September, 2022

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In surprise result, Alzheimer’s drug from Eisai, Biogen shows benefit in large trial

Bio Pharma Dive

The companies said the drug, called lecanemab, met all of its goals in the Phase 3 study. The data are a significant finding and provide stronger support for a much-debated hypothesis for treating Alzheimer’s.

Drugs 363
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Novo Nordisk partners with Microsoft for AI-driven drug discovery

Pharmaceutical Technology

Novo Nordisk has signed a new strategic partnership with Microsoft to expedite the discovery and development of drugs leveraging big data and artificial intelligence (AI). Under the deal, Microsoft's computational services, Cloud and artificial intelligence (AI) will be merged with the drug discovery, development and data science expertise of Novo Nordisk.

Drugs 348
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Fungi find their way into cancer tumors, but what they’re doing there is a mystery

STAT News

For a while, scientists thought the trillions of microbes on our bodies lived in landscapes connected to the outside world — our skin, hair, and gut — but research in the last few years has shown that’s not so. When Ravid Straussman, a cancer biologist at the Weizmann Institute of Science in Israel, looked deeper, he and several other research groups around the world found bacteria in the milieu of tumors.

Bacteria 145
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After being bitten by a rabid fox, a congressman wants cheaper rabies treatments

NPR Health - Shots

California Rep. Ami Bera was bitten by a rabid fox on Capitol Hill in April. He's OK, but now, he wants to make sure the cost of the lifesaving treatment isn't a burden for those who need it.

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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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Arcturus announces $63m award from US government to support development of self-amplifying mRNA vaccine

BioPharma Reporter

Arcturus Therapeutics has obtained an award for up to $63.2m from the Biomedical Advanced Research and Development Authority (BARDA): allowing the company to expand its current influenza vaccine program to include development of a pandemic influenza vaccine based on its proprietary self-amplifying mRNA platform.

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The discovery of a new and compounding cybersecurity threat to pharmacies

pharmaphorum

Sam Crowther, founder and CEO of cybersecurity company Kasada, tells us about a recent discovery his company made that revealed tens of thousands of accounts with prescription drug attachments in major online pharmacies had been compromised. While performing analysis for a client of online accounts for sale, Kasada uncovered a new and illegal way bots are being used – to steal pharmacy customers’ accounts and resell prescriptions on a secondary market for in-demand substances, such as Oxyc

Pharmacy 138

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Micro-robots, smart toilets, and 3D bioprinted organs: the future of healthcare

Pharmaceutical Technology

It is the year 2030. You have just received the results from your whole genome sequencing test, offered through your public health provider, and discovered that you have a 75% chance of developing a rare form of cancer. But you are not panicking; your genomic data was automatically uploaded, with your permission, to your electronic health record (EHR), which is fully secured with blockchain technology.

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Opinion: Doctors who knowingly spread Covid-19 lies should be held accountable

STAT News

The California State Legislature has sent a bill to Gov. Gavin Newsom that strengthens discipline for doctors who knowingly spread Covid-19 misinformation. Legislation like this is sorely needed across the country. More than two years into the pandemic, Covid-19 misinformation still runs rampant. Some comes from doctors spreading lies about unproven — and actually harmful — “treatments” for Covid-19 and promoting anti-vaccine conspiracy theories.

Doctors 145
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A box of 200 mosquitoes did the vaccinating in this malaria trial. That's not a joke!

NPR Health - Shots

Volunteers for the trial put an arm over a box with hundreds of mosquitoes carrying a genetically modified malaria parasite. Here's why they did it that way — and why the trial holds promise.

Trials 145
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Novo Nordisk teams up with Microsoft for faster and scaled use of AI in drug discovery

BioPharma Reporter

Novo Nordisk and Microsoft have entered a new strategic collaboration to combine Microsoftâs computational services, cloud, and artificial intelligence (AI) with Novo Nordiskâs drug discovery, development, and data science capabilities.

