Tue.Oct 24, 2023

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Amgen plans to lay off 350 former Horizon employees after $28B buyout

Fierce Pharma

In the biopharma industry, post-merger layoffs are often a question of when and how many. | In the biopharma industry, post-merger layoffs are often a question of when and how many. In the case of Amgen’s $27.8 billion buyout of Horizon, they came quickly. Around 350 former Horizon employees are being told this week that their positions will be eliminated.

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Finding a Collaborative, Data-Driven Future for Pharma

MedCity News

The future of pharmaceutical innovation hinges on enhanced data discovery and collaboration. Through data sharing and collective effort, the pharmaceutical industry can accelerate the development of new therapies.

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Trending Sources

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ESMO: Merck, in flurry of studies, shows Keytruda's power and limitations

Fierce Pharma

At this year’s congress of the European Society for Medical Oncology (ESMO), Merck & Co. unleashed a flurry of studies showing Keytruda’s power across multiple tumor types. | Across four separate studies, Merck’s PD-1 juggernaut Keytruda—in combination with other cancer meds—charted complete and partial wins in cervical cancer, early breast cancer and stomach cancer.

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Why Some Pharmacy Staff at Walgreens Are Staging Walkouts

MedCity News

Walgreens pharmacy staff are staging walkouts from October 30 to November 1. One organizer said it’s because pharmacy staff are being tasked with too many responsibilities, making it difficult for them to safely fill prescriptions.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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AstraZeneca's self-administered nasal flu vaccine gets one step closer to FDA approval

Fierce Pharma

On the market for two decades, AstraZeneca’s nasal spray flu vaccine, FluMist, may become available for self-administration as soon as next year. | On the market for two decades, AstraZeneca’s nasal spray flu vaccine, FluMist, may become available for self-administration as soon as next year. The FDA has accepted AZ’s supplemental biologics license application (sBLA) for self-administered FluMist Qudrivalent.

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How WedMD Is Helping Providers Stay Compliant When Using Web Tracking Tools

MedCity News

WebMD Ignite — the company’s division that offers tech solutions to providers and health plans — teamed up with healthcare privacy platform Freshpaint. Through the partnership, WebMD Ignite is seeking to help its customers — which include organizations such as Providence, Trinity Health, Advocate Aurora, VillageMD and Centene — use web tracking technology to grow their businesses while staying clear of data privacy risks.

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DTX Payer Landscape: Barriers and Solutions

MedCity News

Demand is increasing, yet many payers are still hesitant to cover them – in large part thanks to laws that govern coverage, a lack of clarity regarding coverage approaches, and questions regarding evidence generation for these solutions.

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Novartis delays Pluvicto filing as CEO spots industry 'conundrum' with FDA

Fierce Pharma

Novartis entered a new era after spinning off Sandoz earlier in October. | Novartis entered a new era after spinning off Sandoz earlier in October. As the pure-play innovative medicines company reports strong growth from the business it’s now built on, one product faces a delay.

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Focus on Accessibility to Improve the Patient Experience

MedCity News

Providing accessible healthcare experiences is simply a must, whether to stabilize digital care as a revenue channel or to simply do right by the patients who need it. So, if digital accessibility is a driver of differentiation and patient satisfaction, and it’s mandated by law, why are so many providers failing to deliver in this area?

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With $350M payment to LianBio, Bristol Myers scoops up Asian rights to Camzyos

Fierce Pharma

Under a 2020 collaboration with MyoKardia, LianBio has held Asian rights to the potential blockbuster cardio drug mavacamten. | LianBio originally held the med's Asia commercialization rights under a 2020 collaboration with MyoKardia, which was later bought by Bristol Myers. Now, BMS is ponying up for those rights.

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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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BrainStorm Cuts 30% of Staff to Refocus on ALS Cell Therapy’s New Phase 3 Trial

MedCity News

A month after an FDA advisory committee voted against recommending approval of BrainStorm Cell Therapeutics’ stem cell therapy for ALS, the company is preparing to try again with a new Phase 3 study. To help pay for it, the biotech is restructuring and laying off 30% of its staff.

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ADDF announces speech database to identify biomarkers for Alzheimer’s

Pharmaceutical Technology

SpeechDx will contain recorded voice samples and other data, which will be used to develop algorithms for creating new speech biomarkers.

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Proliferation of Benefits Providers Highlights Greater Need for Integration and Navigation, Survey Finds [Sponsored]

MedCity News

Consultants are spending more time evaluating vendors and parsing options in growing areas such as mental health, inclusive family planning and chronic care, according to “The 2023 Benefit Consultant Sentiment Index” conducted over the summer in partnership with Quantum Health.

