Tue.Aug 02, 2022

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IDRx, a new biotech startup, raises $122M to develop better cancer drug combinations

Bio Pharma Dive

Founded by serial entrepreneur Alexis Borisy, the company comes equipped with two experimental medicines it licensed from Merck KGaA and Blueprint Medicines.

Licensing 306
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Samsung Biologics, GreenLight conclude Covid-19 vaccine engineering run

Pharmaceutical Technology

Samsung Biologics and GreenLight Biosciences have completed the initial commercial-scale engineering run for their messenger ribonucleic acid (mRNA) Covid-19 vaccine under their manufacturing collaboration. Last year, the companies entered a strategic collaboration. Subsequently, technology transfer as well as scale-up from the lab bench to the commercial facility of Samsung were carried out in a period of seven months.

Engineer 262
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AbbVie, targeting a well-known protein family, expands a partnership into neuroscience

Bio Pharma Dive

It’s the second deal in as many years between AbbVie and Sosei Heptares, which together have been trying to develop drugs that target so-called G protein-coupled receptors.

Protein 268
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Are online health searches private?

World of DTC Marketing

A Gizmodo investigation into some of the nation’s biggest data brokers found more than two dozen promoting access to datasets containing digital information on millions of pregnant and potentially pregnant people across the country. At least one of those companies also offered an extensive catalog of people using birth control targeted by more restrictive states, But is this true?

Marketing 205
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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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Strand CEO on founder-led biotech, venture capital and the market’s retreat

Bio Pharma Dive

Jake Becraft, founder and current chief of mRNA startup Strand Therapeutics, argues biotech would be healthier if more scientists and researchers lead the companies they start.

Scientist 267
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EC’s HERA signs Covid-19 vaccine procurement deal with HIPRA

Pharmaceutical Technology

The Health Emergency Preparedness and Response Authority (HERA) of the European Commission (EC) has entered a co-procurement framework contract for HIPRA HUMAN HEALTH’s bivalent recombinant protein Covid-19 vaccine. A total of 14 member states and countries are participating in this deal and can procure up to 250 million vaccine doses. . Once the HIPRA vaccine receives a positive assessment from the European Medicines Agency (EMA), this contract will aid in making the doses available rapidly to

More Trending

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Implementation of electronic health records will improve the quality of care

Pharmaceutical Technology

The increasing digitisation of the healthcare sector is enabling real-time access to patient-related data in a manner that was not previously possible. With more healthcare facilities transitioning from paper charts to electronic records and electronic health records (EHRs) becoming more integrated and technologically advanced, EHRs are expected to drive big changes in the provision of healthcare and clinical research delivery.

Big Data 162
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How Belite Bio, a small, under-the-radar drugmaker, emerged as one of biotech’s best performing IPOs

Bio Pharma Dive

Belite's shares have risen nearly 500% from their IPO price at a time when many other newly public biotech companies are struggling to hold their value.

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Sosei Heptares and AbbVie to develop therapies for neurological ailments

Pharmaceutical Technology

Sosei Heptares , a corporate brand of Sosei Group Corporation, has signed a new drug discovery partnership and option-to-license agreement with AbbVie for discovering, developing and marketing new therapies for neurological ailments. Under the deal, the companies will develop small molecules that can modulate new G protein-coupled receptor (GPCR) targets linked to neurological diseases.

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August 3, 2022: Economic Evaluation of Platform Trial Designs Featured in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

In this Friday’s PCT Grand Rounds, Dr. Jay JH Park of McMaster University will present “Economic Evaluation of Platform Trial Designs.” The Grand Rounds session will be held on Friday, August 5, 2022, at 1:00 pm eastern. Dr. Park is director of the Platform Trials Initiative in the Canadian Critical Care Trials Group and an assistant professor in the Department of Health Research Methods, Evidence, and Impact at McMaster University.

Trials 130
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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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US FDA grants approval for Janssen’s Stelara to treat psoriatic arthritis

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for the Janssen Pharmaceutical Companies of Johnson & Johnson (J&J) ’s Stelara (ustekinumab) to treat paediatric patients aged six years and above with active psoriatic arthritis (PsA). The latest approval was based on pharmacokinetic (PK) findings and extrapolation of the validated efficacy and current safety profile of Stelara in various Phase III clinical trials carried out in adult and paediatric moderate-to-severe plaque

Antibody 130
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Voters in Kansas decide to keep abortion legal in the state, rejecting an amendment

NPR Health - Shots

In the first test of its kind since the Dobbs ruling, Kansas voters have decided not to amend the state constitution, keeping abortion legal in the state — for now.

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August 2, 2022: IMPACT Collaboratory Announces New Funding Opportunities

Rethinking Clinical Trials

The NIA IMPACT Collaboratory announced requests for applications for 2 new funding opportunities: the Pilot Grant Program and the Demonstration Projects Program. These programs support research and training to increase the nation’s capacity to conduct pragmatic clinical trials of nonpharmacological interventions within healthcare systems to improve care for people living with Alzheimer disease related dementias and their care partners.

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Opinion: Life hacks from India on how to stay cool (without an air conditioner)

NPR Health - Shots

Heat wave researcher Gulrez Shah Azhar grew up in Uttar Pradesh, India, without an A/C unit. He shares tips on how to deal with the heat — including wearing a wet scarf around your neck.

Research 137
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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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Roche scores phase 3 win for subcutaneous Tecentriq, eyes filings

pharmaphorum

Roche’s Tecentriq could become the first drug in the PD-1/PD-L1 inhibitor class to be approved in a subcutaneous formulation, after the new version matched the original intravenous formulation in a phase 3 trial. The results of the IMscin001 study found that an injection of Tecentriq under the skin taking just a few minutes was non-inferior to a 30 to 60-minute infusion with the IV version in terms of pharmacokinetics – how the active ingredient behaves in the body after administration.

