Tue.Jun 13, 2023

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Biogen refreshes board as chairman departs, adding a Langer while leaving 2 empty seats

Fierce Pharma

Biogen has taken a step to “significantly refresh” its board of directors, departing chair Stelios Papadopoulos, Ph.D., said. | Biogen has taken a step to “significantly refresh” its board of directors, departing chair Stelios Papadopoulos, Ph.D., said. But the reported romantic relationship between a new nominee and a departing member raises questions about one appointment.

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To Get Better Staffing Levels, Hospitals Must Prioritize Nurses’ Hiring Demands

MedCity News

Many health systems aren’t employing the right tactics for hiring and retaining nurses, according to a new report. It argued that hospitals would have an easier time hiring and retaining nurses if they focused more on the things workers want most from their employers — such as flexible scheduling and professional development opportunities.

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After Albireo buyout, Ipsen's Bylvay picks up new FDA-approved use

Fierce Pharma

After Ipsen made a splash at this year's J.P. | After Ipsen made a splash at this year's J.P. Morgan Healthcare Conference by scooping up liver disease specialist Albireo, the centerpiece of the buyout, Bylvay, has won a coveted label expansion.

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Ipsen Itching Drug Scratches Off a Second FDA Approval in Rare Liver Indication

MedCity News

Ipsen drug Bylvay is now FDA approved for treating pruritus, or severe itching, which is a complication of the rare liver disease Alagille syndrome. The oral drug was previously approved for treating pruritus in another rare inherited liver disease called PFIC.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Amgen, Horizon blast FTC's 'baseless assumptions' in response to antitrust lawsuit

Fierce Pharma

As Amgen and Horizon pursue their $27.8 billion merger, they're facing off against the U.S. Federal Trade Commission and its lawsuit to block the deal. | As the FTC seeks to block Amgen's $28 billion buyout of Horizon with a lawsuit, the two companies have fired back with a response that says the agency's accusations are "simply made up.

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How California’s New Legislation Could Affect Healthcare M&A Activity

MedCity News

Healthcare dealmakers must prepare for a new law and a recently-introduced bill in the California Senate, both of which aim to increase oversight in the healthcare M&A space. This is a legislative trend other states are beginning to participate in too — such as New York, Massachusetts and Connecticut.

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Piecing Together the Cybersecurity Puzzle: A Call to Action for Healthcare Leaders

MedCity News

Healthcare executives must recognize the 10,000-piece cybersecurity puzzle is more likely solved by engaging leaders throughout the organization to share in responsibility instead of dropping the box of pieces on the desk of the CIO to solve alone.

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Beacon Therapeutics enters gene therapy arena with $120m launch

Pharmaceutical Technology

Beacon Therapeutics has kickstarted its entry into the gene therapy field with a $120m Series A financing. The British investment trust Syncona Limited launched the new ophthalmic gene therapy company by combining Applied Genetic Technologies Corporation’s (AGTC’s) late-stage X-linked retinitis pigmentosa (XLRP) programme with two proprietary preclinical programmes.

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ASCO Reflections: In the Fight Against Cancer, Health Coverage is Not Enough

MedCity News

Although the revolutionary work of my colleagues has contributed to a 33% reduction in the cancer death rate over the last three decades, too many patients – particularly the most vulnerable – still never benefit from these innovations.

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FDA accepts AstraZeneca’s NDA for breast cancer combination therapy

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has accepted AstraZeneca’s new drug application (NDA) for the combination of capivasertib and FASLODEX (fulvestrant), and granted it priority review. The combination therapy is intended to treat hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in adult patients, after recurrence or progression on or after an endocrine-based regimen.

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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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How a Virtual-First Care Network Can Bridge the Divide Between Dental and Healthcare to Support Healthier Patients

MedCity News

Although leveraging and adapting telehealth techniques for oral health has only quietly and slowly made its way into dental practices, telehealth can shape total patient wellness by improving the efficiency and convenience of accessing and receiving care.

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World’s largest lutetium-177 production site opens

European Pharmaceutical Review

A new therapeutic radionuclide facility, the world’s largest production site of lutetium-177, has opened in Germany. ITM Isotope Technologies Munich SE ( ITM )’s manufacturing plant in Neufahrn near Munich will produce the innovative medical isotope for targeted cancer therapies. “Radiopharmaceuticals are an essential new class of anti-cancer drugs that have the potential to improve therapy outcomes and quality of life for many patients.

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Novartis Lines Up $3.2B Deal for Kidney Disease Drugs, But FTC Questions Loom

MedCity News

Novartis is acquiring Chinook Therapeutics in a $3.2 billion deal that brings two late-stage drug candidates for a rare kidney disorder. The Novartis drug pipeline already has a molecule in late-stage development for the same kidney disease, which could raise questions from antitrust regulators.

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The ingredients of a successful biopharma collaboration

PharmaVoice

Collaboration is important along the entire spectrum and lifecycle of biopharma, and finding an effective partner is harder than it sounds.

