September, 2021

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Pfizer, Merck launch large new trials of oral COVID-19 drugs

Bio Pharma Dive

Both companies are racing to prove their oral antivirals as treatments for COVID-19. Key clinical results could come later this year.

Trials 363
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World Pharmacists Day 2021 Celebration

Pharma Mirror

25th September is celebrated as world pharmacists day, and it brings a new theme every year. The main motive behind this celebration is to give an excellent message to improve people’s health worldwide. And also, create an acceptance and encourage the role of a pharmacist in health. The pharmacist community from all over the world arranges different campaigns, exhibitions, lectures, etc., for serving this purpose.

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What is Biogen and can they repair their reputation?

World of DTC Marketing

SUMMARY: If I were to ask you, “what type of company is Biogen?” what would be your response? I tried asking that of several colleagues in the industry, and they couldn’t come up with an answer. Biogen has lost its way and is in desperate need of a corporate rebranding. This week two colleagues, who worked at Biogen, left the company because they knew that the ax was coming after the failure of Aduhelm.

Drugs 222
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In the News: August 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. Some Drugs May Require Reclassification to Devices. On August 9, the FDA published a Federal Register notice requesting information and comments regarding products currently classified as drugs which may require reclassification as devices.

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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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New report sheds light on medicine shortages in Northern Ireland following Brexit

Pharma Times

Informa Pharma Intelligence (IPI) has found that some drug firms may withdraw up to 90% of their products from Northern Ireland, once the Brexit grace period has passed.

Medicine 158
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FDA Approves First Human Trial for Potential CRISPR-Led HIV Cure

BioSpace

?The FDA's IND approval sets the stage for the very first Phase I/II trial to evaluate EBT-101 as a functional cure for chronic HIV based on the endpoints of safety, tolerability, and efficacy.

More Trending

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How pharmacists can partner with health coaches

Pharma Mirror

What is a health coach? A health coach is someone with expertise in wellness who assists people achieve good health by being a mentor and educator on lifestyle and nutritional changes. It is important to understand that health coaching is not only about nutrition, but instead, health coaches offer people a holistic approach to creating and sustaining healthy habits.

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Medicare savings won’t make a dent in healthcare costs

World of DTC Marketing

SUMMARY: Allowing Medicare to negotiate drug prices is popular with voters because the media has been focused on the high price of some drugs, but this measure won’t lead to lower healthcare costs. Still, in a JAMA study, the median net income (earnings) expressed as a fraction of revenue was significantly greater for pharmaceutical companies than nonpharmaceutical companies (13.8% vs. 7.7%).

Drugs 222
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AI could be used to guide drug therapy for heart failure

pharmaphorum

UK researchers have used artificial intelligence (AI) to develop a way to identify patients with heart failure who would benefit from treatment with beta blockers, by interrogating data from nine landmark clinical trials. The study applied machine learning to trial data involving 15,659 patients who were being treated for heart failure with reduced ejection fraction (HFrEF), a form of heart failure where the left side of the heart isn’t able to pump blood effectively around the body.

Drugs 145
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JCVI does not recommend COVID-19 vaccination for all 12 to 15-year-olds

Pharma Times

UK’s chief medical officers will now provide ‘further advice’ on COVID-19 vaccination in this age group

Vaccine 152
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Regulatory Strategy Considerations for Working with the FDA vs the EMA, Part 2

Camargo

As regulatory requirements become increasingly harmonized across the globe, the development and marketing of pharmaceutical products worldwide are also becoming more streamlined. However, global regulations are not one-size-fits-all, and sponsors aiming to market their products in multiple regions should be aware of the current standards and processes they may encounter during development.

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FDA halts tests of BioMarin drug amid heightened focus on gene therapy safety

Bio Pharma Dive

On the heels of a two-day FDA meeting in which experts debated the risks of gene therapy, the biotech said its early-stage PKU treatment was associated with cancer in mice.

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Codivir Shows Promising Effect Against COVID-19

Pharma Mirror

TEL AVIV, ISRAEL / DE BILT, NETHERLANDS – Codivir, a short synthetic 16 amino-acid peptide, derived from the HIV-1 integrase, was originally discovered at the Hebrew University in Israel. Code Pharma discovered that the peptide had a direct antiviral effect against SARS-CoV-2, the novel Coronavirus causing COVID-19. In-vitro studies conducted at the British virology research laboratory Virology Research Services in London then demonstrated a potent antiviral activity against SARS-CoV-2 and

In-Vitro 245
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Time to shape the future of DTC

World of DTC Marketing

SUMMARY: Like it or not, there will not be a return to normal for DTC marketing. The onset of wrong, inaccurate, or confusing medical information forces people to go online or talk to their doctor about treatment options. DTC marketers need to get more personal and stop using a generic formula for marketing. Visting my doctor for my annual physical, I noticed huge LCD screens in each exam room with rotating ads for everything from prescription drugs to vitamins.

