Sat.Jun 04, 2022 - Fri.Jun 10, 2022

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ASCO 2022: Gilead's tough weekend, bispecific progress and 'gamma delta' cell therapy

Bio Pharma Dive

The biotech's highly anticipated breast cancer data were upstaged by a rival, while presentations from Roche, J&J and Adicet Bio highlighted emerging alternatives to CAR-T treatment.

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Monday Healthcare Headlines

World of DTC Marketing

Medicare Advantage plans are endangering the lives of older adults and people with disabilities. The HHS Office of the Inspector General (OIG), which works to fight waste, fraud, and abuse, recently issued a devastating report showing that these corporate health plans, which contract with the government to deliver Medicare benefits, are denying large amounts of care inappropriately. .

Insulin 174
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How celebrity investor Mark Cuban is tackling out-of-control drug prices

pharmaphorum

American entrepreneur and investor Mark Cuban tells us why he and his partners launched the Mark Cuban Cost Plus Drug Company (MCCPDC), a public-benefit corporation and online pharmacy that provides patients access to medications at a lower cost. . US drug prices have soared over the last several decades, causing, at times, financial hardship for patients and their families, so Cuban says he developed MCCPDC with a simple mission – “to be the low-cost provider of medications to patients.”.

Drugs 144
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A Cancer Trial’s Unexpected Result: Remission in Every Patient

NY Times

The study was small, and experts say it needs to be replicated. But for 18 people with rectal cancer, the outcome led to “happy tears.”.

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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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Immatics and Editas join up to bring CRISPR to 'gamma delta' cell therapy

Bio Pharma Dive

The two biotechs will use gene editing to make prospective treatments more potent, adding to a recent flurry of activity involving the fast-emerging form of cellular immunotherapy.

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CDCDB: A large and continuously updated drug combination database

Drug Patent Watch

This article was originally published by Guy Shtar, Louise Azulay, Omer Nizri, Lior Rokach & Bracha Shapira in Scientific Data volume 9, Article number: 263 under a Creative Commons Attribution…. The post CDCDB: A large and continuously updated drug combination database appeared first on DrugPatentWatch - Make Better Decisions.

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Moderna takes mRNA influenza candidate into Phase 3 trials

BioPharma Reporter

Moderna has dosed the first participants in a Phase 3 study of the companyâs seasonal influenza vaccine candidate, mRNA-1010.

Trials 144
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FDA panel backs Bluebird gene therapy despite safety risks

Bio Pharma Dive

Advisers to the agency voted 15-0 in support of the rare disease treatment eli-cel, which was linked to a bone marrow cancer in three study participants.

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Controlling Diabetes: Advances & Adherence

Pharmaceutical Commerce

Proper control of type 1 and 2 diabetes can greatly reduce the personal impact and economic burden of this pervasive public health condition. To that end, stakeholders are exploring many parallel routes to help individuals and society maintain the upper hand, as the toll of diabetes continues to skyrocket.

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How digital is transforming the commercial leader’s role in biopharma

pharmaphorum

Pharma’s evolving role in patient care. The digital revolution has already reshaped the commercial engine of biopharma companies. Pharma’s digital initiatives now routinely enable new channels that educate and market to patients, physician engagement that is more efficient and effective, and novel payment mechanisms and distribution models that improve access to therapies.

Marketing 133
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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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Can the industry elevate the success rate of cancer trials?

Outsourcing Pharma

During the upcoming BIO International Convention, experts from CerFlux, the MD Anderson Cancer Center, and Aga Khan University will weigh in with insights.

Trials 111
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'Dramatic' study results for AstraZeneca, Daiichi drug suggest new way to treat aggressive breast cancer

Bio Pharma Dive

A quarter century after Roche's Herceptin became an option for HER2-positive breast cancer, positive study results for Enhertu could push doctors to consider a new classification of "HER2 low" disease.

Doctors 317
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Westminster Drug Project and Gilead Sciences join forces to take on hepatitis C

Pharma Times

The companies have partnered for a second time to support sector-wide efforts to eliminate hepatitis C virus in drug and alcohol services

Drugs 122
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Apple adds medication tracking to iPhone and Apple Watch

pharmaphorum

Owners of an iPhone or Apple Watch have a new health feature, an app called Medications, that will help them manage and track their use of medicines. The new tool works as a component of Apple’s Health app and will let users add drugs or other health products like vitamins and supplements to a personal list – either by scanning a label or finding the product in a directory – and create custom schedules for them.

Medicine 131
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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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Research Shows Stem Cells Might Become a Game Changer for Multiple Sclerosis

BioSpace

The Tisch MS Research Center of New York has been researching the concept of using cell therapy as a therapeutic strategy to promote repair and regeneration in certain patients with MS.

Research 102
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GSK claims first positive Phase 3 result for an RSV vaccine

Bio Pharma Dive

The British drugmaker now plans to seek approval of what could be the first preventive shot for the common lung infection. However, Pfizer, Johnson & Johnson and Moderna are close behind.

