Thu.Mar 28, 2024

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March 28, 2024: Health Equity Core Provides Reference for Equitable Language in Pragmatic Trials

Rethinking Clinical Trials

Dr. Rosa Gonzalez-Guarda The NIH Pragmatic Trials Collaboratory’s Health Equity Core developed a written aid to offer guidance on inclusive language and terms to use when referring to specific people, groups, and communities. The Equitable Language Cheat Sheet is available on the Health Equity Core webpage and will be updated as terminology and guidance evolves.

Trials 219
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Gilead bets on Xilio cancer drug as biotech restructures

Bio Pharma Dive

Xilio will get just over $40 million from Gilead in return for a license to its experimental IL-12 immunotherapy. The biotech is also discontinuing other work and laying off staff.

Licensing 298
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Measles cases continue to rise in US amid lagging vaccination rates

Pharmaceutical Technology

According to the CDC, over 64 cases of measles have been documented in the US in 2024, already exceeding 2023's total of 58.

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FDA approves Akebia anemia pill, two years after rejection

Bio Pharma Dive

The agency gave Akebia’s drug an OK after receiving more safety data, but imposed a strict boxed warning for its use that may limit uptake.

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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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Nanoscope Therapeutics exhibits positive top-line Phase IIb results for MCO-010

Pharmaceutical Technology

Nanoscope Therapeutics released promising top-line results for its RESTORE trial, which is studying the gene therapy MCO-010 in patients with retinitis pigmentosa (RP).

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Biotech veteran Art Krieg postpones retirement to build an unorthodox drug startup

Bio Pharma Dive

With Zola Therapeutics, Krieg plans to design and sell a series of cancer immunotherapies without the help of outside investors, he told BioPharma Dive.

Drugs 195

More Trending

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‘The heart is back,’ says Cardior CEO, as Novo’s $1B deal boosts field

Bio Pharma Dive

Novo Nordisk’s acquisition of Cardior Pharmaceuticals is a bet on new approaches to cardiovascular disease, says Cardior head Claudia Ulbrich.

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Gen AI and its use in medical devices and SaMD

Pharmaceutical Technology

AI is fast becoming a valuable tool for developers of regulated health apps. In an exclusive Q&A, SaMD solutions provider Huma tells us how AI is allowing clinicians to make better decisions and why the human factor will remain a critical element of healthcare.

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PMLiVE’s T40 – open for submissions!

Pharma Times

Healthcare agencies can submit their entries free of charge with a deadline of 30 April

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Intelligence officials warned lawmakers WuXi AppTec furnished China with client's intellectual property: Reuters

Fierce Pharma

An alleged development in the national security crackdown against WuXi AppTec and a handful of other Chinese companies in the U.S. | An alleged development in the national security crackdown against WuXi AppTec and a handful of other Chinese companies in the U.S. suggests intelligence officials and lawmakers may have good reason to be concerned about the CDMO’s potential political ties to its home country.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Strand Therapeutics develops new class of mRNA molecules for cancer

Pharma Times

The self-replicating mRNA molecule could be used in cancer and potentially a broad range of other diseases

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Protein and peptide synthesis and manufacturing solutions for the pharmaceutical industry

Pharmaceutical Technology

Pharmaceutical Technology has listed the leading protein and peptide synthesis solutions and suppliers. Download for free here.

Protein 130
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University of Liverpool to lead £125m research facility supported by UKRI investment

Pharma Times

Set to open in 2032, the RUEDI facility is funded by the UKRI’s recent infrastructure fund worth £388m

Research 121
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ReAlta signs deal with NIAID to develop drug for radiation poisoning

Pharmaceutical Technology

RLS-0071 is being evaluated for the treatment of radiation poisoning, which can cause damage to the gastrointestinal tract.

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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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Johnson & Johnson gets a new opportunity to contest science in talc litigation

Fierce Pharma

Johnson & Johnson will get a do-over in its defense against more than 50,000 lawsuits that claim the company’s iconic baby powder can cause ovarian cancer. | Johnson & Johnson will get a do-over in its defense against more than 50,000 lawsuits claiming that the company’s iconic baby powder can cause ovarian cancer. A New Jersey court ruled on Wednesday that J&J can contest the scientific findings that back those cases.

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Pharmaceutical compounding companies in contract manufacturing for the pharmaceutical industry

Pharmaceutical Technology

View the Leading Pharmaceutical Compounding Companies in Contract Manufacturing for the Pharmaceutical Industry. Download Free Guide Here.

