Mon.Dec 05, 2022

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AstraZeneca partner FibroGen slaps former employees with trade secret theft lawsuit

Fierce Pharma

AstraZeneca partner FibroGen slaps former employees with trade secret theft lawsuit. zbecker. Mon, 12/05/2022 - 10:31.

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WHO/PAHO launch free digital health assistant to cut alcohol-related diseases

pharmaphorum

A digital health assistant that can help people at risk of becoming dependent on alcohol has been launched in Belize, its first country, by the World Health Organisation (WHO) and Pan-American Health Organisation (PAHO). The artificial intelligence-powered assistant – called Pahola and available as a free online chat-based site – is designed to provide information and guidance to help people reduce their alcohol consumption, helping to prevent more than 200 health conditions linked to excessive

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SABCS: Lilly aims Verzenio at broader post-surgery breast cancer nod as Novartis' rival draws near. Will FDA bite?

Fierce Pharma

SABCS: Lilly aims Verzenio at broader post-surgery breast cancer nod as Novartis' rival draws near. Will FDA bite? aliu. Mon, 12/05/2022 - 15:10.

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Kaiser Nurses Ratify New Contract That Raises Wages by 22.5% And Improves Staffing

MedCity News

About 21,000 Kaiser Permanente nurses in Northern California ratified a new four-year contract — one that includes provisions for a 22.5% wage increase, improved staffing and more. The contract’s approval comes about two weeks after Kaiser reached an agreement with California Nurses Association to avert what would have been the biggest private sector nurses strike in American history.

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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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In free fall, Clovis defaults on loan and agrees to further restrict Rubraca use

Fierce Pharma

In free fall, Clovis defaults on loan and agrees to further restrict Rubraca use. kdunleavy. Mon, 12/05/2022 - 09:34.

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Amgen Weighs In to Chase Rival Obesity Drugs From Novo Nordisk and Eli Lilly

MedCity News

An Amgen drug led to weight loss that was sustained, clinical data that support advancing the molecule to a Phase 2 test expected to start in early 2023. While AMG 133 trails rival products from Novo Nordisk and Eli Lilly, Amgen hopes to offer patients a dosing edge.

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More Trending

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Virtual Reality: The New Tool in Healthcare Training

MedCity News

Virtual reality exceeds the traditional training methods facilities often use, and this new immersive, experiential way to train staff members is critical for their proficiency and satisfaction.

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Sanofi and Queensland collaborate to build $190m research facility

Pharmaceutical Technology

Sanofi has signed an agreement with the Queensland Government in Australia to establish a $190m (A$280m) research facility in Brisbane. With the establishment of this Translational Science Hub, Queensland is set to become an international messenger ribonucleic acid (mRNA) vaccine hub. According to the latest deal, the University of Queensland (UQ) and Griffith University will serve as foundational partners.

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FDA Tells Verve What to Do to Get Hold Lifted From Gene-Editing Therapy

MedCity News

Verve Therapeutics received the formal FDA letter outlining what the agency wants to see before it lifts the clinical hold placed on the biotech’s gene-editing therapy. The lifting of a clinical hold on another experimental genetic medicine was among the other recent regulatory news from the past week, which included two drug approvals and one rejection.

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Cannabinoids receptors: popular preclinical target but banned in 137 countries

Pharmaceutical Technology

Cannabinoid receptors are a popular therapeutic target for cannabinoid-based drugs in the treatment of pain, neurological disorders and inflammation, according to GlobalData’s Pharma Intelligence Centre Drugs database. In 2022, a surge in the pipeline has led to cannabinoid receptors becoming the most popular target in preclinical development. Despite this, the medical use of cannabinoid drugs is heavily restricted, including being banned in 137 countries, according to the United Nations.

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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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3 Employer Health Trends for 2023: Affordability Tops the List

MedCity News

Employers have several strategies for combatting rising healthcare costs, including moving to more value-based care arrangements, said Ellen Kelsay, President and CEO of Business Group on Health. Other top health trends for employers next year will be continued support of wellbeing programs and health equity.

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Pluvicto™ offers survival benefits for metastatic prostate cancer

European Pharmaceutical Review

Novartis has announced its Phase III PSMAfore study with Pluvicto , lutetium (177Lu) vipivotide tetraxetan, demonstrated improved radiographic progression-free survival (rPFS) in patients with prostate-specific membrane antigen (PSMA)–positive metastatic castration-resistant prostate cancer (mCRPC) after androgen-receptor pathway inhibitor (ARPI) therapy, compared to a change in ARPI.

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Among Employers Offering Retiree Health Benefits, More Are Turning to MA Plans

MedCity News

Currently, only 13% of large employers — or companies with 200 or more employees — offer retiree health benefits, the Kaiser Family Foundation survey found. Of this group, 50% provide these benefits through a Medicare Advantage plan, up from 26% in 2017.

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Cipla- Openings for QC/ Production/ Engineering/ QA/ EHS/ Stores Dept. -Apply Now

Pharma Pathway

Cipla- Openings for QC/ Production/ Engineering/ QA/ EHS/ Stores Dept. -Apply Now. Job Description. Company Profile. Cipla Limited is an Indian multinational pharmaceutical company, headquartered in Mumbai, India. Cipla primarily develops medicines to treat respiratory, cardiovascular disease, arthritis, diabetes, weight control and depression. Career for Women at Cipla.

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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.