Trials 105
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They lost Medicaid when paperwork was sent to a pasture, signaling the mess to come

NPR Health - Shots

Tennessee expects to soon disenroll about 300,000 people from Medicaid. But families like the Lesters have been entangled in bureaucracy and clerical mistakes, causing them to unfairly lose coverage.

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How the WHO hepatitis strategy measures up in the field

pharmaphorum

According to the World Health Organization (WHO), approximately 296 million people globally live with hepatitis B, with most unaware of their infection. Africa is the worst impacted region for hepatitis B with a prevalence of 7.5 percent compared to 0.5 percent in the Americas. Hepatitis C impacts an estimated 58 million people across the globe. Again, Africa is the worst-impacted region with a prevalence of 0.8 percent while the Americas see a prevalence of 0.5 percent.

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Pregnant? Georgia says that fetus counts as a dependent on your taxes

NPR Health - Shots

A person at least six weeks pregnant on or after July 20 through Dec. 31, 2022, can submit the fetus as a dependent on their state tax returns starting next year.

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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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STAT+: How much are patients actually using mental health apps? Research on engagement is elusive

STAT News

As companies selling health care apps struggle to prove to a skeptical system that they really deliver results, we’re about to start hearing a lot more about “engagement.” A new paper scrutinizing six clinical trials supporting four mental health apps cleared by the Food and Drug Administration argues there’s an urgent need to close the “gap between intention and real-world efficacy for digital therapeutics” — specifically, the dearth of data on h

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An Idaho abortion law draws a Justice Department lawsuit

NPR Health - Shots

The DOJ argues that a restrictive new ban conflicts with a federal law that requires doctors to give pregnant women appropriate medical care, including abortion when necessary.

Doctors 126
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Opinion: Paxlovid rebound happens, though why and to whom are still a mystery

STAT News

As an emergency department physician in New York, I often field calls about medical issues from family members, friends, and even friends of friends. Since the Covid-19 pandemic began, the number of these calls has dramatically increased. The latest slew of these, about Paxlovid and rebound Covid-19 — which President Biden now apparently has — has revealed the confusion surrounding this phenomenon for me, my physician colleagues, and at least one Nobel laureate.

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The Space Force is scrapping the annual fitness test in favor of wearable trackers

NPR Health - Shots

The new approach aims to promote overall fitness instead of focusing on specific exercises, and the devices will also give Guardians feedback about mental health, balanced eating and sleep. (Image credit: Eric Schmid/St.

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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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STAT+: Medicare reverses course on plan to hide hospital safety data next year

STAT News

Medicare will continue to report hospital safety data as usual next year after the program, apparently swayed by backlash from patient safety advocates, reversed course on its plan to keep some information under wraps. Medicare revealed its change of heart in its final hospital payment rule for 2023, released Monday. Months ago in a preliminary version of the rule, regulators said the safety data in question would be so skewed by the Covid-19 pandemic, it wouldn’t be useful to patients.

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The vote in Kansas on abortion could be close

NPR Health - Shots

The fate of abortion in Kansas could be in the hands of voters today. They'll decide whether the state constitution explicitly does not protect the right to an abortion.

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Opinion: STAT+: Hospitals, health systems play critical roles in the real-world data movement

STAT News

Since the start of the pandemic, the health care and life sciences sectors have relied more heavily on real-world data and real-world evidence as they work to develop new drugs and devices and survey the world outside of clinical trials. Hospitals and health systems are key to these efforts. The Food and Drug Administration defines real-world data as data relating to a patient’s health status and/or the delivery of health care routinely collected from a variety of sources, such as electro

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New book chronicles how America's opioid industry operated like a drug cartel

NPR Health - Shots

Two Washington Post journalists say pharmaceutical companies collaborated with each other — and with lawyers and lobbyists — to create laws to protect the industry. Their new book is American Cartel. (Image credit: Patrick T.

Drugs 118
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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.

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Cities are lobbying to host the ARPA-H headquarters. Experts don’t understand why

STAT News

WASHINGTON — America’s mayors are drooling over President Biden’s new high-stakes research agency, ARPA-H. They picture a futuristic office building transforming a city’s skyline. Inside it sits a cadre of best-in-class scientists, working feverishly to help local companies develop the next generation of biomedical breakthroughs, transforming the city’s economy along the way.

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Where to find support if you experience mitral valve regurgitation

Antidote

Mitral valve regurgitation is a common kind of heart disease in the United States. Not only does it impact many people today, but its prevalence is expected to double by 2030.

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STAT+: U.S. appeals court panel decides AbbVie’s ‘patent thickets’ for Humira don’t thwart competition

STAT News

In a significant victory for AbbVie, a U.S. appeals court panel declined to revive a lawsuit that accused the company of using a so-called patent thicket to forestall competition for its Humira medication, a franchise product that generates billions of dollars in sales each year. The opinion shot down arguments by unions, insurers, and the city of Baltimore, which alleged that AbbVie “abused the patent system” and “erected significant barriers to entry to block biosimilar co

Sales 98
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Post Marketing Research

Cloudbyz

Premarketing drug studies vs Post- Marketing research. Premarketing drug studies consist of phase I-III trials, and are represented by pharmacokinetic and pharmacodynamic studies, dose ranging studies, and Randomized Controlled Trials (RCTs). Approximately only 20 % of the drugs that enter phase I are approved for marketing. Post-marketing research is a generic term used to describe all activities after drug approval by the regulatory agencies, such as the Food and Drug Administration (FDA).

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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.