Tue.Aug 23, 2022

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What should DTC do?

World of DTC Marketing

Consumers would ask their doctor about an advertised prescription drug in a perfect world. In our REAL world, that isn’t the way it happens. Is there a disconnect between what DTC marketers think will happen and what happens with DTC? The research was straightforward. Ask current patients what drove them to get an Rx for a branded product (MS drug).

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Gilead’s Sunlenca receives EC approval to treat HIV

Pharmaceutical Technology

Gilead Sciences has obtained the European Commission (EC) marketing authorisation for Sunlenca (lenacapavir) injection and tablets to treat human immunodeficiency virus (HIV) infection. The twice-yearly treatment is indicated to be administered along with other antiretroviral(s) in adult patients with multi-drug resistant HIV infection who otherwise cannot have a suppressive anti-viral regimen.

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Bayer unit BrainVectis cleared to start Huntington gene therapy trial

pharmaphorum

France’s BrainVectis, a subsidiary of Bayer’s Asklepios BioPharma (AskBio) unit, has been given the green light by regulators in France to start dosing patients with its gene therapy candidate for devastating neurodegenerative disorder Huntington’s disease. The phase 1/2 study is due to get underway before the end of the year and will test BrainVectis’ one-shot BV-101 gene therapy, which will be delivered using an adeno-associated virus (AAV) vector directly to areas of

Safety 105
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How Non-Profits Can Affordably Create Impactful Video

Storyvine

It's a new day for non-profits and advocacy organizations. More than ever, your message needs to be heard. But with time and resources limited, what's the best way to do that? Video is the most popular form of content—78% of people watch online videos once a week—and it's especially effective for non-profits. With a real person telling a real story, combined with music and good editing, you can take your audience on an emotional journey that is very powerful.

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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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Overcoming mental health’s drug development challenges with AI

PharmaVoice

PsychoGenics is leveraging AI-driven drug discovery platforms to advance mental health treatments for schizophrenia, bipolar disorder and treatment-resistant depression.

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Cancer overtakes musculoskeletal conditions as the most expensive condition for large employers

MedCity News

A new survey by the Business Group on Health found that 83% of employers said cancer is now the leading condition driving up healthcare costs, compared to 76% who said musculoskeletal conditions.

More Trending

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The story behind the PharmaVoice 100

PharmaVoice

Taren Grom, our editor-in-chief emeritus, explains how the coveted PharmaVoice 100 awards got its start and what makes it stand out in the industry.

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Takeda gets first approval for its dengue vaccine

pharmaphorum

Japan’s Takeda has secured its first regulatory approval – in Indonesia – for its dengue fever vaccine TAK-003, which has been tipped as a potential blockbuster product. Indonesia’s National Agency for Drug and Food Control (BPOM) has approved the vaccine as Qdenga to protect against the virus in people aged six to 45, on the back of data showing that it can cut dengue-related hospitalisations by 84%, with 61% protective efficacy against symptomatic illness seen up to three years aft

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The EU HTA regulation: a new frontier for access to innovative technologies

European Pharmaceutical Review

ON 11 JANUARY 2022, Regulation (EU) 2021/2282 on health technology assessment (HTA) came into force. 1 The regulation is the culmination of a long debate between European Union (EU) Member States and health sector stakeholders, triggered by joint actions such as European Network for Health Technology Assessment (EUnetHTA) and formalised through the European Commission (EC)’s proposal in January 2018. 2.

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As COPD cases climb, rural people lack critical access to pulmonology care

MedCity News

it is imperative that rural healthcare organizations take steps now to ensure that they provide access to a specialist, through traditional or digital solutions to meet these patient’s critical needs.

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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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Common pharma compliance concerns cited by FDA warning letters

European Pharmaceutical Review

A study of the causes of warning letters issued by the US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) between 2010 and 2020 revealed that poor current good manufacturing practice (cGMP) compliance and misbranding were the most common citations. Of the cGMP letters, three major types of violations – deficiencies in process validation, documentation practices (data integrity) and quality control – account

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BMS protein degradation drug research turns to a startup to find molecular glues

MedCity News

Bristol Myers Squibb’s drug R&D includes targeted protein degradation, an approach that can require proteins that don’t normally interact to find a way to stick together. BMS is turning to startup A-Alpha Bio to discover “molecular glues” that can accomplish the task.

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Securing every dose with an edible security technology for safe medicines

European Pharmaceutical Review

FAKE MEDICINES are not a new problem, and pose a tremendous threat to patient safety and public health in society regardless of a country’s economic status. The prevalence of fake drugs is a continually growing problem worldwide. Fake drugs can be categorised as substandard, falsified, counterfeit and diverted drugs, and the World Health Organization (WHO) broadly defines a counterfeit medicine as “one which is deliberately and fraudulently mislabelled with respect to identity and/or source.” 1

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Alcon ups its glaucoma game again with $770M Aerie Pharma acquisition

MedCity News

The Aerie Pharma acquisition brings Alcon two commercialized glaucoma products, as well as a pipeline of programs in various stages of development for other eye diseases. Alcon has been an active dealmaker, turning to M&A as a way to bolster its eye products portfolio and pipeline.

Pharma 85
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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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$6mn grant to advance purification membranes for viral vectors

European Pharmaceutical Review

Researchers from the University of Arkansas (U of A) and two partner institutions have been awarded a $6 million grant by the US’s National Science Foundation (NSF) to develop purification membranes for future large-scale manufacturing of viral vectors and virus-like particles. According to the team, the successful development of commercial-grade purification membranes will increase access to new treatments for genetic and chronic diseases, especially for middle- and low-income people.

