Fierce Pharma

DECEMBER 14, 2023

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.

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MedCity News

DECEMBER 13, 2023

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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European Pharmaceutical Review

DECEMBER 11, 2023

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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PharmExec

DECEMBER 18, 2023

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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Management 116

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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

Distribution

PM360

DECEMBER 20, 2023

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.

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pharmaphorum

DECEMBER 7, 2023

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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MedCity News

DECEMBER 22, 2023

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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European Pharmaceutical Review

DECEMBER 14, 2023

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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PharmExec

DECEMBER 5, 2023

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.

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Pharmaceutical Technology

DECEMBER 6, 2023

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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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.

Safety

PM360

DECEMBER 20, 2023

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.

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Fierce Pharma

DECEMBER 12, 2023

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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Medicine Government Doctors Patients 360

MedCity News

DECEMBER 17, 2023

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.

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European Pharmaceutical Review

DECEMBER 12, 2023

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.

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Advertiser: ZoomInfo

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

Competition

PharmExec

DECEMBER 13, 2023

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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Pharmaceutical 115

PharmaVoice

DECEMBER 18, 2023

Advancements in cloud and AI technology will transform clinical trial efficiency and engagement.

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Pharmaceutical 136

Pharmaceutical Technology

DECEMBER 29, 2023

FDA warns that levetiracetam and clobazam can cause DRESS, a rare hypersensitivity reaction which can be life threatening.

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FDA 111

Fierce Pharma

DECEMBER 22, 2023

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.

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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.

FDA

MedCity News

DECEMBER 17, 2023

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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PharmaTimes

DECEMBER 20, 2023

The findings could lead to new treatments to target the mTOR and ease PD symptoms - News - PharmaTimes

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PharmExec

DECEMBER 1, 2023

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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PharmaVoice

DECEMBER 20, 2023

In a shifting market focused on targeted therapeutics, drugs that generate big profits are still a priority.

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Marketing 119

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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.

Specialization

Pharmaceutical Technology

DECEMBER 22, 2023

As the number of patients with cancers continues to grow globally, research into personalised cancer vaccines is vital.

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Patients 111

Fierce Pharma

DECEMBER 8, 2023

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).

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MedCity News

DECEMBER 19, 2023

Despite artificial intelligence’s growing role in drug research, a fully AI-generated molecule has yet to advance from discovery all the way through clinical development. A novel molecule may eventually meet that goal, but some industry observers say it’s too early to focus on winning a race that has many twists and turns yet to come.

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PharmaTimes

DECEMBER 14, 2023

The collaboration aims to develop biomarker-based diagnostics for the condition - News - PharmaTimes

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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.

Management

PharmExec

DECEMBER 6, 2023

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.

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PharmaVoice

DECEMBER 15, 2023

Markups for generics can be as high as 7,000%, the researchers said.

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pharmaphorum

DECEMBER 13, 2023

Pharnext hit again as rare disease drug flunks phase 3 test Phil.

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Fierce Pharma

DECEMBER 27, 2023

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.

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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.

Patients