Wed.Apr 20, 2022

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Satellite Bio launches with new approach to bioengineering tissues

Bio Pharma Dive

Backed by $110 million in venture funding, Satellite is led by Dave Lennon, formerly head of Novartis Gene Therapies.

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HCPs sound off on pharma marketing

World of DTC Marketing

We just finished talking to over 200 hundred HCPs about pharma marketing and salespeople to measure any differences since before the pandemic. Attitudes are indeed changing, but one need remains clear: access to data obtained during clinical and ongoing trials. We’ve all heard that digital is the way to reach HCPs, and we found out that’s still mostly true, but not all digital tactics are created equal.

Marketing 218
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Merck brings former executive back to lead ex-US pharmaceuticals business

Bio Pharma Dive

Joseph Romanelli is returning from a short stint at the Chinese drugmaker Ji Xing Pharmaceuticals. In his new role at Merck, he will oversee more than 75 markets outside the U.S. and about 14,000 employees.

Marketing 177
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Clinical trial evolution, innovation center of Oracle Health Sciences event

Outsourcing Pharma

The two-day Oracle Health Sciences Connect will gather an array of research experts to discuss how to make the most of emerging technologies and practices.

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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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AbbVie ends research alliance on BioArctic Parkinson's drug

Bio Pharma Dive

The company's decision is a blow to Sweden-based BioArctic, which two months ago was expecting AbbVie to advance the drug into Phase 2 this year.

Drugs 161
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Digital therapy for osteoarthritis tops other methods, says study

pharmaphorum

A meta-analysis of published studies looking at web- app- or telehealth-based therapy for osteoarthritis has concluded that they outperform standard approaches to care. The study – published in the journal Osteoarthritis and Cartilage – focused on patients with osteoarthritis of the hip or knee, and compared the digitally-delivered exercises to standard approaches such as in-person physiotherapy, other forms of care, waitlisting and patient education.

Research 104

More Trending

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Teva’s long-acting schizophrenia drug rejected by FDA

pharmaphorum

Teva’s long haul to a turnaround of its business has been dealt a blow by the FDA, which has just declined to approve the company’s long-acting formulation of schizophrenia drug risperidone. The US regulator issued a complete response letter (CRL) for the MedinCell-partnered drug, and the companies haven’t been forthcoming on the reasons behind the rejection, saying merely that they would work with the FDA to try to get the programme back on track.

Drugs 98
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Oncomatryx announces 15m euros funding to conduct clinical trials

Pharma Times

Company at the forefront of developing personalised treatments against invasive cancer has raised 15m euros to conduct clinical trials

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Arcturus’ self-amplifying COVID-19 mRNA vaccine meets Phase 3 primary efficacy endpoint

BioPharma Reporter

Arcturus Therapeutics Holdings Inc. has reported topline data from an ongoing Phase 1/2/3 trial evaluating ARCT-154, its self-amplifying mRNA COVID-19 vaccine candidate.

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New bird app spreads its wings

Scienmag

Researchers from The University of Queensland have helped design an app to protect birds at risk of extinction across the world by breaking down language barriers between scientists. Credit: UQ Researchers from The University of Queensland have helped design an app to protect birds at risk of extinction across the world by breaking down language […].

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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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Advanced analytic tools can improve safety reporting: IQVIA

Outsourcing Pharma

An expert from the health tech company explains how AI, natural language processing, and other tools can improve pharmaceutical product safety reporting.

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Study challenges theories of earlier human arrival in Americas

Scienmag

A new analysis of archaeological sites in the Americas challenges relatively new theories that the earliest human inhabitants of North America arrived before the migration of people from Asia across the Bering Strait. Conducted by University of Wyoming Professor Todd Surovell and colleagues from UW and five other institutions, the analysis suggests that misinterpretation of […].

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Five Takeaways from the Big Three PBMs’ 2022 Formulary Exclusions (rerun)

Drug Channels

This week, I’m rerunning some popular posts while I prepare for this Friday’s live video webinar: PBM Industry Update: Trends, Controversies, and Outlook. Click here to see the original post and comments from January 2022. For 2022, the three largest pharmacy benefit managers (PBMs)—Caremark (CVS Health), Express Scripts (Cigna), and OptumRx (United Health Group)— increased the number of drugs they excluded from their standard formularies.

Insulin 82
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Western University researchers urge legislation to end organ donation anonymity

Scienmag

Philadelphia, April 21, 2022 – A team of researchers at Western University is calling for an end to a long-held, strict policy of anonymity in organ donations, pushing for new legislation that will allow donor families to connect with organ recipients, if they choose to. Credit: Hamilton Health Sciences Philadelphia, April 21, 2022 – A […].

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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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Hired and retired: New appointments in the biopharma industry

BioPharma Reporter

Pfizer, Merck and Moderna are among the companies making changes in top-level jobs this month.

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Geoengineering could return risk of malaria for one billion people

Scienmag

WASHINGTON —Geoengineering the climate would have massive repercussions for the health of billions of people at risk of malaria who live in tropical countries, according to a new finding by scientists at Georgetown University Medical Center and colleagues. The study appeared April 20, 2022, in Nature Communications. Credit: Centers for Disease Control and Prevention WASHINGTON […].