Doctor 43
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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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How blockchain can revolutionise medical records and save lives

pharmaphorum

Balancing medical privacy with ease of access for healthcare professionals is a challenge, but technology could provide the solution, says Aleph Zero Foundation’s Matthew Niemerg. Most people don’t think of healthcare when they hear blockchain, and that’s understandable; the technology so far hasn’t gone much beyond financial instruments – at least, not in the eyes of the public.

Doctors 145
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Novavax begins COVID-19, flu combination vaccine trial

Pharma Times

The trial will aim to enrol 640 healthy adults, aged 50- to 70-years-old

Trials 148
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Moderna to develop mRNA therapeutic for very rare disease

BioPharma Reporter

Moderna and the nonprofit Institute for Life Changing Medicines (ILCM) are collaborating to develop a new messenger RNA (mRNA) therapeutic (mRNA-3351) for Crigler-Najjar Syndrome Type 1 (CN-1), an ultra-rare disease.

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After talks with FDA, a biotech prepares to submit its closely watched ALS drug

Bio Pharma Dive

Executives at Amylyx Pharmaceuticals said that based on the agency's recent feedback, they will ask for approval of AMX0035 — likely within the next six months.

Drugs 360
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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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Pharmacists must be mobilised to mitigate health impacts of air pollution

Pharma Mirror

The Hague, Pharmacists must be allowed to do more to manage respiratory conditions in communities if the urgent need to address the harmful effects of air pollution on health is to be met, the International Pharmaceutical Federation (FIP) said today. The expansion of pharmacists’ roles in mitigating the health threats of air pollution is among several actions described in a call to action issued by FIP, marking the United Nations International Day of Clean Air for Blue Skies.

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Of course, ageism exists in pharma

World of DTC Marketing

SUMMARY: Those working in pharma know that ageism exists, especially in the sales force. Pharma has been purging older employees for some time, and when you reach the magic age of 50+, you’re going to be pushed to take “early retirement.” My workstation while at Lilly was right next to the sales training center. Some of the trainees looked like they were right out of school, but they all had one thing in common; they were young and great-looking.

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Italian ‘chatbot’ predicted COVID-19 spikes, says study

pharmaphorum

An online tool used by people in Italy to manage their potential exposure to COVID-19 using a simple chat interface has shown that it can spot emerging trends days ahead of the national surveillance system. The decision support system (DSS) – developed by Italian digital health startup Paginemediche – provided a way for people to assess and interpret their symptoms and provide guidance on what to do next, such as self-isolate or seek out a test.

Scientist 145
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Pfizer UK, Entia partner on home blood monitoring device for breast cancer patients

Pharma Times

Through Entia’s virtual oncology platform, patients are able to perform their own blood tests

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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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How Has COVID-19 Changed the Way We Work in the Life Sciences?

XTalks

The world as we know it has changed because of the COVID-19 pandemic. We’ve adopted and embraced new technologies at a much faster pace in order to conform to these changes. Simple examples include the increased popularity of food delivery apps and at-home meal kits, but in the larger picture, the nature of working has changed entirely for many companies and people.

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Fourth trial volunteer dies in Astellas gene therapy study

Bio Pharma Dive

The study, which was suspended following three deaths last year, had been restarted in February after Astellas lowered the treatment dose used.

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Remote Patient Monitoring Industry

Pharma Mirror

Increasing burden of chronic diseases and rising awareness about necessity of early warning signs are fuelling the demand of remote patient monitors With the COVID-19 pandemic, health systems or hospitals rapidly adopted remote patient monitoring technology to maintain social distancing and thereby control viral spread. Patients suffering from COVID – 19 need to monitor blood oxygen level and heart rate regularly.

Marketing 242
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The hypocrisy of big pharma

World of DTC Marketing

SUMMARY: Pfizer will earn over 26 billion dollars from their COVID vaccine, while Moderna and J&J also look to their vaccines for more profit dollars. The suggestion by Pfizer’s CEO that drug pricing negotiations with the government would slow innovation is PR doubletalk. Recently Pfizer’s CEO sent a video message to company employees urging them to fight proposed government drug price negotiations and expressing frustration with Congress, considering using the projected savings

Vaccine 214
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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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Amazon names 10 finalists in its first digital health accelerator

pharmaphorum

Amazon’s push into healthcare takes many forms, and one is decidedly biotech-like – running an accelerator to identify and support startups with promising technology platforms. The online commerce giant’s first accelerator kicked off in June, focusing on digital health companies, and 427 applications from 31 countries around the world have now been winnowed down to 10 finalists.

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UK trial to evaluate existing drugs for secondary breast cancer

Pharma Times

Trial will test if radium-223 plus avelumab can improve outcomes for metastatic breast cancer patients

Trials 137
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Phony Diagnoses Hide High Rates of Drugging at Nursing Homes

NY Times

At least 21 percent of nursing home residents are on antipsychotic drugs, a Times investigation found.

Nurses 122
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After long wait, Editas reveals first data for CRISPR gene editing treatment

Bio Pharma Dive

Early study results offer some hopeful signs of efficacy, but the small number of patients treated and short follow-up limit firmer conclusions.

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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