Sat.Aug 19, 2023 - Fri.Aug 25, 2023

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Apellis finds faulty needles in probe of rare eye drug side effects

BioPharma Drive: Drug Pricing

The company doesn’t know if the needles have caused retinal vasculitis in some people receiving its geographic atrophy drug Syfovre, but is no longer recommending their use.

Drugs 98
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Fourteen HP&M Attorneys Recognized by Best Lawyers® in 2024 in America

FDA Law Blog: Biosimilars

Hyman, Phelps & McNamara, P.C. (“HP&M”) is is proud to announce that 14 of the Firm’s attorneys have been selected to the 2024 edition of The Best Lawyers in America®. Newly recognized this year are attorneys Josephine M. Torrente (FDA Law), Michelle L. Butler (FDA Law), Sara W. Koblitz (FDA Law), Allyson B. Mullen (FDA Law), and Anne K. Walsh (FDA Law), as well as McKenzie E.

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'Eco-Friendly' Paper Straws Contain Harmful PFAS Chemicals

Drugs.com

FRIDAY, Aug. 25, 2023 -- Paper straws, meant to be an eco-friendly alternative to plastic, may not be better for the environment, a new study concludes, warning that they also contain “forever chemicals” that can harm human.

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Therapeutic frontiers: the potential of RRx-001 and AdAPT-001

Drug Target Review

What makes RRx-001 a first-in-class hypoxia-activated therapeutic, and how does its dual mechanism of action differ from traditional cancer treatments? Most, if not all, traditional cancer treatments are single minded. Their mechanisms of action are completely consistent no matter the tissue or environment in which they find themselves. RRx-001 (nibrozetone) is different because in tissues where 3 “Hs” are present, namely hypoxia (low oxygen), hyperaemia (over-vascularisation), and high hydrogen

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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Foundery, a new biotech venture firm, sets out to speed early immune drug research

BioPharma Drive: Drug Pricing

Billing itself as both a scientific and investment partner, Foundery aims to provide research grants and drug development support to researchers developing new immunotherapies.

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Six Challenges to Navigate When Shifting From Wholesale to Direct-to-Consumer Models

Perficient: Drug Development

The transition from a wholesale-centric business model to include a new direct-to-consumer (D2C) approach presents lucrative opportunities alongside a suite of technical and operational intricacies to consider. While the move brings manufacturing companies closer to end consumers, it also requires several considerations spanning content creation, post-purchase support, and overall brand experience.

More Trending

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Watermelon Pangenome Reveals Origins of Sweetness

PLOS: DNA Science

As autumn looms, we’re enjoying the last bites of sweet, juicy watermelon. Conventional agriculture has molded our fruits and veggies to suit our palates, gradually crafting domesticated Citrullus lanatus from three ancestral melon species. But the process may have also removed valuable traits. Researchers at the Boyce Thompson Institute in Ithaca, New York, have analyzed genomes of watermelon and its ancestors, revealing traits that early breeders may have inadvertently removed in their q

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FDA approves Novartis’ copycat of blockbuster Biogen drug

BioPharma Drive: Drug Pricing

According to one analyst, the approval was the last hurdle keeping Sandoz’s Tyruko from directly competing in the U.S. market against Biogen’s inflammation-regulating medicine Tysabri.

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Cancer immunotherapy: GDF-15’s role in Anti-PD-1 resistance

Drug Target Review

The focus of this study is on Growth Differentiation Factor-15 (GDF-15), a cytokine known for its critical role in feto-maternal tolerance, which has now been found to be hijacked by tumours to evade immune attack. We will explore how GDF-15 impacts the tumour microenvironment and hinders the infiltration of T cells into the tumour, as well as the implications of neutralising GDF-15 to reverse its inhibitory effects and sensitise tumours to anti-PD-1 treatment.

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Sepsis Almost Killed Jake Tapper's Daughter, Alice. Now, She's Working to Keep Others Safe

Drugs.com

FRIDAY, Aug. 25, 2023 -- Alice Tapper felt deathly ill, suffering from severe abdominal pain, a 102-degree fever and vomiting. Emergency room doctors found that Alice -- the daughter of CNN anchor Jake Tapper -- had a rapid pulse of 135 beats per.

