2023

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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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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 grants emergency use listing to SK bioscience’s SKYCovione

Pharmaceutical Technology

The World Health Organisation (WHO) has granted an emergency use listing (EUL) to SK bioscience’s Covid-19 vaccine, SKYCovione. SKYCovione is a self-assembled nanoparticle vaccine and the 12th Covid-19 vaccine to receive a EUL from the regulator. Developed using pharmaceutical company GSK’s pandemic adjuvant, the vaccine targets the receptor-binding domain of the SARS-CoV-2 spike protein.

Safety 145
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Supporting integrity of the scholarly record: Our commitment to curation and selectivity in the Web of Science

Clarivate

We have the important responsibility of providing our customers with trustworthy intelligence to help them transform the world for the better. The need for high-quality data from rigorously selected sources is becoming ever more important as the scholarly record becomes increasingly polluted. A trusted record of research is essential for the global R&D community to effectively use published research outcomes to elevate ideas that will benefit everyday life.

Leads 145
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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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 135
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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.

Sales 362

More Trending

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How ChatGPT will Impact the Healthcare Industry?

Medico Reach

The healthcare sector is one of the fastest-growing industries. It is now adapting to new changes and implementing new technologies like artificial intelligence to enhance the patient experience. A compound annual growth rate (CAGR) of 12.25% is a testament to the healthcare segment’s exponential and steady rise. So, as a business in this domain, you must leverage hi-tech solutions to capitalize on the budding market.

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Actor and epilepsy advocate Greg Grunberg wants the world to ‘talk about it’

PharmaVoice

The actor of “Heroes” and “Star Wars: The Force Awakens” fame is starring in another role as a patient advocate for people with epilepsy.

Patients 138
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Google and DeepMind share work on medical chatbot Med-PaLM

pharmaphorum

Google and DeepMind have developed an artificial intelligence-powered chatbot tool called Med-PaLM designed to generate “safe and helpful answers” to questions posed by healthcare professionals and patients. The tool is an example of a large language model or LLM, which are designed to understand queries and generate text responses in plain language, drawing from large and complex datasets – in this case, medical research.

Medical 137
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The Transformative Potential of AI and Machine Learning in Biomedical Research and Healthcare

PharmExec

Oxford Academic report explores the positive improvements these technological capabilities could bring to the industry.

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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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FDA Eyes New Strategies to Spur Gene Therapy Development

PharmaTech

An increase in applications for gene therapies is putting stress on FDA’s resources.

FDA 141
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Samay’s AI-assisted wearable technology accurately diagnoses COPD

PharmaTimes

The device successfully diagnosed COPD in patients with 90% accuracy - News - PharmaTimes

Patients 127
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BioNTech’s RNA vaccine sparks potential in pancreatic cancer

Pharmaceutical Technology

Results published in Nature for a personalised pancreatic cancer vaccine that uses neoantigens from patients’ tumours have lent further support to early positive signals. The vaccine, developed by BioNTech, led to half of the patients with pancreatic cancer in the Phase I trial remaining cancer-free 18 months later. In the study, 16 patients were treated with a vaccine called autogene cevumeran that contained a maximum of 20 neoantigens, alongside Roche’s anti-PD-L1 immunotherapy Tecentriq (atez

Patients 138
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Highly Cited Researchers 2023: The evolution of our evaluation and selection policy to support a robust scholarly landscape

Clarivate

Every year, the unveiling of the Highly Cited Researchers list sparks anticipation within the global research community as both researchers and their affiliated institutions or organizations scrutinize the list. Today, we present our 2023 list , recognizing 6,849 individuals from more than 1,300 institutions across 67 countries and regions. These Highly Cited Researchers stand out for their significant and broad influence in various scientific and social science domains, representing a small fra

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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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How Meditech Plans to Integrate Google’s Generative AI Into Its EHR

MedCity News

Over the past year, Meditech has deepened its relationship with Google Cloud by exploring ways to embed Google’s generative AI into its EHR. Some of the use cases the EHR vendor is exploring include an enhanced search and summarization tool that would present clinicians with a longitudinal view of their patient and a tool that would generate predictive summaries of what a patient’s stay might look like at the time of admission.

Patients 143
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Pfizer site in Connecticut in line for layoffs amid $3.5B cost-cutting campaign

Fierce Pharma

With layoffs hitting employees on both sides of the Atlantic, Pfizer’s $3.5 billion cost-cutting spree has kicked it into high gear this month. | The company's Groton, Connecticut, research site is the latest to fall victim to job cuts as part of Pfizer's massive $3.5 billion cost-cutting mission, following layoffs across the U.S. and the U.K.

