December, 2023

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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 363
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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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8 Tactics to Increase HCP Engagement in 2024

PM360

A significant battle for the hearts and minds of healthcare professionals (HCPs) will play out in social media during 2024. A series of studies and surveys have documented the fact that substantial numbers of physicians, nurses, and allied health professionals are active on or prefer social media for professional purposes and to connect directly with peers.

Media 122
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A Look Back: The Life Sciences Industry in 2023 and a View for 2024

PharmExec

In the coming year, efficiency and automation will take center stage to maximize constrained resources but balancing sensible financial management with strategic investments will be vital.

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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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BioNTech wins round in CureVac mRNA patent dispute

pharmaphorum

Shares in CureVac have plummeted after a German court ruled that a patent it holds on mRNA-based COVID-19 vaccines was invalid. The validity of the patent is at the heart of patent litigation between CureVac and fellow German biotech BioNTech and its partner Pfizer, claiming infringement by their Comirnaty coronavirus shot.

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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.

Patients 114

More Trending

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A Step Too Far: Congress Must Act on Insurance Company Tactics that Delay Critical Care for Patients

MedCity News

This bipartisan legislation will help create a more transparent process that allows patients and physicians to seek exceptions to step therapy protocol. Although it only applies to employer-sponsored health plans, the bill represents an important step towards reining in this troubling practice.

Insurance 136
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Defining Biotech Success in a Challenging Fundraising Environment

PM360

With 2024 on the horizon, many in the biopharma space are taking stock of 2023 and what the current environment means for their potential success next year. After a promising start to the year on the merger and acquisitions (M&A) front, the third quarter was a disappointment for those hoping that the challenging commercial situation was coming to an end.

Biopharma 111
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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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AbbVie swoops on Pfizer spin-out Cerevel with $8.7bn offer

pharmaphorum

AbbVie has announced its second major takeover deal in the space of a few days, offering $8.7 billion to buy central nervous system drug specialist Cerevel Therapeutics which spun out of Pfizer in 2018.

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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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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.

Safety 113
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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.

Medicine 354
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Gene Therapy and a New Medicine Delivery Approach Signal Progress for Cystic Fibrosis Patients

MedCity News

It’s time to build the infrastructure needed to scale up inhaled gene therapies targeting cystic fibrosis, and to bolster investment that supports several key program components.

Medicine 131
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Audio Prime—Taking Audio Marketing to the Next Level

PM360

I asked two friends of mine who know media and healthcare marketing and are wizzes when it comes to audio for input on this story. Alas, they were busy. Life, right? So, I asked Professor Scott Galloway’s AI for some words I could use in this story. Because if you can’t rely on an AI trained to think like a marketing prof you follow on LinkedIn, then, well, I have no idea how you can call yourself a modern marketer.

Marketing 110
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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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FDA Grants Breakthrough Designation to Johnson & Johnson’s Novel Treatment for HR-NMIBC

PharmExec

TAR-200 has a novel targeted releasing system for the treatment of patients with Bacillus Calmette-Guérin-unresponsive high-risk non-muscle-invasive bladder cancer who are ineligible for bladder removal surgery.

FDA 116
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Roche makes obesity play with $2.7bn deal to buy Carmot

pharmaphorum

Roche has agreed a deal to acquire US biotech Carmot Therapeutics that if consummated will thrust it into the increasingly competitive market for incretin-based therapies for diabetes and obesity. The Swiss pharma group has agreed to pay $2.7 billion upfront in cash when the deal closes, with shareholders in the US company also in line for up to $400 million if the drug programmes covered by the agreement meet various milestones.

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What to watch in the life sciences in 2024

Clarivate

It’s the season of predictions and projections. Here are a few trends in life sciences and healthcare our analysts are keeping an eye on – and what they expect to see in 2024: Move over, oncology – metabolic drugs are the new hotness: The successful launches of Novo Nordisk’s Wegovy® and Eli Lilly’s Mounjaro® represent a revolutionary pharmacological breakthrough of rare proportions.

Pharma 111
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2024 forecast: M&A saw an uptick in 2023. Analysts expect the trend to continue

Fierce Pharma

Even with the Federal Trade Commission keeping a watchful eye on the biopharma industry and the economic landscape giving some players pause, mergers and acquisitions are back on the rise. | Even with the Federal Trade Commission keeping a watchful eye on the biopharma industry and the economic landscape giving some players pause, mergers and acquisitions are back on the rise.

