October, 2022

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Cloud robotics labs are accelerating drug discovery and development

Pharmaceutical Technology

Drug discovery and development is an incredibly expensive and time-consuming process, taking between 12 and 18 years, and costing on average between $2 billion and $3 billion. Considering the low chances of success, with only 10% of drug candidates making it into clinical development, pharma companies must prevent the increased erosion of profit margins.

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With new startup, immunotherapy pioneer Lieping Chen tries to turn ‘cold’ tumors ‘hot’

Bio Pharma Dive

Chen, who discovered the cancer-protecting protein PD-L1, will work closely with startup Normunity to find targets that can help the immune system reach ‘cold’ tumors.

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Actinium eyes filing as conditioning drug for AML aces trial

pharmaphorum

Actinium Pharma is on course to submit its targeted radiotherapy for acute myeloid leukaemia (AML) patients needing a bone marrow transplant in the US, buoyed by top-line data from a pivotal trial. The New York biotech said today that the SIERRA trial of Iomab-B – an antibody armed with a radioisotope designed to deliver targeted treatment to tumours and spare healthy tissues – met its primary objective.

Trials 124
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The hidden faces of hunger in America

NPR Health - Shots

More than 1.2 million people struggled to put food on the table at some point last year in the Washington, D.C. region. Tens of millions more are struggling across the country.

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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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Boston University researchers’ testing of lab-made version of Covid virus draws government scrutiny

STAT News

Research at Boston University that involved testing a lab-made hybrid version of the SARS-CoV-2 virus is garnering heated headlines alleging the scientists involved could have unleashed a new pathogen. There is no evidence the work, performed under biosecurity level 3 precautions in BU’s National Emerging Infectious Diseases Laboratories, was conducted improperly or unsafely.

Research 145
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Bridging the Translational Gap between Alzheimer’s Advances and Patients

BioSpace

With diagnostics for Alzheimer's already approved and therapeutics in late-stage clinical trials, the next hurdle is to translate these advances into clinical practice. The Davos Alzheimer's Collaborative is working on it.

More Trending

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‘In vivo’ cell therapy: expanding beyond CAR-T

Bio Pharma Dive

At least five startups have emerged with new ways to genetically modify immune cells within the body, an approach that, if successful, could widen the field of CAR-T treatment.

In-Vivo 359
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Meet Florence, WHO’s AI-powered digital health worker

pharmaphorum

An artificial intelligence-powered digital health worker has been unveiled by the World Health Organisation (WHO) as its latest tool for disseminating reliable health information to the public. Originally developed by New Zealand tech company Soul Machines with support of the Qatar Ministry of Health, the first version of the virtual health worker was used to combat misinformation about the pandemic.

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What it's like being an abortion doula in a state with restrictive laws

NPR Health - Shots

"I'm an abortion doula, I fund people's abortions, I make sure they can get to their appointments, period," said Ash Williams of North Carolina. "I can do that. I just need to keep doing that.

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Opinion: Maternity care in the U.S. is in crisis. It’s time to call the midwife

STAT News

After pushing for several hours, my patient looks exhausted but happy, clutching her seconds-old newborn to her chest. As I help her put her baby to breast for the first time, she isn’t thinking about anything other than the tiny human blinking up at her. As well she shouldn’t.

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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

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Innovative Sites and CROs Find Ways to Retain Top Talent

ACRP blog

Talent poaching. Aggressive recruiters. Signing bonuses. No, it’s not the National Football League draft. It’s actually the shocking state of play today in the world of clinical trial staffing, where clinical research coordinators (CRCs) and clinical research associates (CRAs) are being courted like star athletes, and sites and contract research organizations (CROs) are left reeling as they try to cobble together study teams amidst turnover, burnout, and rising demand for trials.

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Lilly agrees to acquire gene therapy developer Akouos for $610m

Pharmaceutical Technology

Eli Lilly and Company has signed a definitive agreement for the acquisition of all outstanding shares of precision genetic medicine firm Akouos for a total deal value of up to nearly $610m or up to $15.50 for each share in cash. The deal comprises an acquisition value of $12.50 for each share in cash payable at closing along with one non-tradeable contingent value right per share (CVR) of up to another $3 in cash.

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CAR-T pioneer Carl June on founding biotech startups and cell therapy’s next act

Bio Pharma Dive

The University of Pennsylvania immunologist and inventor of Kymriah spoke with BioPharma Dive about working with pharma, starting companies and the future of the cell therapy field.

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Verge Genomics takes AI-sourced drug for ALS into clinic

pharmaphorum

Verge Genomics has joined a select group of biotechs who have taken a drug discovered and developed using artificial intelligence into human testing. The small-molecule PIKfyve inhibitor – called VRG50635 – has been administered to the first subject in the phase 1 trial involving healthy volunteers, according to the San Francisco-based biotech, which was founded in 2015 by Alice Zhang and Jason Chen.

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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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'Where is humanity?' ask the helpless doctors of Ethiopia's embattled Tigray region

NPR Health - Shots

Civil war has blockaded the country's northern region and decimated a hospital system that serves nearly 7 million people. Without basic supplies, power and medicine, thousands are needlessly dying.

Doctors 145
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Opinion: Messaging — the unrecognized coefficient in pandemic control — matters

STAT News

A little over a century ago, scientists working in laboratories discovered that microbes were the cause of many epidemics. Once they understood that, they began to put their faith more and more in laboratory science. This major transformation, called the bacteriological revolution, began in the 1880s. During this period, diphtheria was one of the leading causes of death among mostly poor children in New York City.