Drugs 129
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Running Decentralized Trials at Scale: Planning for Success

There’s been a rapid shift towards decentralization in clinical trials & it’s clear why. The potential for reaching a larger pool of recruits is possible when sponsors can bring more trial activities to the patient. Tele visits, digital consent, new monitoring sensors, & direct-to-patient supply are virtual tools that existed before the pandemic, but now there’s swift adoption of these methods because they’ve been proven to help launch & complete trials more effectively.

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FDA drops PreCert report, new digital health guidances

pharmaphorum

The US FDA’s Center for Devices and Radiological Health (CDRH) dropped a bevy of new digital health guidances and reports today and yesterday, providing some long-awaited clarity and peeks into the agency’s future plans. . The Pre-Cert pilot report. The push started yesterday with the 31-page key findings report from the FDA Pre-Certification Program pilot.

Radiology 135
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Sarepta asks FDA to approve first gene therapy for Duchenne muscular dystrophy

Bio Pharma Dive

The application comes a year earlier than previously had been expected, as company says drug reviewers are open to accelerated review based on data from early-stage trials.

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Tetra and Cellvera partner to develop oral Covid-19 treatment

Pharmaceutical Technology

Tetra Bio-Pharma and Cellvera have entered an agreement to jointly develop ARDS-003 as an oral combination therapeutic candidate with 400mg Qifenda (Favipiravir) for Covid-19. A first-in-human drug product, ARDS-003 contains the active pharmaceutical agent, Onternabez. Onternabez is a selective full agonist of the type 2 cannabinoid receptor (CB2R).

RNA 331
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On the Texas-Mexico border, a bold plan to diversify Alzheimer’s research takes shape

STAT News

BROWNSVILLE, Texas — Gladys Maestre is on a scouting mission. The Alzheimer’s disease researcher is driving through Southmost, a Mexican American neighborhood just north of looming sections of the border wall and a checkpoint that leads to Mexico. She passes barking dogs and “no trespassing” signs, but doesn’t see a single person outside, despite the comfortable stuffed recliners, refrigerators, and shade canopies that furnish many yards.

Research 145
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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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J&J tried to block lawsuits from 40,000 cancer patients. A court wants answers

NPR Health - Shots

Critics say a legal maneuver by one of the world's wealthiest corporations could set a precedent, allowing non-bankrupt companies and rich individuals to avoid liability for wrongdoing.

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Benchling launches purpose-built tools to accelerate RNA R&D

BioPharma Reporter

Technology firm, Benchling, has developed what it calls the biopharma industryâs first set of full capabilities for designing, modelling, and studying both natural and chemically modified RNA in a single platform.

RNA 119
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The future of AI drug discovery & development in immunology and GPCR research

pharmaphorum

Alphabet subsidiary and precision health company Verily recently announced a breakthrough in its AI drug discovery GPCR research collaboration with Sosei Heptares. A mere six months ago Verily launched the study with Sosei Heptares – a global leader in GPCR structure-based drug design – with an aim to “prioritise protein targets for therapeutic targeting in immune-mediated disease”.

Drugs 135
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Sangamo presses ahead with Fabry disease gene therapy

Bio Pharma Dive

Preliminary results from a Phase 1 study show Sangamo’s treatment to be safe and suggest it is working as intended, leading the biotech to move into the trial’s next phase.

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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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bluebird bio wins back-to-back landmark FDA approvals for first-in-class gene therapies

Pharmaceutical Technology

After several setbacks, bluebird bio bounces back with two major FDA gene therapy approvals. Last month, Zynteglo (betibeglogene autotemcel), or beti-cel, was approved as a one-time potentially curative gene therapy for patients with beta-thalassaemia who require regular blood transfusions. Shortly after this, the FDA announced the accelerated approval of bluebird's Skysona (elivaldogene autotemcel), or eli-cel, on 19 September.

