Mon.Jan 15, 2024

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9 Hot Takes from JPM24

MedCity News

I didn’t make it to this year’s J.P. Morgan Healthcare Conference in San Francisco, so I reached out to leaders from across the industry to hear how it went and learn about their takeaways from the event. This is a list of the nine most interesting responses that I received.

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Keytruda Granted Latest FDA Approval in Cervical Cancer

Pharmaceutical Commerce

FDA approves Keytruda (pembrolizumab) combined with chemoradiation for the treatment of patients with FIGO 2014 stage III to IVA cervical cancer, which is the 39th overall approved indication for the drug in the United States.

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Trending Sources

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If Dexcom’s CEO Had a Magic Wand …

MedCity News

Kevin Sayer would love to bring his company’s Dexcom G7 continuous glucose monitor to more people and more quickly. But despite being CEO of a successful device company, he feels frustrated from time to time about how and what the U.S. health system will pay for.

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MHRA approves ‘safer’ medicine alternative for rare disease

European Pharmaceutical Review

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Agamree ® (vamorolone), as a safer alternative to corticosteroids, for Duchenne muscular dystrophy (DMD). “In addition to its anti-inflammatory efficacy, both the EMA and the MHRA recognise the benefits of treatment with Agamree for bone health and growth,” Dr Shabir Hasham, Chief Medical Officer of Santhera Pharmaceuticals shared.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Genetic Medicines Biotech Dyne Pulls In $345M for Clinical Tests of Muscle Drugs

MedCity News

Dyne Therapeutics recently reported encouraging Phase 1/2 clinical data in myotonic dystrophy type 1 and Duchenne muscular dystrophy. At the J.P. Morgan Healthcare Conference, CEO Joshua Brumm said Dyne’s existing cash combined with the new capital is expected to last through 2025—well beyond the next key milestones for both therapeutic candidates.

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AI could revolutionise pharma compound synthesis

pharmaphorum

Researchers at the University of Cambridge and Pfizer have developed an AI-powered approach to make it easier to design and make pharma molecules

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Santhera debuts DMD drug Agamree in Germany

pharmaphorum

Santhera’s new treatment for Duchenne muscular dystrophy Agamree has been launched in its first market, Germany, following its EU approval last month.

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Unlocking 4 Areas of Provider Network Value in the Wake of Surprise Billing Mandates

MedCity News

Provider network teams need a better way to streamline healthcare delivery and amplify provider satisfaction.

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As Novartis backs off, Amgen said to be after Cytokinetics

pharmaphorum

Speculation about a takeover play for Cytokinetics isn’t going away, with Amgen the latest company to be linked to the company and its highly-anticipated cardiovascular drug aficamten.

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MedCity FemFwd: Shortcomings in Menopause Care with Dr. Bruce Dorr

MedCity News

In this episode, we’re joined by Dr. Bruce Dorr, an OB-GYN. Dorr discusses how the lack of medical training for menopause has led to insufficient treatment.

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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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Keytruda breaks new ground in cervical cancer

pharmaphorum

MSD’s Keytruda has been cleared by the FDA as the first PD-1 inhibitor for newly diagnosed cervical cancer patients with less severe disease

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CellVoyant secures £7.6 million AI stem cell boost

PharmaTimes

CellVoyant’s platform combines AI with live cell imaging

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German union will resist any plan to split up Bayer

pharmaphorum

Germany’s IG BCE trade union has pushed back against any break-up of Bayer, claiming it could put thousands of domestic jobs at risk

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Kanabo and City Dock Pharmacy team up

PharmaTimes

Companies collaborate to launch walk-in pain clinic

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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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ixlayer Becomes Member of American Heart Association Center for Health Technology & Innovation Consortium

Pharmaceutical Commerce

The group—known as the Innovators' Network—is meant to serve as a link between entrepreneurs, providers, researchers, and payers while they strive to combat cardiovascular disease.

