Wed.Mar 10, 2021

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Vertex begins human testing for diabetes cell therapy

Bio Pharma Dive

While Vertex is confident in the therapy, which came via the $1 billion acquisition of Semma Therapeutics, it will still be a few years before the company has a good read on its effects in Type 1 diabetes patients.

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Is it time for DTC marketers to use a CMP?

World of DTC Marketing

SUMMARY: In its simplest form, a creative management platform , or CMP, is a cloud-based software that allows marketing teams to create, distribute, and measure the performance of digital advertising. The advantage is that marketing teams can create online ads without relying on an agency but it requires a digital marketer who fully understands the brand’s target customer.

Marketing 190
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Bluebird says gene therapy 'very unlikely' cause of cancer case in trial

Bio Pharma Dive

The biotech is discussing its findings with U.S. and European regulators in hopes of resuming study of the treatment as well as sales of a related product.

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Technology Transfer: What Is It, and How Is It Done?

Camargo

Technology transfer is a critical step in any drug development program, occurring for various reasons and at different development stages. A sponsor may be looking for a contract development and manufacturing organization (CDMO) for clinical trial manufacturing; to transfer a manufacturing process to a larger, commercial-scale CDMO; or to replace a CDMO that has quality issues.

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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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Lilly builds case for COVID-19 drug cocktail with new data

Bio Pharma Dive

A low-dose combination of Lilly antibodies for COVID-19 reduced deaths and hospitalizations in a Phase 3 trial, a finding that could boost its use.

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CPhI Report forecasts explosion of contract services growth due to surging INDs and 75 FDA approvals by 2025

Pharma Mirror

A post-pandemic pharma report from CPhI predicts the next few years will deliver strong growth in pharma innovation, with oncology and rare diseases potentially the biggest beneficiaries of positive covid legacies – including accelerated development timelines, remote trials and new technologies in genetic and target screening. The report anticipates breakthroughs in multi-modal disease therapies within five years, mRNA platforms to transform many new non-infectious disease treatment options, and

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How to Use Public Relations to Improve your Recruitment Strategy

BioSpace

Using public relations strategies creates more opportunities for passive candidates to be exposed to your organization – and learn about your open roles.

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Black engineer awards expand Sandia Labs spotlight

Scienmag

Ten pre-eminent problem solvers honored for scientific, community feats Credit: Randy Montoya ALBUQUERQUE, N.M. — Ten Sandia National Laboratories engineers received Black Engineer of the Year Awards, including Most Promising Scientist, Modern Technology Leaders and Science Spectrum Trailblazers. Honorees include Sandia systems, chemical, computer, electrical, petroleum, manufacturing and mechanical engineers who excel in their respective […].

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COVID-19 One Year Mark – Losses Far Greater than Imagined

BioSpace

It has been one year since COVID-19 was declared a global pandemic. In that time, more than 118 million people have contracted the virus and 2,622,190 people, including 529,267 in the United States, have died as a result.

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Fishers at risk in ‘perfect storm’

Scienmag

Credit: Laurence Hartwell Stormier weather will increasingly force fishers to choose between their safety and income, researchers say. Climate change is causing more extreme weather in many locations. Storms will likely increase around the UK in the future, while many fishers in the UK also face economic insecurity. The new study – led by the […].

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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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Hospitalized COVID-19 Death Risk Dropped by 92% With NSAA Drug

BioSpace

Topline results from a trial in Brazil show that treatment with Kintor’s proxalutamide cut mortality risk by 92% and significantly shortened the median length of hospital stay by nine days compared with standard of care in hospitalized patients with COVID-19.

Drugs 101
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CQC publishes new agreement with Equality and Human Rights Commission

Pharma Times

Agreement aims to safeguard rights of people receiving health and social care in England

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Intellia Establishes Proof-of-Concept for in vivo CRISPR Bone Marrow Editing

BioSpace

Intellia Therapeutics presented preclinical data of its non-viral genome editing platform at the Keystone eSymposium: Precision Engineering of the Genome, Epigenome and Transcriptome.

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New patent for Blue Earth drug AXUMIN

Drug Patent Watch

Annual Drug Patent Expirations for AXUMIN Axumin is a drug marketed by Blue Earth and is included in one NDA. It is available from one supplier. There are five patents…. The post New patent for Blue Earth drug AXUMIN appeared first on DrugPatentWatch - Make Better Decisions.

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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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AMR Fund and Global Cohorts Working to Prevent Another Pandemic

BioSpace

According to the Centers for Disease Control and Prevention, more than 35,000 Americans perish each year from antibiotic-resistant infections, and estimates have AMR claiming the lives of as many as 10 million globally by 2050.

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MUSC is first in nation to enroll kids in trial of novel MIS-C therapy

Scienmag

Using an investigational cell therapy, Medical University of South Carolina pediatricians successfully treated two patients with multisystem inflammatory syndrome in children, a rare but life-threatening complication of COVID-19. Credit: Medical University of South Carolina, Sarah Pack A team of pediatricians at the Medical University of South Carolina (MUSC) was the first in the nation to […].

