Return-to-Office Pushes Can Cause a ‘Riot’
Copyright Clearance Center
JANUARY 23, 2024
A growing number of managers want workers in the office more often, citing the connections, collaborations, and innovations that in-person work can bring.
January, 2024
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Pfizer's layoff campaign ramps back up with dozens of SF-area cuts expected next month
Fierce Pharma
JANUARY 29, 2024
The start of the new year doesn’t seem to have dulled the zeal of Pfizer’s global cost-cutting campaign, which has already left hundreds of jobs in its wake. | Come mid-February, Pfizer will lay off some 52 employees at a facility in South San Francisco, according to a recent Worker Adjustment and Retraining Notification Act alert. The site is the former headquarters of Global Blood Therapeutics.
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Pharma Horizons: Artificial Intelligence
European Pharmaceutical Review
JANUARY 24, 2024
The first in our inaugural Pharma Horizons report series is dedicated to exploring the latest advances in artificial intelligence (AI) and machine learning (ML) for drug development, pharmaceutical manufacturing and quality control. AI/ML is predicted to be the top technology investment for 60 percent of life sciences companies over the next two years, according to a recent survey 1 from the Pistoia Alliance.
We’ve Actually Treated Tens of Thousands of People on Ozempic to Date – Here’s What Really Happens and What It Likely Means for Solving Our Obesity Epidemic
MedCity News
JANUARY 31, 2024
We and our collective organizations’ providers have treated 10,000’s of Americans, who suffer from obesity and/or Type 2 diabetes with GLP-1 drugs. And we believe we have important observations to share.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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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
Merck is on the lookout for more opportunities within immunology
Pharmaceutical Technology
JANUARY 29, 2024
At the JP Morgan Healthcare conference, Merck (MSD) indicated its eagerness to continue to establish its place in the immunological space.
How Quantum Computing Will Impact Pharma in 2024: Q&A With Erik Huestis, Partner at Foley Hoag
PharmExec
JANUARY 8, 2024
Huestis discusses the ways that quantum simulation and quantum systems can be used in areas such as drug discovery and the creation and protection of intellectual property in the life sciences industry.
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Former Pfizer statistician found guilty of insider trading on Paxlovid trial results
Fierce Pharma
JANUARY 19, 2024
A jury has found a former Pfizer statistician guilty of insider trading after a two-week trial in federal court in the Southern District of New York. | A federal jury has found a former Pfizer statistician guilty of insider trading after a two-week trial in Manhattan. The jury convicted Amit Dagar, 44, of Hillsborough, N.J., of using advance information on successful trial results for Pfizer’s COVID-19 treatment Paxlovid to make more than $270,000 in stock trades.
Transforming pharmaceutical manufacturing: The AI revolution
European Pharmaceutical Review
JANUARY 9, 2024
Revolutionising quality control In the backdrop of stringent quality standards and regulatory demands inherent to pharmaceutical manufacturing, the addition of AI technologies introduce a paradigm shift. This article highlights the manifold applications of AI, particularly cutting-edge image recognition and computer vision systems, which profoundly impact quality control.
Ex-Pfizer Employee Convicted for Insider Trades Ahead of Positive Paxlovid Data
MedCity News
JANUARY 19, 2024
The former Pfizer statistician worked on the clinical trial for the Covid-19 drug Paxlovid. A jury found the employee guilty of insider trading for transactions made before clinical data for the antiviral were publicly announced.
Adverse Event Reports Linked to Counterfeit Ozempic on the Rise
Pharmaceutical Commerce
JANUARY 26, 2024
Concerns regarding hypoglycemia potentially linked to a counterfeit version of Ozempic come at a time in which reports have grown regarding the improper use of GLP-1 receptor agonists for the purpose of cosmetic weight loss.
How Machine Learning Drives Clinical Trial Efficiency
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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.
Three ways research offices can lead researchers to more funding
Clarivate
JANUARY 19, 2024
Over half of research office leaders say researchers are disengaged. How can you close the gap to win more funding? In late 2023, Research Professional News, an editorially independent part of Clarivate , surveyed research office leaders and staff as well as researchers around the world, taking a close look at the challenges facing them today and in the future.
Merck, Johnson & Johnson Announce Acquisitions to Bolster Respective Oncology Pipelines
PharmExec
JANUARY 9, 2024
Merck has acquired Harpoon Therapeutics with its clinical stage T-cell engager, whereas Johnson & Johnson acquired Ambrx Biopharma with its expertise in next generation antibody drug conjugates and targeted oncologic therapies.
Millions of doses of Pfizer's Paxlovid will go to waste in UK, EU as COVID demand plummets
Fierce Pharma
JANUARY 2, 2024
On the heels of a major Paxlovid inventory write-off in the United States, many more doses of Pfizer's COVID-fighting antiviral are going to waste overseas. | At the end of November, more than 1.5 million courses of Pfizer’s Paxlovid had expired unused in European countries, analysts at Airfinity said in a new report. The total tally of expired doses in Europe is expected to hit 3.1 million by the end of next month, representing a value of $2.2 billion.
CG Oncology is first biotech IPO of 2024, raising $380m
pharmaphorum
JANUARY 24, 2024
CG Oncology completes the first biotech IPO of 2024, raising $380 million for its oncolytic virus bladder cancer immunotherapy.
