Fri.Dec 02, 2022

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With buyout on Horizon, Amgen and Sanofi eye cash plays for rare disease drug maker

Fierce Pharma

With buyout on Horizon, Amgen and Sanofi eye cash plays for rare disease drug maker. fkansteiner. Fri, 12/02/2022 - 09:51.

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How Patient Care Is Being Improved by Technology Everyday

MedCity News

From streamlining long-held manual processes to creating entirely new diagnostic devices, new tech is cropping up all over the medtech industry—resulting in a real-world impact on patients’ quality of life.

Patients 128
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Trending Sources

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UPDATED: GSK, with new trial win, looks to expand PD-1 Jemperli in endometrial cancer

Fierce Pharma

UPDATED: GSK, with new trial win, looks to expand PD-1 Jemperli in endometrial cancer. zbecker. Fri, 12/02/2022 - 11:22.

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What Should Health Systems’ Patient Access Strategies Be Heading into 2023?

MedCity News

Health system leaders believe that improving patient access should be their top priority when strategically planning for 2023, according to a new report from the KLAS Research and UPMC’s Center for Connected Medicine. To improve patient access, respondents agreed that their health systems will need to make changes in three key areas — people, process and technology.

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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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Fierce Pharma Asia—Eisai's lecanemab Alzheimer's debate; BeiGene's Imbruvica showdown; Shionogi's COVID drug nod

Fierce Pharma

Fierce Pharma Asia—Eisai's lecanemab Alzheimer's debate; BeiGene's Imbruvica showdown; Shionogi's COVID drug nod. aliu. Fri, 12/02/2022 - 08:55.

Pharma 191
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DTC Metabolic Tracker Company To Expand Personalized Nutrition Guidance With $62M

MedCity News

Lumen sells a handheld device that measures users’ metabolism through breath and connects to an app that helps track goals and provides nutrition coaching. The funding round was led by Pitango Venture Capital, and included participation from Hanwha Group and Resolute Ventures.

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Panel Orders UnitedHealthcare to pay $10.8M for Allegedly Underpaying Physicians

MedCity News

The lawsuit is one of nine cases throughout the country that TeamHealth has brought against United for alleged underpayments. The other eight cases are still ongoing. .

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Rigel scores green light in AML just 4 months after buying asset from Forma

Fierce Pharma

Rigel scores green light in AML just 4 months after buying asset from Forma. kdunleavy. Fri, 12/02/2022 - 10:00.

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The FDA Is Opening the Use of Registry Data in Drug Development – What Does It Mean for Patient Advocacy Groups?

MedCity News

FDA’s draft guidances on real-world data do not provide strict requirements for industry stakeholders to abide by, but they offer patient advocacy organizations with a clearer understanding of how to model their registries to have a more substantial impact for their patient communities.

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Introduction to Pharmaceutical QMM Model: QMM Assessment to Promote Pharmaceutical Operational Excellence

PharmaTech

QMM is an evolutionary advancement in FDA’s quality management maturity initiative that provides industry with a viable methodology to assess and improve manufacturing quality and supply chain reliability.

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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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The Top 10 Clinical Research Companies in the USA

Medico Reach

To bring effective medicines and Innovations in healthcare industry , a Clinical Research Organization or Contract Research Organization (CRO) are a must for the Biotech, Medtech, and pharma industries. A CRO offers comprehensive support to their efforts to test, examine, refine and market the latest medicines and devices that help in improving Healthcare Industry.

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Improving trial predictability: leveraging AI-powered analytics to guide trial design, strategy, and operations

pharmaphorum

Enrolling for clinical trials has become more challenging in recent years, with trial competition, increasingly complex protocols, and precision medicine targeting more niche patient populations. This emphasises sponsors’ need for enrolment predictability. The challenge the industry faces, however, is that operational certainty is exacerbated by the impact of global disruptions, such as the effect of COVID-19, natural disasters, and regional conflicts.

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StartUPDATES: New developments from healthcare startups

MedCity News

Check out new developments from Medvantx, Medisafe, Medical Informatics Corp., Journey Biosciences, and GSR Ventures.

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Vaccines Europe launches first pipeline review

European Pharmaceutical Review

Vaccines Europe has unveiled its first pipeline review of its 15 members companies, with 100 vaccine candidates as of July 2022. . The review revealed a pipeline aimed at tackling current and future challenges, such as antimicrobial resistance (AMR) and respiratory tract infections, through leveraging a wide range of new technology platforms. The data indicated 46 percent of the vaccine candidates target infections that do not have an available vaccine.

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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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Intas Pharmaceuticals Ltd-Walk-In Drive for M.Sc (Microbiology) in Quality Control On 7th Dec’ 2022

Pharma Pathway

Intas Pharmaceuticals Ltd-Walk-In Drive for M.Sc (Microbiology) in Quality Control On 7th Dec’ 2022. Job Description. Company Profile: INTAS Pharmaceutical is a leading, vertically integrated global pharmaceutical formulation development, manufacturing, and marketing company. Intas is committed to challenging the unmet medical and societal needs through a comprehensive pharmaceutical value chain spanning across the world.