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Where caregiving is a family affair, Alzheimer’s places a heavy burden on children and spouses

STAT News

HARLINGEN, Texas — Here in the Rio Grande Valley almost everyone knows, or cares for, someone with dementia. It’s not a surprise. The region has some of the nation’s highest rates of the disease. But what’s less appreciated is the enormity of the burden carried by the mostly Mexican American caregivers. In a culture where caregiving is a family affair, it’s almost unthinkable for children and spouses to place loved ones in nursing facilities or ask for outside

Nurses 145
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Scientists debate how lethal COVID is. Some say it's now less risky than flu

NPR Health - Shots

They argue the threat posed by COVID has lessened because of preexisting immunity and access to treatment. Plus, some deaths may be incorrectly blamed on COVID. Others caution it's too soon to tell.

Scientist 145
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Intranasal TIPs therapy study shows potential to reduce COVID-19 transmission

Outsourcing Pharma

Gladstone Institutes seek FDA approval for human clinical trial after single-dose, intranasal TIPs treatment for SARS-CoV-2 infection limits transmission in infected animals by decreased viral shedding.

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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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Bridge Bio will use Brainomix AI in lung fibrosis trial

pharmaphorum

Brainomix has reeled in another pharma partner for its artificial intelligence-powered biomarker software, used to track the performance of therapeutic interventions in clinical trials. South Korea’s Bridge Biotherapeutics has signed up to use the UK medtech firm’s e-ILD software package in a phase 2 trial of BBT-877, its experimental therapy for serious lung disease idiopathic pulmonary fibrosis (IPF).

Trials 128
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FDA, NIH initiative aims to speed development of drugs for ALS, other brain diseases

Bio Pharma Dive

The public-private partnership plans to bring together scientific experts, private entities and patient groups to better understand certain neurodegenerative disorders and find new treatments.

Drugs 354
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AstraZeneca on the hunt for new acquisitions

Pharmaceutical Technology

Following AstraZeneca’s success in vaccine development during the Covid-19 pandemic , the pharmaceutical giant is now looking to expand its scope through acquisitions across a range of indications, says CEO Pascal Soriot. “We want to be a sustainably growing company. Until 2025, we have strong growth ahead of us, but we also believe we can continue to grow very strongly post-2025 and it’s all about innovation in the pipeline.”.

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Ebola experimental vaccine trial may begin soon in Uganda

STAT News

A clinical trial of one or perhaps two experimental vaccines designed to protect against the Ebola Sudan virus could soon begin in Uganda, as long as the country agrees to allow the research to take place, an official of the World Health Organization said Wednesday. The trial could get underway within a couple of weeks and definitely before the end of October, said Ana Maria Henao-Restrepo, who heads WHO’s R&D Blueprint effort to develop drugs, diagnostics, and vaccines to respon

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Mandatory COVID Vaccination Policy Template

New vaccine mandates and testing policies will affect employers with more than 100 workers. Get Paycor’s free, customizable vaccination policy template to communicate critical details and new requirements to your employees. Get Paycor’s Template today!

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New York's subway now has a 'you do you' mask policy. It's getting a Bronx cheer

NPR Health - Shots

Millions of New Yorkers embraced an "all in this together" motto during the pandemic — and many are roasting the city's transit agency over updated signs explaining its newly relaxed masking policy.

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NIH launches new program to expand use of AI in biomedical research

BioPharma Reporter

The US National Institutes of Health plans to invest $130m in accelerating the widespread use of artificial intelligence (AI) by the biomedical and behavioral research communities through its Bridge2AI program.

Research 111
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Novartis probed by Swiss authorities over ‘unlawful’ patent use

pharmaphorum

The competition authorities in Switzerland said this morning they have carried out a raid on a pharma company – now confirmed to be Novartis – as part of an investigation into a “possible unlawful use of a patent to reduce competitive pressure.” The Swiss Competition Commission (COMCO) arrived unexpectedly at Novartis at dawn on Tuesday morning, to gather information on an unidentified dermatology drug, as part of a wider investigation into the drugmaker by the European Commission.

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FDA advisers back Amylyx ALS drug, reversing earlier position

Bio Pharma Dive

Committee members voted 7-2 in support of the experimental medicine, which is under a closely watched FDA review. A decision on approval is expected by the end of the month.

Drugs 352
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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.