Thu.May 04, 2023

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Moderna warns of severe sales slowdown in Q2, takes $378M charge amid lull in vaccinations

Fierce Pharma

Moderna warns of severe sales slowdown in Q2, takes $378M charge amid lull in vaccinations aliu Thu, 05/04/2023 - 10:02

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VC Identifies 3 Startups That Will Shake Up the Future of Cancer Care

MedCity News

Oncology Ventures recently announced investments in three cancer startups — VivorCare, Gabbi and Health Universe. The fund’s founding partner said each company demonstrated an ability to tackle a specific problem within the cancer care space, such as enabling earlier breast cancer diagnoses and providing personalized care plans for cancer survivors.

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Trending Sources

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J&J's consumer group Kenvue set for $41B IPO, the largest US market debut in more than a year

Fierce Pharma

J&J's consumer group Kenvue set for $41B IPO, the largest US market debut in more than a year esagonowsky Thu, 05/04/2023 - 09:58

Marketing 234
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Report: Noncitizens Will Account for One-third of Uninsured Population in 2024

MedCity News

A recent Urban Institute report found that the uninsurance rate for nonelderly people who aren’t citizens will be 39.2% in 2024, about four times higher than it is for the entire U.S. population at 9.8%.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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As Eylea sales fall again, Regeneron looks forward to approval of its longer-lasting follow-up

Fierce Pharma

As Eylea sales fall again, Regeneron looks forward to approval of its longer-lasting follow-up kdunleavy Thu, 05/04/2023 - 11:00

Sales 230
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Mount Sinai Doctors Vote to Strike Over Pay, Benefits Disparities

MedCity News

Resident physicians at Mount Sinai’s Elmhurst Hospital in Queens have voted to authorize a strike. The union that represents these residents has noticed significant disparities in Mount Sinai’s compensation and benefits when compared to the resident physicians employed at the health system’s flagship hospital in Manhattan.

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More Trending

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Forge Biologics and Labcorp partner for gene therapies development

Pharmaceutical Technology

Forge Biologics and global life sciences company Labcorp have announced a strategic adeno-associated virus (AAV) gene therapy development and manufacturing collaboration. Gene therapy clients will gain access to coordinated scientific expertise, drug development services and AAV manufacturing capabilities, advancing the development of new gene therapies.

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Judge orders J&J, talc opponents to engage in settlement talks: Bloomberg

Fierce Pharma

Judge orders J&J, talc opponents to engage in settlement talks: Bloomberg kdunleavy Thu, 05/04/2023 - 15:22

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Vertex secures FDA clearance for infants’ cystic fibrosis therapy

Pharmaceutical Technology

Vertex Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for KALYDECO (ivacaftor) to treat children with cystic fibrosis (CF) aged between one and four months. The approval allows KALYDECO to be used in infants who have at least one mutation in their cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to the therapy, on the basis of clinical and/or in vitro assay results.

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Amid high demand, Novo Nordisk temporarily throttles US supply of low-dose Wegovy

Fierce Pharma

Amid high demand, Novo Nordisk temporarily throttles US supply of low-dose Wegovy zbecker Thu, 05/04/2023 - 10:38

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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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Selling Its MA Business May Be Bright Health Group’s Only Option, Experts Say

MedCity News

Bright Health Group said last week it is “exploring strategic alternatives” for two Medicare Advantage plans in California: Brand New Day and Central Health Plan, which the insurtech purchased several years ago for $500 million. One expert said selling is necessary as the company faces bankruptcy.

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Amgen sues Novartis' Sandoz for alleged infringement on bone drugs Xgeva, Prolia

Fierce Pharma

Amgen sues Novartis' Sandoz for alleged infringement on bone drugs Xgeva, Prolia zbecker Thu, 05/04/2023 - 17:48

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Transforming oncology with antibody therapeutics

European Pharmaceutical Review

Data announced at the European Lung Cancer Congress (ELCC) earlier this month revealed the long-term efficacy and safety of RYBREVANT ® (amivantamab) in patients with post-platinum EGFR Ex20ins-mutated advanced non-small cell lung cancer (NSCLC). Amivantamab was the first bispecific monoclonal antibody (BsMAb) approved in the EU to treat advanced NSCLC with EGFR exon 20 insertion mutations post chemotherapy.

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Fierce Pharma Asia—Astellas' eye drug buy; J&J's latest CAR-T deal; Sun's clinical hold

Fierce Pharma

Fierce Pharma Asia—Astellas' eye drug buy; J&J's latest CAR-T deal; Sun's clinical hold aliu Thu, 05/04/2023 - 17:10

Pharma 130
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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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Endogena finalises enrolment for retinitis pigmentosa trial

PharmaTimes

The treatment is a small molecule that activates endogenous retinal stem and progenitor cells

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'The Top Line': Part 2 of a series on Narcan, the life-saving nasal spray

Fierce Pharma

'The Top Line': Part 2 of a series on Narcan, the life-saving nasal spray tcarey Thu, 05/04/2023 - 17:42

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BioSenic progresses cGvHD system and submits patent to EPO

PharmaTimes

Patent will allow the development of an industrial biomarker analysis kit which could be available worldwide

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Pharma 2023: Working with Patient Advocacy Groups

PharmExec

Rebecca Vermeulen, VP Global Patient Networks, Product Development Medical Affairs for Roche discusses how they approach patient engagement.

