Sat.Feb 18, 2023 - Fri.Feb 24, 2023

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The Benefits of a Sales Pilot for Pharmaceutical Products

MaBiCo

The Benefits of a Sales Pilot for Pharmaceutical Products A sales pilot is a short-term experiment that tests a product’s sales performance or a new sales approach. The value of a sales pilot is that it’s restricted to a particular geographic area for a limited period of time and in that way, it helps sales executives to discover what works best and what doesn’t before committing to a larger investment.

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Moderna pays US government $400M 'catch-up payment' under new COVID-19 vaccine license

Fierce Pharma

Moderna pays US government $400M 'catch-up payment' under new COVID-19 vaccine license esagonowsky Fri, 02/24/2023 - 09:18

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Healthcare is Moving to the Home. Are Health Plans Ready?

MedCity News

The future of healthcare means more home-based care. By taking steps now to embrace this shift, health plans will set the pace for supporting patients in the place where they most want to receive care.

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Medicinal cannabis: the route to good manufacturing practice registration

European Pharmaceutical Review

The UK medicinal cannabis sector has witnessed important regulatory advances in recent years. After the substance became legal in the UK in 2018, pharmaceutical companies have faced numerous obstacles to attain a fairer position in the industry. Crucially, January 2023 marked a key moment: the Medicines and Healthcare products Regulatory Agency (MHRA) granted Celadon Pharmaceuticals the first good manufacturing practice (GMP) registration since legalisation in 2018 for high Δ9-tetrahydrocannabin

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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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GenScript ProBio and RVAC partner for Covid-19 vaccine pDNA

Pharmaceutical Technology

GenScript ProBio has announced a strategic collaboration with RVAC Medicines to manufacture GMP-grade plasmid DNA (pDNA) for the latter’s RVM-V001, an mRNA Covid-19 vaccine candidate. Under the agreement, GenScript ProBio will offer GMP plasmid manufacturing service for the RVM-V001 programme. This collaboration is expected to help expedite the clinical manufacturing of RVM-V001 and future mRNA-based vaccines that target infectious diseases such as Clostriodioides difficile infection (CDI) and R

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Merck's COVID pill Lagevrio takes another hit with thumbs-down from EU regulator

Fierce Pharma

Merck's COVID pill Lagevrio takes another hit with thumbs-down from EU regulator kdunleavy Fri, 02/24/2023 - 09:38

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First successful CAR-T treatment for muscle inflammation

European Pharmaceutical Review

University Hospital Erlangen in Germany is the first in the world to use chimeric antigen receptor (CAR) T-cells to successfully treat a patient suffering from a severe case of muscle inflammation (myositis). The researchers noted that risk of developing a very severe form of the autoimmune inflammatory disease is high. The patient who received the CAR T treatment was diagnosed with anti-synthetase syndrome.

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Raman-Based Urine Sensor Detects Cancer Metabolites

Medgadget

Researchers at the Korea Institute of Materials Science (KIMS) creaetd a Raman-spectroscopy-based urine test that can detect metabolic compounds that are produced by pancreatic and prostate cancers, potentially allowing for rapid and convenient cancer screening. The technology consists of a paper strip onto which a urine sample can be added. The paper contains ‘coral-shaped’ structures that assist in amplifying the optical signal of cancer metabolites in the urine when the paper strip is illumin

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Gilead, Teva and J&J's HIV antitrust case inches closer to trial as judge keeps most claims on the table

Fierce Pharma

Gilead, Teva and J&J's HIV antitrust case inches closer to trial as judge keeps most claims on the table zbecker Wed, 02/22/2023 - 14:40

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3 reasons Why Natural Language Processing Will go Mainstream This Year

MedCity News

NLP in healthcare can accurately give voice to the massive amount of unstructured data of the healthcare universe, and here are the three reasons why I believe 2023 is the year that we will see increased adoption of NLP across the industry.

