July, 2021

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Celldex pins its hopes for a comeback on skin disease drug

Bio Pharma Dive

After several setbacks, most notably the failure of a brain cancer vaccine, Celldex has a chance at reinvention should early drug results pan out for the 16-year-old biotech.

Drugs 363
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HCPs use of digital

World of DTC Marketing

SUMMARY: 62% of HCPs spend 3 hours per day accessing digtal resources. More HCPs chose to use smartphones to access digital resources as well and usage has increased when accessing a wide variety of professional content. HCPs increasingly turn to trusted colleagues on digital networks for reliable information. Source: Build Relationships and Personalize Your Interactions With HCPs (Wolters Kluwer).

Doctors 313
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Gene Therapy and Pharmacokinetics

Camargo

How and When to Incorporate PK Design into Your Gene Therapy Development Plan. Gene therapy, which was in its infancy around 30 years ago, is now becoming a more prominent treatment method in many therapeutic areas, from personalized therapy to mass vaccinations against COVID-19. When developing a clinical development program for these increasingly popular therapies, it is important that sponsors use modeling and pharmacokinetic (PK) analysis to evaluate parameters that can be measured while dos

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New hope for long COVID blood tests after antibody discovery

Pharma Times

Researchers discover presence of 'autoantibodies' in people with persistent COVID-19 symptoms

Antibody 181
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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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Virtual reality therapy: The future of chronic pain management?

pharmaphorum

Could virtual reality tools be effective in helping patients ‘unlearn’ their chronic pain? p harmaphorum speaks to Professor Christopher Eccleston from the University of Bath’s Centre of Pain Research to find out how digital therapeutics are shaping the future of pain management. A digital software developed by Finnish drugmaker Orion is aiming to address chronic pain conditions using virtual reality (VR) devices that provide an immersive gamified therapeutic treatment program.

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Preclinical Data on New Pancreatic Cancer Drug Shines with over 90% Efficacy

BioSpace

Preclinical data for its drug candidate, LP-184, reportedly showed over 90 percent efficacy in shrinking pancreatic cancer tumors in mouse models in vitro, in-vivo, and ex-vivo.

In-Vivo 145

More Trending

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Is pharma hiring the right people?

World of DTC Marketing

SUMMARY: Older, more experienced employees are being shoved aside in favor of more inexperienced ones. The culture within pharma is driving people away, including new hires. More and more meetings are based on ROI, not the voice of the patient. Don’t hire people who want big salaries; hire people who want to be part of an industry that helps patients.

Marketing 309
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The State of Pediatric Clinical Research: An Interview with Paidion CEO Barry Mangum, PharmD, FCP

Camargo

Barry Mangum talks the importance of pediatric research, its evolution over the years, and the obstacles and opportunities that the industry faces as it moves forward. How long have you been in pediatric clinical research, and how did you enter the field? I’ve been in the pediatric arena since 1976, and in those days, I was going to develop my career in pediatric oncology, specifically acute lymphocytic leukemia (ALL).

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Oxford researchers launch HIV vaccine trial

Pharma Times

Vaccine will be evaluated in 13 HIV-negative adults aged 18-65 years old

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Moderna plans triple vaccine targeting flu, COVID and RSV

pharmaphorum

Buoyed by the success of its COVID-19 vaccine, Moderna has started a phase 1/2 trials of its mRNA-based shot for seasonal influenza, targeting four different flu strains. . The first patents have now been enrolled into the study of the shot – codenamed mRNA-1010 – which is designed to generate antibodies against influenza A H1N1, H3N2 and influenza B Yamagata and Victoria – all of which are recommended by the World Health Organization (WHO).

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Johnson & Johnson Recalls Sunscreen Because of Benzene Traces

NY Times

The company said it had determined that daily exposure to five Neutrogena and Aveeno sprays would not cause adverse health effects, but recalled the products out of an abundance of caution.

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5 FDA decisions to watch in the third quarter

Bio Pharma Dive

The agency is under pressure to grant full approvals to two coronavirus vaccines and faces important questions on how to handle the next Alzheimer's drugs after Aduhelm. A safety review of several arthritis medicines, meanwhile, is ongoing.

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There is some really bad DTC on TV

World of DTC Marketing

SUMMARY: TV continues to be the dominant channel for DTC advertising. Some of the TV spots for drugs are horrible, and some products should even be on TV because of terrible fair balance. TV ads only drive awareness as the first step for online health seekers. More conversations are happening on social media, and pharma seems to be immune to the conversations.

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A Rationally Designed Therapeutic Vaccine for Herpes

BioSpace

The designation was awarded for RVx201, a live-attenuated therapeutic vaccine the company is developing for genital herpes resulting from the herpes simplex type 2 (HSV-2) virus.

