European Pharmaceutical Review

AUGUST 1, 2022

Dubbed Disability Diversity in Clinical Trials (DDiCT), the initiative aims to provide recommendations on how to improve access, engagement, speed of enrolment and participation of people with disabilities in clinical trials. The goal is to “ensure all patient groups are reflective of the real-world population and aligned with the epidemiology of the disease studies,” a statement said.

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Pharmaceutical Technology

AUGUST 1, 2022

Moderna has entered a new supply contract with the US Government to deliver 66 million doses of its Covid-19 vaccine booster candidate, mRNA-1273.222. The contract comprises a $1.74bn award to produce and supply these vaccine doses and options to further procure up to 234 million additional doses of the company’s booster candidates. A bivalent booster candidate, the mRNA-1273.222 vaccine comprises Spikevax along with the Omicron BA.4/5 strain messenger RNA (mRNA).

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MedCity News

AUGUST 1, 2022

At the INVEST PhamaTech conference last month, five startups shared their vision for how they are seeking to reinvent clinical trials as part of the Pitch Perfect contest.

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pharmaphorum

AUGUST 1, 2022

Sarepta is pressing forward with a bold plan to file with the FDA for accelerated approval of its gene therapy SRP-9001 for Duchenne muscular dystrophy (DMD) in the next few months, with a view to making it available in sometime around the middle of 2023. The US biotech – which already has three antisense drugs for DMD on the market – had said earlier it was planning to delay the application into 2023, so the new announcement marks an acceleration of its plans.

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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

Distribution

MedCity News

AUGUST 1, 2022

Apple makes a case that it is a pioneer in the health technology field in a nearly 60-page report. It’s received criticism in the past for not doing enough in health tech compared to competitors.

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Spotio

AUGUST 1, 2022

The Complete Guide for Solar Sales Leaders. SPOTIO has been helping solar field sales take their teams to the next level and achieve more since 2014. Today, we work with hundreds of residential and commercial solar companies worldwide. From our unique position, we’ve been able to distill down the best tips, tricks, and benchmark performance data to help the entire industry overcome today’s challenges and continue to thrive in the future.

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Salesforce

AUGUST 1, 2022

If the number of new management books , conferences , and executive education programs are any indication, senior leaders and team managers are going to need a whole new set of skills to succeed in the new model of company culture — flexible work. . Surveys show that employees want, and employers will oblige, flexible work arrangements where employees work in the office only part of the time.

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MedCity News

AUGUST 1, 2022

Beam Therapeutics’ application to begin human testing of a cell therapy made with base-editing technology is now under an FDA clinical hold. In other clinical hold news, the FDA lifted a hold on a Celyad Oncology cell therapy clinical trial that was halted in March.

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Clarify Health

AUGUST 1, 2022

At the beginning of Dr. Anikia Nelson’s career, she realized she wanted to have an impact beyond the scope of direct patient care. She’s making a big impact here at Clarify Health as our Senior Director of Clinical Product Management. She’s a physician by training and now specializes in driving Clarify’s product strategy and roadmap to enhance clinical nuance, improve actionability and ensure the most impactful use of social determinants of health (SDoH) insights.

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MedCity News

AUGUST 1, 2022

Engage Venture Partners, a Minneapolis-based venture capital firm, recently launched with a focus on early stage medical tech companies. The firm was established to decrease friction between early stage medical tech companies and their investors by bringing its investments to market via special purpose vehicles (SPVs).

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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.

Safety

Pharmaceutical Technology

AUGUST 1, 2022

AbbVie has reported net revenues of $14.6bn for the second quarter (Q2) of 2022 as against $14bn in the year-ago quarter, indicating a 4.5% rise on a GAAP basis. Net revenue surged by 6.1% on an operational basis during the quarter. The GAAP diluted earnings per share (EPS) for the quarter ended 30 June grew by 21.4% to 0.51 from $0.42 in Q2 2021. An 11.2% surge in adjusted diluted EPS of $3.37 was reported in Q2 this year against $3.03 in the prior-year quarter.

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MedCity News

AUGUST 1, 2022

Without reimbursement policies that can meet the opportunity of this new innovative era, patients and their providers will be denied access to the most cutting-edge, care. .

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Patients 103

Pharmaceutical Technology

AUGUST 1, 2022

GreenLight Biosciences has entered a partnership with the US National Institutes of Health (NIH) for the development of Covid-19 vaccines, which offer broader protection against new variants and with durable effects. The company will jointly design and analyse messenger ribonucleic acid (mRNA) Covid-19 vaccines in partnership with the NIH unit National Institute of Allergy and Infectious Diseases’ Vaccine Research Center (VRC).

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European Pharmaceutical Review

AUGUST 1, 2022

The joint Big Data Steering Group of the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) has published a third workplan, setting actions to be delivered by 2025. According to EMA, the new plan will further enhance the efficient integration of data analysis into the regulatory evaluation of medicinal products. “Using novel technologies and the evidence generated from big data will benefit public health by accelerating medicine development, improving treatment outcomes an

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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.

