Thu.Jan 05, 2023

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AstraZeneca, Sanofi tee up 3-way RSV battle in 2023 as FDA signals expedited review for antibody

Fierce Pharma

AstraZeneca, Sanofi tee up 3-way RSV battle in 2023 as FDA signals expedited review for antibody. aliu. Thu, 01/05/2023 - 10:13.

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Healthcare’s Digitization: Coming to Terms with Cybersecurity Supply Chain Risk

MedCity News

Providers are, in many cases, getting the equivalent of a Russian nesting doll of third-party risks whenever they acquire a complex new technology solution. Cybersecurity supply chain risk management is the process of identifying and mitigating potential risks that may arise from these third-party products and services within an organization’s IT infrastructure.

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After large asset swap, Sanofi and Boehringer expect answers in Zantac dispute this year

Fierce Pharma

After large asset swap, Sanofi and Boehringer expect answers in Zantac dispute this year. esagonowsky. Thu, 01/05/2023 - 09:14.

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Drug Approvals in 2022: A Recap of Notable FDA Regulatory Decisions

MedCity News

Fewer new drugs won FDA approvals in 2022 compared to previous years, but some of the products that passed regulatory muster are indicative of trends expected to continue into 2023. For example, more gene and cell therapies are on track to face regulatory decisions in the coming year.

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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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Unleashing the power of R&D talent

Fierce Pharma

Unleashing the power of R&D talent. jpiatt. Thu, 01/05/2023 - 12:07.

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Season Health, HealthAlign Partner To Provide Nutrition Benefits to MA Beneficiaries

MedCity News

Through the partnership, food and meals will be offered as a service on HealthAlign’s marketplace. Season Health will provide those services to about 5,500 members a month of three out of the six largest Medicare Advantage plans.

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Leaning In: How eCOA can Help Advance Mental Health Research

MedCity News

Electronic Clinical Outcomes Assessment and digital health tools were well-suited to accommodate the rapid rise of virtual and telehealth shifts during the Covid-19 pandemic and there is no going back. The adoption of eCOA technology in mental healthcare research can make pivotal advancements in mental health patient care.

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Jazz sues generics makers for infringement on cannabis-derived epilepsy drug

Fierce Pharma

Jazz sues generics makers for infringement on cannabis-derived epilepsy drug. zbecker. Thu, 01/05/2023 - 11:03.

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Timely Referrals to Hospice Can Help Patients with Advanced Lung Disease Breathe Easier

MedCity News

There’s a lingering misperception among many patients, loved ones, and even healthcare professionals that hospice care is useful only in a patient’s last days or weeks of life.

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Pharma execs see inflation as the No. 1 challenge in 2023: survey

Fierce Pharma

Pharma execs see inflation as the No. 1 challenge in 2023: survey. kdunleavy. Thu, 01/05/2023 - 10:10.

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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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Tumor-Zapping Device Scores in Pivotal Study, Sends Shares of Novocure Soaring

MedCity News

Novocure’s electrical field-producing medical device, in combination with standard drug therapies, improved overall survival in a pivotal study that enrolled patients with advanced non-small cell lung cancer. The medtech company now plans to seek regulatory approvals.

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Point-Of-Care Biosensor to Detect Oral Cancer

Medgadget

Researchers at the University of Florida have created a point-of-care biosensor that can rapidly detect a biomarker for oral cancer. The device uses test strips, such as those used in blood glucose tests, to spot cell proliferation regulating inhibitor of protein phosphatase 2A (CIP2A), a protein biomarker that can reveal the presence of oral cancer.

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AVS Rakes in $20M to Advance Plaque-shattering Arterial Disease Treatment

MedCity News

Boston-based medical device company AVS recently raised $20 million in Series B funding to bring its arterial disease treatment closer to FDA clearance. The system that AVS is developing uses pressure waves to shatter calcium that has built up in arteries.

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How To Run Outstanding Marketing Events for Senior Living Communities

Clear Pivot

Warmth, hospitality, and friendliness are all crucial for senior living communities. In fact, your success as a business depends on it. These qualities are all easy to communicate with face-to-face interactions, so make sure you're taking advantage of one of the most effective ways to get them: events.

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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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Centene, Western Sky Community Care Donate $3M for Project Serving Unhoused

MedCity News

The donation will go to the One Albuquerque Fund for its project called “The Gateway.” This project will create a new medical center that will provide emergency overnight beds and other services for those experiencing homelessness.