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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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Unveiling the Power and Potential of GraphQL in Modern Web Development

Perficient: Drug Development

In the dynamic world of web development, where user expectations are higher than ever and application complexity continues to grow. The need for efficient data retrieval and flexible APIs has become paramount. Enter GraphQL, a revolutionary query language for APIs that is reshaping how data is requested, fetched, and managed. In this comprehensive exploration, we’ll dive deep into the essence of GraphQL, its core principles, benefits, and real-world applications.

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Roche’s surprise study results spur new optimism for TIGIT drugs

BioPharma Drive: Drug Pricing

Data inadvertently published from a closely watched lung cancer study suggest a drug blocking the protein TIGIT may help extend survival, a finding that boosted shares of other developers.

Drugs 98
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What happens in each clinical trial phase? [infographic]

Antidote

Before any new treatment is able to be approved, it is required to go through the vigorous testing process known as clinical trials. These trials are aimed at determining whether or not a drug, medical device, therapy, or other type of intervention is safe and effective for the public.

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Gut Troubles Could Be Early Signal of Parkinson's Disease

Drugs.com

FRIDAY, Aug. 25, 2023 -- It might not seem like constipation or difficulty swallowing could signal a neurological problem, but new research suggests that these gut conditions could be an early indicator of Parkinson’s disease. Gastrointestinal.

Disease 98
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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.

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Making Sitecore Sites More Accessible and Screen Reader Friendly

Perficient: Drug Development

Aria labels provide alternate text to adaptive technology tools such as screen readers. This helps website visitors navigate the site more accurately. One use case for aria-labels is on html anchor tags. Sitecore does not a way to manage this text by default. Follow along and I’ll show you how to modify the various link dialogs and give content authors the ability to manage this text.

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Brown fluid dynamics researchers shed light on how partially submerged objects experience drag

SCIENMAG: Medicine & Health

PROVIDENCE, R.I. [Brown University] — One of the most common and practically useful experiments in all of fluid dynamics involves holding an object in air or submerging it fully underwater, exposing it to a steady flow to measure its resistance in the form of drag.

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Huntington’s disease and potential therapies

Drug Target Review

This Q&A explores how pre-clinical research is being used to identify potential therapies for Huntington’s disease, a devastating condition that currently lacks disease- modifying treatments. By leveraging the power of naturally occurring antibodies , Alchemab’s research has significant potential to transform the landscape of neurodegenerative disease research and improve the lives of those affected by these challenging conditions.

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Tobacco Company Coupons Raise Odds Ex-Smokers Will Light Up Again

Drugs.com

FRIDAY, Aug. 25, 2023 -- Coupons for tobacco products appear to have a big impact on relapse rates for smokers who have recently kicked the habit, researchers report. A study of more than 5,000 former smokers who participated in a national survey.

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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic

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Why Choose a Composable Architecture

Perficient: Drug Development

If you’ve been following Sitecore’s architectural movement over the last few years, a lot has changed. Instead of the “all-in-one” approach of Sitecore XP, XM Cloud , and Headless encourage a composable architecture – one where Sitecore itself offers 11 SaaS products categorized into three clouds : Content Cloud, Engagement Cloud, and Commerce Cloud.

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Boehringer sues to block US drug price program

BioPharma Drive: Drug Pricing

The pharma’s suit, which claims Medicare’s new power to negotiate certain drug prices is unconstitutional, comes days before the agency will reveal the first 10 medicines to be included under the plan.

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HPV-associated head and neck cancers identified

Drug Target Review

To unravel the mysteries behind the treatment response, researchers from the Department of Otolaryngology/Head and Neck Surgery at UNC School of Medicine collaborated with experts from Yale Cancer Center, the Yale Head and Neck Cancer Specialised Program of Research Excellence (SPORE), and the ECOG-ACRIN Cancer Research Group. Their study, published in Proceedings of the National Academy of Sciences , unveiled the existence of two distinct subtypes of HPV + head and neck cancers.

