Tue.Oct 05, 2021

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Collins to step down as NIH head in transition for research agency

Bio Pharma Dive

After 12 years in the top job, the veteran director says a new scientist should assume leadership of the world's largest biomedical research institution.

Research 294
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Pharma is “big business” that uses excuses to keep prices high

World of DTC Marketing

SUMMARY: Americans spend twice as much per capita on drugs as residents of other wealthy nations, because ours is the only country that lets drugmakers set any price they want for their products. Seventy-nine percent of Americans think the price of prescription drugs is “unreasonable,” according to a 2019 Kaiser Family Foundation poll , and about 9 in 10 say they support the idea of the government negotiating prices.

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J&J asks FDA to clear booster dose of its coronavirus vaccine

Bio Pharma Dive

The agency is holding an advisory committee meeting on Oct. 15 to discuss a second dose of J&J's shot, as well as boosting with different vaccines.

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The ‘patient of the future’ is driving radical innovation in healthcare

pharmaphorum

Digital data collection, utilisation of real-word data and patient-centric thinking will all contribute to the rapid development of a new healthcare landscape, says Debiopharm Innovation Fund’s Tanja Dowe. In recent years, we have seen thinking shift from focusing on a disease’s treatment to seriously considering the wider potential for its prevention, enabled by dramatic advances in data science and supported by a pressing need to reduce healthcare costs.

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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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Rejuvenate Bio is Reversing Age-Related Diseases to Increase Healthspan

BioSpace

Unlike most companies addressing the diseases associated with aging, Rejuvenate Bio tackles multiple cardiac, metabolic and renal issues at once.

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Transform patient experience with intelligent hyper-personalisation

pharmaphorum

Since 2019, pharmaceutical companies have been speeding to integrate digital channels and processes into their marketing efforts and patient outreach, to prepare for the wave of digitisation in the healthcare industry. As part of these efforts, customer experience (CX) became a key focus area to ensure customer engagement and loyalty. Significant strides have been made by the industry when it comes to embedding forward-thinking practices into its strategic marketing goals with healthcare profess

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5 Benefits of Monoclonal Antibodies

Pharma Focus Asia

Antibody development has dramatically changed the pharmaceutical world, allowing for the creation of life-saving drugs and improvements to healthcare that would otherwise be impossible. An industry valued at approximately 115.2 billion US dollars in 2018 by the Journal of Biomedical Science, therapeutic antibody treatments are able to target a wide variety of medical conditions, ranging […].

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Moderna Seeks to Shore Up Patent Protection on COVID-19 Vaccine

BioSpace

Moderna seeks to invalidate two patents of Arbutus Biopharma Corp. The company hopes to appeal a preemptive challenge to the patents upheld by the U.S. Patent Trial and Appeals Board.

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AiPharma forms alliance with Appili Therapeutics

Pharma Times

Private biopharmaceutical research, development, and commercialisation company, AiPharma, has announced a strategic alliance with biopharmaceutical company Appili Therapeutics Inc (Appili), to advance the global development of Avigan®/Reeqonus™ (favipiravir).

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DNA plasmid manufacturer taking orders for mid-2022 production slots at new site

BioPharma Reporter

VGXI, Inc, a provider of plasmid DNA manufacturing and development services, says multiple construction milestones have been reached for its new headquarters and manufacturing facility in Texas.

DNA 96
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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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Pfizer and Voyager Launch $630 Million Gene Therapy Technology Pact

BioSpace

Voyager Therapeutics entered a deal with Pfizer that allows Pfizer to exercise options to license novel capsids created by Voyager’s RNA-driven TRACER screening technology.

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Informatics useful in advancing personalized medicine: Washington University

Outsourcing Pharma

A representative from the school explains how tools like artificial intelligence and natural language processing can help elevate personalized medicine.

Medicine 103
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Merck’s Davis Looking to Diversify in Preparation for Keytruda Patent Cliff

BioSpace

Newly appointed CEO Rob Davis must find a way to balance Merck’s portfolio before investors get (even more) antsy. And he is looking to be aggressive.

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Natural compound in basil may protect against Alzheimer’s disease pathology

Scienmag

Tampa, FL (Oct. 5, 2021) – Fenchol, a natural compound abundant in some plants including basil, can help protect the brain against Alzheimer’s disease pathology, a preclinical study led by University of South Florida Health (USF Health) researchers suggests. Credit: USF Health/University of South Florida Tampa, FL (Oct. 5, 2021) – Fenchol, a natural compound […].

