Sat.Jul 09, 2022 - Fri.Jul 15, 2022

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Moderna founder launches Apriori with $50M to stay ahead of virus variants

Bio Pharma Dive

Flagship Pioneering’s latest startup aims to use predictive technology to find “variant-proof” treatments and vaccines for infectious diseases before they might be needed.

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California’s low-cost insulin plans receive $100m manufacturing boost

Pharmaceutical Technology

Insulin prices made the headlines again as California governor Gavin Newsom announced plans on 7 July for the state to manufacture low-cost insulin. In a budget change proposed in February and confirmed in May , California’s Department of Health Care Access and Information (HCAI) requested a one-time investment of $100 million for Newsom’s CalRx Biosimilar Insulin initiative.

Insulin 328
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Pharma’s platinum handcuffs

World of DTC Marketing

To address the “retention” problem, pharma companies are paying employees exorbitant salaries. The problem with that system is that people do whatever they need to to “hold onto” their high-paying jobs and become employees who are content not to excel. This is NOT what pharma needs. Last week I briefly chatted with someone in the industry evaluating another job offer.

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New Anti-Hangover Pill Claims to Rapidly Break Down Alcohol, But Does It Work?

AuroBlog - Aurous Healthcare Clinical Trials blog

A new anti-hangover supplement has just gone on sale in the UK. It is marketed by Swedish firm Myrkl as “the pre-drinking pill that works” The pill is said to break down up to 70 percent of alcohol after 60 minutes. This means that if someone drinks 50 ml of 40 percent spirits, which contains […].

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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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Agios CEO to step down, handing role to veteran in rare disease drug sales

Bio Pharma Dive

A former Celgene executive, Jackie Fouse has led Agios since 2019, overseeing its transformation into a company focused solely on uncommon diseases. In August, she will transition to chair its board of directors.

Sales 312
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Vertex signs agreement to acquire ViaCyte for $320m

Pharmaceutical Technology

Vertex Pharmaceuticals has signed a definitive agreement for the acquisition of biotechnology company ViaCyte in a deal totalling $320m in cash. ViaCyte focuses on offering new stem cell-derived cell replacement therapies as a functional cure for type 1 diabetes (T1D). Through the acquisition, Vertex plans to advance its potentially curative VX-880 programmes in T1D.

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The WHO Is About to Decide if Monkeypox Has Become a ‘Global Public Health Emergency’

AuroBlog - Aurous Healthcare Clinical Trials blog

The World Health Organization said Wednesday it will reconvene its monkeypox experts to decide if the worsening outbreak now constitutes a global public health emergency – the highest level of alert. The UN health agency’s director-general Tedros Adhanom Ghebreyesus said he would hold a second meeting of the emergency committee on monkeypox, with more than […].

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Vertex acquires another maker of potentially curative diabetes treatments

Bio Pharma Dive

For $320 million, Vertex said it plans to buy ViaCyte in a deal that would provide “complementary assets, capabilities and technologies” to the ones it picked up through the 2019 acquisition of Semma Therapeutics.

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AI in IVF: a fertile field

Pharmaceutical Technology

Despite entering its fourth decade of availability, in vitro fertilization (IVF), a medical technique used to facilitate the conception of a baby for those facing fertility problems, remains an elusive dream for many. Artificial intelligence (AI) could change this, with many researchers looking to harness the technology to increase IVF’s reliability, affordability, and availability.

In-Vitro 264
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The new 988 crisis number is about to launch. Here's what to know

NPR Health - Shots

Mental health advocates hope the new hotline will make it much easier to get support if you're in crisis or helping someone who is. Here's how it works and what could stand in its way.

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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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New Studies Link Air Pollution With Autoimmune Disorders, Chronic Diseases

AuroBlog - Aurous Healthcare Clinical Trials blog

The link between air pollution and autoimmune diseases just got a little clearer thanks to a massive study that dove into the health records of over 6 million Canadians. Led by public health researcher Naizhuo Zhao of McGill University, the study found that long-term exposure to air pollutants was associated with a slightly increased […].

Research 204
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Ultragenyx sells rare disease drug royalties to Canadian pension fund

Bio Pharma Dive

In exchange for $500 million, the fund, called OMERS, will get a 30% royalty on future sales of Ultragenyx’s drug Crysvita in the U.S. and Canada, where it’s approved to treat two rare conditions.

Drugs 306
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Health Canada grants approval for Moderna’s Covid-19 vaccine in children

Pharmaceutical Technology

Health Canada has granted approval for the usage of Moderna’s messenger RNA (mRNA) Covid-19 vaccine, Spikevax, in a 25µg two-dose regimen for active immunisation to prevent Covid-19 in children aged six months to five years. So far, children aged below five years were not eligible to receive the Covid-19 vaccine in Canada. The two-dose initial vaccine regimen in children of this age group is completed in one month, which is the same dosing schedule in adults, adolescents and children aged above

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Pharmacies may violate civil rights if they refuse meds linked to abortion, feds warn

NPR Health - Shots

Pharmacists refusing to fill prescriptions for medications used for abortion could be violating civil rights law. The meds are also used to treat miscarriages, arthritis and ulcers.