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How Nebraska’s HIE Is Leveraging Real-Time Data to Improve Maternal, Postpartum Health

MedCity News

The next generation of HIEs must think beyond the transfer of information and explore how they can use real-time health data to improve population health outcomes, according to the CEO of Nebraska’s HIE. A key way that her HIE is seeking to improve population health outcomes is through a program it launched six months ago to improve equity in maternal and postpartum care through identifying high-risk patients and sharing real-time information with providers.

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Hetero Biopharma-Walk-In Interview for M.Sc/ B.Tech Biochemistry/ Biotechnology in Production On 10th Dec’ 2022

Pharma Pathway

Hetero Biopharma-Walk-In Interview for M.Sc/ B.Tech Biochemistry/ Biotechnology in Production On 10th Dec’ 2022. Job Description. Greetings from Hetero Biopharma !!! Walk-In Interview for M.Sc/ B.Tech Biochemistry/ Biotechnology in Production @ Hetero Biopharma. Department: Production. Designation: Sr. Executives. Experience: 3-8 years. Qualification: M.Sc/ B.Tech Biochemistry/ Biotechnology.

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Can Hospitals Succeed in VBC and Improve Their Overall Financial Health? An Oxymoron, It Is Not

MedCity News

Here are three proven strategies for hospital executives to create an overall winning proposition (while keeping patients at the center of it).

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Gland Pharma-Walk-In Interview for B.Sc, B.Pharm, M.Sc, M.Pharm in Production Department On 9th Dec’ 2022

Pharma Pathway

Gland Pharma-Walk-In Interview for B.Sc, B.Pharm, M.Sc, M.Pharm in Production Department On 9th Dec’ 2022. Job Description. Walk-in for experienced Production candidates on 9th December @ Gland Pharma Unit 1, Pashamylaram | Experience: 1-7 years | Immediate Joiners Preferred | Parenteral Experience Mandatory|. Production: Hands on experience in Vial, Ampoule, Aseptic Area Filling/ Vial Sealing/ Line Chemist/ Compounding/ Autoclave operators.

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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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Facing the Challenges and Opportunities in Digital Health Data Security

Impetus Digital

This is a guest article provided by Cybernews and does not necessarily reflect the views and values of Impetus Digital. Digital health data security is a growing concern for individuals, organizations, and government agencies. The industry is under immense pressure to adopt new technologies and systems that can protect patient data while allowing easy sharing with authorized parties.

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Dr. Reddy’s Laboratories Ltd.-Multiple Vacancies in Quality Assurance/ Quality Control- Apply Now

Pharma Pathway

Dr. Reddy’s Laboratories Ltd.-Multiple Vacancies in Quality Assurance/ Quality Control- Apply Now. Job Description. Dr. Reddy’s Laboratories Ltd. is an integrated global pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three business-Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary Products.

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Raw Materials Testing for Cell & Gene Therapy Manufacturing

PharmaTech

Eurofins BioPharma Product Testing’s Biologics Raw Materials testing team has vast experience in cell & gene therapy testing, including evaluating critical quality attributes for ancillary and raw materials.

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AI company zeros in on compounds to treat addiction by rewiring the brain

PharmaVoice

GATC Health is driving a novel approach it believes could work for several major neurological conditions.

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.

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EMA accepts momelotinib marketing application

European Pharmaceutical Review

GSK has announced that the European Medicines Agency (EMA) has validated the marketing authorisation application (MAA) for momelotinib, a new oral treatment for myelofibrosis, which, if approved, could be the only medicine available to address myelofibrosis, including anaemia, symptoms, and splenomegaly. Momelotinib has a differentiated mechanism of action, with inhibitory ability along three key signalling pathways: Janus kinase (JAK) 1, and JAK2 and activin A receptor type I (ACVR1), which cou

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The New Hit Factory: Podcasts and Audiobooks

Copyright Clearance Center

The post The New Hit Factory: Podcasts and Audiobooks appeared first on Copyright Clearance Center.

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An FDA proposal could make OTC switches easier. Here’s what the industry has to say

PharmaVoice

How the FDA’s proposal to create a new OTC approval pathway could impact the pharma industry.

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Valneva shares positive chikungunya vaccine results

PharmaTimes

99% of participants retained very high neutralising antibody levels 12 months after treatment

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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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Big passion for small biotech and its potential to address complex diseases

PharmaVoice

A conversation with Teresa Nunes, chief medical officer of Allucent.

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FDA grants fast-track designation for Istesso’s IPF candidate

PharmaTimes

The therapy has reduced inflammation and supported the remodelling of damaged bone

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Novartis’ Pluvicto presents survival benefit for castration-resistant prostate cancer

pharmaphorum

It has been announced today that Novartis’ Pluvicto (lutetium vipivotide tetraxetan) has shown statistically significant and clinically meaningful radiographic progression-free survival benefit in patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC). Prostate cancer is the most frequently diagnosed cancer in men in 112 countries.

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Lupkynis approved for the treatment of LN in the EU and UK

Pharmaceutical Technology

On September 19, Lupkynis (voclosporin), a therapy for lupus nephritis (LN), received European Commission (EC) approval, becoming the second therapy approved in the EU for the treatment of LN after Benlysta (belimumab) from GlaxoSmithKline. The UK Medicines and Healthcare products Regulatory Agency (MHRA) has also since granted the Great Britain marketing authorisation of Lupkynis to treat adults with active LN.

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Clinical Supply Strategies for CROs

When a CRO is bidding on a project where clinical supplies will be one of the aspects to manage on behalf of the client via a partner, leveraging the expertise of a chosen clinical supply partner can be a valuable resource in demonstrating the CRO’s understanding of and ability to deliver upon critical drug-supply related aspects of the project, and ability to hit key milestones such as FPI for their client.