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Capsida Biotherapeutics and Prevail to develop CNS gene therapies

Pharmaceutical Technology

Capsida Biotherapeutics and Eli Lilly and Company ’s wholly owned subsidiary Prevail Therapeutics have announced a partnership for the development of non-invasive gene therapies for central nervous system (CNS) diseases. Under the multi-year strategic partnership, Prevail will detect and advance capsids, which are clinically translatable, along with its cargo to develop the transformative genetic medicines by using Capsida’s novel adeno-associated virus (AAV) engineering platform.

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3 Steps CMS Can Take to Rein in Misleading MA Marketing

MedCity News

By creating a marketplace that empowers consumers to choose the right health care coverage for their unique and individual needs, CMS will continue to put consumers first and strengthen Medicare Advantage, already the chosen program of America’s seniors.

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How Market Access Can Determine Commercial Success

PharmExec

Using market access data from day one of your drug development and commercialization journey puts your brand in the best position to succeed at launch.

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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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Dr. Reddy’s Laboratories Ltd.-Walk-In Drive for Multiple Positions On 8th Jan’ 2023

Pharma Pathway

Dr. Reddy’s Laboratories Ltd.-Walk-In Drive for Multiple Positions On 8th Jan’ 2023. 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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Prescription: Definition, Important Parts, Handling, Labelling, Dispensing Process, and Errors

Teachntest

Definition: A prescription is a written order for a patient to receive a medication or treatment. It is typically written by a physician or other authorized healthcare provider and given to the patient, who then takes it to a pharmacy to have it filled.

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GitHub is Sued, and We May Learn Something About Creative Commons Licensing

Copyright Clearance Center

The post GitHub is Sued, and We May Learn Something About Creative Commons Licensing appeared first on Copyright Clearance Center.

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Aurobindo Pharma-Walk-In Interviews for Quality Control/ Production On 7th Jan’ 2023

Pharma Pathway

Aurobindo Pharma-Walk-In Interviews for Quality Control/ Production On 7th Jan’ 2023. Job Description. Company Profile: Aurobindo Pharma Ltd’ (APL). APL is a growing India multinational pharmaceutical manufacturing firm with turnover of over US$2.8 Billion revenues for 2018-19, with presence in more than 34 countries fronted presence with products exported to 155 nations.

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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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FDA Policy Change Heightens Debate Over Medicated Abortion

PharmaTech

The agency revised a regulation to enable pharmacies to dispense mifepristone directly to individuals with a prescription.

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Lilly, Biogen, Eisai brace for Alzheimer’s boom or bust in 2023

PharmaVoice

As controversies abound and new drugs rise on the regulatory horizon, this year will be big for Alzheimer’s.

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Boost for mRNA as Moderna to acquire OriCiro for $85 million

pharmaphorum

Biotech Moderna, Inc. and OriCiro Genomics K.K. have announced they have entered into a definitive agreement for Moderna to acquire OriCiro at a cost of $85 million. The deal marks 10-year-old Moderna’s first acquisition. The company develops mRNA therapeutics and vaccines , and the move will enable it to utilise the synthetic biology and enzyme tech of 2018-founded Japanese company OriCiro, which develops cell-free DNA synthesis and amplification technologies, and thereby expand Moderna’s portf

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SMS Lifesciences India Limited- Walk-In Interviews for Production/ Production Documentation/ Maintenance On 7th Jan’ 2023

Pharma Pathway

SMS Lifesciences India Limited- Walk-In Interviews for Production/ Production Documentation/ Maintenance On 7th Jan’ 2023. Job Description. Walk-In Interviews for Freshers & Experienced in Production/ Production Documentation/ Maintenance @ SMS Lifesciences India Limited. Departments: Production/ Production Documentation/ Maintenance. Position: Trainee Chemit/ Sr.

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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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A new mission in menopause — extending the lives of women

PharmaVoice

Why Evernow CEO Alicia Jackson thinks menopause is the perfect inroad to helping women live longer lives.

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The Boston Globe Again Names CCC a Top Place to Work

Copyright Clearance Center

The post The Boston Globe Again Names CCC a Top Place to Work appeared first on Copyright Clearance Center.

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SanegeneBio and Orbit join forces to establish targeting peptides

PharmaTimes

Agreement covers cell-based studies, with an additional option to further develop screening activities

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Gene Therapies: 2023 Predictions and Commercialization Challenges

PharmExec

In episode 125, Chris Fox, president of Novartis Gene Therapies, shares insights into her work with gene therapies, commercialization challenges, her role at Novartis, and what the team are most excited about in 2023.

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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.