September, 2023

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Digital Therapeutics: A Panacea for Care or Overvalued Health Tech?

MedCity News

Digital therapeutics will be one of the topics discussed at INVEST Digital Health scheduled for October 26 at Health Wildcatters headquarters in Pegasus Park in Dallas. Register today!

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The 2023 PharmaVoice 100

PharmaVoice

This year’s honorees are influential and devoted leaders lifting the pillars of the industry to new heights.

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Pfizer, Moderna score FDA nods for next round of seasonal COVID-19 vaccines

Fierce Pharma

Out with the old and in with the new: Monday, the U.S. | The FDA has approved Pfizer and Moderna’s separate vaccine formulations that target current variants of the disease. Each company’s shot is approved for people ages 12 and up and emergency authorized for patients 6 months old to 11 years old.

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Developing an effective contamination control strategy

European Pharmaceutical Review

As part of The Future of Pharma/Biopharma Analysis 2023 , which took place on 28-29 June 2023, European Pharmaceutical Review ( EPR ) gathered an expert panel to discuss developing a modern contamination control strategy. The participants were: Dr Tim Sandle, Head of GxP Compliance at Bio Products Laboratory Limited (BPL) as moderator; Dr Edward Tidswell, Executive Director within the Microbiological Quality and Sterility Assurance organisation of Merck & Co; Frederic Ayers, Research Scienti

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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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Virtual Reality Headset Takes EEG Measurements

Medgadget

Researchers at the University of Texas at Austin have developed an electroencephalogram (EEG) sensor that is incorporated into a virtual reality headset. The technology can measure brain activity while someone is undergoing an immersive virtual reality experience. The device may assist in enhancing medical virtual reality interventions, such as those used to treat post-traumatic stress disorder or phobias, by revealing brain activity during different tasks or experiences that help clinicians to

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Clarivate announces the inaugural Eugene Garfield Memorial Lecture

Clarivate

Dr. Henry Small will deliver the lecture to commemorate the 50th anniversary of his groundbreaking paper on co-citation in scientific literature. To commemorate the legacy of Eugene Garfield, founder of the Institute for Scientific Information (ISI) , Clarivate is proud to announce the inaugural Eugene Garfield Memorial Lecture. It will be delivered by Dr.

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Three years after an FDA rejection, DBV sees a path for its peanut patch

PharmaVoice

Despite lower-than-expected demand for a competing treatment, DBV’s chief medical officer says the company’s topical skin patch could be a game-changing option for patients.

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Novo, Lilly set to dominate $71B GLP-1 drug market by 2032: J.P. Morgan

Fierce Pharma

Demand is so strong for Novo Nordisk’s obesity drugs that the only limitation on sales—in the short term—seems to be the company’s ability to produce them. | Promising heart data for Novo Nordisk's Wegovy are a "paradigm shift," according to J.P. Morgan, which has doubled its market projection for GLP-1 diabetes and obesity treatments to $71 billion for 2032.

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Small molecule drug shows promise in rare disease

European Pharmaceutical Review

The CBL-0201DD Phase II study evaluating the first-in-class small-molecule drug CBL-514 for Dercum’s disease, a rare disorder, has demonstrated significant efficacy in reducing lipoma size and complete clearance. Dercum’s disease is characterised by painful lipomas developing primarily on the trunk in the body. Currently there are no approved or effective medicine, so the data from the Phase II study shows potential of a treatment for this indication.

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21Grams, Area 23, and IPG Health Dominate The Creative Floor Awards 2023

PM360

The Creative Floor Healthcare Awards , celebrated the world’s best health and wellness creative work, agency talent, and clients yesterday at its 10 th -year anniversary party. Area 23 won the Most Awarded Agency and IPG Health won the Most Awarded Network. 21Grams took home Best Communications Agency. Bravest Client Awards went to Uyum Evcin from CSL Vifor and Peter Zenobi from Sanofi.

