Sat.Oct 21, 2023 - Fri.Oct 27, 2023

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AZ seeks FDA okay for first self-administered flu vaccine

pharmaphorum

AZ seeks FDA okay for first self-administered flu vaccine Phil.

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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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Patient groups have become a powerhouse in R&D. Here’s a look at their impact.

PharmaVoice

“They have the money,” and they’re using it to influence drug development, according to the executive director of the IQVIA Institute for Human Data Science.

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The Data Tsunami is Here—And it’s Time for “Smart” Views of Clinical Data

MedCity News

The healthcare industry must prioritize the development and implementation of universal tools that can efficiently navigate, interpret, and derive value from the growing wealth of health data.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Rescheduling Cannabis to a Schedule III Controlled Substance: A Regulator’s Perspective

PM360

On August 30, the U.S. Department of Health and Human Services (HHS) made a recommendation to the U.S. Drug Enforcement Administration (DEA) that cannabis be moved from a Schedule I Controlled Substance to a Schedule III Controlled Substance under the federal Controlled Substances Act. While a great deal has been speculated about the potential impact of rescheduling on state licensed cannabis businesses, pharmaceutical companies, health plans, insurance companies, and federal agencies such as th

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Novartis claims ex-staffer jumped to Takeda with 'thousands' of sensitive files

Fierce Pharma

Novartis believes a former employee of its Egyptian affiliate made off with thousands of files before jumping ship to Takeda. | Novartis believes a former employee of its Egyptian affiliate made off with thousands of files before jumping ship to Takeda. Now, the Swiss pharma giant wants a peek at Takeda’s business records to find out whether its confidential information has been used improperly.

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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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3 Ways AI is Already Changing Advertising (and None Are Generative AI)

PM360

Everyone’s buzzing about generative artificial intelligence (AI), and it’s true that technology like ChatGPT is already having an enormous impact on advertising and marketing. But other AI tools that our industry has been using for years have changed the face of media planning and buying. The examples below share how we have been utilizing AI for our pharma clients.

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Sanofi CEO Hudson's new 'Play to Win' pivot sends stock plunging

Fierce Pharma

Sanofi acolytes are none too happy with the latest chapter of CEO Paul Hudson’s "Play to Win" strategy. | Sanofi acolytes are none too happy with the latest chapter of CEO Paul Hudson’s "Play to Win" strategy. After unveiling the pivot alongside third-quarter earnings Friday, Sanofi’s stock plunged nearly 20%, with one analyst group suggesting the plan came “at the wrong time.

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The 2023 Red Jacket honorees

PharmaVoice

This year's inductees to the PharmaVoice 100 "hall of fame" are leaders who have been at the forefront — and will stay at the forefront — of industry change.

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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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Forget Fair-Weather Healthcare: Disruptors of This Industry Are Already in It

MedCity News

Companies built for other businesses are attempting to offroad their skills into a brand new field. These fairweather healthcare players are unprepared for the terrain. Meanwhile, the true disruptors of this industry are already in it.

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Navigating Shared Decision-Making in Healthcare: The Impact of Innovative Branding on Patient and Family Wellness

PM360

When it comes to healthcare decisions, patients are not the only ones calling the shots. Shared decision-making is a process where multiple parties work together to make decisions on testing, treatments, and care plans, among other things. This relationship between the patient and their provider is the backbone of modern healthcare, but we often overlook influential and extremely common stakeholders that medical brands sometimes miss: the patient’s family.

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Eisai, Biogen's injectable Leqembi clears toxic protein in Alzheimer's disease. What about safety?

Fierce Pharma

With concerns growing over the burden Leqembi could impose on healthcare infrastructure, Eisai and Biogen have trotted out data for an under-the-skin version of the Alzheimer’s disease drug that ma | Eisai and Biogen have trotted out data for a subcutaneous version of the Alzheimer’s disease drug Leqembi. The self-injected version showed an encouraging efficacy result but a seemingly increased risk of ARIA, which analysts said shouldn't be too much of a concern.

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DCT Opportunities in Clinical Research

PharmExec

A discussion of the biggest digital trends in clinical research, how COVID-19 impacted digital use for sponsors/CROs, what the future of DCT services looks like, and more.

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How to Stay Competitive in the Evolving State of Martech

Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr

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2.3M People Would Gain Coverage If Remaining 10 States Expanded Medicaid

MedCity News

If the remaining 10 states expanded Medicaid, uninsured rates would greatly drop for women of reproductive age, non-Hispanic Black adults and young adults, a new Urban Institute report found.

