Wed.Apr 19, 2023

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Goodbye, original COVID-19 vaccines: FDA updates shot guidance, pulls monovalent authorizations

Fierce Pharma

Goodbye, original COVID-19 vaccines: FDA updates shot guidance, pulls monovalent authorizations zbecker Wed, 04/19/2023 - 11:04

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What Are the Best Practices in Implementing AI in Healthcare?

MedCity News

With AI being so new, there are some best practices for companies to follow when bringing it into healthcare. This includes partnerships and understanding the shortcomings of AI, several experts said during a session at the HIMSS 2023 conference.

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J&J, Legend's Carvykti cut risk of progression or death by whopping 74% in earlier myeloma, leaked abstract shows

Fierce Pharma

J&J, Legend's Carvykti cut risk of progression or death by whopping 74% in earlier myeloma, leaked abstract shows aliu Wed, 04/19/2023 - 09:10

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Answers Healthcare Providers Need to 5 Burning AI Questions in Revenue Cycle Management

MedCity News

Automation, AI, and machine learning can all be used to identify issues that lead to denials, streamline the patient billing process, reduce manual processes, and provide real-time data to quickly process claims.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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With hard-fought Polivy approval, Roche looks to shake up decades of established practice in lymphoma

Fierce Pharma

With hard-fought Polivy approval, Roche looks to shake up decades of established practice in lymphoma esagonowsky Wed, 04/19/2023 - 15:39

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FDA approves allogeneic stem cell transplant therapy

European Pharmaceutical Review

“The approval of Omisirge is a significant development in hematopoietic stem cell transplantation” Omisirge ® (omidubicel-onlv), now US Food and Drug Administration (FDA) approved , is the first allogeneic stem cell transplant therapy to be given marketing authorisation based on results from a global, randomised Phase III clinical study. The treatment is indicated for patients 12 years and older with hematologic malignancies planned for umbilical cord blood transplantation, following myeloablati

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The Healthcare System Isn’t a System, Health Exec Says

MedCity News

Patients are struggling to find the right care, and that’s because the healthcare system is fragmented, according to Andrea Walsh, president and CEO of HealthPartners, an integrated healthcare provider and insurance company. Walsh made these comments Wednesday at the HIMSS 2023 conference in Chicago.

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There’s No Place Like Home When It Comes to Oncology Care and Clinical Trials

Fierce Pharma

There’s No Place Like Home When It Comes to Oncology Care and Clinical Trials mteefey Wed, 04/19/2023 - 13:40

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The Case for Automatic Surveillance during Dialysis

MedCity News

This lack of monitoring is a serious problem—both for patients and for the overall healthcare system. The data show that in a typical dialysis center, each patient will suffer an average of 1.7 access blockages per year.

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GSK faces strike threat in UK, again, after workers pan pay raise

Fierce Pharma

GSK faces strike threat in UK, again, after workers pan pay raise fkansteiner Wed, 04/19/2023 - 10:17

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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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GSK to acquire BELLUS Health for $2bn

Pharmaceutical Technology

GSK has signed an agreement to buy Canadian late-stage biopharmaceutical company BELLUS Health for $2bn (£1.6bn). GSK will buy all the outstanding shares in BELLUS for $14.75 per share in cash. GSK expects that the BELLUS Health acquisition will boost its speciality medicines and respiratory pipeline. The company will gain access to BELLUS’s investigational, twice-daily oral P2X3 receptor antagonist, camlipixant, to treat refractory chronic cough (RCC).

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In a year of turnover, Seagen doled out $126M to a trio of CEOs

Fierce Pharma

In a year of turnover, Seagen doled out $126M to a trio of CEOs kdunleavy Wed, 04/19/2023 - 09:58

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Noah Medical Rakes In $150M for Its Robotic Lung Biopsy Platform

MedCity News

Medical robotics startup Noah Medical recently closed a $150 million Series B funding round. The company’s robotic platform, called the Galaxy System, was designed to help physicians find, biopsy and diagnose lung cancer lesions with more ease and confidence.

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Conditions for worker burnout in biotech are ripe. Here’s how to beat it

PharmaVoice

One of the country’s leading burnout experts explains how companies can help keep high stress from becoming a high desire to leave the job.

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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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New FDA Nod for Roche Drug Moves It to the Front Line in Treating Blood Cancer

MedCity News

Roche’s Polivy is now approved as an earlier line of treatment for patients who have diffuse large B-cell lymphoma. Accelerated approval of the drug in 2019 had made the drug a third treatment option for patients with advanced cases of this type of blood cancer.

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Electronic smart packaging market to value nearly $3b in 2033

European Pharmaceutical Review

A market report has identified that global demand for electronic smart packaging will reach $2.6 billion in 2033. This represents a compound annual growth rate (CAGR) of 15.4 percent from 2023, according to the data. Smart packaging has potential for the integration of electronic functionality, enabling compliance, material identification, condition monitoring and asset tracking of pharmaceutical products.

