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.
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.
PharmaVoice’s Crystal Ball: What’s next in drug innovation and clinical trials
PharmaVoice
JANUARY 11, 2024
As advanced therapies and patient perspectives strengthen their foothold in R&D, pharma is poised to deliver impactful treatments in record time.
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.
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.
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.
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.
Will new therapeutic agent replace antibodies for bacterial detection?
European Pharmaceutical Review
JANUARY 23, 2024
As a tool for detecting and identifying bacteria, aptamers are a promising new class of synthetic nucleic acid molecules that can be used to detect and treat of pathogenic bacteria. With the ability to be developed against a whole bacterium, a microbial toxin, or some proteins, for some bacteria, “aptamers against pathogens can not only supplement the deficiency of antibodies but can also enrich the aptamer database to develop efficient analytical regents”, according to a paper published in the
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
How Digital Health Fundraising Took On a Different Shape in 2023
MedCity News
JANUARY 10, 2024
In 2023, digital health fundraising took on a bit of a different shape, according to a new Rock Health report. Startups tried out some creative ways to keep their businesses afloat — including series extension rounds, unlabeled fundraises and silent deals from existing investors.
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.
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.
Digital prescriptions added to NHS App
pharmaphorum
JANUARY 30, 2024
From today, a new feature added to the NHS App used in the UK will allow millions of people to submit and view prescriptions, in a bid to save time for patients and doctors. The digital prescription function, which does away with the need for paper scrip, was put through its paces in a pilot trial last year involving a million users of the app, now being used by three-quarters of the UK population or around 33.5 million people.
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.
Collaboration to develop novel AI-designed oncology therapy
European Pharmaceutical Review
JANUARY 5, 2024
Under a new licensing agreement, Stemline Therapeutics, Inc., a wholly-owned subsidiary of the Menarini Group, gains the global rights to develop and commercialise a novel, small molecule KAT6A inhibitor. This treatment has potential for hormone sensitive cancers such as breast cancer, and other oncology indications. The therapeutic is designed using the artificial intelligence (AI)-platform from Insilico Medicine, the biotech company that is also part of this collaboration.
‘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.
Ron Lanton, Partner, Lanton Law PLLC, Discusses New Drug Plus Pricing Models
Pharmaceutical Commerce
JANUARY 29, 2024
In an interview with Pharma Commerce Associate Editor Don Tracy, Ron Lanton, Partner, Lanton Law PLLC, discusses recent moves by CVS and Express Scripts to follow Mark Cuban's drug plus model.
Moderna leads the development of mRNA vaccines in infectious diseases
Pharmaceutical Technology
JANUARY 29, 2024
The rapid sequencing of the SARS-CoV-2 and the subsequent development of mRNA vaccines led to the authorisation of the first of these vaccines in late 2020.
New anti-smoking drug set for rapid NHS rollout
pharmaphorum
JANUARY 17, 2024
Oral cytisine therapy for smoking cessation from Consilient Health will launch in the UK next week, helping to alleviate a shortage of prescription drugs to help people quit
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.
First European ustekinumab biosimilar to Stelara approved
European Pharmaceutical Review
JANUARY 11, 2024
The European Commission (EC) has granted a marketing authorisation for Uzpruvo ® (AVT04) in Europe, a biosimilar candidate to Stelara ® (ustekinumab). Ustekinumab biologic Once the European Supplementary Protection Certificate (SPC) for Stelara expires in July 2024, this will open up market entry as soon as possible for Uzpruvo, now that it is approved in Europe” Ustekinumab is a human IgG1κ monoclonal antibody (mAb).
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
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.
AstraZeneca Vice President, Head of Breast Cancer Franchise, Discusses Impact of Truqap Approval
PharmExec
JANUARY 8, 2024
In an interview with Pharmaceutical Executive associate editor Don Tracy, Ashley Gaines, VP, head of breast cancer franchise, discusses newly approved Truqap.
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.
Verona cuts $400m loan deal as it preps COPD drug for market
pharmaphorum
JANUARY 2, 2024
Verona Pharma has agreed a new $400 million debt facility with Oxford Finance and Hercules Capital designed to help the company navigate the possible approval and launch of ensifentrine, its therapy for chronic obstructive pulmonary disease (COPD). The Anglo-US company has already tapped $50 million of the funding and can take another $100 million if an ongoing review of ensifentrine by the US FDA results in regulatory approval.
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.
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