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COVID Vaccine Boosters Crucial for Some Cancer Patients: Study

Drugs.com

THURSDAY, Aug. 24, 2023 -- Cancer patients with immune systems weakened by treatment are among the groups most concerned about the continued spread of COVID-19 and the chance of the infection becoming severe. New research suggests more guidance on.

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Solving Healthcare Challenges with Digital Health Platforms

Perficient: Drug Development

To meet clinical, business, and evolving consumer needs, healthcare and life sciences organizations are focused on care delivery that enables innovation in patient engagement, data and analytics, and virtual care. According to Gartner’s 2022 Industry Cloud Survey , about 40% of IT leaders say they have started to adopt industry cloud platforms, with another 15% in pilots; another 15% are considering deployment by 2026.

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Accelerate and Optimize Rare Disease Patient-Finding with AI

Fierce BioTech

In this podcast, Dan Fisher, managing director for IPM.ai, a division of Real Chemistry, explains how real world health data generated from more than 300 million de-identified patient records can h | Using artificial intelligence to predict and uncover de-identified rare disease patients shortens the time to diagnosis, benefiting both patients and life science companies.

Disease 97
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J&J-backed startup raises another $150M for brain drug development

BioPharma Drive: Drug Pricing

The funding for Rapport Therapeutics saw participation from a series of so-called crossover investors, many of which have pulled back from biotech startups in recent years.

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First Biosimilar Approved to Treat Multiple Sclerosis

Drugs.com

FRIDAY, Aug. 25, 2023 -- The U.S. Food and Drug Administration approved Tyruko (natalizumab-sztn), the first biosimilar to Tysabri (natalizumab) injection, for the treatment of relapsing forms of multiple sclerosis, the agency announced.

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Sedentary time in children linked with heart damage in young adulthood

SCIENMAG: Medicine & Health

Amsterdam, Netherlands – 23 Aug 2023: Hours of inactivity during childhood could be setting the stage for heart attacks and strokes later in life, according to research presented at ESC Congress 2023.

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Perficient Included in IDC Market Glance: Digital Business Professional Services Report

Perficient: Drug Development

Today’s environment is relentlessly volatile. It rewards speed over size, agility over efficiency, and cross-functional flow over rigid structure. You must be ready to shift and scale your teams as priorities change. The way forward requires a comprehensive digital strategy that defines the capabilities, agility, and alignment to put you on the right side of digital disruption.

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Startup Cellares adds $255M as investors pour cash into cell therapy production

BioPharma Drive: Drug Pricing

Bristol Myers Squibb is among those backing the startup, which claims the manufacturing capacity at its New Jersey plant can surpass that of conventional CDMO facilities.

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Do Fish Oil Supplements Really Boost Your Health?

Drugs.com

THURSDAY, Aug. 24, 2023 -- Stroll past the supplements in any drugstore and you’ll find broad claims about fish oil helping everything from heart and brain health, to joints, eyes and immune systems.

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Why Including Patients in FDA Engagement Will Benefit Your Trial

Conversations in Drug Development Trends

Patients are the backbone of clinical trials, playing an essential role in the drug development process. However, patients also play a vital role in engaging directly with the FDA. This engagement is often less understood and is underutilized by sponsors, meaning a significant element of the trial and drug experience is missed during sponsor engagement with the FDA.

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Novel research reveals existence of altered mesocortical connectivity in obesity

SCIENMAG: Medicine & Health

ROCKVILLE, Md.—For the first time, researchers have discovered that the ventral tegmental area (VTA) of the brain—a key structure involved in motivation and reward appreciation has altered connectivity patterns with specific brain regions in patients with obesity.

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FDA expands use of Neurocrine drug to Huntington’s patients

BioPharma Drive: Drug Pricing

Analysts expect the approval of Ingrezza in Huntington’s patients with a movement disorder known as chorea to intensify a commercial battle between Neurocrine and Teva.

FDA 97