Specialization

PharmaVoice

AUGUST 1, 2022

Catherine Owen, senior vice president of major markets, discusses the hurdles — and successes — of bringing the two ‘powerhouses’ together.

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Pharmaceutical Technology

AUGUST 1, 2022

Before the Covid-19 pandemic, government-led investment and engagement in life sciences was relatively restricted worldwide, with the industry mostly funded via private investment. The pandemic forced governments to acknowledge that this status quo had to change. Since 2020, government agencies have provided funding for expensive late-stage vaccine development and the expansion of manufacturing capacity, as well as other key pharmaceutical activities.

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MedCity News

AUGUST 1, 2022

Andrew Dahl, founder and chairman of BioMEMS Diagnostics, shared how his business seeks to transform the diagnostics sector, in response to emailed questions.

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Medgadget

AUGUST 1, 2022

Researchers at the University of Sydney in Australia engineered a new spray coating for surfaces that provides long-term protection against bacterial and viral contamination. The material is intended as a long-term alternative to disinfectant sprays and combines hydrophobic properties with antimicrobial nanoparticles to reduce microbial contamination.

Engineering 90

Engineering Healthcare Healthcare Networking 90

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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.

Safety

MedCity News

AUGUST 1, 2022

The FDA approved Arcutis Biotherapeutics drug Zoryve, a topical treatment for plaque psoriasis. With the decision, the company will proceed with a pricing strategy it believes will speed up insurance coverage and patient adoption of the new treatment for the chronic inflammatory skin disorder.

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European Pharmaceutical Review

AUGUST 1, 2022

ViiV Healthcare and the Medicines Patent Pool (MPP) have signed a new voluntary licensing agreement to increase access to cabotegravir long-acting (LA) for HIV pre-exposure prophylaxis (PrEP) in least developed, low-income, lower middle-income and Sub-Saharan African countries. Through this agreement, selected generic manufacturers will have the opportunity to develop, manufacture and supply generic versions of cabotegravir LA for PrEP in 90 countries, subject to required regulatory approvals be

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Manufacturing Medicine Healthcare Healthcare 93

pharmaphorum

AUGUST 1, 2022

Bristol-Myers Squibb has revealed that its checkpoint inhibitor combination of Opdivo and Yervoy failed a phase 3 trial as adjuvant (post-surgery) therapy for renal cell carcinoma (RCC), the most common form of kidney cancer. The disappointing outcome from the CheckMate -914 trial undermines BMS’ hopes of moving PD-1 inhibitor Opdivo (nivolumab) and CTLA4 inhibitor Yervoy (ipilimumab) treatment into earlier-stage cancers.

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Patients Pharma 78

PharmaVoice

AUGUST 1, 2022

WinterLight’s machine learning platform assesses speech to more accurately identify neurodegenerative diseases.

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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.

Management

Copyright Clearance Center

AUGUST 1, 2022

The post Content Authenticity Initiative: The Solution to Information’s Provenance Problem? appeared first on Copyright Clearance Center.

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pharmaphorum

AUGUST 1, 2022

This article follows part one of our two-part series, where we discussed how Philips designs innovation and digital health solutions for areas of India’s healthcare system where options are sparse. . Ties Kroezen, venture leader of Community Life Centers and business development manager for Philips Africa, tells us about the challenges present within the African healthcare system, solutions the company developed to help patients and providers connect, and how pharma can assist with deliver

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Healthcare Healthcare Pharma Government 76

PharmExec

AUGUST 1, 2022

A modular content strategy enables better processes, better governance, and better digital asset management.

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Management Government 98

Copyright Clearance Center

AUGUST 1, 2022

The post E-Book Price Suit Is “Implausible” Say Amazon, Publishers appeared first on Copyright Clearance Center.

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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

Leads

Clarify Health

AUGUST 1, 2022

Leveraging behavioral science and actionable insights, Clarify Advance enables clinicians to direct patients to higher-value settings of care without the need for new payment models. SAN FRANCISCO, August 1, 2022 – Clarify Health , a leading cloud analytics and value-based payments platform company, announced the launch of Clarify Advance , a new software solution rooted in behavioral science that can be used to positively influence decision-making at the point of care, provides timely and salie

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Networking Healthcare Healthcare Leads 59

Copyright Clearance Center

AUGUST 1, 2022

The post The Content Authenticity Initiative appeared first on Copyright Clearance Center.

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PharmaTimes

AUGUST 1, 2022

Study data demonstrates positive effects of CY6463 on cognition and inflammation

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Rep-Lite

AUGUST 1, 2022

The medical and pharmaceutical field is very competitive. Many companies are working hard to be successful in making money and providing the best healthcare to their consumers. To remain on top, companies need to ensure that they have the team which is best suited to them. It can be challenging to find a team of medical sales reps and pharmaceutical sales reps who can efficiently collaborate with other members of the group.

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Recruitment Medical sales reps Sales Pharmaceutical Sales 52

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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.

Patients