Sat.Feb 25, 2023 - Fri.Mar 03, 2023

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Is the microbiome therapy hype up for a reckoning?

Pharmaceutical Technology

In the last decade, the idea of tapping into the gut has attracted much interest from investors and the public, but recent years have showed that a lot more work needs to be done before such treatments enter the mainstream. This is largely due to the FDA’s rigorous approach to the safety of microbiome therapeutics, which has manifested in clinical holds, resulting in delays that have dimmed the enthusiasm in the space in recent times.

Bacteria 278
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Viatris taps new CEO to lead second phase of business revamp

Bio Pharma Dive

Celgene veteran Scott Smith will take over for Michael Goettler on April 1 as the generic drugmaker prepares for a return to growth after divestitures and the addition of a new eye care division.

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March 1, 2023: This Week’s PCT Grand Rounds Highlights Implementation Lessons From GGC4H

Rethinking Clinical Trials

In this Friday’s PCT Grand Rounds, Dr. Margaret Kuklinski and Dr. Stacy Sterling will present “Adoption, Implementation and Sustainment of Family-Focused Prevention in Health Care Systems: How Do We Get There?” Kuklinski and Sterling are the principal investigators of GGC4H , an NIH Pragmatic Trials Collaboratory Demonstration Project.

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Tennessee becomes the first state to pass a ban on public drag shows

NPR Health - Shots

Tenn. Gov. Bill Lee signed a bill banning drag performances the same afternoon he signed a ban on youth gender-affirming care. Advocates say some are asking whether staying in the state is worth it.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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US FDA approves Reata Pharmaceuticals’ SKYCLARYS for Friedreich’s ataxia

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has approved Reata Pharmaceuticals ’ oral, once-daily medication SKYCLARYS (omaveloxolone) to treat Friedreich’s ataxia patients. SKYCLARYS is indicated to treat the ultra-rare, inherited neurodegenerative disorder in 16 years and above-aged adults and adolescents in the US. SKYCLARYS is the first approved treatment in Friedrich’s Ataxia and marks a milestone for drug development in this complex disease.

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FDA rejects Cytokinetics’ heart failure drug

Bio Pharma Dive

The biotech said the FDA was unconvinced by available study evidence and asked for data from an additional clinical trial, which the company currently does not plan to run.

More Trending

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They could lose the house — to Medicaid

NPR Health - Shots

Depending on where they lived, demands for repayment can drain the assets that a patient on Medicaid leaves behind after they die. Iowa aggressively collects "clawback" funds.

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US FDA approves Regeneron-Sanofi’s Kevzara to treat polymyalgia rheumatica

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Regeneron Pharmaceuticals and Sanofi ’s Kevzara (sarilumab) to treat polymyalgia rheumatica (PMR) in adult patients. Kevzara has been approved as the first and only biologic indicated for PMR adult patients who did not respond to corticosteroids or who cannot tolerate corticosteroid taper.

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FDA clears Intellia to start US tests of ‘in vivo’ gene editing drug

Bio Pharma Dive

The announcement, which follows recent regulatory setbacks for some of Intellia’s peers, is a “big win” for the gene editing field, according to one analyst.

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Report: Obesity could cost the world over $4 trillion a year by 2035

STAT News

The costs of obesity are projected to soar globally, in step with rising prevalence, according to a new report from the World Obesity Federation, the only group focused solely on tracking global obesity trends and a partner of the World Health Organization. Over half the world’s population will be either overweight or have obesity by 2035, the report projected, while the economic impact of a high BMI could reach $4.32 trillion annually, if current trends continue and policy inertia around

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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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Pandemic food assistance that held back hunger comes to an end

NPR Health - Shots

Millions of people who depend on the Supplemental Nutrition Assistance Program known as SNAP will see a cut of $90 a month or more. Some recipients say it will make it harder to buy healthy food.

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Merck reports rise in group net sales in fiscal 2022

Pharmaceutical Technology

Merck has reported an increase in group net sales by 12.9% to €22.23bn in fiscal 2022 against €19.68bn in 2021. The growth in sales was driven by all regions and business sectors, particularly Life Science. Organically, the company generated an increase of 6.4% in group sales in fiscal 2022. Favourable foreign exchange effects of 6.1% resulted primarily from the development of the US dollar and the Chinese renminbi.

Sales 245
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Amid industry turbulence, Chroma raises fresh funding to edit the epigenome

Bio Pharma Dive

At a time when many startups have struggled to gain cash, the biotech has raised another $135 million to back its research, a new twist on genetic medicine.

Genetics 311
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How policymakers could tweak HIPAA to better protect abortion records

STAT News

WASHINGTON — Patient privacy law offers little protection if law enforcement requests a person’s medical records — an issue that’s fueled concern as states impose restrictions on abortion after the Supreme Court overturned Roe v. Wade. “I think it’s important to know that right now, your health records aren’t necessarily protected.

