $19 million take home.

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Understanding how cancer can relapse

Scienmag

University of Missouri researchers discover a novel cell-to-cell communication network that helps tumors regrow following treatment. Credit: University of Missouri In the fight against cancers, activating mutations in the RAS family of genes stand in the way of finding viable treatment options. Now, scientists at the University of Missouri and Yale University have discovered that […].

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Brooklyn ImmunoTherapeutics, Overland ADCT BioPharma Name New CEOs

BioSpace

The biopharmaceutical industry saw two CEO appointments made today, including Howard J. Federoff, M.D., Ph.D., to Brooklyn ImmunoTherapeutics and Eric Koo to Overland ADCT BioPharma.

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Estimated Effectiveness of Case-Based and Population-Based Interventions on COVID-19 Containment

JAMA Internal Medicine

This comparative effectiveness research study examines case-based and population-based interventions and their association with COVID-19 control in Taiwan.

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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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Podcast on Race Reveals Deep Divides in the Medical Community on Racial/Ethnic Disparities

BioSpace

Several weeks ago, a podcast published on the Journal of the American Medical Association's website featured a statement that questioned whether racism exists in medicine, a statement that spurred a barrage of complaints from concerned readers, scientists and even public opinion leaders.

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Vilcek honors immigrant scientists: Ruth Lehmann, Mohamed Abou Donia, Ibrahim Cissé, Silvi Rouskin

Scienmag

In lieu of an awards gala, Vilcek Foundation has launched a digital celebration to recognize the 2021 Vilcek Foundation Prizewinners. Credit: Courtesy of the Vilcek Foundation NEW YORK, April 6, 2021— The Vilcek Foundation has launched an online celebration to honor the recipients of the 2021 Vilcek Foundation Prizes. Formatted as a microsite, the online […].

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IDbyDNA’s Metagenomics Suite Future-Proofs Labs for Coming Pathogen Crises

BioSpace

IDbyDNA’s metagenomic approach to viral strain identification combines very sensitive detection with next-gen sequencing to identify emerging and mutant viruses much sooner than either genomic or surveillance methods alone.

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Deep dive into key COVID-19 protein is a step toward new drugs, vaccines

Scienmag

Credit: OSU College of Science CORVALLIS, Ore. – Researchers in the Oregon State University College of Science have taken a key step toward new drugs and vaccines for combating COVID-19 with a deep dive into one protein’s interactions with SARS-CoV-2 genetic material. The virus’ nucleocapsid protein, or N protein, is a prime target for disease-fighting […].

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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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AstraZeneca Vaccine Thrombosis Saga Continues with No Clear Answers

BioSpace

In mid-March, more than a dozen countries suspended the deployment of the AstraZeneca-Oxford University vaccine after incidences of blood clots were reported.

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Going deep: Artificial intelligence improves accuracy of breast ultrasound diagnoses

Scienmag

Scientists train deep learning algorithms to classify breast lesions from ultrasound images in a large multi-center study Credit: Chinese Medical Journal In 2020, the International Agency for Research on Cancer of the World Health Organization stated that breast cancer accounts for most cancer morbidities and mortalities in women worldwide. This alarming statistic not only necessitates […].

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After Emergent COVID-19 Manufacturing Mess, J&J Team Takes Charge

BioSpace

In order to have full control of J&J’s product, the production of the AstraZeneca vaccine, which was being conducted at the same facility, will move elsewhere.

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Health policy researchers propose filling health care coverage gap to help ‘near poor’

Scienmag

Credit: University of Pittsburgh PITTSBURGH, April 5, 2021 – “Near-poor” Americans–people just above the federal poverty level but still well below the average U.S. income–who rely on Medicare for health insurance face high medical bills and may forgo essential health care, according to new research led by health policy scientists at the University of Pittsburgh […].

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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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2021 COVID-19 News: Moderna Pays out $1 Million for Security and More

BioSpace

Please check out the biopharma industry's COVID-19 stories that are trending for April 6, 2021.

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New patent expiration for Ferrer Internacional drug XEPI

Drug Patent Watch

Annual Drug Patent Expirations for XEPI Xepi is a drug marketed by Ferrer Internacional and is included in one NDA. It is available from two suppliers. There are three patents…. The post New patent expiration for Ferrer Internacional drug XEPI appeared first on DrugPatentWatch - Make Better Decisions.

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Bioinformatics Jobs: How to Succeed in This Competitive Space

XTalks

Bioinformaticians use a combination of mathematics, computer science and biology to help scientists make sense of the data gathered from research projects. Bioinformatics jobs are commonly found in the fields of computer information science, pharmaceuticals, biotechnology, medical technology, computational biology, proteomics and medical informatics.

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Making cleaner, greener plastics from waste fish parts

Scienmag

Credit: Mikhailey Wheeler WASHINGTON, April 5, 2021 — Polyurethanes, a type of plastic, are nearly everywhere — in shoes, clothes, refrigerators and construction materials. But these highly versatile materials can have a major downside. Derived from crude oil, toxic to synthesize, and slow to break down, conventional polyurethanes are not environmentally friendly.

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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.