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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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Retrotope Drug Improves Survival in Ultra-Rare Genetic Childhood Disease

BioSpace

Retrotope cited data from its Phase II/III trial of RT001 in patients with infantile neuroaxonal dystrophy and reported on a natural history study of INAD patients’ disease onset and progression.

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Cancer breakthrough: Exercise may stop disease in its tracks

Scienmag

October 5, 2021 Credit: ECU October 5, 2021 Cancer breakthrough: Exercise may stop disease in its tracks Forget bedrest, research from Edith Cowan University (ECU) has shown exercise may be a key weapon in cancer patients’ battle against the disease. Exercise causes muscles to secrete proteins called myokines into our blood – and researchers from […].

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Colossal Wants to Bring Back the Woolly Mammoth. Should It?

BioSpace

The idea is not just a flight of fancy by a brilliant mind with big dreams. It is part of a larger de-extinction strategy aimed at solving climate change.

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CHMP positive option for Pfizer-BioNTech COVID-19 vaccine in the EU

Pharma Times

Pfizer and BioNTech have announced that the Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the administration of the Pfizer-BioNTech COVID-19 vaccine as a booster shot six months after the second dose.

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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 Pauses Narcolepsy Studies, Forges $1.1 Billion Gene Therapy Deal

BioSpace

A safety concern has forced Takeda Pharmaceutical to suspend the dosing of patients in two Phase II studies of an experimental treatment for narcolepsy.

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Dynavax and US Department of Defense collaborate on adjuvanted plague vaccine development

BioPharma Reporter

Dynavax will conduct a Phase 2 clinical trial combining the US Department of Defenseâ rF1V vaccine with its CpG 1018 adjuvant.

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Money on the Move: September 29 – October 5

BioSpace

These life sciences companies scored enough capital this week for pumpkin spice and everything nice, and to propel their candidates in the clinic. Here's a look.

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Late persistence of human ancestors at the margins of the monsoon in India

Scienmag

The longest lasting tool-making tradition in prehistory, known as the Acheulean, appears more than 1.5 million years ago in Africa and 1.2 million years ago in India, and mainly consists of stone handaxes and cleavers (Figure 1). New research led by the Max Planck Institute for the Science of Human History has re-examined a key […].

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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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Holmes Legal Team Attempts to Spread Blame to Former Theranos Lab Director

BioSpace

Attorneys for Holmes have speculated that the lab failures at Theranos are the fault of Rosendorf and not Holmes herself.

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‘The mother of all cannabinoids’: anti-seizure compounds discovered in cannabis

Scienmag

Research from pharmacologists at the University of Sydney provides new insights into how cannabis extracts may work to treat epilepsy. Credit: Lambert Initiative for Cannabinoid Therapeutics at the University of Sydney Research from pharmacologists at the University of Sydney provides new insights into how cannabis extracts may work to treat epilepsy.

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Gemini Will Cut 20% of Staff, Pivot All Resources to Geographic Atrophy

BioSpace

?The company announced that they are reducing its employee headcount and ceasing some of its research programs to focus on its geographic atrophy (GA) trial.

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NEW: The 2021–22 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors

Drug Channels

I am pleased to announce our new 2021–22 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors , available for purchase and immediate download. Click here to download a free report overview (including a summary of industry trends, the Table of Contents, and a List of Exhibits) New Drug Channels Institute Study: Biosimilars Are Delivering Higher Profits for Drug Distributors (press release) We’re offering special discounted pricing if you order before October 15, 2021!

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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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Making the most of trial data can benefit patients: Parexel

Outsourcing Pharma

An expert from the CRO explains the evolution of data technologies put to use in clinical studies and offers advice on how to best make them work in trials.

Trials 59
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Changes in older adults’ life space during lung cancer treatment

Scienmag

New research published in the Journal of the American Geriatrics Society found that older adults with non-small cell lung cancer often have low life-space mobility prior to starting lung cancer treatment. Life-space mobility is the ability to move within one’s environment from the home to the greater community. Credit: Journal of the American Geriatrics Society New research […].

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New patent for Gilead Sciences drug GENVOYA

Drug Patent Watch

Annual Drug Patent Expirations for GENVOYA Genvoya is a drug marketed by Gilead Sciences Inc and is included in one NDA. It is available from two suppliers. There are thirteen…. The post New patent for Gilead Sciences drug GENVOYA appeared first on DrugPatentWatch - Make Better Decisions.

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What level of antibody response protects against COVID-19 death?

Scienmag

In a study of patients with COVID-19 being treated in intensive care units, people who mounted only a low antibody response against the SARS-CoV-2 virus faced a higher risk of dying. Credit: Journal of Internal Medicine In a study of patients with COVID-19 being treated in intensive care units, people who mounted only 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.