Tue.May 02, 2023

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Pfizer pulls off Q1 surprise with strong sales even as COVID vaccine demand plummets

Fierce Pharma

Pfizer pulls off Q1 surprise with strong sales even as COVID vaccine demand plummets kdunleavy Tue, 05/02/2023 - 09:27

Sales 299
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Kindbody Receives $25M from Morgan Health to Scale Family-building Care

MedCity News

Through Morgan Health’s $25 million investment, Kindbody will continue expanding into new markets. It will also grow its services, including menopause treatment and male fertility.

Marketing 104
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GSK staffers kick off series of strikes in UK for the first time in drugmaker's history

Fierce Pharma

GSK staffers kick off series of strikes in UK for the first time in drugmaker's history aliu Tue, 05/02/2023 - 14:22

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Taking your biotech global? Here’s how you can navigate cultural norms

PharmaVoice

What’s so different about doing pharma business in the U.K. versus Japan? One of Moderna’s top brass shares her tips for navigating choppy cultural waters.

Pharma 105
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Poland takes its COVID-19 vaccine fight to Pfizer's shareholders, urging the company to be a good corporate citizen

Fierce Pharma

Poland takes its COVID-19 vaccine fight to Pfizer's shareholders, urging the company to be a good corporate citizen zbecker Tue, 05/02/2023 - 16:34

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Why R&D innovation holds the key to greater patient impact

European Pharmaceutical Review

Cancer remains a global threat with around 10 million people dying from the disease each year worldwide, making it the second leading cause of death. 1,2 In the EU, an estimated 2.7 million people are diagnosed with cancer annually and the number is growing. 3 With greater scientific understanding of cancer, the industry has made significant progress in developing innovative medicines to help patients.

Patients 101

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How Receiving Positive Patient Feedback Can Help Boost Clinicians’ Job Satisfaction

MedCity News

Feedtrail believes healthcare workers become more satisfied in their roles when they’re connected to messages of patient gratitude, so it built technology to deliver that positive feedback to clinicians. The company recently announced the results of a five-month clinician retention workgroup, finding that 77% of clinicians agreed that consistently receiving positive patient messages reinforced their purpose.

Patients 100
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With FDA nod for Lumryz, Avadel is set to Jazz up the narcolepsy market

Fierce Pharma

With FDA nod for Lumryz, Avadel is set to Jazz up the narcolepsy market kdunleavy Tue, 05/02/2023 - 06:53

Marketing 212
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FDA accepts Bristol Myers Squibb’s Reblozyl sBLA for anaemia  

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has accepted the supplemental biologics licence application submitted by Bristol Myers Squibb for Reblozyl (luspatercept-aamt) as a first-line treatment of anaemia in adults with lower-risk myelodysplastic syndromes (MDS). The regulatory body has also granted priority review to the application and set 28 August 2023 as a target date for the prescription drug user fee act (PDUFA).

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Bristol Myers accuses AstraZeneca of infringing patent on cancer blockbuster Opdivo—again

Fierce Pharma

Bristol Myers accuses AstraZeneca of infringing patent on cancer blockbuster Opdivo—again zbecker Tue, 05/02/2023 - 10:54

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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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Ultrasound Patch Delivers Drugs Through the Skin

Medgadget

Engineers at MIT have developed a patch that uses ultrasound to deliver drugs through the skin. Ultrasound can create temporary openings in skin, allowing drugs to pass through. The skin is typically a difficult area for drug delivery, as it forms a tough barrier. However, the patch, which contains piezoelectric transducers, can push drugs through the skin highly efficiently.

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Merck entitled to $1.4B in cyberattack case after court rejects insurers' 'warlike action' claim

Fierce Pharma

Merck entitled to $1.

Insurance 311
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From science to strategy, this exec is painting Genmab’s bigger picture into the next decade

PharmaVoice

Martine van Vugt, recently named Genmab’s chief strategy officer and executive vice president, aims to usher in the company’s next wave of "knock your socks off" antibodies.

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Report: MA Enrollment Increases to Half of All Eligible Medicare Beneficiaries

MedCity News

Out of 59.82 million people with Medicare Part A and Part B in January 2023, 30.19 million people were enrolled in Medicare Advantage plans, the Kaiser Family Foundation found in a recent analysis.

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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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Cells with Backpacks to Treat Multiple Sclerosis

Medgadget

Researchers at the Harvard Wyss Institute have developed a new type of cell therapy for multiple sclerosis patients. The technique involves taking a blood sample from the patient being treated, isolating a sample of myeloid white blood cells, and then modifying them with ‘backpacks’ that contain anti-inflammatory molecules. The modified cells can then be administered back to the patient, and the backpack ensures that they maintain an anti-inflammatory phenotype.

