Wed.Apr 26, 2023

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Eli Lilly's weight-loss drug passes 2nd trial with flying colors, setting up likely approval

Fierce Pharma

Eli Lilly's weight-loss drug passes 2nd trial with flying colors, setting up likely approval aliu Wed, 04/26/2023 - 22:30

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Kaiser Permanente to Acquire Geisinger, Along with 5-6 More Health Systems in the Near Future

MedCity News

Kaiser Permanente announced that it expects to acquire Pennsylvania-based Geisinger Health. Kaiser’s move is part of a larger plan — Geisinger will be the first health system to join Risant Health, a new company Kaiser launched to operate nonprofit health systems under value-based care models. Kaiser said it expects to invest $5 billion in Risant and fold five or six health systems into the company over the next five years.

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FDA approves first oral microbiome therapy Vowst. Will Nestlé be around to help Seres with the launch?

Fierce Pharma

FDA approves first oral microbiome therapy Vowst. Will Nestlé be around to help Seres with the launch?

FDA 299
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CommonSpirit, Dignity Health Team Up to Launch Nurse Retention Program

MedCity News

CommonSpirit Health has co-developed a nurse residency program with Dignity Health Global Education. The program, which is designed to increase nurse retention, comes at a time when turnover rates for newly graduated nurses are at an all-time high. Through the program, the partners are aiming to increase newly graduated nurse retention by at least 20% at CommonSpirit.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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UPDATED: Gearing up for key approvals, GSK projects 'Shingrix-like' sales for its RSV vaccine

Fierce Pharma

UPDATED: Gearing up for key approvals, GSK projects 'Shingrix-like' sales for its RSV vaccine fkansteiner Wed, 04/26/2023 - 09:52

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Breathing easy: How digital inhalers are changing asthma treatment

Pharmaceutical Technology

AstraZeneca , Teva Pharmaceuticals , and Novartis , and other companies, are expanding their reach in the asthma space by capitalizing on digital technologies to enhance the patient experience. But experts say the complete integration of these devices and platforms into the healthcare system remains to be seen. Dr. Amy Chan, senior clinical research fellow at the School of Pharmacy, University of Auckland, says digital inhalers have existed for almost 30 years.

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Orbital Therapeutics Raises $270M to Bring RNA-Based Medicines to New Heights

MedCity News

ARCH Venture Partners-backed Orbital Therapeutics’ is researching next-generation RNA medicines that offer advantages over currently available therapies. The startup’s three areas of focus are vaccines, protein replacement, and immunomodulation.

Medicine 111
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After shutting down, Akorn recalls its 70-plus products nationwide

Fierce Pharma

After shutting down, Akorn recalls its 70-plus products nationwide zbecker Wed, 04/26/2023 - 16:06

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Leverage Analytics and Technologies to Improve Quality of Care [Sponsored]

MedCity News

MedCity News connected with Global Health Leader at EY, Aloha McBride, to share details on the company’s upcoming survey on what consumers are looking for in value-based care.

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After IRA, lawmakers look for more ways to cut drug prices

Fierce Pharma

After IRA, lawmakers look for more ways to cut drug prices kdunleavy Wed, 04/26/2023 - 13:38

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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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New Analysis Shows 9 Key Metrics That Will Support Medicaid Coverage During Redeterminations

MedCity News

Between eight to 24 million people could lose Medicaid coverage during the redetermination process, which began April 1, according to Kaiser Family Foundation. To mitigate losses, several states have implemented policies like taking the full year to complete renewals and automating the process.

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'Eligibility challenges' derail specialized trial of GSK's Zejula in breast cancer

Fierce Pharma

'Eligibility challenges' derail specialized trial of GSK's Zejula in breast cancer fkansteiner Wed, 04/26/2023 - 13:19

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AHIP Targets Big Pharma in New Campaign

MedCity News

America’s Health Insurance Plans’ new campaign aims to show how health insurers are working to create savings for Americans while also targeting Big Pharma (or more specifically drug manufacturers) for increasing drug costs. The ads will be distributed on TV, social media and streaming services.