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Newest Improvements to CCC Marketplace Enhance Publisher-User Experience for Medical Communications Professionals

Copyright Clearance Center

The post Newest Improvements to CCC Marketplace Enhance Publisher-User Experience for Medical Communications Professionals appeared first on Copyright Clearance Center.

Medical 85
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Client Management: Useful Tips for Medical Sales Reps

MedReps

It’s important to have good relationships with your clients. However, these relationships can often feel like a roller coaster ride because you are actively trying to sell your products to them. Whether they stop being interested in the medical products you represent or they are very busy and difficult to get ahold of, it’s up to you to maintain the relationship.

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Mining Ultrasound Data to Improve Liver Diagnostics: Interview with Beth Rogozinski, CEO at Oncoustics

Medgadget

Oncoustics , a medtech company based in Ontario, Canada, developed the OnX Liver Assessment Solution, an AI-powered ultrasound-based diagnostic system for liver disease. At present, detecting liver disease is a challenge, potentially involving high-end imaging systems, specialists, and invasive biopsies. These challenges, and the related expense, can limit patient access to such testing for those with strong indications of liver disease.

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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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Pfizer, BioNTech seek US okay for Omicron BA.4/BA.5 booster

pharmaphorum

Pfizer and BioNTech have asked the FDA for emergency authorisation of an Omicron-targeted COVID-19 booster vaccine ahead of the planned autumn immunisation campaign in the US. The new version of their Comirnaty vaccine includes mRNA for the spike protein of the wild-type SARS-CoV-2 that first emerged in late 2019, as well as for the BA.4 and BA.5 subvariants of the now-dominant Omicron variant.

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Take a look inside drug delivery devices

European Pharmaceutical Review

While combing for our typical insights into the pharmaceutical industry, we came across Scan of the Month and could not help but share their drug delivery device edition – a fascinating insight into the complexities of drug delivery devices many may take for granted. Using computerised tomography (CT) scanning, we can see beyond the consumer friendly design to the inner workings of two common drug delivery devices: the powder asthma inhaler and Mylan’s well-known EpiPen ®.

Safety 75
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What healthcare startups need to know to create a secure environment for sensitive data [Sponsored]

MedCity News

Actions ranging from data theft to ransomware cost the healthcare industry over $9.2 million on average for every breach. Guidelines for making computing environments that house and utilize sensitive protected healthcare data more secure are highlighted in a new whitepaper by Ventech.

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Can Hepatitis C drugs reduce symptoms of PTSD?

European Pharmaceutical Review

A study led by Boston University School of Public Health (BUSPH) and the White River Junction Veterans Affairs Medical Center in Vermont has completed a rigorous analysis to compare the effectiveness of direct acting antivirals on improving symptoms of posttraumatic stress disorder (PTSD). . The researchers studied 254 VA patients who were diagnosed with PTSD and hepatitis C between October 1999 and September 2019.

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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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Alcon eyes $770m takeover of ophthalmology specialist Aerie

pharmaphorum

Swiss eyecare firm Alcon has made a move to boost its position in ophthalmological medicines with a $15.25 per share offer to buy Aerie Pharmaceuticals that value the US company at around $770 million. If completed, the deal will add two commercial products to Alcon’s range – glaucoma therapies Rocklatan (netarsudil/latanoprost) and Rhopressa (netarsudil) – as well as a pipeline of clinical and preclinical drug candidates currently headed by AR-15512, in phase 3 for dry eye disease.

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Combination Flu, COVID-19, RSV mRNA Vaccine Could Change Immunizations Landscape

Pharmacy Times

Francesca Ceddia, MD, senior vice president of respiratory vaccines at Moderna, said the company is in early stages of development for a combined mRNA vaccine for influenza, COVID-19, and RSV.

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EMA accepts application for leukaemia drug from Otsuka and Astex

PharmaTimes

The marketing authorisation application is supported by results from a phase 3 trial for AML

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Considerations When Choosing a B2B Data Provider

Scott’s Directories

Data providers play the most decisive role in the success of marketing and sales campaigns. A competent data provider is likely to get better marketing outcomes and, thus, more sales. A good data provider provides companies with updated and relevant information, enabling marketers to develop an effective strategy targeting potential customers. High-value data, such as in the Ontario Physician Directory , saves time and effort.

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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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EMA accepts Mundipharma’s application for candidiasis drug rezafungin

PharmaTimes

Despite current treatments, the mortality rate for patients with invasive candidiasis remains high

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3 Ways Our Public Spaces Can Become More Wheelchair Accessible

Happy Living Medical Sales

The number of people living with physical disabilities continues to rise. There are millions of residents in the United States living with different physical disabilities, according to the Centers for Disease Control. Out of this number, a significant portion of residents use wheelchairs for daily mobility. Accessing buildings and public spaces can be challenging due to poor accessibility features.

Safety 52
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The Traditional Pharma Model Isn’t Working – It’s Time to Evolve!

PharmaKinnex

The Traditional Pharma Model Isn’t Working – It’s Time to Evolve! August 23, 2022. dstansberry@costellocreativegroup.com. The pharmaceutical industry of 2022 is very different from the space that we all knew in 2012, 2016, or even 2020. From new legislation to functional shifts in marketing and advertising, the pharma industry works hard every day to keep up with new regulatory requirements and the constantly evolving expectations of prescribers and patients.

Pharma 52
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CRM Mapping Software: 11 Ways to Accelerate Outside Sales Performance

Spotio

CRM mapping software can give your outside sales team a major competitive advantage. How efficient is your outside sales team? How many times have your sales reps walked into the office of a prospective lead, only to find that they’ve already spoken to another rep in your company? Or, what about the times your reps go all the way out to the boondocks to meet with a lead, and realize only once they step back into the office that they could’ve visited another lead just a few miles down the road?

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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.