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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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Uber Health Launches Grocery, Over-the-counter Delivery Service for Patients

MedCity News

Providers and payers will be able to use Uber Health to deliver healthy groceries and over-the-counter items to patients who need them. They’ll be able to do this on the same platform they use to request non-emergency medical transportation and prescription delivery.

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How To Get Results With Sales Activity Management In 2023

Spotio

At the end of every month, sales managers may be asking themselves a single question: Why is my sales team falling short of their selling quota? Sales metrics might answer that question, but too often, sales managers look at metrics that are outside of their control. A Harvard Business Review study found that of 306 metrics sales managers track, only 17% are sales activities.

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Invizius’ ‘angry blood’ research recruits 300th patient

PharmaTimes

525-patient trial intends to assess ‘complement activation’ during HD in patients with end stage renal failure - News - PharmaTimes

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Questions That Increase Coaching Effectiveness

Integrity Solutions

Without question, retaining top talent today requires investing in making great managers. They are the key to employee engagement, satisfaction and retention. Manager behavior is a large driver of people leaving — or staying at — companies. According to research in MIT’s Sloan Management Review , toxic work culture is the biggest factor that leads to people quitting.

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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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Asynchronous Care: Advancing Equitable Access to Healthcare

MedCity News

Asynchronous care represents a transformative approach in healthcare, enabling equitable access to quality care while overcoming geographical and technological barriers.

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Bringing Data Science to the Information Center

Copyright Clearance Center

Learn how one information professional is learning to focus on her internal users’ data needs, as told by Mary Ellen Bates.

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Discover If Your Medical Sales Reps Feel Safe Opening Up to You

MedReps

Communication is important, especially between medical sales reps and sales team leaders. In order for everyone to be on the same page, as well as deal with successes and setbacks accurately, there needs to be open communication. If your medical sales reps are too afraid to talk to you about their issues with the job, such as problems making a certain sale or the inability to find a certain client’s pain point, then they will more than likely not meet their quotas and start looking to find anoth

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Amid Opioid Crisis, Big Pharma Reaches Settlement with Multiple States

PharmExec

Deal will pay $19 billion to states accusing companies of contributing to the issue.

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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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US FDA approves Neobiosis’ IND for post-Covid syndrome therapy

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has approved Neobiosis’ investigational new drug (IND) application for ViXome to treat post-Covid-19 syndrome (also known as long Covid). ViXome is an acellular product derived from amniotic fluid. It comprises a heterogeneous population of growth factors, exosomes, cytokines, microRNAs and chemokines. In pre-clinical testing, the therapy showed potent immunomodulatory and pro-reparative effects.

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FDA Panel Unanimously Approves Alzheimer’s Treatment Leqembi

PharmExec

Decision based on data collected from patients in the early stages of the disease.

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Questions That Increase Employee Coaching Effectiveness

Integrity Solutions

Without question, retaining top talent today requires investing in the development of great managers. They are the key to employee engagement, satisfaction and retention. After all, employee engagement is rooted in emotional factors, and managers, their coaching effectiveness and the coaching culture they create can make or break those emotional ties.

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Accelerating Clinical Trials and Reducing Human Error through Innovative Data Solutions (June 2023)

PharmaTech

This is the final segment of this three-part PPD Tech Talk series on Improving Clinical Trials with Innovative Data Solutions featuring experts John Maier and Renay Perry of PPD®, part of Thermo Fisher Scientific.

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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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How To Sell Effectively In Diagnostic Testing Sales With Kelly Buber

Evolve Your Success

Being a successful representative in the medical sales space requires a combination of factors. You have to have grit and determination, the willingness to put in the hours and work hard. You have to be familiar with the ins and outs of your product because the education piece is also a key aspect of being a sales rep. These and a lot of other things are what Kelly Buber learned from his 10-year career in medical sales.

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Post-ASCO Excitement Report

InCrowd

Physician Perspectives on the 2023 ASCO Annual Meeting Curious what doctors thought about ASCO? Nearly 100 oncologists and hematologist oncologists shared with us the findings and developments they were most excited about. Check-out our 2023 Post-ASCO report to understand the event’s areas of greatest interest to prescribers in the field. Download the report today!

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A Letter to the COVID Collaborators

Zymewire

Thinking back to the first half of 2020 often causes a mixed wave of emotions to resurface. At the time, society as a whole shared an immense feeling of uncertainty as we tip-toed through uncharted territory. Of course, we’re talking about the onset of the COVID-19 pandemic.

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New Micro-Incentive Program Rewards Physicians for Referring to Higher-Value Specialists

Clarify Health

At-risk program for health plans is fully managed by Clarify Health San Francisco, CA (June 13, 2023) – Clarify Health , a leading healthcare analytics and value-based payments platform company, is pleased to announce its newest program to improve specialist referrals delivered through its Clarify Advance solution. The new and improved micro-targeted incentive program rewards primary care physicians for referring patients to the highest quality, most affordable specialists in their geography.

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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.