Fri.Sep 30, 2022

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The ascent of pharma marketing

Dominic Tyer

Pharmaceutical companies with a chief marketing officer are thin on the ground, but their number will shortly see a slight increase thanks to a new appointment at Pfizer

Marketing 130
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Mass producing biodegradable stem cell therapy microrobots

European Pharmaceutical Review

Professor Hongsoo Choi’s team at The Department of Robotics and Mechatronics Engineering at the Daegu Gyeongbuk Institute of Science & Technology (DGIST), Korea, developed revolutionary technology that produces over 100 microrobots per minute. The collaboration with Professor Sung-Won Kim’s team at Seoul St. Mary’s Hospital, Catholic University of Korea and Professor Bradley J.

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bluebird bio wins back-to-back landmark FDA approvals for first-in-class gene therapies

Pharmaceutical Technology

After several setbacks, bluebird bio bounces back with two major FDA gene therapy approvals. Last month, Zynteglo (betibeglogene autotemcel), or beti-cel, was approved as a one-time potentially curative gene therapy for patients with beta-thalassaemia who require regular blood transfusions. Shortly after this, the FDA announced the accelerated approval of bluebird's Skysona (elivaldogene autotemcel), or eli-cel, on 19 September.

FDA 115
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The future of healthcare is efficient, effective … and surprisingly personal

MedCity News

Virtual specialty care networks may provide the sort of longitudinal healthcare relationship we haven’t seen since the era of house calls and doctors’ bags—benefiting patients and physicians alike.

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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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Elite Teledentistry Companies in the USA

Medico Reach

Teledentistry has made dental services easily accessible to patients. Customers can avail dental services right from their comfort. It includes online consultation via video calls, text messages, or live chat. That’s why the teledentistry industry is gradually evolving. In fact, the industry will likely cross $2105.76 million by 2028 , with more teledentistry companies entering the market.

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Solving healthcare’s last mile problem: 3 ways to better reach patients

MedCity News

There are a few key priorities providers and digital health companies should consider in their efforts to better reach patients — including scaling up their commitment to value-based care and working to engage patients beyond their episodic care needs — according to a recent healthcare innovation panel.

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More Trending

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How to make community-based clinical trials a reality

MedCity News

When patients can travel to a pharmacy or doctor’s office in their own neighborhood, they can reach the site on foot or using public transit. They also have to take less time off work and request childcare less often.

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10-Step Sales Action Plan to Crush Quota

Spotio

Whether you’re a software entrepreneur, an executive, or a sales manager , one of the best things that you can do to set yourself up for success is to write a sales action plan that supports your company and helps it to grow. Unfortunately, a lot of business leaders struggle with developing a strategy that can enrich and empower their operations. A sales action plan is the easiest way to lay out your objectives, strategies, and tactics for success, in a way that your whole team can understand.

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Novo Nordisk pays $70M for a Phase 1-ready cardiometabolic disorder drug

MedCity News

Novo Nordisk is acquiring global rights to a Ventus Therapeutics drug candidate with potential applications in cardiometabolic disorders such as NASH and chronic kidney disease. The small molecule blocks a protein that has become an attractive target for big pharmaceutical companies, such as Roche and Novartis.

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Relief for Amylyx as FDA clears controversial ALS drug Relyvrio

pharmaphorum

Patient organisations have been celebrating the FDA approval yesterday of Amylyx’ amyotrophic lateral sclerosis (ALS) therapy Relyvrio, after not one but two advisory committee meetings that arrived at different conclusions about the drug. The approval makes Relyvrio (sodium phenylbutyrate and taurursodiol) the first new therapy option for ALS – also known as motor neuron disease (MND) – since Mitsubishi Tanabe Pharma’s intravenous Radicava (edaravone) was cleared by the FDA in 2017.

FDA 82
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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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Employer point solution fatigue: How can health startups rise above?

MedCity News

Employers are having a difficult time navigating all the point solutions in healthcare. But it’s not necessarily a bad thing, as its generating more competition and forcing companies to get creative. Several experts discussed the topic at MedCity’s Invest Digital Health conference.

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Low-Priced Oncology Disruptors: The Cuckoo in the PD-1/PD-L1 Nest or the Runt of the Clutch?

pharmaphorum

Part I. Novel oncologic drugs continue to command premium pricing, driven by a combination of unmet needs, and delivering often-iterative, sometimes-significant improvements in survival or maintenance of a progression-free state. The stable of PD-1/PD-L1 checkpoint inhibitors, led by Keytruda (pembrolizumab), represents the current generation of high value, high price drugs to tackle a variety of cancers in mono- or combination therapy.

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Clinically responsive workflows are the key to EHR usability

MedCity News

While EHRs are often viewed as essential clinical tools, most were originally designed to facilitate billing operations. By incorporating clinically responsive workflows that readily present the right information to clinicians at the point of care, EHRs can finally fulfill their destiny – to drive better patient care.

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CCC Announces RightFind Cite It for Mac

Copyright Clearance Center

September 29, 2022 – Danvers, Mass. – CCC , a leader in advancing copyright, accelerating knowledge, and powering innovation, announced today that RightFind Cite It is now available for Mac users. RightFind Cite It is CCC’s easy-to-use reference management tool that automatically formats bibliographies directly within Microsoft Word with the style and citations its customers use, saving manual work and time.

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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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The status quo is a death sentence for the US health system

MedCity News

Of all systematic changes to healthcare, these four adjustments would be easy enough to roll out quickly and would have a massive impact on the country’s health outcomes.

