Wed.Jul 05, 2023

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Moderna strikes deal worth up to $1B to develop, produce mRNA drugs in China: reports

Fierce Pharma

Despite political tensions between Washington and Beijing, foreign pharmaceutical investments are progressing in China. | In a deal that could be worth up to $1 billion, Massachusetts-based Moderna inked a memorandum of understanding, plus a land collaboration agreement, to research, develop and manufacture mRNA medicines in China.

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Why Digital Health Startups Should Embrace a Provider-Centric Approach, Per an AMA Exec

MedCity News

Providers often have a checklist of requirements they use to determine whether they should bring new technology into their organization. Digital health startups would be wise to learn about these criteria when taking their products to market, said Meg Barron, the AMA’s vice president of digital health strategy, at a recent conference. That way, startups can build their products around meeting providers’ needs.

Marketing 109
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Sarepta sells FDA priority review voucher to mystery buyer for $102M as prices continue to slip

Fierce Pharma

While the price of just about everything has increased over the last six years in the U.S., the same can’t be said for the cost of an FDA priority review voucher. Just ask Sarepta Therapeutics. | The price of priority review vouchers is falling. Just ask Sarepta Therapeutics. Since 2017, the company has sold off three PRVs—getting less in return for each successive sale.

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Have Insurtechs Truly Disrupted the Mainstream Health Insurance Industry?

MedCity News

Insurtechs like Bright Health Group, Clover Health and Oscar Health set out to disrupt health insurance — but have they actually done so? Not in a positive way, several experts say.

Insurance 109
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Go for the Gulf: Sanofi partners with local drugmakers to crank out vaccines at new manufacturing plant in Saudi Arabia

Fierce Pharma

Go for the Gulf: Sanofi partners with local drugmakers to crank out vaccines at new manufacturing plant in Saudi Arabia fkansteiner Wed, 07/05/2023 - 15:19

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Butterfly Network Launches AI Tool for Point-Of-Care Lung Ultrasounds

MedCity News

Butterfly Network recently launched an AI tool that can provide medical practitioners with an accurate B-line count from just a six-second lung ultrasound clip. By automatically counting B-lines in a lung image, the tool helps doctors quickly identify and assess a patient’s lung issues at the point of care.

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Health Equity in Pharma: Communities Most Impacted by Racial Bias

PharmExec

Rose Blackburne, MD, MBA, vice president, global head, general medicine, PPD Clinical Research, Thermo Fisher Scientific, discusses health equity in pharma, specifically racial biases, and how the industry can address inequities in access and care going forward.

Pharma 105
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Roche pulls a Gavreto approval before Blueprint severance, citing unfeasible trial

Fierce Pharma

Another FDA accelerated approval has run its course, with Roche giving up on a niche indication for cancer drug Gavreto. | Another accelerated approval has run its course, with Roche giving up on a niche indication for cancer drug Gavreto. The move comes as the Swiss pharma giant prepares to terminate a collaboration with Blueprint Medicines.

Medicine 161
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Report: 1.5 Million Medicaid Enrollees Have Been Disenrolled from Coverage

MedCity News

Due to the end of the Medicaid continuous enrollment provision, at least 1.5 million Medicaid enrollees have lost coverage as of June 29, according to KFF. About 71% of those who were disenrolled from Medicaid were disenrolled for procedural reasons.

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Gilead, Teva prevail in high-stakes trial over HIV drug pay-for-delay claims

Fierce Pharma

Gilead and Teva have chalked up an important legal victory in a California court, defeating allegations that they created an anticompetitive scheme to delay generic competition to lucrative HIV tre | Gilead and Teva were accused of conspiring to keep HIV generics off the market in a 2019 lawsuit seeking $3.6 billion in damages. The two companies already settled part of the case in May.

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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 AMJEVITA impact: Innovative U.S. biosimilar pricing models

Clarivate

The month of July could see seven FDA-approved adalimumab biosimilars launch in the United States, an unprecedented situation for a market that has been relatively slow to embrace biosimilars. By end of year, as many as ten adalimumab biosimilars could be on the U.S. market. The Biosimilars Forum has hailed 2022 as a watershed year that could create a more competitive U.S. biologics market and reduce prescription drug costs.

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Improving Maternal Health Outcomes Starts with Reducing Unnecessary C-Sections

MedCity News

Reducing C-sections that are not medically necessary will save lives and reduce complications such as excessive bleeding and infections. Only through comprehensive education and awareness can we give both mothers and obstetric care teams the tools they need to make the right decision about whether a C-section is medically indicated.

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Incyte’s non-segmental vitiligo treatment approved in UK

Pharmaceutical Technology

Following FDA approival and CE marking for Incyte’s JAK-inhibiting cream Opzelura (ruxolitinib), the MHRA has followed suit in the UK.

FDA 105
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FDA Approves BioMarin’s Roctavian, the First Gene Therapy for Treating Severe Hemophilia A

PharmaTech

FDA has approved Roctavian (valoctocogene roxaparvovec-rvox), a gene therapy from BioMarin Pharmaceutical for treating severe hemophilia A in adults.

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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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MHRA reveals new corporate plan to expedite drug regulatory journeys in UK

Pharmaceutical Technology

The corporate strategy aims to introduce new legislation for faster regulations, new international collaborations, and digitisation.

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PDA revises report on glass container manufacturing

European Pharmaceutical Review

Revised for 2023, the Parenteral Drug Association (PDA) has published an update to its Technical Report No. 43: Identification and Classification of Nonconformities in Moulded and Tubular Glass Containers for Pharmaceutical Manufacturing. The long-awaited PDA TR 43 report provides an approach to a quality decision-making process and represents best practices for the identification and classification of visual nonconformities for (empty) glass containers as pharmaceutical product packaging.