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New NHS cell and gene therapy centre opens

European Pharmaceutical Review

Today marks the opening the NHS Blood and Transplant (NHSBT)’s new Clinical Biotechnology Centre (CBC) in Bristol. The state-of-the-art facility was part-funded by a £9.43 million Government grant and is designed to expand the UK’s ability to manufacture new gene and cell therapies. The CBC will help the UK grow its cell and gene therapy industry in a rapidly growing international market.” “The CBC will help the UK grow its cell and gene therapy industry in a rapidly growing international

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FDA Approves MDMA for Clinical Trial Use Investigating Schizophrenia

Pharmacy Times

The study will assess the use of the drug to treat impaired social motivation, or asociality, which is a difficult-to-treat symptom of schizophrenia that can cause significant functional impairment.

FDA 72
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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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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.

Patients 128
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FDA pulls AZ’s Evusheld for COVID, citing lack of efficacy

pharmaphorum

AstraZeneca’s revenue boost from COVID-19 therapy Evusheld looks set to be curbed early, as the FDA withdraws authorisation for the antibody on the grounds that it is ineffective against most subvariants now circulating in the US. Evusheld (tixagevimab and cilgavimab) was cleared by the FDA towards the end of 2021, becoming the first antibody to be authorised for prevention of COVID-19 infection, and it rapidly found use among people with compromised immune systems, such as cancer chemothe

FDA 135
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Moderna loses a COVID vaccine patent in Europe amid heated clash with BioNTech, Pfizer

Fierce Pharma

With litigation spanning many countries, the COVID-19 vaccine giants remain engaged in a heated patent war. | Moderna pledged to appeal after the European Patent Office ruled one of its patents invalid in the intellectual property battle that spans multiple countries.

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FDA investigates 'serious risk' of secondary cancer following CAR-T treatment

Fierce Pharma

In a blow to CAR-T therapies, the FDA is investigating a “serious risk” of patients developing new cancers after treatment with these highly efficacious oncology drugs. | In a blow to CAR-T therapies, the FDA is investigating a “serious risk” of patients developing new cancers after treatment with these highly efficacious oncology drugs.

FDA 363
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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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 360
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With COVID sales in free-fall, Pfizer slashes revenue forecast by $9B and preps for major cost cuts

Fierce Pharma

As the coronavirus outbreak has shifted to the endemic phase, drugmakers have warned of a drop in demand for COVID-19 products, with the impact coming into focus during the fall vaccination season. | Pfizer has slashed its 2023 revenue projection by $9 billion because of declining demand for COVID products. The company now expects sales to reach between $58 billion and $61 billion, down from a prior range of $67 billion to $70 billion.

Sales 363
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Novo Nordisk fights back at Lilly with Wegovy combo trial against Zepbound in obesity

Fierce Pharma

In response to an onslaught from Eli Lilly, Novo Nordisk is escalating the obesity market battle with a new head-to-head trial against its archrival. | In response to an onslaught from Eli Lilly, Novo Nordisk is escalating the obesity market battle with a new head-to-head trial against its archrival.

Marketing 361
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Pfizer, Moderna score FDA nods for next round of seasonal COVID-19 vaccines

Fierce Pharma

Out with the old and in with the new: Monday, the U.S. | The FDA has approved Pfizer and Moderna’s separate vaccine formulations that target current variants of the disease. Each company’s shot is approved for people ages 12 and up and emergency authorized for patients 6 months old to 11 years old.

FDA 363
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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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UPDATED: Pfizer plans to shutter New Jersey site, discloses layoffs amid $3.5B cost-cutting drive

Fierce Pharma

Editor's note: This story has been updated with a comment from Pfizer. An earlier version of the story stated that nearly 800 jobs would be affected. | After plunging COVID revenues prompted Pfizer to embark on a cost-cutting crusade, more details about the company's savings efforts are coming into focus.

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Pfizer's cost-cutting campaign hits Sandwich site in UK, where 500 workers will lose jobs

Fierce Pharma

Earlier this month, Pfizer’s $3.5 billion cost-cutting campaign crossed overseas to Ireland. Now, just a week later, Pfizer is announcing hundreds more job cuts in the U.K. | Pfizer plans to cut approximately 500 roles and ax its Pharmaceutical Sciences Small Molecule capabilities at its site in Sandwich in Kent in the U.K. The move is a consequence of Pfizer’s enterprisewide cost realignment program, which the drugmaker unveiled in mid-October.

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Bernie Sanders proposes price caps on drugs developed with federal funds

Fierce Pharma

After becoming chairman of the powerful Senate Health, Education, Labor and Pensions Committee earlier this year, Sen. | After becoming chairman of the powerful Senate Health, Education, Labor and Pensions Committee earlier this year, Sen. Bernie Sanders, I-Vermont—a longtime opponent of Big Pharma—has become even more ubiquitous in his efforts to reduce drug prices.

Education 363
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Pfizer cuts 200 jobs at COVID drug, vaccine plant in Michigan amid $3.5B savings campaign

Fierce Pharma

Pfizer’s plunging COVID-19 product demand has spurred a companywide cost-cutting campaign, with nearly 200 jobs now on the chopping block in Michigan. | Pfizer is cutting roughly 200 positions at its Kalamazoo site following a review of demand for its COVID-19 vaccine and antiviral Comirnaty and Paxlovid.

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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.