Fierce Pharma

APRIL 28, 2023

EU plots major pharma reforms—but industry is already pushing back zbecker Fri, 04/28/2023 - 18:04

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Pharma 271

MedCity News

APRIL 28, 2023

Amazon recently announced that it is shuttering its Halo division, a line of wearable health and fitness devices. This marks the third time in about two years that the e-commerce giant has closed one its healthcare businesses — Amazon Care failed last year, and Haven failed in 2021.

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Healthcare Healthcare 118

Fierce Pharma

APRIL 28, 2023

With negative FDA panel vote, AstraZeneca may look at narrow Lynparza nod in prostate cancer aliu Fri, 04/28/2023 - 13:31

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FDA 223

MedCity News

APRIL 28, 2023

In some ways, the Drug Enforcement Agency’s (DEA) proposed rules for prescribing controlled substances via telemedicine are a sign of progress.

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Fierce Pharma

APRIL 28, 2023

Playing catch-up with Merck, Pfizer scores pediatric approval for Prevnar 20 kdunleavy Fri, 04/28/2023 - 07:11

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PharmaTech

APRIL 28, 2023

Todd Andrews, global director of Applications and Business Development at CPC, discusses sterile aseptic connectors, flexibility in manufacturing, and more in an interview held at INTERPHEX 2023.

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Manufacturing 105

Pharmaceutical Technology

APRIL 28, 2023

The US Food and Drug Administration (FDA) has granted an Orphan Drug Designation to Editas Medicine’s gene therapy EDIT-301 in sickle cell disease, based on an April 27 announcement. The US agency previously granted the Orphan Drug Designation to EDIT-301 for its study in beta thalassemia, in May 2022. The company is studying EDT-301 in sickle cell disease in a Phase I/II RUBY study (NCT04853576), and is on track to provide a clinical update by mid-2023.

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Food and Drug Administration Engineering Patients Food 105

Fierce Pharma

APRIL 28, 2023

Otsuka, Lundbeck gain FDA nod for longer-acting version of schizophrenia drug Abilify kdunleavy Fri, 04/28/2023 - 10:29

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FDA 200

MedCity News

APRIL 28, 2023

Merck, Sanofi, and Eli Lilly joined the Series A financing of Therini Bio, a startup developing a drug that selectively targets fibrin as a way of reducing disease-driving inflammation in neurodegeneration and eye disorders such as diabetic macular edema. Therini is preparing to advance its lead program to clinical testing.

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Leads Biopharma Pharma 104

Fierce Pharma

APRIL 28, 2023

The first Humira biosim is doing Amgen more harm than good—for now aliu Fri, 04/28/2023 - 09:52

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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.

Safety

MedCity News

APRIL 28, 2023

The Rockefeller Foundation is funding two produce prescription pilot programs at VA healthcare systems in Salt Lake City, Utah, and Houston, Texas. Eligible veterans will be able to enroll in About Fresh’s Fresh Connect program, which provides $100 per month through a debit card, allowing the veterans to buy healthy foods at the grocery store.

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Food Medicine Prescription Healthcare 101

European Pharmaceutical Review

APRIL 28, 2023

NEW, FLEXIBLE, data-driven manufacturing models are emerging to address the pharmaceutical industry’s need for greater operational efficiency. While new approaches aim to solve the unique challenges of the sector, like adhering to strict compliance regulations, digitalisation has quickly developed into a pathway for achieving information technology (IT)/operational technology (OT) integration, edge-to-enterprise connectivity, and overall operational excellence.

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Pharma Pharmaceutical manufacturing Manufacturing Pharmaceutical 92

MedCity News

APRIL 28, 2023

Too often today, BIPOC communities must deal with mental health obstacles without the necessary education, support, and coping strategies. Fortunately, healthcare organizations have opportunities to start addressing these challenges by building cultural competency and by strengthening community education, trust, and access.

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Education Healthcare Healthcare 101

European Pharmaceutical Review

APRIL 28, 2023

A new global research consortium is being established to address the global impact of antimicrobial resistance (AMR). Centres for Antimicrobial Optimisation Network (CAMO-Net) , brings together research teams from the University of Liverpool and Imperial College London in the UK, the University of Cape Town in South Africa, the Infectious Diseases Institute in Uganda and the Faculty of Medicine at the University of São Paulo in Brazil. ”… this network… represents a major commitment t

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Networking Medicine Leads Pharmaceutical 91

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Distribution

MedCity News

APRIL 28, 2023

Ask the Investor sessions at MedCity INVEST at the Ritz Carlton in Chicago May 22-24 offer opportunities for startups to talk with investors in intimate settings. Spots are limited so register today!

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European Pharmaceutical Review

APRIL 28, 2023

The European Commission ’s (EC’s) reform of the EU pharmaceutical legislation published on 26 April 2023, adopted a proposal for a new Directive and a new Regulation. These amend and replace the existing general pharmaceutical legislation. According to the EC, the revision is intended to: Ensure all EU patients can access safe, effective, and affordable medicines Enhance the security of medicine supply and availability, regardless of where patients live in the EU Continue to make Europe an attra

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Pharmaceutical Pharma Medicine Competition 86

PharmaVoice

APRIL 28, 2023

An industry veteran, innovator and curator, Dr. Amir Kalali’s vision for the future is patient-focused.