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Simulator-Driven SKO Prep: Boosting Readiness and Confidence

Quantified

Sales kickoff (SKO) events address many different objectives, such as energizing the sales team, communicating goals, and keeping everyone up to date on product releases. Education is one of the top seven objectives behind a well-run SKO event. Traditionally, this training would take the form of hands-on demos and in-person role-play scenarios. However, conventional sales role-play exercises have other challenges ranging from low engagement to the time demands they place on trainers.

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From Hawthorne to AI: A Century of Science Fueling Sales Success

Contrarian Sales Techniques

Imagine a time before CRM systems and chatbots, when salespeople relied on charm, wit, and maybe a bit of good luck. Well, brace yourselves, because we're going back in time (and then zooming forward!) to explore the history of sales science, from its quirky beginnings to the AI-powered future. Get ready for a story packed with psychology, tech, and some seriously cool discoveries that'll change the way you see closing deals forever.

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Government Policy, Science Research, and Machine Authors

Copyright Clearance Center

AI tools now conduct systematic review of scientific literature for government officials by searching millions of information sources. And the machines are expected to do much more in years ahead.

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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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Uduak Ekong

Curzon Consulting

Senior Consultant Contact me +44 (0)1653 628596 With over 8 years of experience across infrastructure, engineering consulting, and product strategy, Uduak is a seasoned professional who thrives on turning complex challenges into impactful solutions. She blends her analytical skills, strategic foresight, and deep industry knowledge to unlock new possibilities and navigate diverse landscapes.

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Merck's Keytruda Receives Third FDA Approval for Cervical Cancer

PharmExec

The FDA issued the 39th overall approval for Keytruda (pembrolizumab), with the latest in combination with chemoradiation for the treatment of patients with FIGO 2014 stage III to IVA cervical cancer.

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Navigating Cultural Nuances in Business: A Deep Dive into 'Thick Face, Black Heart'

Contrarian Sales Techniques

It's really interesting that I've picked up "Thick Face, Black Heart" by Ching Ning Chu. Diving into different business cultures is super insightful, offering a window into diverse approaches that can help in understanding, communicating, and collaborating more effectively. But, it's crucial to tread carefully here. Labelling entire groups of people based on their national or cultural background can be problematic and quite often, just plain wrong.

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Orion buys stake in LegoChem amid pivot to cancer and pain

pharmaphorum

Orion buys stake in LegoChem amid pivot to cancer and pain Phil.

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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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Presentation at J.P. Morgan Healthcare Conference Highlights Growth of Platform for AI, Data

PharmExec

Ginkgo Bioworks announces projected total revenue of $250–$260 million for 2023 for large scale data generation and artificial intelligence for biopharma R&D.

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Precautionary Measures Recommended in Use of Valproate Medicines

PharmaTech

The European Medicines Agency safety committee says there is a potential risk of neurodevelopment disorders in children born to men treated with valproate.

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MSD’s Keytruda wins expanded FDA combo approval in cervical cancer

Pharmaceutical Technology

MSD’s blockbuster immunotherapy, set to lose patent protection in 2028, secures third FDA approval in cervical cancer.

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FDA Clears AnX Robotica’s NaviCam SB for Expanded Indications

PharmExec

OncLive serves as the connection to oncology, including groundbreaking cancer news and interviews with top oncologists in multimedia formats.

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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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Basilea buys Spexis’ preclinical antibiotics programme for $2.3m

Pharmaceutical Technology

The acquired programme consists of antibiotics against gram-negative bacteria, including multidrug-resistant strains.

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Report: Pharmaceutical Contract Manufacturing Market Expected to Hit $140 Billion by 2030

PharmExec

OncLive serves as the connection to oncology, including groundbreaking cancer news and interviews with top oncologists in multimedia formats.

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Amgen showcases exciting potential in the obesity space at JPM24

Pharmaceutical Technology

If new treatments are shown to maintain weight loss, they will become game changers within the obesity space.

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Boehringer Ingelheim Expands Facility in Greece for Production of New Therapeutics

PharmaTech

Boehringer Ingelheim is investing €120 million (US$131 million) into its Koropi, Greece site to expand production for new therapeutics.

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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.