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Daiichi Sankyo and AstraZeneca’s Enhertu delivers promising trial results

Pharma Times

Enhertu reduced the risk of disease progression or death compared to chemotherapy in certain patients with metastatic breast cancer

Trials 120
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Eversana aims athletes’ mental coaching at pharma sales reps

pharmaphorum

Eversana’s suite of commercialisation tools for pharma companies will soon have a new component – cognitive behavioural training tools designed to improve the performance of sales representatives. The addition to the company’s portfolio – which already spans services like patient support, digital engagement, dispensing and distribution, and data/analytics – has arrived on the back of an alliance with business and wellness coaching specialist Limitless Minds.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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Small Study of GSK Rectal Cancer Drug Yields "Unheard of" Results

BioSpace

In a small study of 14 rectal cancer patients, researchers at Memorial Sloan Kettering Cancer Center published results where 100% of the 12 patients who completed treatment went into remission.

Drugs 108
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FDA advisers offer unanimous support to second Bluebird gene therapy

Bio Pharma Dive

By a 13-0 vote, the panel agreed the benefits of Bluebird’s beta thalassemia treatment outweigh its risks, one day after reaching a similar conclusion for another of the company’s drugs.

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The European Parkinson’s Disease Association (EPDA) Discusses Current Initiatives and Patient Engagement in Parkinson’s Research

XTalks

The European Parkinson’s Disease Association (EPDA) is Europe’s Parkinson’s umbrella organization that connects and engages with the Parkinson’s community in Europe and the world. The EPDA represents national Parkinson’s associations across Europe and advocates for the needs and rights of more than 1.2 million people living with Parkinson’s in Europe.

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Praxis wields the axe as lead depression drug fails

pharmaphorum

Shares in Praxis Precision Medicines were in freefall today after the company’s efforts to develop a new therapy for major depressive disorder (MDD) ended in failure, forcing a restructuring and staff cuts. The selloff followed the announcement of the phase 2/3 Aria study results with PRAX-114 as a monotherapy for MDD, which showed the GABA positive allosteric modulator was unable to show a significant benefit on any of the study’s primary and secondary endpoints.

Drugs 111
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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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Aldeyra Prepares to Submit Dry Eye Disease Treatment to FDA

BioSpace

Aldeyra Therapeutics reported that its reproxalap hit the mark in the Phase III Tranquility-2 study for dry eye disease. The drug showed statistical superiority for its two primary endpoints.

Drugs 102
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Roche keeps the faith in new cancer immunotherapy despite trial setbacks

Bio Pharma Dive

An ambitious development plan has so far resulted in two late-stage disappointments, but the Swiss drugmaker remains confident there's more to come from its combination treatment.

Trials 306
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Yo! Egg’s Plant-Based Poached and Sunny-Side-Up Eggs + World Food Safety Day 2022 – Xtalks Food Podcast Ep. 64

XTalks

Israeli food tech startup Yo! Egg, which has developed plant-based poached and sunny-side-up eggs, announced that it plans to launch in US restaurants later this year. In this episode of the Xtalks Food Podcast, Sydney introduces the team to Yo! Egg’s plant-based “whole egg” alternative, which is made up of two parts — the “white” and the “yolk.” While the taste and texture of Yo!

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Sanofi furthers its digital ambitions with Paris accelerator

pharmaphorum

Sanofi has launched a new initiative in its drive to integrate digital technologies throughout its business, setting up an accelerator based in Paris that will serve as the lynchpin of the effort. The accelerator has been set up to “develop products and solutions that will support Sanofi’s mission to transform the practice of medicine with the use of digital, data and artificial intelligence (AI)”, said the drugmaker.

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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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Ensysce’s Novel Opioid Appears Impervious to Abuse

BioSpace

Ensysce Biosciences is developing solutions that make opioids safer, and virtually impossible to abuse. BioSpace spoke with CEO Lynn Kirkpatrick about the company's novel technology.

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FTC to investigate CVS Caremark, others in probe of PBM business practices

Bio Pharma Dive

The decision to launch an inquiry reversed a vote earlier this year, when FTC commissioners had deadlocked over whether to look into the drug pricing middlemen.

Drugs 317
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Interview with Inventor of New Smart Stent Vascular Monitoring System Dr. Woon-Hong Yeo – Xtalks Life Science Podcast Ep. 64

XTalks

This episode features an interview with Georgia Institute of Technology researcher Dr. Woon-Hong Yeo who has helped lead a team of researchers to develop a novel vascular monitoring system based on a specially designed smart stent. Hear about how the implantable smart stent system offers real-time and continuous monitoring of metrics like blood pressure and blood flow, as well as Dr.

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Is COVID in pregnancy linked to infant development issues?

pharmaphorum

Babies born to mothers who contracted COVID-19 during seem to be at slightly higher risk of neurodevelopmental delays, say US researchers, although they caution their findings are preliminary. Their retrospective study looked at more than 7,500 infants delivered during the pandemic, including 222 born to mothers with a positive COVID-19 test during pregnancy.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.