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Patients 98

Copyright Clearance Center

APRIL 28, 2023

The post Publishing Opens Its Salary Wallet appeared first on Copyright Clearance Center.

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Safety

PharmaTimes

APRIL 28, 2023

Therapy concerns the treatment of adults with axial spondyloarthritis and psoriatic arthritis

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Pharmaceutical Technology

APRIL 28, 2023

The US Food and Drug Administration (FDA) has approved Pfizer’s 20-valent pneumococcal conjugate vaccine, PREVNAR 20 , to prevent invasive pneumococcal disease (IPD) in infants and children aged six weeks to 17 years. PREVNAR 20 has been designed to avert IPD caused by 20 streptococcus pneumoniae (pneumococcal) serotypes. It has also been approved by the FDA for otitis media prevention in infants and children aged between six weeks and five years caused by the original seven serotypes contained

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Food and Drug Administration FDA Safety Media 59

PharmaTimes

APRIL 28, 2023

Kite’s two CAR T-Cell therapies involve treating several different types of blood cancer

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PharmaTech

APRIL 28, 2023

Sarah Stevens, senior vice-president and head of Drug Product Development & Manufacturing at Quotient Sciences, discusses various facets of the modern outsourcing industry.

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Manufacturing 52

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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.

Specialization

Clarify Health

APRIL 28, 2023

Unlocking value from analytics—do you have the right fuel? Data and analytics are driving healthcare organizations forward. However, with rising economic pressure, IT and data science teams spread thin, and many health systems suffering losses this year, CIOs and data and analytics leaders need to do more with less. Building a growth and value strategy at scale, with speed and precision, requires big data efficiencies, and the ability to draw upon billions of patient journeys.

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Physicians Healthcare Healthcare Patients 52

Penrod

APRIL 28, 2023

Here at Penrod, Kevin helps plan, create, maintain, improve, and deliver reusable solutions for sought-after Healthcare use cases. “My current role is to transform these solutions into reusable assets for any Healthcare project,” he says. On a weekly basis, he stays busy by seeking out Delivery team members with availability to collaborate on creating and improving our reusable solution library.

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Consulting Healthcare Healthcare Management 52

Pharmaceutical Technology

APRIL 28, 2023

Ocugen has received orphan drug designation from the US Food and Drug Administration for its OCU410ST (AAV5-hRORA) to treat ABCA4 – linked retinopathies. OCU410ST is an adeno-associated virus (AAV) serotype 5 capsid protein, which comprises a gene construct that encodes human retinoic acid receptor (RAR)-related orphan receptor alpha. It is intended to treat ABCA4-linked retinopathies including retinitis pigmentosa 19 (RP19), Stargardt disease and cone-rod dystrophy 3 (CORD3).

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Food and Drug Administration Transportation FDA Food 52

Contrarian Sales Techniques

APRIL 28, 2023

Discovering Your Inner Compass Let’s dive into the fascinating world of nurturing self-awareness. You might be thinking, "Why should I even care about self-awareness?" Well, my friend, self-awareness is the cornerstone of personal growth, and it's an essential ingredient for living a more intentional, fulfilling life. Let's explore this together, shall we?

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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

Leads

Pharmaceutical Technology

APRIL 28, 2023

Novo Nordisk’s leading drug Ozempic (semaglutide) is forecast to demonstrate a sales growth of 23% in 2023. Ozempic’s forecast 2023 sales of $12.5bn consolidate its position as the dominant market leader, with projected sales in 2023 54% greater than closest competitor Trulicity (dulaglutide) by Eli Lilly, which anticipates sales of $8bn. Originally granted approval in its largest market, the US, in 2017, Ozempic has subsequently obtained approval for three distinct dosages, 0.5mg, 1.0mg, and 2.

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Sales Marketing Medical Patients 52

Legacy MEDSearch

APRIL 28, 2023

Kerecis ® today announced MariGen ® Shield, which integrates the company’s proven fish-skin graft with a silicone contact layer for treating chronic and complex wounds. The medical-fish-skin company also announced the results of a clinical study comparing the effectiveness of the Kerecis fish-skin grafts to a standard of care for diabetic foot ulcers.

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Recruitment Prospecting Medical Management 52

Pharmaceutical Technology

APRIL 28, 2023

An EU study claims that building more API facilities in Central and Eastern Europe could help solve drug shortages and weaknesses in the supply chain. The literature review suggests the Czech Republic, Poland, and Hungary as sites for new production locations in Europe given that their staff costs are lower than in Western Europe, but notes that higher-income countries, such as Germany, the Netherlands, and Belgium also make attractive production locations.

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Government Transportation Manufacturing Pharmaceutical 52

Pharmatutor

APRIL 28, 2023

Expert Committee on Pharmacy Education, Law and Regulator admin Fri, 04/28/2023 - 15:45 ABOUT AUTHOR Dr. R. S. Thakur Chief Editor, Journal of Pharmaceutical Research Krupanidhi College of Pharmacy, Bengaluru, India. Email : drramsthakur@gmail.

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Education Pharmaceutical research Pharmaceutical 52

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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.

Management