Wed.Sep 27, 2023

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As Viatris seeks growth in eye care, its Ocuphire-partnered dilation drop Ryzumvi wins FDA nod

Fierce Pharma

Viatris just notched a win on its quest to reach $1 billion in eye care sales by 2028. | The FDA on Wednesday approved Viatris and Ocuphire’s Ryzumvi, also known as phentolamine ophthalmic solution, to treat pharmacologically-induced mydriasis, or dilation of the pupils. The partners plan to make Ryzumvi available in the U.S. in the first half of 2024.

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Brainstorm’s ALS Data Fail to Persuade FDA Advisors, Who Vote Down the Stem Cell Therapy

MedCity News

NurOwn, Brainstorm Cell Therapeutics’ experimental stem cell therapy for ALS, did not win the backing of an independent panel of FDA advisors. Many advisory committee members said they want to see more data from another clinical trial, the same guidance the FDA has given the biotech for nearly three years.

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NICE poised to reject AstraZeneca, Daiichi’s Enhertu in HER2-low breast cancer

Fierce Pharma

NICE poised to reject AstraZeneca, Daiichi’s Enhertu in HER2-low breast cancer aliu Wed, 09/27/2023 - 10:40

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Virgin Pulse, HealthComp To Merge Through $3B Deal

MedCity News

As a combined entity, Virgin Pulse and HealthComp will serve more than 1,000 self-insured employers and more than 20 million members. New Mountain Capital will be the majority owner.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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'We can't forget about this': As chemotherapy shortage ebbs and flows, attention shifts to long-term solutions

Fierce Pharma

It’s been about 10 months since FDA inspectors rebuked a | As some cancer centers struggle to secure access to key platinum-based chemotherapies, a national spotlight gives the issue newfound political importance. But will this be a turning point for the recurrent shortage issue? ASCO's Julie Gralow, M.D., certainly hopes so.

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Evvy Secures $14M for Vaginal Healthcare Platform

MedCity News

Evvy’s $14 million funding round was led by Left Lane Capital and included participation from General Catalyst, LabCorp Venture Fund, RH Capital, Ingeborg Investments, G9 Ventures, Virtue and Amboy Street Ventures. In total, Evvy has raised $19 million.

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Transcarent Partners With 10 Health Systems To Launch Provider Network

MedCity News

Transcarent announced a new provider network, which seeks to help its employer customers provide their staff with access to high-quality, affordable care. The network includes 10 health systems — including Mount Sinai, Mass General Brigham and Intermountain Health.

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Will Big Pharma engage in Medicare price negotiations? The verdict's not in

Fierce Pharma

Will Big Pharma engage in Medicare price negotiations?

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New playbook: virtual patient engagement

Impetus Digital

Authentic patient engagement and insight-gathering are becoming must-haves in Pharma. However, multiple obstacles remain before patient-centricity becomes more than a buzzword. In our latest playbook , we take a deep dive into the top barriers preventing cross-functional teams from wholeheartedly adopting patient-centric practices, along with how to overcome these obstacles.

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Four Reasons to Take a Fresh Look at Contract Sales Organizations

Fierce Pharma

It’s been over a quarter-century since contract sales outsourcing (CSO) emerged as a model for supplementing in-house field forces. | Revitalize your perspective. Discover four compelling reasons to embrace contract sales organizations as part of your commercial strategy.

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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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Generics expected to improve access for patients with idiopathic pulmonary fibrosis

Pharmaceutical Technology

The idiopathic pulmonary fibrosis (IPF) market is underserved with just two licensed pharmaceutical treatments approved by the FDA in 2014.

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Inside Bavarian Nordic’s late-stage stumbles — and its drive to become a vaccine giant

PharmaVoice

Despite recent phase 3 setbacks in RSV and COVID-19, CEO Paul Chaplin sees a promising path forward in the travel vaccine market for the Dutch biotech.

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NHS Confederation research supports investment in NHS services

PharmaTimes

Report shows that if the health service invests in community services hospital admissions will reduce - News - PharmaTimes

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Glenmark to market Winlevi in Europe and South Africa after Cosmo deal

Pharmaceutical Technology

The popular acne treatment will soon be available in 15 EU countries in addition to UK and South Africa.

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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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Portsmouth NHS Trust maternity team enhances patient experience

PharmaTimes

Patient waiting times to receive an appointment have reduced from 6-8 weeks to just 24 hours - News - PharmaTimes

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Torx Software and CDD Vault to Collaborate on Global Drug Discovery

PharmaTech

The collaboration will provide easy access and transfer between data in Torx and CDD Vault, upping the efficiency of the small-molecule discovery process.