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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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A biopharma CEO opens up about executive salaries — and why he wants to change the status quo

PharmaVoice

With leaders at the biggest biopharma companies bringing in millions, the CEO of Corvus Pharmaceuticals opted for a pay cut to pour more funds into science.

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Drug Digest: Advancements in the Implementation of Continuous Manufacturing

PharmaTech

In this episode of Drug Digest, Pharmaceutical Technology editors discuss the advantages and savings that continuous manufacturing may offer as well as the very real obstacles that might make a fully continuous process not feasible, especially in biologics manufacturing.

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Angel Medical Systems, Creator of the Guardian™, First Implantable Cardiac Alert System, Changes Name to Avertix Medical Inc. and Welcomes New CEO and CFO to Drive Continued Growth and Success

Legacy MEDSearch

Angel Medical Systems Inc. (dba AngelMed), a company focused on improving long-term management of high-risk coronary disease in patients who have survived one or more heart attacks, today announced it has changed its corporate name to Avertix Medical Inc. (Avertix) , and appointed Tim Moran as President and Chief Executive Officer and Philip Tom as Executive Vice President and Chief Financial Officer, effective immediately.

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5 Best Practices for Healthcare Referral Coordinators

Referral MD

As a healthcare referral coordinator, your role is critical in ensuring patients receive the most appropriate care. An appropriate clinical referral can improve the transition between primary care providers and secondary care specialists ; increasing the legibility and accuracy of referrals reduces errors that occur through incomplete information or lost referrals.

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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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Adheris Health Earns Second Consecutive Retail Excellence Award for Technology & Automation

PM360

Adheris Health , a MedAdvisor company, and leading provider of patient engagement solutions, earned its second consecutive Retail Excellence Award (REX) for Technology & Automation from Drug Store News (DSN) , the number one source of news and information for retail pharmacy professionals. DSN’s REX Award recognizes companies that have gone above and beyond to assist their retail partners with innovative solutions, patient communications, or logistical efficiencies.

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Tetra Pharm Technologies debuts first drug in Germany

Pharma Leaders

Denmark-based biotech firm Tetra Pharm Technologies has introduced its first product in Germany. The launch involves the firm’s XATEPA product, a pain-relieving pharmaceutical drug developed using cannabinoids. The company aims to boost the sales of XATEPA as well as launch the drug in new markets in Europe and beyond in future. Furthermore, the firm signed a deal with pharmaceutical and healthcare products wholesale distributor PHOENIX Pharma-Einkauf for distribution of XATEPA in Germany.

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Magenta Therapeutics and Dianthus agree to merge operations

Pharmaceutical Technology

Magenta Therapeutics has signed a definitive merger agreement to combine its business with clinical-stage biotechnology firm Dianthus Therapeutics. The all-stock deal will see the creation of a new entity that will support further development of Dianthus’ new complement inhibitors pipeline, including DNTH103, which is currently in a Phase I study. The consolidated firm will run under the Dianthus Therapeutics brand and trade on the Nasdaq under the ‘DNTH’ ticker symbol.

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The First Step to Becoming a Successful Salesperson: Self-Awareness

Contrarian Sales Techniques

Today, let’s talk about something that I believe is crucial to becoming a successful salesperson: self-awareness. You see, when it comes to sales, it's not just about having a good product or a great pitch. It's about understanding yourself and your customer so that you can build a real connection and close that sale. So, what exactly is self-awareness, and why is it so important?

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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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ARTHEx Biotech raises funds to advance DM1 therapy to clinical trial

Pharmaceutical Technology

Clinical-stage biotechnology firm ARTHEx Biotech has raised $46.36m (€42m) in a Series B financing round to advance its lead compound, ATX-01, to treat myotonic dystrophy type 1 (DM1), a rare progressive muscle-wasting disease. Led by Columbus Venture Partners, the financing round has seen the participation of existing investors the Centre for the Development of Industrial Technology (CDTI), AdBio Partners and Invivo Capital.

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Sales is All About Communication

Contrarian Sales Techniques

How to Master the Art Sales is all about communication. At its core, sales is about connecting with people, understanding their needs, and offering solutions that address those needs. Whether you're selling a product, a service, or an idea, your success depends on your ability to communicate effectively with your audience. Effective communication is not just about speaking well or being articulate.

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Idorsia’s Quviviq receives marketing authorisation from Health Canada

Pharmaceutical Technology

Idorsia has received marketing authorisation from Health Canada for Quviviq (daridorexant) to manage insomnia in adult patients. The dual orexin receptor antagonist (DORA) Quviviq acts on orexin 1 and orexin 2 receptors equipotently. It blocks only the orexin receptors activation that promote wakefulness, rather than inducing sleep through broad inhibition of brain activity (sedation).

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Why Resilience and Motivation Are Critical for Sales Success

Contrarian Sales Techniques

Having worked in sales for years, I've realized some traits are crucial for success in this field. While there are many important qualities that sales professionals should possess, two of the most critical are resilience and motivation. Resilience is the ability to bounce back from setbacks, rejections, and failures. In the world of sales, resilience is key because you're going to face a lot of rejection.

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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.