Sat.Dec 09, 2023 - Fri.Dec 15, 2023

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3 Innovative Ways to Empower Patients with Interactive and Educational Ads

PM360

Empowering patients with comprehensive information about their health and medical conditions is a critical step towards fostering their active involvement in healthcare decisions. By equipping them with knowledge, patients can make more informed choices and collaborate effectively with healthcare providers (HCPs), ultimately enhancing the quality of care they receive.

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Done deal: Pfizer completes $43B acquisition of Seagen, doubling its oncology pipeline

Fierce Pharma

Pfizer’s $43 billion acquisition of Seagen is in the books, the company said on Thursda | It’s a done deal. Pfizer’s $43 billion acquisition of Seagen is in the books, as it becomes the largest M&A transaction in the biopharma industry since AbbVie snatched up Allergan for $63 billion in 2019. The buyout of the antibody-drug conjugate specialist has doubled Pfizer’s pipeline to 60 programs.

Biopharma 360
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Who Really Benefits From Medicare Advantage Plans?

MedCity News

Health systems have been increasingly dropping MA contracts, saying that they cause their organizations to lose too much money and result in dangerous patient care delays. To mitigate this issue, experts think large MA plans need to delegate more utilization management duties to health systems rather than handling it themselves.

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Finding that Spark

PharmExec

Lisa Conte, founder, president, and CEO of Jaguar Health, discusses how a climb up Mount Kilimanjaro would vault her to her true career calling—and spark a decades-long quest to accelerate breakthroughs in plant-based pharmaceuticals and supportive care.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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ASH 2023: microbiome-based therapy shows potential in graft-versus-host disease

European Pharmaceutical Review

Results from MaaT Pharma’s Early Access Program (EAP) for its microbiome-based therapy MaaT013, have demonstrated positive overall response and overall survival rates in European patients with graft-versus-host disease (GvHD). The findings were presented at the 2023 American Society of Hematology (ASH) Annual Meeting. MaaT013 is an off-the-shelf, pooled-donor, enema Microbiome Ecosystem Therapy TM.

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Pfizer warns of further sales decline for COVID products, plots $500M in additional cost cuts

Fierce Pharma

Using Tuesday to announce good news—that its $43 billion acquisition of Seagen would be | Using Tuesday to announce good news—that its $43 billion acquisition of Seagen would be finalized on Thursday—Pfizer sandwiched its bad news, which came on Wednesday with its 2024 guidance. The company expects revenue to reach between $58.5 billion and $61.5 billion next year, coming up short of the analyst consensus of $63.2 billion, largely because of the plummeting demand for its COVID-19 products.

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The Weight Loss Medication Dilemma: A Physician’s Perspective

PM360

Survey any physician if they’ve been asked by a patient about a prescription weight loss medication and you’ll hear a resounding “yes.” The recent Sermo Barometer confirms that 89% of 300+ global practitioners have seen an increase in patients proactively requesting prescription weight loss medications. 1 I predict this number will only steadily increase.

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Understanding the evidence used in drug product withdrawals

European Pharmaceutical Review

In the ever-evolving landscape of regulatory decisions, the quest for safeguarding public health remains paramount. Decisions to remove medicines from market are not taken lightly and are often based upon all evidence available to inform a benefit/risk balance. This evidence can come from a range of sources, such as randomised controlled trials (RCTs), observational studies, and spontaneous reporting.

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Europe names hundreds of critical medicines in quest to counter drug shortages

Fierce Pharma

Over the past several years, drug shortages have vexed doctors and patients on both sides of the Atlantic, prompting lawmakers and government agencies to take action in both Europe and the U.S. | Tuesday, the European Medicines Agency laid out a list of more than 300 critical generic drugs that could fall prey to future shortages. Inclusion in the list doesn’t mean a particular drug is likely to experience a shortage anytime soon, the EMA said.

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‘I’ll Ask My Wife About This’: The Silly Things Women’s Health Entrepreneurs Hear From Male VCs

MedCity News

There are a lack of women at venture capital firms. This makes it difficult for women’s health startups focused on stigmatized conditions to get funding when pitching to those who don’t always have a good understanding, startups say.

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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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Patient Centric Diabetes Care

PharmExec

A discussion of the current standard for diabetes care and how the importance of patient centricity, including addressing patient's mental health, are imperative to the future of the space.

Patients 105
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NK cell immunotherapy: what’s next in clinical development?

European Pharmaceutical Review

Yannis Morel, Executive Vice President of product portfolio strategy and business development of Innate Pharma SA, offers insight on engineering antibodies to develop antibody-based NK cell therapeutics. He discusses why NK cell therapy’s ability to generate ‘synthetic immunity’ in the body means this modality holds potential as an anti-cancer treatment.

Pharma 108
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Arcutis' Zoryve bags 2nd FDA nod, this time as a foam to treat 'the great neglected disease in dermatology'

Fierce Pharma

About a year after Arcutis Biotherapeutics unveiled positive data on roflumilast foam at the European Academy of Dermatology and Venereology congress 2022, the company has clinched a second FDA OK. | About a year after Arcutis Biotherapeutics unveiled positive data on roflumilast foam at the European Academy of Dermatology and Venereology congress 2022, the company has clinched a second FDA OK.

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Report: Less than Half of Employers Are Confident In Integrity of Hospitals, PBMs

MedCity News

About eight in 10 employers think drug costs, high-cost claims and hospital prices are a “significant threat to affordability,” according to a new survey from National Alliance of Healthcare Purchaser Coalitions.