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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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Patent wars: what’s behind Amgen’s possible win over Sanofi at the US Supreme Court

Pharmaceutical Technology

Amgen could be the winner of a high-stakes patent spat with Sanofi as tensions run high weeks before the March 27 US Supreme Court hearing. While some courts were previously on Sanofi’s side, it is possible that Amgen’s case could win this time, some legal experts say. However, Sanofi’s side also has significant support, highlighting the dispute’s contentious nature.

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European Pharmaceutical Review Issue 1 2023

European Pharmaceutical Review

Included in this issue of European Pharmaceutical Review : FOREWORD Accelerating drug development David Elder, David P Elder Consultancy RAMAN SPECTROSCOPY Shining a light on Raman for microbiological analysis Tim Sandle, Bio Products Laboratory LIMS Overcoming barriers to capturing data in a laboratory Samantha Kanza, University of Southampton ENVIRONMENTAL MONITORING Endotoxin trends: sustainability, automation and beyond Miriam Guest, AstraZeneca UK REGULATORY INSIGHT UPC opt-out – a strateg

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Sanofi, poised to rival Roche in hemophilia, nabs FDA approval for Altuviiio

Fierce Pharma

Sanofi, poised to rival Roche in hemophilia, nabs FDA approval for Altuviiio zbecker Thu, 02/23/2023 - 15:45

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LGBTQ+ Health Advocates Sound Alarm Over CDC Data On American Youth

MedCity News

In 2021, 69% of LGBQ+ teens reported experiencing persistent feelings of sadness or hopelessness in the past year, compared to 35% of heterosexual teens, according to a recent CDC report. This stat is likely understated because the report did not include information about those who identify as transgender, experts said.

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How to Stay Competitive in the Evolving State of Martech

Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr

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Eko Launches SENSORA™ Cardiac Disease Detection Platform

Legacy MEDSearch

Eko , a digital health company applying artificial intelligence (AI) in the fight against heart and lung disease, today announced the launch of the SENSORA Cardiac Disease Detection Platform. SENSORA currently features AI that objectively identifies structural murmurs, a sign of valvular heart disease, and Care Pathway Analytics software that provides downstream visibility and metrics of the patient journey through the healthcare system.

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Survey Finds 57% of U.S. Physicians Have Changed Their Perception of a Medication as a Result of Info on Social Media

PharmExec

Sermo and LiveWorld survey of 50+ pharma marketers and 200+ physicians finds that social media plays a major role in influencing perceptions of medications, prescribing Habits, ongoing medical education and professional networking.

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GSK's first state-level Zantac trial delayed as judge reviews science behind the arguments: report

Fierce Pharma

GSK's first state-level Zantac trial delayed as judge reviews science behind the arguments: report fkansteiner Fri, 02/24/2023 - 10:28

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Virtual Care, Real Outcomes

MedCity News

The proof is here: a survey done by the American Medical Association (AMA) reported that 80% of physicians they surveyed believed that telehealth provided patients better access to care since using telehealth. People of all ages also find telehealth to be beneficial.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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FDA grants Fast Track status for Biohaven’s taldefgrobep alfa to treat SMA

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted Fast Track designation for Biohaven ’s new anti-myostatin adnectin, taldefgrobep alfa, to treat spinal muscular atrophy (SMA). The new myostatin-targeting biologic investigational agent has been designed for specific binding to myostatin (GDF-8) to reduce overall levels of myostatin. It also works as a receptor antagonist to block myostatin signalling in skeletal muscles.

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Vitiligo treatment gets positive CHMP opinion

European Pharmaceutical Review

The Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of ruxolitinib cream (Opzelura ) for non-segmental vitiligo with facial involvement in people over 12 years old. “With no centrally approved treatment option currently available in the EU, this positive opinion marks a significant milestone for the vitiligo community,” explained Dr Steven Stein, Chief Medical Officer, Chief Medical Officer, Incyte.