How to Stay Competitive in the Evolving State of Martech
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
Making the Most of Real-World Data in Clinical Trials
MedCity News
JANUARY 1, 2024
Biomarkers, electronic health records (EHR), genomic data, imaging data, labs, social media, wearable sensors, and more provide enormous new sources of RWD that can aid in new discoveries for the quality, efficacy, and safety of new drug therapies.
Expert analysis: the latest in HIV research and clinical trials
Pharmaceutical Technology
JANUARY 3, 2024
A new report from Novotech delves into the multifaceted landscape of HIV, focusing on its impact, treatment, and global initiatives.
Tonix closes in on the first new fibromyalgia drug in more than a decade
PharmaVoice
JANUARY 29, 2024
In addition to the chronic disease, the non-opioid drug may have applications in other painful conditions.
More Gen AI, Direct to Patient Models & Digital Health Top What’s On the Horizon in 2024: Q&A With Scott Snyder, Chief Digital Officer at EVERSANA
PharmExec
JANUARY 10, 2024
Snyder discusses potential trends for various technologies, including AI, digital therapeutics, and virtual reality.
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.
FDA wants classwide boxed warning on all commercial CAR-T therapies amid secondary cancer safety probe
Fierce Pharma
JANUARY 22, 2024
As many have feared, the FDA’s investigation into secondary T-cell cancers following treatment with existing CAR-T therapies is poised to lead to a classwide black box warning. | As many have feared, the FDA's investigation into secondary T-cell malignancies following treatment with existing CAR-T therapies is poised to lead to a classwide black box warning.
Women’s health gap estimated at $1trn in new report
pharmaphorum
JANUARY 17, 2024
The disparity in access to healthcare between women and men around the world is often talked about but has never been given a dollar value – until now.
‘Food Equity Can’t Be a Side Gig’: How Food as Medicine is Becoming A Core Team Capability
MedCity News
JANUARY 28, 2024
As the food as medicine movement grows, some payers and healthcare organizations are carving out specific roles and teams dedicated to food and nutrition. Doing so can be beneficial considering the significant impact diet can have on health outcomes.
AbbVie and Umoja to develop new CAR-T therapies for cancer
Pharmaceutical Technology
JANUARY 5, 2024
AbbVie and Umoja Biopharma partnered for the development of in-situ CAR-T cell therapy candidates for oncology targets.
Roles and Responsibilities of Specialized Clinical Supply Experts
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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.
Risk model predicts response and survival of cancer patients treated with ICIs
PharmaTimes
JANUARY 4, 2024
Metastatic cancer is estimated to be responsible for 90% of cancer deaths
Statins Could Potentially Slow Deterioration of Cognitive Function for Those With Alzheimer Disease
Pharmacy Times
JANUARY 4, 2024
Due to the observational nature of the study, the study authors said they cannot determine causal relationships between statins and cognitive decline for patients with Alzheimer disease.
Gilead's Trodelvy fails to extend survival in lung cancer study, prompting selloff
Fierce Pharma
JANUARY 22, 2024
Even as Gilead looks to become an oncology powerhouse in the coming years, the company on Monday recorded a major setback for its antibody-drug conjugate (ADC) Trodelvy. | The antibody-drug conjugate did not significantly improve survival outcomes compared with a chemotherapy alone in previously treated patients with metastatic non-small cell lung cancer.
Novartis calls time on Tim3 drug sabatolimab in MDS
pharmaphorum
JANUARY 31, 2024
Novartis ends development of Tim3 antibody sabatolimab in myelodysplastic syndromes after failed phase 3 trial.
Accelerating Clinical Supply Through Integrated Drug Development
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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.
How Are Healthcare AI Developers Responding to WHO’s New Guidance on LLMs?
MedCity News
JANUARY 29, 2024
This month, the World Health Organization released new guidelines on the ethics and governance of LLMs in healthcare. Reactions from the leaders of healthcare AI companies have been mainly positive. However, one leader pointed out that fear or the risks associated with LLMs shouldn’t hinder innovation, and another noted that the guidance may have failed to mention a major topic.
JPM24: Pfizer CEO promises 'year of execution' after recent struggles, Seagen buyout
Fierce Pharma
JANUARY 9, 2024
Pfizer knows it had a bad year in 2023. Speaking to reporters at the 2024 J.P. | Pfizer knows it had a bad year in 2023. Speaking to reporters at the 2024 J.P. Morgan Healthcare Conference on Monday, the company’s CEO, Albert Bourla, spoke bluntly about the hits the company took, and he acknowledged the underperformance of certain key launches.
JPM24: As cancer players jump head-first into ADC field, Novartis CEO explains how he's resisted the temptation
Fierce Pharma
JANUARY 8, 2024
San Francisco—Nearly all top cancer drugmakers have struck deals in the sizzling antibody-drug conjugate field—but not Novartis. | Nearly all top cancer drugmakers have struck deals in the sizzling antibody-drug conjugate field—but not Novartis. On Monday, the Swiss pharma’s CEO Vas Narasimhan explained how he's resisted the temptation.
JPM24, Day 2: BioNTech warns of COVID vaccine sales decline; Alnylam looks to become 'top-tier' biopharma player
Fierce Pharma
JANUARY 3, 2024
As the J.P. | As the J.P. Morgan Healthcare Conference rolled on in San Francisco, BioNTech, Alnylam and many other companies updated investors on their strategies heading into 2024.
The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric
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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.
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