Fri.Nov 03, 2023

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Pfizer cuts 200 jobs at COVID drug, vaccine plant in Michigan amid $3.5B savings campaign

Fierce Pharma

Pfizer’s plunging COVID-19 product demand has spurred a companywide cost-cutting campaign, with nearly 200 jobs now on the chopping block in Michigan. | Pfizer is cutting roughly 200 positions at its Kalamazoo site following a review of demand for its COVID-19 vaccine and antiviral Comirnaty and Paxlovid.

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How KelaHealth Slashed the Rate of Post-Surgical Complications at Duke

MedCity News

A new Duke study shows that KelaHealth’s platform was associated with a 21% reduction in acute kidney injury and a 24% decrease in costly readmissions following colorectal surgery. The platform delivers insights about individual patients’ surgical risks and what their care journeys should look like.

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Alvogen's bid to force FDA to approve generic to Bausch's Xifaxan shot down by federal court

Fierce Pharma

Bausch Health’s gastroenterology unit Salix Pharmaceuticals has chalked up a win in its long-running fight to fend off a generic to its irritable bowel syndrome diarrhea (IBD-D) med Xifaxan. | The D.C. federal court denied Alvogen's bid to force the FDA to grant full approval to its proposed Xifaxan generic. The agency previously gave the generic a tentative approval before some patents expire in 2029.

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Revamping HHS’ Complex Organizational Structure Could Improve Its Performance During Public Health Emergencies

MedCity News

Changes in HHS structure, along with well-funded and staffed partners at the state, local, tribal and territorial levels, may prove helpful for success during future public health emergencies and can help earn and maintain the public’s trust.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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In deal worth up to $640M, Pierre Fabre doubles down on its T-cell partnership with Atara

Fierce Pharma

In its attempt to win approval in the United States for its groundbreaking T-cell therapy Ebvallo (tabelecleucel), Atara Biotherapeutics is turning to the same partner it used to gain a green light | In its attempt to win approval in the United States for its groundbreaking T-cell therapy Ebvallo, Atara Biotherapeutics is turning to the same partner it used to gain a green light in Europe—Pierre Fabre Laboratories.

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Unlocking the Power of Healthcare Audiences: Segmenting Stakeholders and Maximizing Impact

MedCity News

This article delves into the importance of audience segmentation, offers guidance on identifying distinct audience groups, and discusses influential personas in healthcare.

More Trending

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Lexeo’s IPO Raises $100M for Gene Therapies That Treat the Heart, Protect the Brain

MedCity News

The gene therapy programs of Lexeo Therapeutics span rare forms of cardiomyopathy and certain types of Alzheimer’s disease. But Lexeo’s IPO comes as a rival gene therapy developer sues the biotech, claiming its work employs stolen trade secrets.

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Why are FSP models gaining traction within clinical research?

Fierce Pharma

Holding more than 25 years of experience in the medical sector spread across numerous pharmaceutical and CRO-based clinical research roles, Edel Shaw knows a thing or two about drug development.

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Improving Intranasal Treatments with Dr. Ferrer BioPharma at CPHI Barcelona

PharmaTech

Pharmaceutical Technology Europe® spoke with Gustavo Ferrer from Dr. Ferrer BioPharma, a US company focused on innovative intranasal medications, at the inaugural Start-Up Market on the show floor at CPHI Barcelona 2023.

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ADHD Drug Shortages: Causes, Implications, and Solutions

PharmExec

Due to a global demand, treatments such as Adderall and Ritalin have been in short supply for the management of attention-deficit hyperactivity disorder.

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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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Report: More Than 10M People Have Been Disenrolled From Medicaid

MedCity News

Amid the unwinding of the continuous enrollment provision, more than 10 million people have lost Medicaid coverage, according to data from KFF. Of those disenrolled from Medicaid coverage, 71% were removed from coverage for procedural reasons.

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MHRA authorises alopecia treatment

European Pharmaceutical Review

The Medicines and Healthcare products Regulatory Agency (MHRA) has authorised Pfizer’s Litfulo (ritlecitinib) for treatment for severe alopecia areata in patients 12 years and older. A hard capsule medicine, Litfulo is recommended to be taken daily as one 50mg oral dose. Litfulo’s active ingredient, ritlecitinib, is an enzyme inhibitor. It works irreversibly and selectively inhibits Janus kinase 3 (JAK3) and the tyrosine (TEC) family of kinases by blocking γ-common cytokine signalling and reduc

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Rapid rollout of NHS blood-thinning drugs has saved thousands of lives

PharmaTimes

Since 2022, an estimated 17,000 strokes and 4,000 deaths have been prevented - News - PharmaTimes

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Kindle Authors To Have AI-Audiobooks

Copyright Clearance Center

KDP authors can now choose from a selection of AI-generated narrators to create a machine-generated audiobook.

