Sat.May 08, 2021 - Fri.May 14, 2021

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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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Thoughts on working with and in the pharma industry

World of DTC Marketing

THOUGHT: I love working in the pharma industry. Yes, I have been critical of the industry because I believe there is too much focus on pleasing Wall Street, yet I believe that there are some really good people starting to climb the ladder and that soon we’ll see some really substantial changes. Believe in what we can do together. One change in the workplace is that employees want more of a say about their company when it comes to social and moral issues.

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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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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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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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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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Marketing to physicians

World of DTC Marketing

QUICK READ: Reaching physicians with key brand messages isn’t hard, but the online landscape has become crowded with many players. By far, Medscape is still number one in physician reach , and medical journal advertising has been proven to result in more branded Rx’s. Deloitte showed there is a significant trust gap between pharmaceutical companies and people working in healthcare.

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More Trending

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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 authorizes Pfizer's coronavirus vaccine for younger teens

Bio Pharma Dive

The emergency clearance greatly expands the pool of people who can be vaccinated in the U.S. just as some states are beginning to report waning demand.

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Strategies for Your Content Marketing to Have Greater Impact

World of DTC Marketing

It’s 2021. Trends are a whole lot different from what they were a decade ago. This doesn’t just relate to fashion or hobby choices, either. It’s also highly relevant in the marketing world. One of the most essential methods to generate organic traffic is content marketing when it comes to marketing. With the right content marketing strategy in place, a website has the ability to do that all-important climb to the first page of Google.

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QED Advocates New British Standard for Soil Sampling

Pharma Mirror

Industry specialists working on contaminated land are being urged to use the new British Standard BS 10176 for soil sampling. BS 10176 was introduced in August 2020 but tests using old methods, which do not conform to the new standard, are still being accepted by regulators and assessors, which has led to concerns that its use is still only sporadic.

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

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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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Heron, on third attempt, secures FDA approval for non-opioid painkiller

Bio Pharma Dive

The San Diego-based biotech's drug, which will now be sold as Zynrelef, had perviously been rejected by the agency in 2019 and 2020.

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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.

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I Holland Present their Latest Tablet Tooling Developments to a Virtual Audience at ACHEMA Pulse

Pharma Mirror

I Holland, the world’s best-known manufacturer of tablet punches and dies for the pharmaceutical and nutraceutical industries, has announced it will be exhibiting some of it most innovative products at ACHEMA Pulse from 15-19 June, including the new die table segment cleaning equipment. The interactive platform will showcase the company’s extensive portfolio of precision tablet tooling solutions and services which have been developed during its 75 year history.

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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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Coronavirus won’t be circulating in UK by August, says outgoing vaccine chief Clive Dix

pharmaphorum

Coronavirus won’t be circulating in the UK by August, according to the outgoing chief of the country’s vaccine rollout scheme, Dr Clive Dix. Dix led the programme from December until he stepped down last week and told the Daily Telegraph that the UK’s vaccination campaign should be enough to protect from the virus and its known variants by the summer.

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Merck, with new breast cancer data, aims to rebound from FDA rejection

Bio Pharma Dive

Study results could address concerns raised by FDA advisers who recently voted against approval of Keytruda in patients with early-stage breast cancer.

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Positive CHMP opinion for self-administered Crysvita

Pharma Times

Crysvita is used for the treatment of the rare metabolic bone disease X-linked hypophosphataemia (XLH)

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Healthcare Staffing: Tips for Recruitment

Pharma Mirror

The success of any healthcare organization depends on its workers. The equipment and structure a hospital or healthcare facility have means nothing if it does not have good workers. This is why most hospitals pay a great deal of attention to their recruiting process. However, the pandemic has made the shortage of healthcare workers even more obvious.

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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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EMA panel probes heart inflammation with Pfizer/BioNTech COVID vaccine

pharmaphorum

A review of side effects reported with coronavirus vaccines by the EMA’s safety committee has uncovered cases of inflammation of the heart in people receiving the Pfizer/BioNTech Comirnaty shot. . The Pharmacovigilance Risk Assessment Committee (PRAC) says it is aware of cases of myocarditis and pericarditis – inflammation of the heart muscle and membrane around the heart – with the vaccine.

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Amgen asks FDA for approval of key asthma drug

Bio Pharma Dive

Tezepelumab is one of Amgen's top experimental medicines and a U.S. OK would help its efforts to offset revenue declines from its aging blockbusters.

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Researchers find CD38-targeting drugs may show promise against prostate cancer

Pharma Times

Researchers are initiating clinical trials to evaluate whether targeting the CD38 pathway can provide benefit for people with prostate cancer

Research 121
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Vaccine Passports in NHS app unethical if they don’t allow date custodianship say FarmaTrust

Pharma Mirror

FarmaTrust, the UK-based global medical supply chain data management provider – has warned that the UK is heading very rapidly down the wrong direction with vaccine passports. The Government last week announced its intention to use the NHS app to provide proof of COVID vaccination status – yet both these solutions are not utilising innovative new technologies to protect individuals, and their data.

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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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AI in action: Report highlights the real-world benefits of AI in healthcare

pharmaphorum

Joined up thinking is the key to converting AI-driven advances into real benefits for healthcare systems, say NHSX. Healthcare systems the world over have been facing the same challenges for some time – and the pandemic has only served to compound them. Aging populations, a growing number of people living with long-term conditions, and dwindling resources meant the NHS was already being asked to do more with less before COVID-19 hit.

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The use of AI in rare disease has hidden flaws

Bio Pharma Dive

A strategy needs to be put in place to profile patients and then form profile-specific strategies to accelerate diagnosis through HCP outreach, education, etc.

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With $52 Million Series A, Appia Bio Anticipates a Bright Future in Cell Therapy

BioSpace

Appia is developing engineered allogeneic cell therapies from hematopoietic stem cells (HSCs) for cancer patients.

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Perigord releases most powerful GLAMS yet – GLAMS 5.0

Pharma Mirror

Perigord announces the release of GLAMS 5.0, the latest update to its industry-leading AMS platform. Developed to the specific needs of the Life Science industry, this latest release boasts an expanded suite of both new and improved features, as well as greatly improved performance. GLAMS 5’s new deep search capabilities break down potential impediments to getting products to market, and allows users to create deep and wide-ranging searches of all their artwork data, including querying active te

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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WHO grants Sinopharm’s COVID-19 vaccine emergency approval

Pharma Times

First COVID-19 jab developed by a non-Western company to gain this recommendation

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Biogen gene therapy misses goal in eye disease study

Bio Pharma Dive

The results are a setback for Biogen, which spent $800 million two years ago to acquire the treatment's developer, Nightstar Therapeutics.

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Cellino Develops Scalable, Closed-Loop System for Autologous Stem Cell Manufacturing

BioSpace

Cellino’s unique blend of lasers and machine learning is transforming the manufacture of autologous stem cell therapies from an inconsistent hand-crafted endeavor to a scalable, efficient, closed-loop, modern process.

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BioNTech to build mRNA manufacturing facility in Singapore

BioPharma Reporter

BioNTech plans to expand its global footprint with a regional headquarters for South East Asia in Singapore; as well as a fully integrated mRNA manufacturing facility.

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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.