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Travere Therapeutics Drug for Rare Kidney Disease Falls Short in Pivotal Test

MedCity News

Sparsentan failed to meet the main goal of a Phase 3 test in focal segmental glomerulosclerosis (FSGS). Nevertheless, Travere Therapeutics says the totality of data points to patient improvement in the rare kidney disorder and the biotech will talk with regulators about a potential path forward.

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CCC to Host Virtual Town Hall on Making Research Data FAIR

Copyright Clearance Center

May 2, 2023 – Danvers, Mass. – CCC , a leader in advancing copyright, accelerating knowledge, and powering innovation, will present a Town Hall discussion via LinkedIn Live on 10 May at 11:00 a.m. EDT/16:00 BST/17:00 CEST where a VIP panel will share best practices for developing research data that is FAIR through culture, training, and technology. Audience members will learn how to identify signals of improvement and create breakthrough interoperability across research domains.

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Scott Burrows, Motivational Safety Team Speaker

Scott Burrows

It is Time to Get Accountable about Safety As a motivational safety team speaker, I am familiar with the many recent studies on isolation and loneliness.

Safety 98
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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 Expands in Cancer, Paying $245M for Two Next-Generation Cell Therapies

MedCity News

Johnson & Johnson is acquiring rights to two next-generation cell therapies from Cellular Biomedicines, both potential treatments for diffuse large B-cell lymphoma. One therapy is already in the clinic while the other is on track to begin human testing this year.

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FDA releases draft guidance for decentralised clinical trials

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has released a new draft guidance to further support the use of decentralised clinical trials (DCTs) for drugs, biologics and devices. The publication includes recommendations for sponsors, investigators and other stakeholders regarding the implementation of DCTs to advance medical product development and research.

FDA 81
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If You Could See Where You Cleaned, Could It Reduce Hospital-Acquired Infections?

MedCity News

Kinnos — a startup reimagining the way hospitals disinfect their surfaces by colorizing the process — recently raised $15 million in financing. Through better sanitization practices, the company is seeking to decrease hospital-acquired infections, which cause 72,000 deaths every year.

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Stimu Sock for Electrical Stimulation in Diabetic Neuropathy

Medgadget

Researchers at Rice University have developed a “Stimu Sock” that can help to treat balance issues and pain in the feet caused by diabetic neuropathy. The socks contain an insole that can provide haptic feedback if someone is overbalancing, helping them to correct things. It can also administer transcutaneous electrical nerve stimulation that can help to reduce pain in the feet.

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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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Using Smart Tools for Smart Development

PharmaTech

The use of smart tools in early drug discovery can have an impact on downstream phases of drug development.

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Don’t Send Your Medical Sales Resume Without These 4 Must-Haves

MedReps

Getting into medical device sales requires quite a bit of knowledge. Many employers, unless the job is for entry-level sales, want to see what type of experience you have in the field as well. Add in the fact that human resources workers and recruiters tend to quickly view your resume looking for specific keywords, and you have a short amount of time to prove your expertise in the field.

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5 Questions for Linguamatics’ Jane Reed

Copyright Clearance Center

The post 5 Questions for Linguamatics’ Jane Reed appeared first on Copyright Clearance Center.

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Astellas Reaches Agreement to Obtain Iveric Bio

PharmExec

Acquisition expected to support pharmaceutical’s blindness regeneration campaign.

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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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ODAIA wins $25m funding to boost commercial insights platform for pharma

Pharmaceutical Technology

ODAIA, a life sciences predictive analytics and commercial insights provider, has secured an investment of $25m in its Series B funding round. The round was led by Threshold Ventures and co-led by Monograph Capital. Another new investor to take part in Series B round was Wittington Ventures. Existing investors including Flint Capital, StandUp Ventures, Graphite Ventures and BDC Capital’s Women in Technology Venture Fund, also participated in this round.

Pharma 59
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Envisioning Digital Pharma Manufacturing

PharmaTech

Digital transformation to the Pharma 4.0 paradigm moves forward in process development and clinical and commercial manufacturing.

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Scott Burrows, Motivational Safety Team Speaker

Scott Burrows

It is Time to Get Accountable about Safety As a motivational safety team speaker , I am familiar with the many recent studies on isolation and loneliness. If you’re currently scratching your head as to what loneliness might have to do with safety, just stay with me for a moment as we move through this article from the Harvard Business Review: “Our study substantiated existing evidence that exclusion is a growing issue.

Safety 52
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Why Personal Development is Key to Sales Success

Contrarian Sales Techniques

It's the Salesperson, Not the Strategies As a salesperson, I've always been fascinated by the idea of finding the perfect sales strategy or tactic that will guarantee success. Over the years, I've read countless books, attended numerous trainings, and tried all sorts of approaches to improve my sales performance. And while I've had my fair share of wins and losses, one thing I've come to realize is this: it's not the sales strategies or tactics that make the biggest difference – it's the salespe

Sales 52
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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.