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Eli Lilly's diabetes drug Mounjaro back in stock amid heightened obesity interest

Fierce Pharma

Eli Lilly's diabetes drug Mounjaro back in stock amid heightened obesity interest aliu Wed, 02/22/2023 - 10:12

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Ambience Healthcare Aims To Reduce Clinician Burnout With New AI Medical Scribe

MedCity News

Ambience Healthcare’s new product, AutoScribe, embeds into the electronic medical record and works in real-time. When clinicians use AutoScribe, they speak to their patient as they normally would while the software listens in the background. Immediately after the visit, the physician gets a draft of the medical notes from the meeting, and then they can edit the notes if needed.

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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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US FDA approves Apellis’ geographic atrophy therapy Syfovre

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Apellis Pharmaceuticals’ Syfovre (pegcetacoplan injection) to treat geographic atrophy (GA), an advanced form of age-related macular degeneration (AMD). Syfovre has been approved for use in people with GA with or without subfoveal involvement and offers dosing flexibility with a regimen of every 25 to 60 days for patients and physicians.

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Pharma Marketers Need AI Now: How to deliver a truly personalized, omnichannel experience for your patients, with William Grambley, CEO of Allazo Health

Pharma Marketing Network

Marketing in the era of consumer-driven healthcare requires new tools and techniques. If you want patients to initiate therapy, you need to connect across more channels, more personally, and in the ways consumers prefer to be engaged. Plus, given today’s budget realities, you’re likely being asked to achieve more with less. In this podcast, William Grambley, CEO of AllazoHealth, explains how pharma marketers can reach their omni-channel engagement objectives with artificial intelligence (AI), an

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Eisai's Leqembi shunned as CMS keeps strict Alzheimer's drug restrictions in place

Fierce Pharma

Eisai's Leqembi shunned as CMS keeps strict Alzheimer's drug restrictions in place aliu Thu, 02/23/2023 - 09:44

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How Technology is Enabling Clinical Labs to Become Profit Centers

MedCity News

Thanks to continued advances in technology and laboratory information systems (LIS) that fully support a lab’s operational and financial operations, and a growing trend of consumerism in healthcare, clinical labs now have the opportunity to increase revenue and expand into other areas of the care continuum.

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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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Pfizer’s Covid-19 vaccine sales forecasts upgraded with sales of $37bn in 2022

Pharmaceutical Technology

Pfizer and BioNTech’s Covid-19 vaccine, Comirnaty, had a phenomenal year with forecast sales of $37bn in 2022. Comirnaty is expected to maintain the sales dominance it saw during the Covid-19 pandemic going into the future, with the average annual sales forecast rising by 19% between H1 and H2 2022, according to GlobalData’s Coronavirus Disease 2019 (Covid-19) Sector Forecast: H2 2022 Global Analyst Consensus Sales Forecast report.

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Streamlining Healthcare Delivery Through Digital Care Journeys

Impetus Digital

In our last episode of “Healthcare goes Digital” (for now), Dr. Joshua Liu , Co-founder & CEO of SeamlessMD , joined Natalie Yeadon, Co-founder & CEO of Impetus Digital, to explore how technology and “Digital Care Journeys” can help hospitals reduce the surgical backlog for high-volume procedures like hip and knee replacements, the evolution of healthcare delivery, and more.

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Merck's COVID pill Lagevrio comes up short in household COVID exposure study

Fierce Pharma

Merck's COVID pill Lagevrio comes up short in household COVID exposure study kdunleavy Tue, 02/21/2023 - 10:18

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The Home Healthcare Boom is Upon Us

MedCity News

According to the National Association for Home Care and Hospice, close to 12 million Americans receive some kind of home healthcare each year, and that number is expected to continue to grow.

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ABM Evolution: How Top Marketers Are Using Account-Based Strategies

In times of economic uncertainty, account-based strategies are essential. According to several business analysts and practitioners, ABM is a necessity for creating more predictable revenue. Research shows that nearly three-quarters of marketers (74%) already have the resources needed to build successful ABM programs.