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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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‘All-clear’ cancer referral patients at higher risk of subsequent cancer

PharmaTimes

Over 63,000 cancer cases were diagnosed between one and five years after referral - News - PharmaTimes

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FDA Approves Abbott's HPV Test to Run on Alinity M Assay Platform

PharmExec

The newly approved Alinity m high risk human papillomavirus (HPV) assay is indicated to detect HPV and for use in routine cervical cancer screening per professional medical guidelines.

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Key E&L Issues to Consider During Formulation (AAPS PharmSci 360)

PharmaTech

Dujuan Lu, PhD, global leader—E&L, SGS Health Sciences, recommends some key issues that pharma manufacturers should consider when formulating products that require a medical device.

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Kura Oncology, Mirati Therapeutics Enter into Clinical Collaboration and Supply Agreement to Evaluate KO-2806 and Adagrasib in Non-Small Cell Lung Cancer

PharmExec

Ongoing phase 1 dose-escalation trial of KO-2806 (FIT-001) for the treatment of patients with KRASG12C-mutated non-small cell lung cancer expected to begin dosing patients in combination with adagrasib by mid-2024.

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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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Improve Healthcare Efficiency with a Digital Front Door

Referral MD

How the Healthcare Digital Front Door Improves Office Efficiency In recent years, the healthcare industry has undergone a transformation driven by digital technologies. One significant aspect of this transformation is implementing a healthcare digital front door. The digital front door refers to the virtual entry point that connects patients with healthcare providers, allowing them to access services and communicate with their healthcare team online.

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PolarisAR Receives Clearance from the U.S. Food and Drug Administration for Stellar Knee

Legacy MEDSearch

POLARIS AR is pleased to announce today that their STELLAR Knee has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). STELLAR Knee is the first clearance for POLARIS AR , a company focused on creating a new category in Mixed Reality surgical guidance. POLARIS AR and STELLAR Knee are building the intersection of physical surgery and virtual surgical guidance, bringing about a one-of-a-kind digital operating room environment.

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Ensuring the Next Generation of Analytical Experts (AAPS PharmSci 360)

PharmaTech

Hollie Barton, senior director, Chromatographic Services, for the PPD clinical research business of Thermo Fisher Scientific, highlights one approach to ensuring the continuation of analytical expertise.

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The large amendment to Poland’s Reimbursement Act—disappointing, but not disastrous

Pharmaceutical Technology

The large amendment to Poland’s Reimbursement Act (Duża Nowelizacja Ustawy Refundacyjnej, DNUR) finally came into legal force on November 1, although a small number of its regulations will only come into force in 2024 and 2025.

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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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Converting to Continuous Manufacturing with CONTINUUS Pharmaceuticals at CPHI Barcelona

PharmaTech

Pharmaceutical Technology Europe® spoke with Leonardo Vincenzi from CONTINUUS Pharmaceuticals, a US company that specializes in process development, at the inaugural Start-Up Market on the show floor at CPHI Barcelona 2023.

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Study finds higher cancer rate in patients given ‘all clear’

pharmaphorum

Study finds higher cancer rate in patients given ‘all clear’ Phil.

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Innovative GLP1R-targeting drugs dominate type 2 diabetes pipeline

Pharmaceutical Technology

Driven by success of recent GLP1R-targeting drugs, there has been a surge in the number of active pipeline drugs addressing this target for type 2 diabetes.

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Aktana Attains Tact.ai’s Field Engagement and Conversational AI Technology

Pharmaceutical Commerce

With new tech acquisition, the software company also introduces a new branded AI assistant for mobile devices specifically for the life sciences sector.

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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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Terremoto secures $175m in Series B to advance small molecule drugs

Pharmaceutical Technology

In May 2022, Terremoto raised $75m on Series A financing for its lysine-based covalency drug development platform.

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PharmaVoice 100s: Entrepreneurs

PharmaVoice

From biotech startups to a services agency, these entrepreneurs are hedging their bets to offer innovative approaches in patient care.

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EC approves Gedeon Richter-Sumitomo’s RYEQO for endometriosis

Pharmaceutical Technology

The European Commission (EC) has approved Gedeon Richter and Sumitomo Pharma’s Type II Variation application for RYEQO for endometriosis.

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Understanding the Continuum of Pharmacist Prescribing

Pharmacy Times

It is crucial to continue to evolve from dependent prescribing to an independent model, and address barriers with opportunities for change.

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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.