Biopharma 343
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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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How WellSpan Health Is Using Artisight’s Virtual Nursing Tech to Reduce Burnout

MedCity News

WellSpan Health launched a virtual nursing pilot involving Artisight’s smart hospital platform. So far, WellSpan’s nurses “are loving it,” said Erin Langmead, the health system’s interim director of clinical informatics and physician informatics support.

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Seattle Children’s Hospital launches BrainChild Bio for CNS therapies

Pharmaceutical Technology

Seattle Children's launched BrainChild Bio to focus on expediting the development of CAR T-cell therapies in central nervous system tumours.

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Artificial Intelligence Changing the Landscape for Healthcare Social Media Marketing

PharmExec

Experts from Hootsuite noted that the primary social media ROI concern for healthcare companies is the time and money it takes to maintain a multi-platform presence.

Media 119
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4 Biotech Executives Share Strategies Behind Successful Fund Raises

PM360

How can biotech companies successfully raise funds in an environment where investment in the industry is headed for a third straight year of decline? At the close of Q3 2023, the SPDR S&P Biotech ETF (XBI), which tracks small and mid-size biotechs, was down 12% compared to the previous year while the S&P 500, an index tracking the stock performance of 500 of the largest companies in the U.S. listed on the stock exchanges, is up 13%, according to Leerink Partners’ “Navigating the Complex

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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.

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MSD, Moderna cancer vaccine aces melanoma study

pharmaphorum

MSD and Moderna’s individualised cancer vaccine mRNA-4157 has shown impressive efficacy in a phase 2b trial in skin cancer melanoma, leaving the partners speculating about a possible regulatory filing.

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FDA approves bluebird's sickle cell disease gene therapy. Can Lyfgenia overcome CRISPR’s halo?

Fierce Pharma

Alongside a historic approval for the first therapy utilizing the Nobel Prize-winning CRISPR/Cas9 gene-editing technology, the FDA has cleared a rival gene replacement therapy, also for sickle cell | Alongside a historic approval for the first therapy utilizing the Nobel Prize-winning CRISPR/Cas9 gene-editing technology, the FDA has cleared a rival gene replacement therapy, also for sickle cell disease (SCD).

FDA 335
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2023’s Wins and Losses in the Reproductive Health Space, Per 2 Advocates

MedCity News

Representatives from the Guttmacher Institute and NFPRHA shared their wins and losses for reproductive health in 2023. Their wins include states moving to protect contraception and the approval of Opill, while their losses include state enactments of abortion bans and the lack of funding for Title X.

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FDA Priority Review Granted to Keytruda/Padcev Combo for Locally Advanced, Metastatic Urothelial Carcinoma

Pharmaceutical Commerce

In clinical trials, Keytruda plus Padcev lowered the risk of disease progression or death by 55% compared with chemotherapy in adult patients with locally advanced or metastatic urothelial carcinoma.

FDA 110
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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.

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Don’t Get Distracted By AI, Instead Focus on Intellectual Property

PharmExec

Artificial intelligence is making it quicker to get drug candidates to the clinic, but it isn’t addressing the fundamental need to marry the right candidate and the right target to the right disease.

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How Clarivate works towards SDG 12: Responsible consumption and production

Clarivate

At Clarivate we put sustainability at the heart of our business goals. Environment, social and governance issues are at the core of our global culture, serving as guiding principles for every decision we make. Our sustainability report is full of real-life examples of how we help our customers, colleagues and communities, with transparent, data-driven results and real insights on where we need to focus moving forward.

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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 107
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Amgen's request for full approval of Lumakras in lung cancer denied by FDA

Fierce Pharma

Amgen’s request to gain full approval of Lumakras in non-small cell lung cancer has been rejected by the FDA. | Amgen’s request to gain full approval of Lumakras in non-small cell lung cancer has been rejected by the FDA. The California biopharma will now have to conduct an additional confirmatory trial to gain the coveted FDA nod.

FDA 318
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Clinical Supply Strategies for CROs

When a CRO is bidding on a project where clinical supplies will be one of the aspects to manage on behalf of the client via a partner, leveraging the expertise of a chosen clinical supply partner can be a valuable resource in demonstrating the CRO’s understanding of and ability to deliver upon critical drug-supply related aspects of the project, and ability to hit key milestones such as FPI for their client.