Pharmacy 145
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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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COVID Lockdowns Exposed The Complex Ways We Respond to Loneliness

AuroBlog - Aurous Healthcare Clinical Trials blog

The COVID-19 pandemic has seen multiple lockdowns in multiple countries as governments have tried to limit transmission – and a new study uses those lockdowns to look at how we experience isolation and feelings of loneliness. What’s clear is that we all experience being on our own differently. For some people, it can be damaging […].

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EMA adds allergic reaction warning to Novavax's COVID-19 vaccine

Bio Pharma Dive

The regulator said there have been “a few” spontaneous severe allergic reactions following administration of the vaccine, which was this week authorized in the U.S.

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Merck and Orion enter partnership to develop ODM-208 for prostate cancer

Pharmaceutical Technology

Merck (MSD outside North America) and Orion have entered an international agreement to develop and market the latter’s investigational candidate ODM-208 to treat metastatic castration-resistant prostate cancer (mCRPC). Under the deal, the companies will also develop various other drugs that act on cytochrome P450 11A1 (CYP11A1), an enzyme vital for steroid production.

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The visa hurdle: Why conference applicants from the global south can't always clear it

NPR Health - Shots

Global health meetings are often held in the West — and that's an obstacle for scientists, doctors and advocates from lower resource countries. Which means their voices aren't being heard.

Doctors 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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A Common ADHD Drug Shows Promise in Treating Some Symptoms of Alzheimer’s

AuroBlog - Aurous Healthcare Clinical Trials blog

The search for a way to treat Alzheimer’s disease has puzzled scientists for decades. This may be why some researchers are shifting their focus slightly, investigating whether treating the systems affected by Alzheimer’s (as opposed to the causes) may better help them find a treatment. This is exactly what researchers of a new study have […].

Scientist 193
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FDA clears Novavax's COVID-19 vaccine as 4th option in US

Bio Pharma Dive

The regulator’s decision comes more than a year after the main part of the principal trial was completed, raising questions about the shot’s effectiveness against omicron.

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Supply chain & logistics innovation among pharma companies has dropped off in the last year

Pharmaceutical Technology

Research and innovation in supply chain & logistics in the pharmaceutical sector has declined in the last year. The most recent figures show that the number of supply chain and logistics related patent applications in the industry stood at 17 in the three months ending May - down from 21 over the same period in 2021. Figures for patent grants related to supply chain and logistics followed a similar pattern to filings - shrinking from 2 in the three months ending May 2021 to 1 in the same per

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Animal rescue groups across the U.S. band together to rescue 4,000 beagles

NPR Health - Shots

A federal judge ordered thousands of dogs to be rehomed from a Virginia research facility after several inspections revealed poor conditions. Animal rescue groups are working to do just that.

Research 144
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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.

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In the label ‘adult failure to thrive,’ medicine reveals its own failures

STAT News

The death certificate made everything worse. Seth Fischer was already angry: a physical feeling, an overwhelming internal buzz. He would go for runs, only to find himself passing the white bulk of mobile morgues, refrigeration whirring — and his mind would end up back on his dad, in respiratory distress, dying of Covid or Alzheimer’s, he’d never know which.

Medicine 137
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Novartis, Beigene cancer drug faces delay as FDA puts off approval decision

Bio Pharma Dive

The deferral puts the drug in regulatory limbo, setting back the Swiss pharma's efforts to catch up to top immunotherapy developers Merck, Bristol Myers Squibb and Roche.

Drugs 284
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How long do clinical trial phases take?

Antidote

Before a potential new therapy can be administered to patients, it must go through several clinical trial phases designed to test the drug or device for safety and effectiveness. For many new treatments, it will take approximately ten years for the therapy to progress from initial discovery to being approved. Clinical trials alone take six to seven years on average to complete.

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These Brazilian besties are inventing an mRNA vaccine as a gift to the world

NPR Health - Shots

Pfizer and Moderna have refused to divulge details of how to make their cutting-edge COVID shots. Here's what two scientists — and longtime best friends — are doing about it.

Scientist 145
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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.

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Moderna’s Nipah virus mRNA vaccine enters Phase 1 trial

BioPharma Reporter

Moderna has dosed the first participant in a Phase 1 trial of its Nipah virus vaccine candidate, mRNA-1215, that has been developed in collaboration with the US National Institutes of Health (NIH).

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Royalty Pharma buys rights to top-selling GSK drug in pair of deals

Bio Pharma Dive

The prolific biopharma dealmaker is paying Theravance $1.1 billion and Innoviva $282 million to acquire rights to royalties on GSK’s asthma and COPD drug Trelegy Ellipta.

Drugs 277
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NYC will use a one-dose monkeypox vaccine strategy to stretch supplies, despite FDA, CDC warnings against the move

STAT News

New York City’s Health Department announced Friday it will speed up the delivery of first doses of monkeypox vaccine to people in the city at high risk of contracting the disease. The move, it warned, may delay the city’s ability to dole out second doses to those who’ve been vaccinated — which would run counter to advice from the Food and Drug Administration and the Centers for Disease Control and Prevention.

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Many try to return to normal from COVID, but disabled people face a different reality

NPR Health - Shots

With COVID safety protocols rescinding around the country, many are returning to a sense of pre-pandemic normalcy. But disabled and immunocompromised people can't do so, and are being left behind.

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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.