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Europe’s pharmaceutical packaging market to value over $35bn by 2028

European Pharmaceutical Review

Europe’s pharmaceutical packaging and labelling market is projected to reach $35.78 billion in 2028, according to a report by Arizton. Having been valued at $27.04 billion in 2022, the pharmaceutical packaging and labelling market in Europe is expected to expand at a compound annual growth rate (CAGR) of 4.78 percent up to 2028. Europe’s position in the global pharmaceutical packaging and labelling market The authors highlighted that Europe led the worldwide market at 27 percent in 2022.

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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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Time Is Running Out to Register for MedCity INVEST Digital Health in Dallas on October 26

MedCity News

The INVEST Digital Health conference in Dallas, a collaboration between MedCity News and the Health Wildcatters accelerator, spotlights a wide range of hot topics in digital health, a startup pitch contest focused on femtech, and networking opportunities with investors and healthcare stakeholders. Register today!

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CCC Hires Ian Palmer as Vice President, Marketing

Copyright Clearance Center

DANVERS, Mass.–(BUSINESS WIRE)–CCC, a pioneer in voluntary collective licensing that advances copyright, accelerates knowledge, and powers innovation, announces Ian Palmer as.

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Employers Need To Ramp Up their Menopause Solutions, Exec Says

MedCity News

Women are in need of more menopause support through their employers, but many are reluctant to talk about it because of the stigma, said Alicia Jackson, CEO and founder of Evernow, during a panel discussion at HLTH.

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Pfizer’s new shot approval adds to a growing vaccine prowess

PharmaVoice

Pfizer brought in a new approval for a five-in-one shot for meningococcal disease, and the company has built a sizable vaccine business over time.

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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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2023 Maddox Prize Winners Announced

Copyright Clearance Center

Since 2012, the John Maddox Prize has recognized individuals who stand up for science and advance public discussions around challenging topics.

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siRNA drug delivery across the blood-brain barrier in Alzheimer’s

European Pharmaceutical Review

Alzheimer’s disease (AD) is a very common neurodegenerative disease in older people, which mainly affects the patient’s cognition, memory and independence. However, it also leads to a decline in the quality of life and the condition can be fatal. According to a report by Alzheimer’s Disease International, the number of dementia patients worldwide is expected to reach 152 million in 2050, of which about 60-70 percent will be AD patients. 1 Drugs that have been approved for marketing regarding AD

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FDA cracks down on off-label drug use messaging

Pharmaceutical Technology

The FDA released a draft guidance giving firms recommendations on provider-directed communication for off-label drug use.

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NIHR awards £1.5m to fund 13 work and health research projects

PharmaTimes

The funding will allow several projects to support the health of working people - News - PharmaTimes

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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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Chefs Panel Discusses AI, Integrity and Open Content in Frankfurt

Copyright Clearance Center

The post Chefs Panel Discusses AI, Integrity and Open Content in Frankfurt appeared first on Copyright Clearance Center.

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Johns Hopkins study shows potential for chemical vaccine against malaria

PharmaTimes

Malaria was responsible for over 600,000 worldwide deaths in 2021 - News - PharmaTimes

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Certa wins FDA orphan drug designation for scleroderma therapy

Pharmaceutical Technology

The candidate recently went through a Phase II trial, with results to be presented in mid-November.

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What Is OEM Sales? With Sean Pitts

Evolve Your Success

OEM Sales is about creating solutions to win customers and making an impact, one deal at a time. In this episode, we have Sean Pitts from GCX corporation to uncover the ins and outs of OEM Sales. Sean breaks down the acronym, demystifying its meaning while sharing his transition from a lab manager to holding the role of Vice President of Global Sales and Marketing.

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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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Pear Therapeutics: a lesson for future DTx developers

Pharmaceutical Technology

Pear Therapeutics was a pioneer in developing DTx for neurological conditions traditionally treated by evidence-based behavioural or psychological management strategies.

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Changing the Paradigm in AI Implementation

PharmExec

How pharma companies can reduce the risk of failure with AI-based innovations.

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Cybersecurity in Healthcare – Protecting Patient Data

Referral MD

According to experts at the American Hospital Association, stolen healthcare information can be sold ten times more often on the dark web than stolen credit card information. Both cyberthieves and nation-state actors seek this information for good reason. Besides protected patient data , healthcare records can also contain the critical financial information of thousands of people and data concerning medical innovation.

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Sponsors urged to compensate oncology patients and meet trial staff face-to-face

Pharmaceutical Technology

Sponsors are being urged to compensate participants in oncological clinical trials, as well as make in-person visits to contract research organisations to keep exploratory studies from slowing down.

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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.