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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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Remote Reliance: The Rise of Oncology Home Care

PharmExec

While hurdles remain, home healthcare could deliver better patient-centered cancer care—providing improved outcomes, enhanced quality of life, and reduced strain on resources.

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Quality and sustainability: The balancing act for pharma manufacturing  

Pharmaceutical Technology

Trends in sustainability and quality assurance were key themes discussed at the recent CPHI Europe 2023 meeting, although the data reveals a lack of implementation of sustainable solutions.

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Pfizer reveals reorganization, executive departure as it gets ready to close $43B Seagen buyout

Fierce Pharma

To complete its acquisition of Seagen, what did Pfizer need to do to satisfy antitrust concerns of the Federal Trade Commission? | By agreeing to donate royalties on its U.S. sales of bladder cancer drug Bavencio, Pfizer has received the go-ahead to finalize its $43 billion buyout of Seagen, the company said on Tuesday. Pfizer expects to close the merger on Thursday.

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Google Unveils Suite of Healthcare-Specific Generative AI Models

MedCity News

Google introduced a new suite of healthcare-focused generative AI models designed to speed up workflows for clinicians and medical researchers. Health systems and medical research organizations, including HCA Healthcare and BenchSci, have been testing these models since April.

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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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Merck and Moderna to Launch Trial of mRNA-4157 Plus Keytruda in Non-Small Cell Lung Cancer

PharmExec

Phase III trial to investigate novel individualized neoantigen therapy V940 (mRNA-4157) in combination with Keytruda (pembrolizumab) as an adjuvant treatment for patients with completely resected Stage II, IIIA, or IIIB non-small cell lung cancer.

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Europe publishes first list of critical medicines

European Pharmaceutical Review

The European Commission, the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have published the first Union list of critical medicines. The list contains more than 200 active substances that are considered “critical for healthcare systems” across the EU/EEA. Continuity of supply is seen as a priority for these substances and shortages should be avoided.

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With new FDA approval, Merck's Welireg takes another step toward blockbuster goal

Fierce Pharma

Since Merck secured approval for kidney cancer pill and blockbuster hopeful Welireg (belzutifan) in August of 2021, sales have grown slowly but surely. | Since Merck secured approval for kidney cancer pill and blockbuster hopeful Welireg (belzutifan) in August of 2021, sales have grown slowly but surely. With a second FDA nod for a much larger patient population, the company can anticipate a more pronounced upswing in revenue from the hypoxia-inducible factor-2 alpha (HIF-2a) inhibitor.

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Sanofi Abandons Deal for Rare Disease Drug Amid FTC’s Monopoly Concerns

MedCity News

Sanofi, which markets the two primary treatments for Pompe disease, was trying to add a third one by licensing rights to a Maze Therapeutics drug candidate with a different therapeutic approach. A Federal Trade Commission complaint alleges the deal amounts to a monopoly player taking out its competition.

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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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Clearing Away the Clutter: Implementing Value-Based Contracting in Pharma

PharmExec

Experts gauge whether the needle is finally moving on the effective structuring of outcomes centered payment agreements—from operational, technology, and acceptance standpoints.

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Positive results for mRNA vaccine in melanoma patients

European Pharmaceutical Review

Moderna and MSD have announced follow-up data from the Phase IIb clinical trial evaluating cancer vaccine mRNA-4157 (V940) in combination with MSD’s Keytruda in patients with resected high-risk melanoma. The randomised study, KEYNOTE-942, evaluated the treatment in patients with high-risk stage III/IV melanoma. Analysis shows that after three years, treatment with mRNA-4157 (V940) in combination with checkpoint inhibitor Keytruda reduced the risk of recurrence or death by 49 percent compared w

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As FDA puts CAR-T safety under microscope, researchers dig into adverse events record of BCMA therapies

Fierce Pharma

BCMA-targeted therapies are transforming care for multiple myeloma patients. But these immunotherapies also come with various potentially dangerous side effects. | A new study examined side effect reports of BMCA immunotherapies from the FDA Adverse Event Reporting System, hoping to help inform doctors in their treatment decisions.

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Fruit Street Health Sues Sharecare for $25M

MedCity News

Fruit Street Health’s complaint alleged that Sharecare violated the terms of their shared business agreement by rolling out its own version of Fruit Street’s diabetes prevention program, which had been previously offered to Sharecare members. Sharecare said that the lawsuit is baseless.

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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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Study Highlights Need for Pharma Industry to Address Stigmatization of Acne

PharmExec

JAMA Network study evaluates current attitudes toward individuals with acne with a call for pharma companies to focus efforts on helping to overcome these stigmas.

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How simulations help device makers meet booming autoinjector demand

Pharmaceutical Technology

Advanced simulation methods and tools are not only paving the way for more efficient manufacturing operations. At SHL Medical, they’re also speeding up the development of new production facilities around the globe.

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Ferring trims US workforce by 134 with layoffs in New Jersey, Minnesota

Fierce Pharma

As waves of layoffs continue to hit the biopharma industry, Ferring Pharmaceuticals is trimming its headcount by 134 across its two U.S. locations. | The drugmaker will lay off 79 at its New Jersey headquarters and 55 at its microbiome subsidiary Rebiotix in Minnesota as a result of a "revised business strategy.

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Navigating the Telehealth Surge: Prioritizing Quality and Continuity of Care

MedCity News

By prioritizing patient care and adapting our business models to meet the demands of our patients, we can ensure that the telehealth industry continues to provide meaningful and lasting benefits to all those who need it.

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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.