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How Far Back You Should Go on Your Medical Sales Resume

MedReps

While you might have decades of experience in the workforce, according to common business norms, you should only reflect between ten- and fifteen years’ worth of jobs on your resume. This may not provide you with enough space to truly describe what you’ve done and what you’re capable of, so how do you put that early experience on your resume? Are there certain situations where you should sidestep this 15-year rule?

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European Commission extends approval of cystic fibrosis medicine

European Pharmaceutical Review

European Commission (EC) has granted approval for the label extension of cystic fibrosis medicine ORKAMBI ® (lumacaftor/ivacaftor) for children aged one to <2 years old. The oral treatment is indicated to treat these individuals with two copies of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene for the first time.

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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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J&J Plans Phase 3 Trial to Keep Pace in the Chase for Oral Psoriasis Drugs

MedCity News

Johnson & Johnson’s oral psoriasis drug met the goals of a mid-stage clinical study, and the pharma giant now plans to advance the twice-daily pill to Phase 3 testing. J&J is one of several biopharmaceutical companies developing pill alternatives to biologic drugs that are injected or infused.

Pharma 68
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Vertex’s Orkambi receives EC approval

PharmaTimes

Orkambi is an oral treatment for very young children that combines both lumacaftor and ivacaftor - News - PharmaTimes

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How to Make Social Media Work for You

Healthcare Success

Organic Social Media When social media exploded onto the scene nearly two decades ago, marketers and healthcare professionals were a little too excited about its potential for healthcare marketing. Who could blame them? The fantasy was great. ‘All I have to do is figure out how to create a free Facebook business page, and then our business will get lots of new patients the next day!

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Transforming the Patient Experience: Leveraging Cloud Monitoring for Seamless Healthcare Service

Impetus Digital

Until a few years ago, cloud computing was limited to the IT industry, particularly for software development or as data backups. Fast forward to today, and this technology is intertwined with a myriad of industries, including healthcare. As of last year, i.e., 2022, the global healthcare cloud computing market was valued at $37.14 billion, and with its current trajectory, it is estimated to be worth $136.92 billion by 2031.

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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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SPOTIO Announces the Fourth Edition of the State of Field Sales Report

Spotio

ADDISON, TEXAS JULY 06, 2023 – SPOTIO, a leading field sales engagement software, is excited to release the highly-anticipated fourth edition of the State of Field Sales Report. As an annual research study, this report provides a comprehensive analysis of the field sales industry, shedding light on the emerging trends and insights driving the global marketplace.

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The Field Guide to Pharmaceutical Powder Characterization (July 2023)

PharmaTech

If you want to learn more about the physical characterization of your pharmaceutical powders, download this free e-book. You will find real measurement data that has been collected from a range of characterization methods, including particle, surface area and pore size analysis, powder rheology, and X-ray diffraction. Deepening your understanding of bulk particle properties is just the first step to get more predictable formulations and optimized processes.

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Clarify at AAPL 2023: A real-world case study on strategic physician outreach

Clarify Health

In June of 2023, Physician Liaisons from around the country came together at the American Association of Physician Liaisons annual conference in Denver, Colorado. Clarify was excited to attend the conference and meet with liaisons to discuss growth strategies and our new Salesforce for PRM integration. We were also thrilled for our Director, Head of Provider Customer Success, Christiana Taylor, to share the stage with April Salazar, Provider Business Development Manager II, of Keck Medicine of U

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5 Tips for Training Your Sales Team to Practice Sales Calls

Quantified

Sales skills take practice. But having new—or even experienced—reps practice sales calls on hard-won qualified leads or referrals can make anyone balk: what if the call goes badly ? It’s not just the sale on the line; it’s also your business’s reputation. At the same time, giving reps cold leads to practice on can quickly burn them out with the series of annoyed ‘no’s and straight-to-voicemail calls.

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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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Clinical research organisation market anticipated to reach $140bn by 2033

European Pharmaceutical Review

The global clinical research organisation (CRO) market is expected to reach $139.56 billion by the year 2033, a report by Future Market Insights has stated. Compound annual growth rate (CAGR) for the market is anticipated to reach 8.4 percent between 2023 and 2033. Challenges for the CRO market Non-uniformity in regulations within various governments is expected to restrain the CRO market going forward, the research predicted.

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How to Get Your Sales Team Engaged in Role Play Sales Training

Quantified

When training managers mention role-play sales training, one word comes to mind for most salespeople (and the managers themselves): cringe. It’s awkward and embarrassing for several reasons, not least that most people dislike performing and like getting judged on performance even less. However, this discomfort doesn’t change a core truth about role-playing: it’s one of the most effective tools for training because it provides both active learning and real practice.

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EC approves Vertex’s Orkambi for cystic fibrosis in children

Pharmaceutical Technology

The EC approved extending the label for Vertex Pharmaceuticals’ Orkambi to treat cystic fibrosis in children aged one to two years.

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How to Develop Sales Role-Play Scenarios Your Sales Team Will Actually Use

Quantified

The devil is in the details when it comes to successful sales calls. Simply switching from starting a ring with “Did I catch you at a bad time?” to “How have you been?” can increase a sales rep’s chances of success by 660%. But having a script of hundreds of tidbit tactics won’t help, and many of your employees may veer toward the first question when faced with a harried “Hello.” To really break through, the granular phrasing, messaging, and respo

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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.