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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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3 abortion bans in Texas leave doctors 'talking in code' to pregnant patients

NPR Health - Shots

Some doctors in Texas are so worried about the abortion bans, they hint to patients with pregnancy complications, "I've heard traveling to Colorado is really nice this time of year.

Doctors 145
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AI offers 'paradigm shift' in study of brain injury

Medical Xpress

From the gridiron to the battlefield, the study of traumatic brain injury has exploded in recent years. Crucial to understanding brain injury is the ability to model the mechanical forces that compress, stretch, and twist the brain tissue, causing damage that ranges from fleeting to fatal.

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Despite study setback, a biotech plans to push tremor drug into late-stage testing

Bio Pharma Dive

An experimental medicine from Praxis Precision Medicines missed the main goal of a Phase 2b trial. But there were also some positive findings, which have encouraged the company to press forward.

Medicine 278
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STAT Madness 2023

STAT News

Welcome to STAT Madness, a bracket-style contest to find the best innovation in science and medicine. Click on each matchup for a short summary of each school’s pioneering research. Then pick your favorites. Help us crown a champ!

Medicine 139
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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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What does the science say about the origin of the SARS-CoV-2 pandemic?

NPR Health - Shots

Two U.S. intelligence agencies reportedly support the lab leak theory — with low-to-moderate confidence. No evidence has been shared. Scientists have strong evidence of animal spillover at a market.

Scientist 145
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A new epigenetic brain defense against recurrence of opioid use

Medical Xpress

Substance use disorder (SUD) is an extremely difficult disorder to overcome, and many individuals with SUD return to regular use after repeated attempts to quit.

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Lilly to lower insulin prices by 70%

Bio Pharma Dive

The pharma company, along with its diabetes drug rivals Novo Nordisk and Sanofi, has long been under pressure over the high cost of insulin — scrutiny that has recently ramped up in the U.S.

Insulin 278
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The FDA has cleared the first home flu and Covid test — but its maker just declared bankruptcy

STAT News

On Friday, the Food and Drug Administration issued an emergency authorization for the first at-home test that can detect flu and Covid-19 — but for the test’s maker, Lucira, the long-anticipated authorization may have taken too long. The company filed for bankruptcy on Feb. 22, directly blaming the “protracted” FDA authorization process for the over-the-counter combination test for its financial troubles.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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To safeguard healthy twin in utero, she had to 'escape' Texas for abortion procedure

NPR Health - Shots

When Lauren Miller found out one of her twins had a fatal condition, she discovered her doctors in Texas would only say: You need to leave the state. She went to Colorado for a selective reduction.

Doctors 143
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Tumor cells' response to chemotherapy is driven by randomness, shows study

Medical Xpress

Cancer cells have an innate randomness in their ability to respond to chemotherapy, which is another tool in their arsenal of resisting treatment, new research led by the Garvan Institute of Medical Research shows.

Research 124
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Seagen reportedly in sales talks again, this time with Pfizer

Bio Pharma Dive

Citing people familiar with the talks, The Wall Street Journal reported over the weekend that Pfizer is trying to acquire Seagen and its suite of cancer therapies in a deal that could be worth more than $30 billion.

Sales 278
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Same patient, same drug, same insurer — coverage denied

STAT News

Janice Morales-Ferrer is a planner. It’s helped her get ahead in her career and in raising three young kids. But it’s hard to plan when you’ve got a rare disease, especially one with no standard treatment regimen or predictable outcome. “I’m a data-driven person,” said the 46-year-old Boston area resident. “It’s frustrating for me to not be able to plan how long I can live for my kids.

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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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A surprise-billing law loophole? Her pregnancy led to a six-figure hospital bill

NPR Health - Shots

Billing experts and lawmakers are playing catch-up as providers get around new consumer protections, leaving patients like Danielle Laskey of Washington state with big bills for emergency care.

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Pfizer, Viatris and more must face 'overarching conspiracy' claims in generic price-fixing suit

Fierce Pharma

Pfizer, Viatris and more must face 'overarching conspiracy' claims in generic price-fixing suit aliu Wed, 03/01/2023 - 10:03

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How life sciences benefits from broader healthcare transformation

Bio Pharma Dive

Digital transformation has much to offer life sciences as well as healthcare — and the synergies between the two can further optimize the power of digital health, clinical trials and patient outcomes.

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Obesity and heart disease

Medical Xpress

It's long been known that being overweight or obese can make a person more apt to develop conditions like high blood pressure or diabetes, which can lead to cardiovascular disease. But experts at Mayo Clinic say obesity also can affect the heart in entirely independent ways.

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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.