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How to Reduce Fuel Costs for Your Field Sales Team

Map My Customers

In a world of continual rising costs and inflation, it is more crucial now than ever to implement ways to minimize and control costs within your business. Everyone within an organization can do their part to contribute to this effort including those within the sales team. A sales team is constantly on the go visiting customers and fuel costs on these travels play a huge role in affecting overall operating costs.

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Amylyx ALS drug’s winding regulatory path leads to long-awaited FDA approval

MedCity News

An Amylyx Pharmaceuticals drug developed to slow the progression of amyotrophic lateral sclerosis is now approved, making it just the third FDA-approved treatment for the disease. Amylyx will market its new product under the name “Relyvrio.”.

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CCC Launches OA Agreement Intelligence?

Copyright Clearance Center

The post CCC Launches OA Agreement Intelligence appeared first on Copyright Clearance Center.

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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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Novo Nordisk grabs NASH drug from Ventus in $703m deal

pharmaphorum

Denmark’s Novo Nordisk has agreed to pay $70 million to license rights to a drug developed by Ventus Therapeutics with potential in non-alcoholic steatohepatitis (NASH) and several other diseases associated with inflammation. The deal – which includes additional milestones of up to $633 million plus tiered royalties on sales and R&D funding – focuses on VENT-01, the lead drug in Ventus’ peripherally-restricted NLRP3 inhibitor programme, which is currently in preclinical developme

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Are you Ready to Discuss Justification for a Price Increase With Customers?

Integrity Solutions

It is no secret that costs are on the rise and that finding justification for a price increase is as easy as looking at everyday purchases. From higher grocery bills to soaring costs for the materials and resources required to produce and deliver products and services, we’ve all felt the impact of inflation and other factors that have steadily pushed prices up over the past year or so.

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Merck defends blockbuster Januvia franchise from patent challenge

pharmaphorum

Merck & Co has been fighting to defend its blockbuster type 2 diabetes therapy Januvia from generic competition for years, and a new judgment looks set to protect its third biggest-selling drug for another few years. The latest verdict – in a federal appeals court – has upheld the validity of a key patent on sitagliptin, the active ingredient in Januvia , as well as metformin combinations Janumet and Janumet XR.

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Sara Blewett: Military Transition & Organization Development Practitioner

MedTechVets

SEPTEMBER 30 – For the past several months, MedTechVets was fortunate to be joined by Military Transition and Corporate Veteran Readiness Specialist , Sara Blewett. Her expertise was utilized to evaluate MTV’s program effectiveness and implement improvements to ensure a sustainable future to assist veterans to their career transition goals. “Sara is such a wonderful bundle of knowledge!

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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.

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InflaRx seeks US FDA authorisation for Covid-19 treatment

Pharmaceutical Technology

InflaRx has submitted an application seeking Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its lead candidate, vilobelimab, to treat Covid-19 patients who are critically ill. The latest development comes after the company had encouraging discussions with the agency at a Type B meeting. In addition, vilobelimab received Fast Track designation from the FDA to treat critically ill, mechanically ventilated, intubated patients with the infection.

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The Power of a Patient Focus

CLD, Inc.

The most impactful and dynamic training deliverables in life sciences focus on the patient. These pieces can help learners have and convey empathy for the burden of disease, discuss the limits and possibilities of treatment, perceive more of the hidden consequences of a disease, and learn about patient and caregiver "wish lists" for managing their disease -- ultimately helping learners better position treatments to HCPs.

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Pheon launches to progress ADCs for solid tumour treatment

Pharmaceutical Technology

Pheon Therapeutics has announced its launch to progress new antibody-drug conjugates (ADCs) for treating solid tumours. The launch comes after the company raised $68m in a series A financing round led by Brandon Capital, Forbion and Atlas Venture. Seed investor Research Corporation Technologies (RCT) also took part in the funding round. The latest financing will aid the company in progressing its lead ADC programme to clinical proof-of-concept (PoC) and validate the new ADC pipeline. .

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Derm Decisions For Younger Children

PharmExec

In episode 118, Paula Brown Stafford, CEO of Novan, discusses the company’s upcoming NDA filing for its topical agent for molluscum contagiosum, what commercialization could look like and her goals for the future.

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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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US FDA grants orphan drug status for Verismo’s mesothelioma therapy

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to Verismo Therapeutics’ SynKIR-110 to treat mesothelin-expressing mesothelioma patients. A next generation cell therapy approach, SynKIR-110 acts on solid tumours. It is said to be the first product to leverage the new KIR-CAR platform, a modified NK-like receptor for boosting efficacy and persistence against aggressive solid tumours.

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Getting approval will only be the first challenge facing lecanemab

pharmaphorum

Biogen and Eisai are riding high on the wave of optimism set in motion by the top-line data drop for Alzheimer’s therapy lecanemab – but a number of breakwaters could lie ahead. First and most obviously is the detailed data from the Clarity AD study reported this week, which will be revealed at the Clinical Trials on Alzheimer’s Congress (CTAD) in November.

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Regulatory approval received for Evgen’s SFX-01 study

PharmaTimes

New formulation may be suitable for large-scale trials and commercial supply in the future

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Name change for Johnson & Johnson offshoot to Kenvue

pharmaphorum

Trusted Johnson & Johnson brands including Tylenol, Aveeno, Neutrogena, Listerine, and Band-Aid are set to fall under the new, independent company name in a next-chapter move of repurposing and modernisation. Johnson & Johnson’s Kenvue – previously the planned New Consumer Health Company – is just one part of the 135-year old company’s plan to reinvigorate its corporate image.

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.