Trials 91
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COVID-19 Vaccine News: Moderna Variant Vaccine Begins Human Testing, AZ Put on Hold in Denmark

BioSpace

Patients in a Phase II trial have begun receiving Moderna’s vaccine against the SARS-CoV-2 variant first identified in South Africa, the company announced.

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MHRA green light for DemeRx’s opioid use disorder trial

Pharma Times

Phase I portion of the trial will be conducted at the Manchester clinical unit of MAC Clinical Research

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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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Takeda Takes on the World with Big Growth Plans for the Decade

BioSpace

The Japanese pharma giant is aiming for double-digit revenue growth of its Growth and Emerging Markets Business Unit (GEM BU) by 2030. Here’s how they plan to do it.

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‘Let us be the architects of a new world’ Mothers in academia address workplace inequalities

Scienmag

Boston University researchers and peers from around the world, after decades of talk, lay out a plan for action Credit: Boston University As the coronavirus pandemic’s grip on the United States stretched from weeks into months, with huge swaths of the American workforce bound to their homes, studies began trickling out revealing that the impact […].

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8 Reasons “Internal Networking” Is Good for Your Career

BioSpace

“Internal networking” is much the same as regular professional networking, except that the connections or ‘network’ you’re building come from your current employer.

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AI platform says Olumiant could be repurposed for Alzheimer’s

pharmaphorum

With so many novel drug candidates for Alzheimer’s disease failing in clinical development, researchers in the US have started using artificial intelligence (AI) to screen already-approved therapies for activity against the neurodegenerative disorder. . A team based at Massachusetts General Hospital and Harvard Medical School has come up with an AI algorithm – called DRIAD (Drug Repurposing In Alzheimer’s Disease) – that it hopes will not only find treatments but also tease out new therapeutic t

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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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Biopharma Companies Take Aim at Spinal Cord Injuries

BioSpace

It’s estimated there are more than 17,000 new cases of spinal cord injuries each year, which can cause permanent damage in patients.

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In Panama, nitrogen-fixing trees unlock phosphorus and other scarce nutrients

Scienmag

By enriching soils, they benefit forest recovery and carbon storage Credit: Credit: Sarah Batterman. A new study, published this week in Proceedings of the National Academy of Sciences, reveals that nitrogen-fixing trees play an underrecognized role in recovering tropical forests by enriching nutrient-poor soils with scarce elements such as phosphorus and molybdenum.

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UK data hub to apply AI to health records for COVID-19 and respiratory research

pharmaphorum

Health Data Research UK’s respiratory hub BREATHE is set to use artificial intelligence (AI) to unlock real-world insights from electronic health records (EHRs) as part of a new partnership. It will apply Savana’s EHRead technology to de-identified EHRs to boost research into COVID-19 and respiratory conditions, work that is also part of the international BigCOVIData study into respiratory disease progression and outcomes.

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Scientists found new way to synthesize chiral tetraarylmethanes

Scienmag

Credit: The Hong Kong University of Science and Technology The research was published on the journal Nature Catalysis on December 14, 2020. A strong bias towards linear and disc-shaped molecules has long been observed in drug molecules. In contrast, spherical molecules have been utilized on far fewer occasions, due to the lack of efficient access […].

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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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COVID-19 Wins and Losses: Genentech’s Actemra Flunks Trial; Vir & GSK’s Antibody Dazzles

BioSpace

Genentech reported its rheumatoid arthritis drug Actemra failed to hit its primary endpoint in a COVID-19 trial, while Vir and GlaxoSmithKline’s antibody against COVID-19 demonstrated 85% efficacy.

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A stronger maths foundation in first grade

Scienmag

Credit: Jan Potgieter, University of Johannesburg First grade teachers can find out who is on track with math and who is lagging, using an accurate diagnostic test that they can administer in the classroom. After Covid-19 school reopening, or during catch-up sessions in the holidays, this is instrument can also be useful, especially in large, […].

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Pfizer/BioNTech COVID jab works against Brazil variant; lab study

pharmaphorum

A laboratory study suggests Pfizer and BioNTech’s COVID-19 vaccine Comirnaty could be effective against a Brazilian variant of the SARS-CoV-2 virus – known as P.1 – that is worrying health officials around the world. . The study suggests that serum taken from patients injected with the mRNA shot, also known as BNT162b2, was able to neutralise a genetically engineered version of SARS-CoV-2 with the P.1 mutations, as well as variants from the UK and South Africa.

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Genetic analysis of ancient massacre reveals instance of indiscriminate killing

Scienmag

Credit: Novak et al, 2021, PLOS ONE (CC-BY 4.0, [link] Genetic analysis provides clarity and also prompts further questions around an ancient massacre in Poto?ani, Croatia, in a study published March 10, 2021 in the open-access journal PLOS ONE by Mario Novak from the Institute for Anthropological Research, Croatia, Ron Pinhasi from the University of […].

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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.