September, 2021

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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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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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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 151
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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.

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

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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 143
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Telling it how it is: The need for plain language summaries in medical journals

BioPharma Reporter

Open Pharma wants to see articles in peer-reviewed medical journals provide plain language summaries: those written in everyday language that is easy to understand by anyone from patients to policymakers. It's now set out its recommendations on how to write a good plain language summary.

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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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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

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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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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 133
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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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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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FDA advisers support booster dose of Pfizer vaccine in older or high-risk adults

Bio Pharma Dive

In a back-and-forth meeting Friday, the committee opposed clearing a third shot widely for use in people older than 16, but agreed the benefits outweighed the risks for adults over 65 or those at risk of severe COVID-19.

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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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Growing Glioblastomas in a Laboratory: 3D Bioprinting a Better Brain Model

BioSpace

This newfound ability to take tumor cells directly from a patient and incorporate them into a more clinically accurate glioblastoma model could lead to greater patient personalization in cancer therapeutics.

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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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Research identifies possible link between antibiotic use and breast cancer growth

Pharma Times

Researchers discovered that treating mice with broad-spectrum antibiotics increased the rate at which their breast cancer tumours grew

Research 122
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Real-world study suggest AI may improve atrial fibrillation screening

pharmaphorum

An artificial intelligence algorithm already shown to be able to detect atrial fibrillation (AF) in clinical testing has also shown its worth in a real-world setting, according to its developers. The AI – developed by the Bristol Myers Squibb-Pfizer Alliance on cardiovascular disease – was developed using machine learning from a UK dataset of almost 3 million patients and previously found to be more effective than existing testing at identifying patients at risk of AF based on retrospective stud

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CyanVac starts Phase 1 clinical trial for intranasal COVID-19 vaccine

BioPharma Reporter

CyanVac LLC and its subsidiary, Blue Lake Biotechnology, Inc., have enrolled the first participant in a Phase 1 clinical trial of their intranasal COVID-19 vaccine in Rochester, NY.

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CDC panel clears way for Pfizer booster shots, but divided on broader use

Bio Pharma Dive

Agency advisers supported giving a third Pfizer vaccine dose to older adults and those with medical conditions. But in a break with the FDA, they voted against recommending it for younger people in high-risk jobs.

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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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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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Pharma in the Courts: Takeda, AbbVie, RedHill, Pfizer and Gilead

BioSpace

Aside from the fraud trial of Theranos founder Elizabeth Holmes, other court-related cases are taking place, including between Takeda and AbbVie over cancer drug, Lupron.

Trials 121
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Dr. Daniel Pauly’s extraordinary life and work revealed in new book

Scienmag

Dr. Daniel Pauly is the world’s most-cited fisheries scientist, but life for the UBC professor has been far from easy. The biracial son of a French woman and an American GI, he was born in Paris and kidnapped as a child to be a live-in servant for a Swiss family. He escaped to Germany at […].

Scientist 110
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Barts Health NHS Trust launches app for cognitively impaired

pharmaphorum

An app to support people with cognitive disabilities, developed with clinicians at Barts Health NHS Trust, has started to be made available more widely to patients. The Hear Me Now app developed with UCLPartners and software company Maldaba is designed to improve quality of care for people with cognitive impairment, specifically adults with a learning disability.

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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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Plant-based biopharma firm iBio licenses novel antibody targeting regulatory T cells

BioPharma Reporter

Anti-CD25 antibodies have emerged as one of the most promising next-generation cancer therapeutics, says US plant-based manufacturer of therapeutics and vaccines, iBio, as it enters the field.

Antibody 111
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Theravance to lay off 75% of employees alongside larger restructuring

Bio Pharma Dive

The move, which will affect an estimated 270 positions, follows a review by the company's board, and comes just weeks after one of its most advanced drugs failed a key test.

Drugs 341
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The right tech can add real-world context to clinical trials: Sharecare

Outsourcing Pharma

According to a leader from the health engagement solutions firm, intelligent use of technology tools can add patient-centricity and realism to a study.

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Llama Nanobodies May be Missing Link in COVID-19 Therapeutics

BioSpace

Monoclonal antibodies play a key role in the treatment of COVID-19, but new research suggests that nanobodies derived from llamas could provide an alternative to monoclonal antibodies.

Antibody 111
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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

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TDP-43 DNA methylation may contribute to the mystery of age-dependent motor cortex involvement in ALS

Scienmag

Niigata, Japan – Amyotrophic lateral sclerosis (ALS) is an intractable neurological disease. Aging is a risk factor for the accumulation of TDP-43 (transduction responsive region DNA-binding protein of 43kDa) in the motor cortex. TDP-43 is a protein that tends to accumulate in increasing amounts, and the amount is strictly controlled by the splicing of TDP-43. […].

DNA 108
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Novavax files its COVID jab to WHO for emergency use listing

pharmaphorum

Novavax and its partner Serum Institute of India have applied to the World Health Organization for an emergency use listing for their COVID-19 vaccine, based on a conventional recombinant protein technology. Getting a WHO emergency use listing (EUL) is a requirement for approvals by many national regulatory authorities, as well as for participation in the COVAX mechanism, which has been set up to procure COVID-19 vaccines for lower-income countries.

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Purdue Pharma Is Dissolved and Sacklers Pay $4.5 Billion to Settle Opioid Claims

NY Times

The ruling in bankruptcy court caps a long legal battle over the fate of a company accused of fueling the opioid epidemic and the family that owns it.

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Worrisome side effects lead Pfizer to narrow Duchenne gene therapy trial

Bio Pharma Dive

Outside trial data reviewers have attributed three cases of severe muscle weakness to Pfizer’s treatment, causing the company to change the design of its closely watched Phase 3 study.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time