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In pleasant surprise for Roche, Vabysmo blasts off as company's biggest growth driver

Fierce Pharma

In pleasant surprise for Roche, Vabysmo blasts off as company's biggest growth driver aliu Wed, 04/26/2023 - 10:46

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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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Novartis releases data for potentially “practice-changing” PNH medicine

European Pharmaceutical Review

Oral iptacopan enabled an estimated 92.2 percent of complement-inhibitor-naïve, paroxysmal nocturnal haemoglobinuria (PNH) patients achieve 2 g/dL or more haemoglobin-level increase from baseline without the need for blood transfusions. The results show “oral iptacopan controls haemolysis while nearly eliminating the need for blood transfusions” These data from the Phase III APPOINT-PNH trial were presented at the 2023 Annual Meeting of the European Society for Blood and Marrow Transplantation (

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Roche nixes Tecentriq trial in early breast cancer, but it's 'still in the game' in key lung cancer use: exec

Fierce Pharma

Roche nixes Tecentriq trial in early breast cancer, but it's 'still in the game' in key lung cancer use: exec aliu Wed, 04/26/2023 - 08:33

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Talking Cybersecurity with Mariano Mattei (INTERPHEX 2023)

PharmaTech

Mariano Mattei, vice-president of cybersecurity and CISO for Azzur Group, goes in depth about cybersecurity in the pharma field.

Pharma 98
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FDA argues AstraZeneca, Merck's Lynparza only works in subset of prostate cancer patients

Fierce Pharma

FDA argues AstraZeneca, Merck's Lynparza only works in subset of prostate cancer patients aliu Wed, 04/26/2023 - 14:19

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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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Season 2 of MedCity Pivot Podcast Launches with Conversation of Zephyr AI CEO

MedCity News

Season 2 of our MedCity Pivot Podcast launches today with a conversation about how AI can be leveraged to transform precision medicine.

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MSF calls on J&J to allow wider access to tuberculosis med Sirturo

Fierce Pharma

MSF calls on J&J to allow wider access to tuberculosis med Sirturo zbecker Wed, 04/26/2023 - 11:28

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CCC Celebrates World Intellectual Property Day 2023

Copyright Clearance Center

The post CCC Celebrates World Intellectual Property Day 2023 appeared first on Copyright Clearance Center.

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Adcentrx raises funds to advance ADCs into clinical development

Pharmaceutical Technology

Biotechnology company Adcentrx Therapeutics has raised $38m in Series A+ financing to advance its pipeline of new antibody-drug conjugate (ADC) therapeutics into clinical development. Lighthouse Capital and Life Venture Partners served as financial advisors to the company. Led by Eight Roads Ventures, the financing round saw participation from strategic investors, including the Trinity Innovation Fund, ABio-X, Delta Capital and F-Prime Capital.

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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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Scientists could finally be closing in on a ‘pill’ for men

PharmaVoice

Drug developers have tried — and failed — to create a male contraceptive for decades. Now, one group of scientists might be on the verge of success.

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Mainz Biomed in collaboration with Instituto de Microecologia

PharmaTimes

Vital link-up aims to expand ColoAlert detection tests in Europe and increase early cancer diagnosis

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7 Best Sales CRM Software (By Category)

Spotio

Are you still tracking leads in a spreadsheet? Then it’s time to upgrade to a full CRM software for sales. Once you do, you’ll have access to the features your sales team needs to close deals consistently. I’m talking about lead tracking, pipeline visualization, activity management, and analytics-type features. Of course, choosing the right CRM for your sales team is easier said than done.

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NICE approval for Janssen’s Darzalex combination

PharmaTimes

Recommendation concerns routine use across the NHS as therapy for multiple myeloma

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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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How to Write an Executive Resume

Rep-Lite

A resume for executives is a summary of a job candidate’s education, skills, accomplishments, and work experience. It is a crucial resource for high-level job seekers to exhibit their qualifications and achievements to companies that may be interested in recruiting them. An effective executive resume should be tailored to the position and company you are applying to, highlight the key skills that make you a qualified candidate, and demonstrate your value as an executive.

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Protected: Disease State Education – Creating a Strong Foundation for a Successful Launch

Pharma Marketing Network

This content is password protected. To view it please enter your password below: Password: The post Protected: Disease State Education – Creating a Strong Foundation for a Successful Launch appeared first on Pharma Marketing Network.

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Moderna’s mRNA vaccine manufacturing centre begins construction

European Pharmaceutical Review

Construction has begun on Moderna ’s Innovation and Technology Centre (MITC) at the Harwell Science and Innovation Campus, Oxfordshire. Built to deliver Moderna’s ten-year strategic partnership with the UK government, announced in March 2023, the MITC will incorporate research, development and a manufacturing facility for mRNA vaccines. Moderna chooses mRNA vaccine manufacturing centre location The collaboration between the UK government and Moderna will provide “NHS patients across the country…

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MiNA and BioMarin partner to speed development of RNAa therapies

Pharmaceutical Technology

MiNA Therapeutics has entered into a research collaboration and option licensing agreement with BioMarin Pharmaceutical to speed up the development of therapeutic ribonucleic acid activation (RNAa) candidates to treat rare genetic diseases. The option licensing agreement is based on early-stage clinical results. Both firms will be involved in the discovery, potential development and commercialisation of the RNAa therapeutic candidates.

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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.