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The power of combining human connection and digital channels 

Star OUTiCO

While technology is undeniably a valuable tool in today’s rapidly evolving pharmaceutical landscape, it’s equally essential to recognise the power of combining the strengths of personal interactions with the reach of digital channels. Our data tells us that the shift to a hybrid sales approach can unlock growth opportunities, however, achieving success in pharma sales isn’t just about having the right technology and digital channels, it’s about having the right people on

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Drug Digest: A Big Impact: Trends Shaping Small-Molecule APIs, Excipients, and Formulations

PharmaTech

In this episode of Drug Digest, Pharmaceutical Technology’s European/Senior Editor, Felicity Thomas, discusses small-molecule APIs, excipients, and formulation advances, including a discussion about novel approaches and solutions to pediatric formulations and taste-masking, a rundown of the fundamental stages of gaining a certificate of suitability for APIs, and a deliberation on the biggest trends impacting the industry and key sessions to visit while at CPHI, with several key industry experts.

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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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QT Medical® Announces Completion of Series B Financing of $12 Million

Legacy MEDSearch

QT Medical, Inc., a medtech company focused on cardiac care technology, announced today that it raised $12 million in Series B financing. This funding will accelerate QT Medical’s market penetration, global expansion, product pipeline development, and long-term strategic planning. QT Medical aims to provide improved cardiac devices and services to revolutionize the care of patients with heart disease.

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Making Obesity Treatments More Affordable

PharmExec

George Hampton, president and CEO, Currax Pharmaceuticals, discusses the obesity treatment landscape, payment options available to insured and uninsured patients, and how pharma can make obesity treatments more affordable in an exclusive Q&A with Pharm Exec.

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Mobile health strategies: Should you build or partner for success?

Pharmaceutical Technology

With GlobalData figures showing the value of pharma’s 2023 digital therapeutics-related deals to have grown by 129% since 2018, and the year still not out, it is clear that projects such as companion apps are becoming an increasing priority for life science firms. Here, we debate the benefits of building versus partnering, and share some important considerations for a successful project.

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Pharmacies and Labs Must Work Together to Accelerate Test and Treat Opportunities, Enhance Patient Care Equity, Improve Health Outcomes

Pharmacy Times

Working together, pharmacies and labs can answer the call to align and back legislation that supports pharmacists as providers, help patients gain greater access to affordable care, and reap the benefits of improved health outcomes while growing business revenue.

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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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Arcturus Therapeutics extends cystic fibrosis treatment deal

Pharmaceutical Technology

Arcturus Therapeutics has extended an existing agreement in place with the Cystic Fibrosis Foundation (CF Foundation) for advancing ARCT-032.

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Pfizer’s Rocky Mount Plant Resumes Production

Pharmaceutical Commerce

Two months after tornado strikes North Carolina facility, manufacturing will undergo a phased approach, with full capacity expected by the end of 2023.

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Avalyn raises $175m in funding to develop inhaled IPF drugs

Pharmaceutical Technology

The funding was part of an oversubscribed Series C financing that will be used to advance its lead IPF therapies into Phase II trials.

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FDA Releases Draft Guidance for Regulatory Considerations for Prescription Drug-Use-Related Software

Pharmaceutical Commerce

The agency differentiates between software that has a notable impact on the effectiveness and safety of drug use.

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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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Alfasigma to buy Intercept Pharmaceuticals for $794m

Pharmaceutical Technology

Alfasigma has signed a definitive agreement for the acquisition of Intercept Pharmaceuticals in an all-cash deal valued at $794m.

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Large Review Suggests IVIG is Effective for Neurological Diseases Following COVID-19 Infection

Pharmacy Times

Intravenous immunoglobulin found to provide fast and long-lasting relief for COVID-19-related neurological conditions, although investigators are still uncovering the pathology of many of these conditions.

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Novo Nordisk and Evotec launch translational drug discovery accelerator

Pharmaceutical Technology

The partnership will help advance preclinical concept in the cardiometabolic disorder space from four academic institutions.

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Yoga Could be an Effective Natural Treatment for Individuals with Heart Failure

Pharmacy Times

Routine yoga therapy has shown endurance, strength, balance, symptom stability and quality of life improvements in individuals with heart failure.

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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.