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Pfizer’s €1.2 billion manufacturing site expansion

European Pharmaceutical Review

Pfizer Inc. has announced it will invest over €1.2 billion in its manufacturing site in Grange Castle , Dublin, the company’s biggest expansion investment to date in Ireland. A new facility will be built on the site premises, doubling the capacity for biologics manufacturing at the facility. It is anticipated a further 400-500 roles will be created, bringing the total Pfizer employees in Ireland to around 5,500.

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India’s CDSCO approves Bharat Biotech’s intra-nasal vaccine for Covid-19

Pharmaceutical Technology

India’s Central Drugs Standard Control Organisation (CDSCO) has granted approval for Bharat Biotech’s BBV154 vaccine for treating Covid-19. BBV154 is claimed to be the first intra-nasal vaccine for Covid-19 in the world. It has been approved for restricted use in emergencies for people aged 18 and above in India for the first two-dose schedule and homologous booster doses.

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FDA approves Rezlidhia™ for leukaemia

European Pharmaceutical Review

Rigel Pharmaceuticals, Inc. has announced the US Food and Drug Administration (FDA) has approved its oral drug Rezlidhia (olutasidenib) for adults with relapsed or refractory (R/R) acute myeloid leukaemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation. The FDA approval was supported by open-label Phase II registrational study data, which showed a twice per day 150mg dose of Rezlidhia facilitated a complete remission (CR) + CRh rate of 35 percent of the 153 patients observed.

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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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Healthcare tech’s biggest busts

PharmaVoice

The metaverse, blockchain, DCTs and more — here are some of the most recent fails in healthcare tech.

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OA Agreement Intelligence: A Collaborative Approach to Innovation

Copyright Clearance Center

The post OA Agreement Intelligence: A Collaborative Approach to Innovation appeared first on Copyright Clearance Center.

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AstraZeneca, MSD raise prostate cancer awareness with ‘Never Miss’ campaign

pharmaphorum

A new global prostate cancer awareness campaign developed by biopharmaceutical companies AstraZeneca (AZ) and Merck & Co. (MSD) has just been launched in the US and Canada: ‘Never Miss’ leverages sport – as well as social media activity and an information website – as a way to help men understand their potential risk of developing prostate cancer, opening up the conversation about this sensitive topic: Never miss a game.

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HarperCollins Union Members On Strike

Copyright Clearance Center

The post HarperCollins Union Members On Strike appeared first on Copyright Clearance Center.

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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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Healthcare leaders warn about unsustainable pressure on mental health services

PharmaTimes

Patients and service users routinely struggle to access mental healthcare across the NHS

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Managing mRNA Instability During Formulation, Manufacturing, and Shipment

PharmaTech

Unique solutions are required to protect inherently unstable messenger RNA.

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Merck KGaA’s arpraziquantel validated by European Medicines Agency

PharmaTimes

Positive scientific opinion by EMA would create pathway for arpraziquantel in African endemic countries

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Eisai’s full lecanemab phase 3 trial results for Alzheimer’s presented at CTAD

pharmaphorum

Following the news of two lecanemab-related deaths reported on the eve of the Clinical Trials on Alzheimer’s Disease (CTAD) 2022 conference, Eisai has now presented the full results from its phase 3 confirmatory Clarity AD study for early Alzheimer’s disease and published them in the New England Journal of Medicine (NEJM). The full result from Eisai’s large, global phase 3 confirmatory Clarity AD clinical study of lecanemab – an investigational anti-amyloid beta (A?

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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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The importance of Upselling and Cross Selling in medical sales (Part2)

Cesare Ferrari

This is the second post about upselling and cross selling where I’ll be talking about how to effectively implement these two often misunderstood tactics. You can check part 1 here to understand the basics. How to effectively upsell and cross sell. 1. Keep customer focus. Active listening is one of the most important skills of an effective sales rep.

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Aspiro Pharma -Walk-In Interviews for Production/ Analytical On 4th Dec’ 2022

Pharma Pathway

Aspiro Pharma -Walk-In Interviews for Production/ Analytical On 4th Dec’ 2022. Job Description. Greetings from Aspiro Pharma !!! Walk-In Interviews for M.Sc/ B.Pharm/M.Pharm/ ITI/ Diploma in Production/ Analytical Department @ Aspiro Pharma . Department: Production/ Analytical. Position: Officer – Sr. Executive/ Operator-Sr. Operator. Experience: 02 to 10 years.

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Mastering Patient Centricity’s Moving Parts: Innovators Share Real-World Examples

PharmExec

Agility and better decisions depend on managing risk and gaining insights from data by prioritizing patient and end-user needs. Companies of all sizes, including GSK, Boehringer-Ingelheim, Sanofi, AstraZeneca, and AbbVie, share best practices.

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FDC Limited- Openings for Quality Assurance/ Packing Departments-Apply Now

Pharma Pathway

FDC Limited- Openings for Quality Assurance/ Packing Departments-Apply Now. Job Description. Department: Quality Assurance/ Packing. Designation : Officer. Qualification: B.Pharm. Experience: 03 to 05 years. Work Location: Goa. Interested Candidates can Share their CV On anesh.shet@fdcindia.com. FDC Limited- Openings for Quality Assurance/ Packing Departments-Apply Now.

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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.