Tue.Jun 07, 2022

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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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?“This [clinical] trial has given our family hope”: A story of cancer survivorship

Worldwide Clinical Trials

In her own words, a daughter shares how a career in cancer research helped support her mother’s courageous battle with late-stage ovarian cancer. By Cathy Purvis, MBA; Site Activation Manager, Oncology and Rare Disease, Worldwide Clinical Trials. I landed in oncology thanks to the luck of the draw. This area happened to be where I was assigned when first starting in Site Activation.

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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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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.

Drugs 119
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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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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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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

More Trending

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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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Pfizer to invest $120M, add jobs in Paxlovid production push

Bio Pharma Dive

After initially struggling to meet demand for Paxlovid, Pfizer is putting significant resources toward expanding an important manufacturing plant in Michigan.

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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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Simple ways to support a presenter and benefit from their talk

pharmaphorum

Oliver Stohlmann’s Corporate Survival Hacks series draws on his experiences of working in local, regional and global life science communications to offer some little tips for enjoying a big business career. This post makes a case for encouraging and supporting presenters in order to get the most out of their expertise. Has this happened to you, too?

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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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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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World Food Safety Day 2022: Theme, History and Ways to Get Involved

XTalks

World Food Safety Day is observed each year on June 7 to mark the importance of healthy food practices and reflect on the global food system and those affected by it. According to the World Health Organization (WHO), this day is marked to “draw attention and mobilize action to prevent, detect and manage foodborne risks and improve human health.” . This year, the theme for World Food Safety Day is “Safer food, better health.

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Vertex trial for hypoglycaemia therapy shows early promise

Pharma Times

New data now reveals significant increases in the blood glucose time-in-range compared to baseline, following VX-880 dosage

Trials 119
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Enhertu Breast Cancer Drug Results in ‘Unheard-of’ Survival Rates

NY Times

For some patients with metastatic tumors not significantly affected by other forms of chemotherapy, the treatment halted their cancer’s growth.

Drugs 98
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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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Bachem and Eli Lilly link up to advance oligonucleotide products

Pharma Times

The agreement will see the two companies expand current oligonucleotide technologies

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Sanofi Celebrates Latest Dupixent Approval, Cambridge Crossing Opening

BioSpace

The approval expands the rapidly growing number of indications for Dupixent, which is the first and only biologic medication with the FDA's nod to treat atopic dermatitis from infancy to adulthood.

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Bavarian Nordic enters smallpox vaccine contract with Canadian government

BioPharma Reporter

The Public Health Agency of Canada (PHAC) will purchase Bavarian Nordicâs smallpox vaccine Imvamune in a five-year contract worth around $56m.

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Researchers Report Gene Therapy May Correct Creatine Deficiency Disorder

BioSpace

UCLA researchers report gene therapy may correct a rare creatine deficiency disorder that results in intellectual disabilities, issues with speech, involuntary movements and recurrent seizures.

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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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Redefining the approach to cancer care – a mission to improve patient outcomes

pharmaphorum

Each year across Europe, 3.7 million people are diagnosed with a form of cancer, resulting in 1.9 million deaths, making cancer the second largest cause of mortality. Although Europe comprises only one eighth of the global population, cancer cases in the region make up a quarter of the world’s total. For a region that often pioneers medical and scientific breakthroughs, these statistics are not only shocking, but unacceptable.

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Vertex Kidney Disease Drug Scores FDA Breakthrough Therapy Designation

BioSpace

The FDA granted Breakthrough Therapy Designation to Verttex's candidate inaxaplin (VX-147). for the treatment of APOL1-mediated focal segment glomerulosclerosis.

Drugs 96
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Biogen bolsters pipeline again with Alectos deal

pharmaphorum

Biogen has added a preclinical-stage drug candidate for Parkinson’s disease via a $722.5 million licensing agreement with Alectos Therapeutic, as it continues to rebuild a pipeline behind its side-lined Alzheimer’s therapy Aduhelm. The deal includes a $15 million upfront payment that gives Biogen global rights to selective GBA2 inhibitor AL01811, which it says has the potential to become a first-in-class oral therapy for Parkinson’s that could strike at the pathological mechani

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Money on the Move: Tech Innovation Reigns Supreme

BioSpace

Funding this week went mostly to companies with sophisticated tech platforms. Financing rounds will support platforms for tumor-targeting antibodies, genome-scale nucleic and acid imaging.

Genome 92
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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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Un ensayo sobre cáncer da un resultado inesperado: remisión en todos los pacientes

NY Times

El estudio era pequeño y los expertos dicen que hay que replicarlo. Pero para 18 pacientes oncológicos, el resultado produjo “lágrimas de felicidad”.

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FTC Probes Prescription Drug Middlemen as Drug Prices Soar

BioSpace

Calls for a reform of drug prices have become a regular occurrence, particularly in the midst of political campaigns. Yet a new report shows the median price of a new drug launched in 2021 was $180,000.

Drugs 90
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New patent expiration for Aclaris drug ESKATA

Drug Patent Watch

Annual Drug Patent Expirations for ESKATA Eskata is a drug marketed by Aclaris and is included in one NDA. There are six patents protecting this drug. This drug has twenty-nine…. The post New patent expiration for Aclaris drug ESKATA appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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Sales and Marketing Jobs in the Life Sciences Industry: a Comprehensive Guide

BioSpace

Sales and marketing roles in the life sciences field are in high demand. To help with your job search, we've compiled a guide to sales and marketing jobs in the life sciences industry.

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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.

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New patent expiration for Eisai Inc drug FYCOMPA

Drug Patent Watch

Annual Drug Patent Expirations for FYCOMPA Fycompa is a drug marketed by Eisai Inc and is included in two NDAs. It is available from one supplier. There are two patents…. The post New patent expiration for Eisai Inc drug FYCOMPA appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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Mineralys Therapeutics Rakes in $118M for Hypertension Therapy

BioSpace

Mineralys Therapeutics, a clinical-stage biopharmaceutical company focused on developing a best-in-class, novel therapy for high blood pressure, closed a $118 million Series B investment round.

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New patent for Secura drug COPIKTRA

Drug Patent Watch

Annual Drug Patent Expirations for COPIKTRA Copiktra is a drug marketed by Secura and is included in one NDA. There are four patents protecting this drug. This drug has one…. The post New patent for Secura drug COPIKTRA appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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Annexon Engages the Target, Sees Stabilization in Phase II Huntington's Trial

BioSpace

Annexon released final data from an open-label phase II clinical trial, showing that its drug candidate ANX005 safely stabilized disease progression in patients with Huntington’s disease.

Trials 76
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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.