Scientist 145
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Positive in vitro results for Imutex’s FLU-v

Pharma Times

Data further supports the continued development of FLU-v as a broad-spectrum influenza vaccine

In-Vitro 158
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Provention and Sanofi enter deal to launch teplizumab for type 1 diabetes

Pharmaceutical Technology

Provention Bio and Sanofi US have signed a co-promotion agreement to launch the former’s lead investigational drug candidate, teplizumab for the delay in the onset of clinical type 1 diabetes (T1D). The agreement aids Provention in leveraging the capabilities and commercial resources of Sanofi to back teplizumab’s launch. The US Food and Drug Administration (FDA) is presently reviewing teplizumab for the delay of clinical T1D in people who are at risk.

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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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A Versant-backed biotech emerges to take on ‘overlooked’ cancer targets

Bio Pharma Dive

Nested Therapeutics touts a deep bench of scientific leaders and advisers, including Kevan Shokat, whose work drugging KRAS — a cancer-related gene once thought to be undruggable — helped lead to the development of Amgen’s Lumakras.

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Janssen leads effort to cut waste in digital health devices

pharmaphorum

A consortium of industry and academic groups – led by Johnson & Johnson’s pharma division Janssen – has been set up to tackle the environmental impact of digital health products, specifically aimed at minimising waste that could end up in landfill. The Digital Health in a Circular Economy (DiCE) group was formed earlier this year with the aim of developing ways to “design, collect, directly reuse, refurbish, remanufacture, and recycle digital health devices.” The programme

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A parents' lawsuit accuses Amazon of selling suicide kits to teenagers

NPR Health - Shots

Amazon sold the food preservative sodium nitrite, which lawyers say has no household use at high purity levels, to people who later killed themselves using the substance, the suit claims. (Image credit: Patrick T.

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Human neurons implanted in a rodent’s brain lead a rat to water — and make it drink

STAT News

The scientist flicked on a laser, filling the rat’s brain with blue light. The rodent, true to its past two weeks of training, scampered across its glass box to a tiny spout, where it was duly rewarded with a drink of water. From the outside, this would appear to be a pretty run-of-the-mill neuroscience experiment, except for the fact that the neurons directing the rat to its thirst-quenching reward didn’t contain any rat DNA.

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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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‘Junk’ DNA may hold the key to neurological disorders

Pharma Times

University of Lincoln and the University of Sheffield are researching how DNA could be repaired

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Merck and Moderna partner to develop and sell cancer vaccine

Pharmaceutical Technology

German pharmaceutical firm Merck has extended its partnership with Moderna to jointly develop and sell mRNA-4157/V940, an investigational personalised cancer vaccine (PCV). In 2016, the companies entered a strategic partnership to develop novel messenger RNA (mRNA) based PCVs. They subsequently expanded the collaboration to include the development of antigen mRNA cancer vaccines in 2018.

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AstraZeneca to acquire gene editing biotech LogicBio

Bio Pharma Dive

Shares in LogicBio had lost nearly all their value since a 2018 IPO, bringing the company to the brink of Nasdaq delisting. The buyout deal represents a premium of over 600%.

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Innovative Medicines Fund and the opportunity for ICSs to mobilise NICE approvals

pharmaphorum

In June, NHSE and NICE published details on the Innovative Medicines Fund, which will help improve patient access to cutting-edge medicines, with a particular focus on rare diseases, and ensure global pharmaceutical and biotech organisations continue to prioritise the UK as a launch destination. Join us on Wednesday 23rd November at 12:30 GMT / 13:30 CET / 7:30 am EST as the panel discuss how the Innovative Medicines Fund works, what the implications are for industry organisations in securing fu

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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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Omicron keeps finding new evolutionary tricks to outsmart our immunity

NPR Health - Shots

SARS-CoV-2 is evolving "rapidly," spawning one new variant after another. But omicron continues to dominate, raising new questions about how evolution of the virus is headed.

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STAT+: European Prosecutor’s Office confirms it’s investigating European Union Covid vaccine contracts

STAT News

In an unusual step, the European Public Prosecutor’s Office (EPPO) confirmed it has opened an investigation into the Covid-19 contracts signed by the European Union, a move that comes shortly after numerous members of the European Parliament harshly criticized a lack of transparency surrounding an agreement with Pfizer. The EPPO is an independent public prosecution office that is responsible for investigating, prosecuting, and bringing to judgment crimes such as fraud, money laundering an

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Kyverna Files First IND to Leverage CAR-T Therapy for Lupus

BioSpace

Kyverna Therapeutics filed its first IND application this week to test the efficacy and tolerability of KYV-101, a CAR-T therapy for lupus nephritis.

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Pfizer acquires Global Blood Therapeutics for $5.4bn

Pharmaceutical Technology

Pfizer has acquired all the outstanding shares of the common stock of biopharmaceutical firm Global Blood Therapeutics (GBT) in a deal worth nearly $5.4bn. The total enterprise value comprised debt and the net of cash acquired. With the latest acquisition, GBT became a wholly-owned Pfizer subsidiary. GBT discovers and develops life-changing therapies for ailments with an initial focus on sickle cell disease (SCD).

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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.