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Gilead wins court order against fraudsters targeting HIV programme

pharmaphorum

Gilead has won a crucial court order in a wide-ranging lawsuit against a network of clinics, prescribers, medical labs and pharmacies in Florida that it claims have been making fraudulent reimbursement claims for HIV medicines. The suit focuses on alleged abuse of Gilead’s Advancing Access programme, a scheme set up in 2004 to provide HIV therapies at no charge to people who lack heath insurance and would be unable to get access to the drugs.

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New York City green roofs planted with native vegetation may perform better at managing stormwater than conventional succulent-planted green roofs, according to case study

Scienmag

New York City green roofs planted with native vegetation may perform better at managing stormwater than conventional succulent-planted green roofs, according to case study Credit: Shetty et al., 2022, PLOS ONE, CC-BY 4.0 ([link] New York City green roofs planted with native vegetation may perform better at managing stormwater than conventional succulent-planted green roofs, according […].

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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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Thread builds in decentralised trials again with CureClick buy

pharmaphorum

Just over a year after partnering on a project to accelerate recruitment into decentralised clinical trials (DCTs), Thread and CureClick have decided to formally tie the knot. The marriage brings together Thread’s artificial intelligence and machine learning-based DCT platform – designed to make it easier for trial sponsors to run remote studies – and CureClick’s community-powered approach to patient recruitment.

Trials 59
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Providing a potential treatment option to infants where there is none

Scienmag

A little over 1% of babies born in the U.S. in 2020 fell under the category of very low birthweight, meaning they weighed less than 1,500 grams at birth or 3 pounds, 4 ounces. And considering that the Centers for Disease Control and Prevention says more than 3.5 million babies were born that year, almost 48,500 were […].

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Ohio Doctor Is Acquitted of Killing Patients With Fentanyl

NY Times

The doctor, William Husel, had faced 14 counts of murder after his patients overdosed on fentanyl, the powerful opioid.

Doctors 72
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African dust crosses the Atlantic

Scienmag

A beautiful sunset over the Atlantic off the Florida coast, or an orangey glow in the Texas sky at dusk may be caused by dust from West Africa, according to researchers who are looking at the paths of particulate matter in the skies over the Sahara desert and the semi-arid Sahel. Credit: Karen Coker / […].

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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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New patent for Therapeuticsmd Inc drug IMVEXXY

Drug Patent Watch

Annual Drug Patent Expirations for IMVEXXY Imvexxy is a drug marketed by Therapeuticsmd Inc and is included in one NDA. It is available from one supplier. There are sixteen patents…. The post New patent for Therapeuticsmd Inc drug IMVEXXY appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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Women with long COVID-19 syndrome have more symptoms

Scienmag

A new study found that females with Long COVID-19 syndrome were more symptomatic than males. Females were statistically significantly more likely to experience difficulty swallowing, fatigue, chest pain, and palpitations at long-term follow-up, according to a study published in the peer-reviewed Journal of Women’s Health. Click here to read the article now.

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New patent for Institut Biochimique drug TIROSINT-SOL

Drug Patent Watch

Annual Drug Patent Expirations for TIROSINT-SOL Tirosint-sol is a drug marketed by Institut Biochimique and is included in one NDA. There are two patents protecting this drug. This drug has…. The post New patent for Institut Biochimique drug TIROSINT-SOL appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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Local committees help close gap between climate information and better farmers’ harvests

Scienmag

Dr. Ana María Loboguerrero Rodríguez, the research director of climate action at the Alliance of Bioversity International and CIAT says that one of the findings of the IPCC report called the Climate Change 2022: Impacts, Adaptation, and Vulnerability report (approved on February 27, 2022) was that improved design and delivery are needed to improve climate services, […].

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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 patent for Amicus Therap drug GALAFOLD

Drug Patent Watch

Annual Drug Patent Expirations for GALAFOLD Galafold is a drug marketed by Amicus Therap Us and is included in one NDA. There are twenty-nine patents protecting this drug. This drug…. The post New patent for Amicus Therap drug GALAFOLD appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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Lab grown, self-sustainable muscle cells repair muscle injury and disease, mouse study shows

Scienmag

In proof-of-concept experiments, Johns Hopkins Medicine scientists say they have successfully cultivated human muscle stem cells capable of renewing themselves and repairing muscle tissue damage in mice, potentially advancing efforts to treat muscle injuries and muscle-wasting disorders in people. Credit: Sunny Sun In proof-of-concept experiments, Johns Hopkins Medicine scientists say they have successfully cultivated human […].

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New patent for Dexcel Pharma drug HEMADY

Drug Patent Watch

Annual Drug Patent Expirations for HEMADY Hemady is a drug marketed by Dexcel Pharma and is included in one NDA. There is one patent protecting this drug. This drug has…. The post New patent for Dexcel Pharma drug HEMADY appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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Prehistoric people created art by firelight, new research reveals

Scienmag

Our early ancestors probably created intricate artwork by firelight, an examination of 50 engraved stones unearthed in France has revealed. Credit: Needham et al., 2022, PLOS ONE, CC-BY 4.0 ([link] Our early ancestors probably created intricate artwork by firelight, an examination of 50 engraved stones unearthed in France has revealed. The stones were incised with […].

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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.