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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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Frontiers Adopts CCC Ringgold Identify Database as its PID Solution

Copyright Clearance Center

September 12, 2023 – Danvers, Mass. – CCC , a leader in advancing copyright, accelerating knowledge, and powering innovation, today announced Gold Open Access (OA) publisher Frontiers has adopted the industry-leading Ringgold Identify Database as its Persistent Identifier (PID) solution to help power its OA models by normalizing and disambiguating organization data.

Leads 116
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Babylon Health’s CEO ‘Should Spend Some Time With Elizabeth Holmes’

MedCity News

U.K. doctor David Watkins has been a public critic of Babylon Health for years, during which has received anonymous emails from Babylon employees saying that the company’s AI is a sham. After Babylon collapsed, a former employee also publicly declared that the AI engine was faulty. As a longtime skeptic of Babylon’s claims surrounding its technology, Watkins said that Ali Parsa, the company’s CEO, belongs behind bars.

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Gain new perspectives on global research: Unveiling the dynamic G20 scorecard from ISI

Clarivate

We are proud to introduce fresh insights into measuring global research performance via our dynamic G20 scorecard for 2023, newly enhanced with online data visualizations. This guide to understanding the G20 scorecard explores how this interactive tool expands our perspective of global research and innovation. Each year, prior to the G20 Summit of the heads of state of the member nations, the Institute for Scientific Information (ISI) at Clarivate releases its annual G20 scorecard.

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Novo Nordisk Foundation pumps $136M into new clinical cell therapy manufacturing 'hub' in Denmark

Fierce Pharma

Looking to establish a “hub” in the cell therapy ecosystem, the Novo Nordisk Foundation is pumping 950 million Danish kroner (about $136 million) into a new clinical production site at the Technica | Looking to establish a “hub” in the cell therapy ecosystem, the Novo Nordisk Foundation is pumping 950 million Danish kroner (about $136 million) into a new clinical production site at the Technical University of Denmark (DTU) in Lyngby.

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How to Stay Competitive in the Evolving State of Martech

Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr

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Neuroplast spinal cord injury study milestone

PharmaTimes

The trial analyses the impact of its ‘Neuro-Cells’ among patients with traumatic spinal cord injuries - News - PharmaTimes

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Consequences of the First 10 Drugs Selected for Medicare’s Negotiation Program

PM360

As many in the industry now know, the Inflation Reduction Act (IRA) is the most significant reform of Medicare prescription drug coverage since the creation of Part D and has wide-ranging implications for the healthcare industry. The recent announcement of the first 10 drugs selected for price negotiations is a significant first step in Medicare’s effort to directly set drug prices for seniors.

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New manufacturing facility could drive gold standard in cell therapy

European Pharmaceutical Review

A new Denmark-based manufacturing facility is set to establish the final development steps and upscaling of cell therapies. To establish it, the Novo Nordisk Foundation is committing up to £127 million. CEO of the Novo Nordisk Foundation Cellerator, Thomas HR Carlsen, told EPR that for cell therapy manufacturing, “The biggest challenge is producing high-quality, consistent cell therapies at the scale required for use in clinical trials… biological complexity [of living cells] means that the man

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HHS Issues Proposal Bolstering Nondiscrimination Protections For People With Disabilities

MedCity News

HHS released a new proposed rule to update nearly 50-year old regulations protecting people with disabilities from discrimination while seeking healthcare. With its new proposal, HHS is amending the regulations to be clearer in their language, as well as more aligned with the Americans with Disabilities Act, the Americans with Disabilities Amendments Act and amendments to the Rehabilitation Act.

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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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Researchers of Nobel class: Citation Laureates 2023

Clarivate

The Citation Laureates 2023 list has been announced, recognizing a select group of influential, highly cited researchers whose contributions are on par with Nobel Prize recipients. We explore their profound impact on our world and their enduring commitment to the pursuit of knowledge, inspiring the next generation of researchers. We at the Institute for Scientific Information (ISI) at Clarivate have announced 23 new Citation Laureates , a designation that recognizes researchers of Nobel class b

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Patent cliffs, divestitures and maturing biotechs all point to more pharma M&A: analysts

Fierce Pharma

Biopharma M&A is on an uptick compared to the post-pandemic doldrums of the last two years. | Biopharma M&A is on an uptick compared to the post-pandemic doldrums of the last two years. Analysts anticipate that the trend will continue in 2023 and into 2024 as companies attempt to beef up their portfolios.