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Striking a Balance: The Secret to Scaling-up Your Digital Products and Strategies Effectively

PM360

When launching a new digital product in pharma, one of the biggest challenges is global rollout and scaling. With a lot to be considered—local regulations, language and translations, capability and capacity, on-boarding regional teams—it can be overwhelming to know where to start to ensure your digital strategy is deployed efficiently, without compromising on quality.

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UPDATED ESMO: Seagen, Astellas and Merck knock it out of the park with Padcev-Keytruda combo in bladder cancer

Fierce Pharma

Lennon and McCartney. Simon and Garfunkel. Richards and Jagger. Padcev and Keytruda? Can the cancer-fighting duo rock on in bladder cancer? | The results are in for a phase 3 bladder cancer trial assessing the combination of Seagen and Astellas' Padcev, plus Merck's Keytruda, versus standard of care chemotherapy. The figures indicate that the combo can be transformative in the indication.

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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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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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Beyond the Bedside: Strengthening Patient-Physician Bonds Through Virtual Care

MedCity News

While some people question how virtual care can be effective without physical touch, it is clear that in-person appointments are not frequently delivering on developing a comprehensive understanding of a patient’s need and holistic health.

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Avalere Health CEO Jon Koch Discusses the Organization’s Rebrand

PM360

Last week, Fishawack Health announced it was changing its name to Avalere Health and unifying all of its various companies under that single brand, which includes Hive and Pollen Health, Dudnyk, 2e, closerlook, StoneArch, Skysis, Fire and Rain, PAI, and PRMA Consulting. The notion of operating the company under a more integrated and unified brand was something PM360 first spoke about with CEO Jon Koch when he arrived in that role just over two years ago.

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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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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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Lack of Autonomy Is a Major Reason Clinicians Are Exiting the Field

MedCity News

Patient safety and lack of autonomy are two of the biggest factors driving so many clinicians away from the medical field, according to a new EY report. Clinicians feel like they aren’t able to provide patients with the quality of care they need and deserve due to workforce shortages, resource constraints, and health system policies over which they have no control.

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A Shift in Medical Affairs Amid the Challenge of Data Management and Rise of AI

PM360

The pharmaceutical industry is rapidly evolving its approach to strategic planning and decision-making. At the heart of this transformation is the role of medical affairs, which is undergoing something of a rebrand as it moves from supporting function to strategic partner within the broader pharma organization. According to a report by McKinsey & Company, the medical affairs function is on track to rise in importance, becoming the third strategic pillar alongside the research and development

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After FDA found misconduct at trial site, BioXcel touts result from third-party audit and eyes filing

Fierce Pharma

After misconduct at a key trial site raised questions of | The FDA previously uncovered evidence of forged emails and trial misconduct in the company's phase 3 Alzheimer's disease agitation study. Now, with a third-party audit in hand, BioXcel looks to push forward with the drug.

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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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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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How Tech Changes to Clinical Trials Help Both Patients and Biopharma Firms

MedCity News

Technology is transforming how clinical trials are run. A panel during MedCity News’ INVEST Digital Health conference discussed the tech trends shaping the design and execution of drug studies.

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Strategies for Combination Therapy in Oncology: Part One – Business as Usual

PM360

This is the first in a three-part series examining the commercial dynamics surrounding combination therapy in oncology across the U.S. and Europe. In this article, we discuss the challenges and opportunities within the current landscape and key issues impacting pricing and access for combination therapy. Combination Therapy in Oncology Combination therapies comprising two or more therapeutic agents have become a cornerstone of oncology management and are increasingly a development focus for the

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Eli Lilly enters crowded ulcerative colitis market with delayed FDA approval for Omvoh

Fierce Pharma

Weight loss contender Mounjaro may be getting Eli Lilly a lot of public attention these days, but the Indiana pharma giant is busy expanding in immunology, too. | Weight loss contender Mounjaro may be getting Eli Lilly a lot of public attention these days, but the Indiana pharma giant is busy expanding in immunology, too.

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An ‘inverse vaccine’ takes aim at autoimmune diseases

PharmaVoice

Backed by Pfizer, Anokion’s innovative approach to treating celiac, MS and more is showing early promise where others failed.

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ABM Evolution: How Top Marketers Are Using Account-Based Strategies

In times of economic uncertainty, account-based strategies are essential. According to several business analysts and practitioners, ABM is a necessity for creating more predictable revenue. Research shows that nearly three-quarters of marketers (74%) already have the resources needed to build successful ABM programs.