May, 2021

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Accelerating patient care through digital transformation and decentralized clinical trials

Bio Pharma Dive

The adoption of digital health technologies (DHTs) in the industry continues to pave the way to enable decentralized clinical trials (DCTs).

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Pharma’s paid media fails

World of DTC Marketing

WTF? The Washington Post reported last year that health and pharmaceutical companies spent almost $1 billion on just Facebook mobile ads in 2019. A complete waste of money, time and effort. Unlike a traditional TV or radio ad, Facebook’s ad categories help those companies target their drug ads at users who likely suffer from a specific illness the drug treats.

Marketing 283
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Rashedi Hassan takes over Sales & Marketing management of Telstar’s subsidiary in Bangladesh

Pharma Mirror

Terrassa (Barcelona). Azbil Telstar announces the appointment of Rashedi Hassan as a Sales & Marketing Manager of the subsidiary of the company in Dhaka, Bangladesh. From 14th February 2021, Rashedi Hassan focuses his responsibility on developing extensive marketing and sales plan to strengthen the Telstar brand position in the local pharmaceutical market and to promote the presence and distribution of Telstar branded Life Sciences service & product solutions in the region, particularly

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In the News: April 2021 Regulatory and Development Updates

Camargo

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. FDA’s Accelerated Approval Program Comes Under Fire. The public’s faith in drugs approved under the FDA’s accelerated approval program is not blind — it relies heavily on the industry’s follow-through on confirmatory trials and the FDA’s subsequent review and final approval.

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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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Janssen seeks EU approval for first CAR-T therapy cilta-cel

Pharma Times

Cilta-cel is an investigational CAR-T cell therapy for the treatment of relapsed/refractory multiple myeloma

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After Months of Prodding, CDC Updates Guidance on COVID-19 Airborne Transmission

BioSpace

The CDC says that COVID-19 is an airborne threat, stating that transmission and subsequent infection can occur via inhalation of very fine respiratory droplets and aerosolized particles.

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More Trending

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Pfizer wants it all

World of DTC Marketing

QUICK THOUGHT: Pfizer has already made $24 billion from their COVID vaccine, but that’s not enough; they want more, a lot more. They are planning to increase the vaccine price, and they’re working on an oral pill that could bring in as much as an additional $2 billion. While the U.S. Government didn’t pay for development, the German Government did.

Vaccine 281
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Study finds Germany trails Spain and the US in digital health

pharmaphorum

Germany is lagging behind other countries in the adoption of digital health, including Spain and the US, according to a new survey carried out on behalf of drugmaker Fresenius. . The three-country poll found that Spain is way out in front, with over half of people asked responding that digital is already playing a major role in the networking of healthcare facilities, diagnosing illnesses and telemedicine.

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FDA INTERACT Meetings: Early Interactions for Cell and Gene Therapy Sponsors

Camargo

Advances in scientific knowledge and growth in the cell and gene therapy space have led to a new and exciting era of medicine for patients, as well as a new motivation for regulators to provide clear, efficient pathways for product developers. These therapies frequently target diseases in patients that are rare (affecting fewer than 200,000 people in the US), serious, and representing an unmet medical need.

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EMA, MHRA to review Vertex' Kaftrio for children with CF

Pharma Times

If approved, up to 2,000 children with CF would be eligible for treatment with the drug

Drugs 146
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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New Cell Therapy Shows Promise in Treating HIV

BioSpace

At the Seraph Research Institute, scientists presented new research at the 2021 ASGCT that shows promise in treating HIV.

Scientist 142
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FDA seeking more consistency from cell, gene therapy developers, top official says

Bio Pharma Dive

A number of drugmakers have recently faced development delays after the FDA's asked for more information on how they measure the potency of their products.

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Corporations: “get healthcare costs under control”

World of DTC Marketing

SUMMARY: A new survey from the Kaiser Family Foundation and the Purchaser Business Group on Health shows signs that corporate executives might be warming to the idea of government getting more involved to rein in the excesses of the healthcare system. It’s affecting their bottom lines, and they won’t stand for that. Big changes are coming.

Marketing 277
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Less is more? New take on machine learning helps us “scale up” phase transitions

Scienmag

Features of large systems yielded from tiny simulations with super-resolution techniques Credit: Tokyo Metropolitan University Tokyo, Japan – Researchers from Tokyo Metropolitan University have enhanced “super-resolution” machine learning techniques to study phase transitions. They identified key features of how large arrays of interacting “particles” behave at different temperatures by simulating tiny arrays before using a […].

Research 141
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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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FDA Designations for Rare Disease Products, Part 4: Humanitarian Use Device

Camargo

The Camargo Blog has published a four-part blog series highlighting those designation programs available specifically for products with rare disease indications. This final installment will explain the criteria, timeline, and benefits of Humanitarian Use Device (HUD) designation. The HUD designation program is designed for medical devices and is similar to the Orphan Drug Designation (ODD) program for drugs and biological products.