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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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EU backs approval of Moderna’s COVID-19 vaccine in 12-17 year-olds

Pharma Times

Study in adolescents met it primary endpoint, successfully bridging immune responses to those observed in an efficacy study in adults

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AI-driven ‘clock’ predicts aging-related illness and mortality

pharmaphorum

Scientists in the US have developed an artificial intelligence-powered ‘clock’ that can estimate a person’s chance of developing an illness or dying based on the pattern of cytokines in their blood. The “inflammatory age” or iAge clock – described in the journal Nature Aging – uses a snapshot of the level of chronic inflammation in the body to predict the chances of developing cardiovascular or neurodegenerative diseases and to give an estimate of lifespan.

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ACD/Labs, Science Data Experts establish AI partnership

Outsourcing Pharma

The two companies will work together to come up with solutions that use machine learning and artificial intelligence to help accelerate innovation in R&D.

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Bluebird preps for split by selling manufacturing plant to well-funded startup

Bio Pharma Dive

The startup manufacturing specialist National Resilience, which raised $800 million when it launched last year, will pay Bluebird $110 million for the North Carolina facility, bringing its North American network up to 10.

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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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Who do you trust? The FDA vs. Pfizer

World of DTC Marketing

SUMMARY: Pfizer says it has data on waning immunity from their COVID vaccine. The FDA and CDC say “not so fast.” Booster shots could bring billions in revenue to Pfizer and Moderna. The media is using scare headlines and is not always presenting accurate stories. Patients are left to wonder if they need a booster shot creating anxiety as a new strain emerges.

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Koselugo: The First Non-Surgical Alternative for Rare Plexiform Neurofibroma

BioSpace

Notably, Koselugo was studied in pediatric populations first, a reversal of the typical development path taken by the majority of drugs.

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Jardiance becomes first SGLT2 inhibitor to show benefit in HFpEF

Pharma Times

Eli Lilly and Boehringer Ingelheim have revealed positive results from a Phase III study of Jardiance in HFpEF patients

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UK biotech ‘booming’ as sector rakes in £1.6bn in Q2 financing

pharmaphorum

The UK’s biotechnology sector is going through a purple patch, attracting almost £1.6 billion ($2.2 billion) in financing in the three months to end-May – which is a record for the industry. The new figures – from the BioIndustry Association and Clarivate – were dominated by more than £1 billion in venture capital funding for UK biotech and life sciences companies, headlined by DNA sequencing company Oxford Nanopore’s £195 million raise in May that was just shy of the £205 million re

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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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Regular monitoring may be only way to prevent large COVID-19 outbreaks in schools

Scienmag

New simulations suggest that waiting until a student tests positive is too late for prevention Credit: Paul Tupper (CC BY 4.0, [link] A new study examines factors that underlie COVID-19 outbreaks in schools and suggests that large outbreaks can only be prevented with regular monitoring of everyone in the school setting. Paul Tupper and Caroline […].

Allergies 132
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Gene therapy for Fabry: early stages, promising results

Bio Pharma Dive

Three companies are testing their gene therapies in early clinical trials, with initial results due later this year. Others are in preclinical stages and aim to follow soon.

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Pharma is big business whose goal is to maximize shareholder value

World of DTC Marketing

SUMMARY: Pfizer asks for accelerated approval for a COVID booster shot even though the FDA says it’s unnecessary. From 2016 to 2020, the 14 leading drug companies spent $577 billion on stock buybacks and dividends—$56 billion more than they spent on R&D over the same period.” From 2016 to 2020, compensation for the 14 companies’ top executives totaled $3.2 billion.

Drugs 292
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AstraZeneca and mRNA COVID-19 vaccines ‘show similar safety profiles’

BioPharma Reporter

A study of more than a million vaccinated people has found 'similar safety profiles' for the AstraZeneca and Pfizer/BioNTech vaccines: adding the incidence of rare blood clots was far higher among people with COVID-19 than those who had received either vaccine.

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2022 Research: The Rapid Rise of Ocean Freight Visibility

A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.

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Kuano raises £1m to further develop AI drug discovery platform

Pharma Times

Company is aiming to transform the discovery of therapeutics focused on enzyme inhibition

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Rapid COVID immune status test launched in UK, Ireland

pharmaphorum

You’ve had your two COVID-19 jabs, but are you actually protected against infection? That’s a question that a fingerprick test launched today in the UK and Ireland could help to answer. The test – originally developed by US manufacturer Chembio Diagnostics – has been introduced into the UK and Irish markets by Guilford-based Luas Diagnostics and tests for the presence of SARS-CoV-2-targeting antibodies in the blood.

Antibody 137
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Catalent Plans Multi-Phase, $100 Million Expansion of Italian Facility to Increase Biologics Manufacturing Capabilities in Europe

Pharma Mirror

SOMERSET, N.J. — Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, today announced that it will commence the first phase of a planned $100 million expansion program at its facility in Anagni, Italy, to add biologics drug substance manufacturing capabilities, supporting the growing European market demand for biologics manufacture and supply.

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A biotech startup raises $117M to deliver gene therapies in a new way

Bio Pharma Dive

Flagship Pioneering, the biotech incubator that created Moderna, is helping fund Ring Therapeutics, a startup hoping to disrupt gene therapy development through the use of a different viral vector.

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An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space

Speaker: Steve Goldstein, Sales Leader

Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g