Thu.Jun 15, 2023

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FDA committee set to discuss strain selection for next round of COVID-19 boosters

Fierce Pharma

While demand for COVID-19 vaccines has plummeted throughout 2023, healthcare officials remain focused on ensuring that the most effective shots are available for those who need them. | While demand for COVID-19 vaccines has plummeted throughout 2023, healthcare officials remain focused on ensuring that the most effective shots are available for those who need them.

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Medivis Snags $20M to Enhance Surgical Navigation With Augmented Reality

MedCity News

Medivis recently raised $20 million in a Series A funding round that included investments from Mayo Clinic, Bob Iger and Kevin Durant. The New York City-based company’s technology can be thought of as a “virtual GPS system” for surgeons — it helps them navigate complex anatomical landscapes during operations and gives them a more accurate, intuitive understanding of the anatomy with which they’re dealing.

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Sandoz reveals plan to boost global biosim uptake, starting in the Americas

Fierce Pharma

As biosimilars gradually gain steam in the U.S. market, one of the biggest manufacturers of the copycat biologics has unveiled a plan to boost uptake across the globe. | Sandoz' Act4Biosimilars action plan includes a detailed report of challenges preventing wider biosimilar access in each region, starting with the Americas. The initiative's steering group will work with stakeholders across the region to implement steps to boost uptake.

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Eloxx repackages ELX-02 data in cystic fibrosis as it eyes pivotal trial

Pharmaceutical Technology

Eloxx has revealed its lead candidate ELX-02 improved predicted forced expiratory volume (ppFEV1) in patients with Class 1 cystic fibrosis (CF) in a new analysis of a Phase II trial that missed its efficacy endpoints. Following underwhelming topline results from the Phase II trial (NCT04135495) announced in late 2022, Eloxx recalculated the results using the change in ppFEV1 (a secondary outcome) from day 1 instead of from baseline.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Coherus breached Humira patent settlement by striking deal with Mark Cuban's drug firm, AbbVie contends

Fierce Pharma

An announcement early this month by Mark Cuban’s deep discount drug company that it would sell Coherus Biosciences’ biosimilar version of AbbVie’s Humira has the Illinois drugmaker calling foul.

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Opinion: New Study Reaffirms Value of Hospice – Policymakers Must Act To Expand and Protect This Type of Care

MedCity News

President Jimmy Carter’s decision to opt for hospice care has highlighted the importance of hospice care. His choice will hopefully help Americans better understand the benefits of hospice and lead to discussions with providers and loved ones about desired goals of care when approaching the end of life. But while hospice may be a newer topic of discussion for some, those of us who work to provide this type of health care have long understood the positive impact it has on patients, families and t

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Cala® Launches The Cala kIQ™ System, Offering Meaningful Tremor Relief for Patients With Essential Tremor and Now Parkinson’s Disease

Legacy MEDSearch

Cala , the bioelectronic medicine leader setting a new standard of care for chronic disease, today announced the commercial launch of its next generation system: the Cala kIQ System, the first and only FDA-cleared wearable device that delivers effective therapy for action hand tremor relief in people with essential tremor and Parkinson’s disease. The Cala kIQ System delivers Cala TAPS (Transcutaneous Afferent Patterned Stimulation) therapy, which is validated by large clinical studies and real-w

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AbbVie sues BeiGene over brand-new Imbruvica patent as blood cancer rivalry heats up

Fierce Pharma

AbbVie has opened a new front in its blood cancer drug rivalry against BeiGene. | AbbVie has opened a new front in its BTK blood cancer drug rivalry against BeiGene. In a lawsuit, the Illinois pharma giant accuses BeiGene of infringing a U.S. patent that was just issued on Tuesday.

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How Should Providers Adapt to Telehealth’s New Era?

MedCity News

Most patients prefer in-person care to virtual, according to a recent report. This finding should drive health systems to refine their telehealth experiences — they should determine which type of visits are best-suited for the modality, and they should ensure their virtual care environments adopt a more human-centric design.

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AbbVie's Skyrizi posts ulcerative colitis win in maintenance study, teeing up FDA nod

Fierce Pharma

After acing a study for the induction treatment of ulcerative colitis, AbbVie’s Skyrizi has snatched another win in a maintenance trial. An approval now looks within reach for 2024. | After acing a study for the induction treatment of ulcerative colitis, AbbVie’s Skyrizi has delivered another win in a maintenance trial. An approval now looks within reach for 2024.

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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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Eli Lilly Puts Up $60M for In Vivo Gene-Editing Med for Cardiovascular Disease

MedCity News

Eli Lilly’s partnership with Verve Therapeutics covers the development of a preclinical therapy addressing a protein associated with cardiovascular disease risk. The in vivo gene-editing therapy is a potential one-time treatment.

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'The Top Line': News from BIO's annual conference, plus this week's headlines

Fierce Pharma

In this episode of "The Top Line," we talk with Fierce’s Max Bayer and Angus Liu about the most important news coming from this year's annual BIO conference. | This week on "The Top Line," we discuss the the top news from this year's annual BIO meeting, plus a COVID lawsuit, an FDA-approved app and the rest of the week's headlines.

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How Walgreens Is Supporting Patients During Medicaid Redeterminations

MedCity News

Now that Medicaid redeterminations have resumed, Walgreens is supporting patients by educating them about renewals and helping them navigate through the process, execs said at AHIP 2023 in Portland.

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Why is microbiological testing in medical device manufacturing important?

European Pharmaceutical Review

A paper published in the Journal of Pharmaceutical Research International has reviewed microbiological testing for medical devices and described their applications and challenges. Microbiological testing is essential for quality control , regulatory compliance and can help minimise the risk of microbial contamination. This approach can also help determine the appropriate manufacturing processes, sterilisation methods, and maintenance procedures.