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Edge Impulse’s Edge ML Series: Explore How to Deploy Advanced Edge ML at Scale [Sponsored]

MedCity News

Invite-only, in-person event series for industry leaders like you. Join us to uncover product and ML innovation with our guests and speakers.

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Plastic Transistor Boosts Signals of Implantable Sensors

Medgadget

Researchers at Northwestern University have developed a transistor that can boost the signal created by electrochemical sensors by 1000-fold. The breakthrough may enable the development of highly sensitive implantable sensors that can measure tiny changes in electrochemical signaling in the body. This could allow clinicians to monitor tissue responses in near real time, instead of running a blood sample on bulky and expensive lab equipment and getting the results hours or even days later.

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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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Touchlight and 20Med partner on vaccine platform

PharmaTimes

Link-up has already delivered data showing the promise of nanoparticle-formulated doggybone DNA

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Social Media Is Touting New Weight Loss Drugs. Are Regulators Watching?

MedCity News

Suzette Zuena is her own best advertisement for weight loss.

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Vital funding for Maxion autoimmune disease research

PharmaTimes

Effective treatment of AID is still a considerable area of unmet medical requirements

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RapidAI Receives First and Only FDA 510(k) Clearance of Non-Contrast CT Imaging Product to Accelerate Acute Stroke Triage

Legacy MEDSearch

RapidAI , the global leader in neurovascular and vascular AI-enhanced clinical decision support and patient workflow, today announced it has received FDA 510(k) clearance for Rapid NCCT Stroke – a major addition to the RapidAI suite of non-contrast based solutions for stroke and trauma care, and the first and only FDA cleared medical device to detect suspected intracranial hemorrhage (ICH) and large vessel occlusion (LVO) from value-based CT imaging.

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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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Everest and SPH Kyuan partner for XERAVA commercialisation in China

Pharmaceutical Technology

Everest Medicines has signed a memorandum of understanding with Shanghai Pharma subsidiary SPH Keyuan Xinhua Pharmaceutical (SPH Kyuan) to support the import and channel distribution of XERAVA (eravacycline) in China. The collaboration will leverage SPH Kyuan’s drug import capabilities and distribution network, along with an improved logistics system.

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Ardelyx resubmits NDA for Xphozah to US FDA

Pharma Leaders

Ardelyx has resubmitted a new drug application (NDA) for Xphozah (tenapanor) to the US Food and Drug Administration (FDA). A first-in-class, phosphate absorption inhibitor, Xphozah will be used to control serum phosphate in adults with chronic kidney disease (CKD) on dialysis and who had an insufficient response or intolerance to a phosphate binder therapy.

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Johnson & Johnson reports 5.6% increase in Q1 2023 sales

Pharmaceutical Technology

Johnson & Johnson (J&J) has reported a 5.6% increase in sales to $24.75bn in the first quarter (Q1) of 2023, up from $23.4bn during the corresponding quarter of 2022. The company reported a net earnings loss of $68m, down by 101.3% from $5.15bn in Q1 2022. A one-time charge related to claims that the company’s talc-based products cause cancer led to a basic loss per share of $0.03.

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The Role of Cytochrome P450 in drug metabolism - A basic review

Pharmatutor

The Role of Cytochrome P450 in drug metabolism - A basic review admin Wed, 04/19/2023 - 16:11 About Author Ambika Shakya , Arabind kumar Ambikashk9@gmail.com, arvindkumarshk@gmail.

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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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Bayer plans to scale back women’s health R&D

Pharmaceutical Technology

Bayer has announced that it will shift the focus of its drug research away from women’s health to four core therapeutic areas: oncology, cardiovascular, neurology and rare diseases/immunology. This news comes after the refinement of Bayer’s early innovation framework, where it had decided to concentrate on the therapeutic areas with the best opportunities for delivering differentiated, high-value breakthrough medicines to patients.

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Celebrating World IP Day: Meet our trademark expert Vanessa Clabau

Clarivate

This year the theme of World Intellectual Property Day is “Women and IP: Accelerating innovation and creativity.” Clarivate helps companies accelerate innovation, achieve long-term growth and realize sustainable success. We are proud to join the global celebration of World IP Day on April 26 by spotlighting our women IP experts whose ingenuity and talent pave the way to major breakthroughs.

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Neuronascent plans Phase II Parkinson’s disease trial with neurorestorative drug

Pharmaceutical Technology

Neuronascent plans to start a potential Phase II trial of its neurorestorative agent NNI-362 in Parkinson’s disease in H1 2024, said CEO Judith Kelleher-Andersson in an interview with P harmaceutical Technology. While the Clarksville, US-based company completed a Phase Ia study in healthy participants to eventually develop the drug for Alzheimer’s disease, it is likely that the company will now focus on Parkinson’s disease in its Phase II study first, said Kelleher-Andersson.

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Woman of the Week: Brii Biosciences’ Ellee de Groot

PharmaVoice

A chemical engineer by training, Brii’s chief technology officer is applying her experience to solve research problems from the clinic to commercial development.

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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.