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Highlighting the disruptors: Innovation for now and tomorrow at WIRED Health 2024, Part One

pharmaphorum

Explore the cutting-edge innovations featured at WIRED Health 2024, including insights on Alphafold, clean air technology, and Lingo. Stay informed about the latest disruptors shaping the future.

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Cheap drugs, inspections, and a future war in Europe – what’s driving drug shortages?

Pharmaceutical Technology

Drug shortages are worsening globally, leaving patients without access to essential medications, and healthcare providers struggling to find alternative treatments.

Drugs 130
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Test could give early warning of motor neuron disease

pharmaphorum

Scientists say a test for motor neuron disease, based on an aptamer for biomarker TDP-43 in brain tissue, could detect at-risk people before symptoms develop.

Scientist 111
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Xilio and Gilead partner up for IL-12 therapeutic development

Pharmaceutical Technology

Under the agreement, Xilio Therapeutics may receive up to $604 million from Gilead Sciences in additional payments.

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Blackstone bankrolls Moderna’s flu shot with $750m

pharmaphorum

Moderna’s development of mRNA vaccines for influenza will be backed by up to $750m in funding from Blackstone in a risk-sharing deal

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CRISPR drug licensing deals secure $21bn in top three therapy areas over five years

Pharmaceutical Technology

Licensing agreements for innovator drugs utilising clustered regularly interspaced short palindromic repeats (CRISPR) technologies saw oncology, immunology, and central nervous system as the top three therapy areas by total deal value with a combined $21bn over the past five years.

Licensing 130
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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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Beckley builds case for its psychedelic depression therapy

pharmaphorum

New data for Beckley Psytech's psychedelic therapy for treatment-resistant depression builds anticipation for a phase 2b readout later this year

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Lab equipment suppliers for the pharmaceutical industry

Pharmaceutical Technology

Pharmaceutical Technology Has Listed the Leading Lab Equipment Suppliers to Assist in Lab Equipment Procurement. Download for Free Here.

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Italfarmaco’s Duvyzat Wins FDA Approval as First Nonsteroidal Treatment for All Genetic Variants of DMD

XTalks

Italy-based drugmaker Italfarmaco has won US Food and Drug Administration (FDA) approval for its oral medication Duvyzat (givinostat) for the treatment of Duchenne muscular dystrophy (DMD) in patients six years of age and older. Duvyzat, a histone deacetylase (HDAC) inhibitor that works to reduce inflammation and muscle loss, is the first nonsteroidal drug approved to treat patients with all genetic variants of DMD.

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Lantern Pharma gets grant for treatment of atypical teratoid/rhabdoid tumor using hydroxyureamethyl acylfulvene

Pharmaceutical Technology

Discover a groundbreaking patent for treating atypical teratoid/rhabdoid tumors with HydroxyUreaMethyl Acylfulvene. Learn how this method targets SMARCB1 gene alterations and enhances efficacy with radiation therapy. Explore the potential of this innovative treatment option today.

Gene 130
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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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What is Edible Food Packaging? + Chocolate Shortage Looms Ahead of Easter – Xtalks Food Podcast Ep. 152

XTalks

In recent years, the food industry has faced growing scrutiny over its environmental impact, particularly concerning the use of plastic packaging. This scrutiny has sparked significant interest and investment in alternative packaging solutions, with edible food packaging emerging as a particularly innovative and sustainable option. In this episode of the Xtalks Food Podcast, Sydney talks about the rise of edible food packaging and the technologies and types of edible packaging available.

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Pieris Pharmaceuticals gets grant for patent granted for novel muteins derived from human lipocalin

Pharmaceutical Technology

Discover the groundbreaking patent by Pieris Pharmaceuticals Inc for novel muteins derived from human lipocalin 2, targeting Alzheimer's disease and tumor neovasculature. Explore the potential of these muteins in diagnostics, therapeutics, and research.

Research 130
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Pharma Pulse 3/28/24: Do Mixed Results Impact Potential Real-World Effectiveness? FDA Issues Letters Over Unapproved, Misbranded OTC Analgesic Products & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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Spruce Biosciences gets grant for treatment of polycystic ovary syndrome with adrenal hyperandrogenism

Pharmaceutical Technology

Discover a groundbreaking method for treating PCOS-FAH with a CRF1 antagonist, targeting adrenal androgens to alleviate symptoms like hirsutism and infertility. Patent US11858932B2 offers new compounds and effective management strategies.

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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.