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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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INVEST Digital Health Conference in Dallas Will Probe True Value and Not Fanciful Valuation

MedCity News

In an environment where capital isn’t as easy to access, INVEST Digital Health conference will seek to arm you with the right connections and meaningful insight to navigate an environment where ROI is king. Hear from payers, providers, startups, life sciences executives, VCs and more.

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Birmingham University reveals antimicrobial discovery

PharmaTimes

Researchers show silver retains antimicrobial activity for longer when it is infused into bioactive glass - News - PharmaTimes

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Bleeding Problems Prompt FDA Partial Hold on Tests of Mersana Cancer Drug

MedCity News

For the second time in three months, Mersana Therapeutics is dealing with an FDA clinical hold. The partial hold on tests of its experimental ovarian cancer drug follows a full hold placed on an early-stage test of a different Mersana therapy in various types of solid tumors.

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Positive profile for Enterome's lymphoma candidate

PharmaTimes

EO2463 is an experimental treatment for indolent non-Hodgkin B cell lymphoma - News - PharmaTimes

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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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Don’t Be Fooled by the ‘Autonomous’ Revenue Cycle Hype

MedCity News

But what AI solutions can’t do is magically eliminate the need for empowered registrars. Maximizing growth while improving efficiency requires both people and technologies.

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Technology Overload: Addressing Site Challenges of Digital Trials

PharmExec

Webinar Date/Time: Wed, Jul 26, 2023 11:00 AM EDT

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The Supreme Court Case of Andy Warhol Foundation v. Goldsmith: What, if Anything, Does it Mean to Artificial Intelligence?

Copyright Clearance Center

The post The Supreme Court Case of Andy Warhol Foundation v. Goldsmith: What, if Anything, Does it Mean to Artificial Intelligence? appeared first on Copyright Clearance Center.

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Effective Data Interoperability for Enhanced Performance in ACOs

Clarify Health

It’s impossible to run a successful accountable care organization (ACO) without data interoperability. Interconnected data is vital for many facets of ACOs, including patient information, care coordination, quality measurement, population health management, value-based reimbursement, research, and analytics. By facilitating the seamless exchange and utilization of data, strong interoperability standards enhance an organization’s ability to deliver accountable, patient-centered care

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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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Regulatory Spotlight - Compendia Updates: USP and USP

PharmaTech

Compendia publications are periodically updated in order to align with industry trends and harmonize with global regulatory practices. Staying abreast of these changes well before they are implemented, and being ready to adapt as necessary, is in the best interest of any bio/pharmaceutical testing laboratory. Eurofins BioPharma Product Testing has proactively adjusted its procedures, collaborating with stakeholders and providing feedback to ensure smooth integration and minimal impact on existin

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How to Build A World-Class Coaching Program for Field Sales With Sebastian Jimenez

Spotio

Listen to the episode on Spotify. How to Build A World-Class Coaching Program for Field Sales With Sebastian Jimenez Sebastian Jimenez, the mastermind behind Rillavoice, the speech recording and analytics software for external sales and service teams, joins us to share invaluable tips and insights on creating an exceptional coaching program for field sales experts.

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Aptamer Group and Neuro-Bio Collaborate to Develop Alzheimer’s Disease Diagnostic Test

PharmaTech

The integration of the binders into a routine lateral flow test will support the clinical and commercial development of rapid diagnostics for Alzheimer’s disease through nasal sampling.

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Astellas and Cullgen to develop small molecule protein degraders

Pharmaceutical Technology

Japan-based Astellas Pharma has entered a partnership with Cullgen to discover and develop multiple targeted protein degraders through the latter’s proprietary uSMITE targeted protein degradation platform, in a deal potentially worth $1.9bn. Under the agreement, Astellas will give an upfront payment of $35m to the San Diego-based biotech, Cullgen. The deal gives Astellas the option to exclusively license its rights for clinical development and commercialisation for any protein degrader compounds

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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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Unlocking New Applications of AI: What IP Practitioners Need to Know Before Selecting an AI-based Solution

Clarivate

For patent and trademark offices, law firms and corporations seeking to automate intellectual property operations and optimize decision making, artificial intelligence is now considered business critical. In this blog, Vashe Kanesarajah, Head of Strategy, IP Organization at Clarivate, explores how artificial intelligence (AI) and machine learning (ML) are progressing and what this means for the intellectual property ecosystem.

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Novo Nordisk to Expand Manufacturing Facilities in Hillerød, Denmark

PharmaTech

The investment, which is taking place in Hillerød, Denmark, will aim to create more production capacity and increase the company’s ability to meet future market demands and to continue development on its future clinical late-phase product portfolio.

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R&D innovation advancing small molecule innovator CDMO market

European Pharmaceutical Review

According to a report by Future Market Insights, the small molecule innovator contract development and manufacturing organisation (CDMO) market is projected to value $48.09 billion in 2023 and $89.43 billion in 2033. Sales in the small molecule innovator CDMO market is expected to grow at a compound annual growth rate (CAGR) of 6.4 percent during the forecast period.

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FDA approves Alentis’ IND for ALE.C04 to treat CLDN1+ tumours

Pharmaceutical Technology

Alentis Therapeutics has received US Food and Drug Administration (FDA) clearance for its investigational new drug (IND) application for ALE.C04 to treat Claudin-1 positive (CLDN1+) tumours. ALE.C04 is an investigational antibody designed to target exposed CLDN1 in cancer cells. This approval has been granted for ALE.C04 both as a monotherapy and in combination with pembrolizumab in a first-in-human clinical study in recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).

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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.