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Biden Backs Suspending Patents on Covid Vaccines

NY Times

The Biden administration, siding with some world leaders over the U.S. pharmaceutical industry, came out in favor of waiving intellectual property protections for coronavirus vaccines.

Vaccine 140
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NurOwn: A Study in the Complexity of ALS Trials

BioSpace

There is also a tacit acknowledgment in the industry that the ALSFRS-R (revised) scale needs to evolve.

Trials 140
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In first, FDA approves KRAS-blocking cancer drug from Amgen

Bio Pharma Dive

For decades, scientists have tried unsuccessfully to target the KRAS gene, which is often mutated in lung, colon and pancreatic cancers. Lumakras is the first drug proven effective.

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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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Three ways to combat stress in a remote working healthcare team

World of DTC Marketing

The pandemic has been uniquely stressful for healthcare teams. With some parts of the sector shifting to remote work, that stress tended to build, having a real impact on mental health. It can be hard to manage a remote team, even more so to take care of their mental health, but there are a few steps that every employer can take. #1 Set up a Digital Helpdesk.

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CVS Health broadens commitment to improving clinical trial infrastructure

Outsourcing Pharma

The owner of the pharmacy giant has announced plans to partner with various stakeholders in an effort to effect improvements across the trial ecosystem.

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AZ' Tagrisso first to win MHRA approval under Project Orbis

Pharma Times

Decision brings the innovative treatment to early-stage lung cancer patients, helping to address unmet need in this setting

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UK ‘planning to widen AstraZeneca COVID jab restrictions’

pharmaphorum

Reports are emerging that the UK may join other countries in imposing restrictions on the use of AstraZeneca’s COVID-19 vaccine in younger people, after a fresh look at the risks and benefits of the shot. . The Joint Committee on Vaccination and Immunisation (JCVI) said last month that it is preferable for adults aged under 30 with no underlying conditions to be offered an alternative to the AZ/Oxford University adenovirus-based vaccine where available.

Vaccine 130
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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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Tips for Budgeting Your Own Laboratory Effectively

Pharma Mirror

If you are trying to set up your own laboratory, then you should prepare for a myriad of expenses. Budgeting is a process that is required throughout the running of your lab. It keeps everything in order and ensures the continued efficiency of whatever operation or experiment you are overseeing. Without the proper financial backing, things may quickly fall apart soon after.

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Fate offers glimpse at 'natural killer' cell therapy for leukemia

Bio Pharma Dive

The biotech's treatment is part of a wave of new treatments meant to mimic the effects of natural killer cell transplants in leukemia, though analysts remain skeptical.

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Disruption my ass! Tech companies want healthcare dollars

World of DTC Marketing

SUMMARY: Amazon has set its sights on healthcare as it smells another profit opportunity. Google has signed an agreement with the Mayo clinic to help analyze data as they want a slice of healthcare dollars but what’s missing from these tech companies is “the human touch” that patients want. Via The New Republic “whether it believes its own rhetoric—or just smells another profit opportunity—the tech industry shows little sign of slowing its march into the world of commerci

Pharmacy 198
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Clearing Up a Misconception: COVID-19 Vaccines and Infertility/Pregnancy Loss

BioSpace

A study, published recently in the New England Journal of Medicine, demonstrated no obvious safety signals among pregnant persons who received the mRNA vaccines.

Vaccine 127
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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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AZ/Daiichi Sankyo’s datopotamab deruxtecan demonstrates ‘promising’ early results in TNBC

Pharma Times

New data presented at the 2021 European Society of Medical Oncology (ESMO) Breast Cancer virtual congress

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BioNTech to set up mRNA manufacturing site in Singapore

pharmaphorum

BioNTech has said it plans to set up a regional base and new manufacturing site in Singapore so that the biotech can keep pace with demand for its mRNA-based coronavirus vaccine and pipeline products in other disease areas. The German firm said the production facility will be able to produce several hundred million doses of mRNA-based vaccine, depending on the requirements of the specific vaccine.

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CPhI Worldwide and Pharmapack Europe given the all-clear by host country governments

Pharma Mirror

The second week of CPhI Discover is open amid news that both the Italian and French governments have confirmed they will allow trade shows to resume – providing formal confirmation for both CPhI Worldwide and Pharmapack Europe. The last year has seen pharma evolve its approach to meeting new partners and existing customers, with wider pools of suppliers now needed, and remote and virtual networking being used to begin conversations much earlier than in the past.

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Moderna founder launches new biotech, looking to cure diseases through 'endless RNA'

Bio Pharma Dive

Laronde comes equipped with $50 million in funding from Flagship Pioneering and a goal to upend how diseases are treated with long-lasting RNA medicines.

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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