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Battery Charged by Tears for Smart Contact Lenses

Medgadget

Researchers at Nanyang Technological University in Singapore have developed a tiny, flexible battery that is intended for use in smart contact lenses. The device is as thin as the human cornea and can be charged by a saline solution, which is particularly useful in the eye, as it is full of salty tears. When the battery-equipped smart lens is not in use, such as at night, then it can be stored in a saline solution, helping to further recharge the battery.

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How Pharma Brands Grow: An Evidence-based Approach to Pharma Brand Marketing

PM360

Pity the poor pharma brand marketer. Over the past many years, they’ve seen their colleagues on the performance marketing side grow in influence and sophistication as their datasets and digital channels have expanded their value to the business. In contrast, brand marketing can feel like a vestige from another era of marketing, poorly understood, with poor metrics, and little consensus of how brand marketing contributes to the overall business.

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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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Generative AI-focused biotech startup Evozyne raises $81m

Pharmaceutical Technology

The company’s algorithms put proteins through millions of years of simulated evolution to identify potential functional candidates.

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Startup Syntax Bio Leverages CRISPR to Transform Cell Therapy Manufacturing

MedCity News

Syntax Bio’s technology platform uses CRISPR to direct stem cells to become a desired cell type in a process that’s more scalable and less expensive than current methods. The startup is raising a Series A round of financing to further demonstrate the potential of its technology.

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The Global Vaccine R&D Pipeline and Delivery Implications

PharmExec

The current vaccine pipeline brings promise of significant global health advancements—yet development gaps remain, and the future delivery challenges must be considered.

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Merck and Eisai's Keytruda-Lenvima combo chalks up 2 more losses, this time in non-small cell lung cancer

Fierce Pharma

Merck and Eisai’s Keytruda-Lenvima tag team can’t seem to catch a break. | Merck and Eisai’s Keytruda-Lenvima tag team can’t seem to catch a break. Following a series of trial shortfalls this year in melanoma, colorectal cancer and head and neck squamous cell carcinoma, the duo has missed the mark in yet another set of clinical trials—this time in non-small cell lung cancer.

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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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Driving Dosage Form Developments

PharmaTech

Dosage forms are being shaped by numerous factors, with patient-centricity continuing to be an important driver of decisions in development.

Patients 116
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Will AI Completely Transform the Patient Experience?

PM360

The healthcare system might not be too keen to hang this report card on the fridge: 26% of Americans rated their healthcare experience as a D (18%) or an F (8%), while 34% gave it a solid C and only 10% gave it an A, that’s according the American Academy of Physician Associates (AAPA) and The Harris Poll’s survey of 2,519 adults age 18+ conducted between February 23 and March 9, 2023. 1 For 65% of respondents, one of the biggest issues was that coordinating and managing healthcare is overwhelmin

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ADDF invest in BrainScope for Alzheimer’s prediction biomarker

Pharmaceutical Technology

The neurotech will receive the investment in Series B equity financing round to invest in Alzheimer’s disease research.

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Most Hospitals Are Still Violating HIPAA By Using Web Tracking Tools, Despite Federal Warnings

MedCity News

The federal government has warned hospitals that using third-party analytics tools on their websites could violate HIPAA, and more than 20 hospitals are facing class-action lawsuits over the use of these tools. But a recent analysis found that hospitals are doing a poor job of fixing their websites and preventing patient data collection.

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Clinical Supply Strategies for CROs

When a CRO is bidding on a project where clinical supplies will be one of the aspects to manage on behalf of the client via a partner, leveraging the expertise of a chosen clinical supply partner can be a valuable resource in demonstrating the CRO’s understanding of and ability to deliver upon critical drug-supply related aspects of the project, and ability to hit key milestones such as FPI for their client.