MHRA agrees licence change for Pfizer-BioNTech’s Comirnaty vaccine
Pharmaceutical Technology
FEBRUARY 12, 2024
The UK MHRA has granted approval for a variation in licence of Pfizer-BioNTech’s Comirnaty XBB.1.5 vaccine targeting Omicron variant.
Mon.Feb 12, 2024
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Gilead to buy CymaBay in $4.3B deal for liver disease drug
Bio Pharma Dive
FEBRUARY 12, 2024
The proposed acquisition is a bet on CymaBay’s drug seladelpar, which is now under FDA review in a chronic liver disease called primary biliary cholangitis.
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Disc wins orphan drug tag for rare blood cancer
Pharmaceutical Technology
FEBRUARY 12, 2024
The humanised monoclonal antibody DISC-3405 is under investigation in a Phase I clinical trial, with data expected this year.
Chart a course for sustainable growth
Bio Pharma Dive
FEBRUARY 12, 2024
Explore how companies are optimizing efficiency, enhancing customer experiences and embracing AI.
ICMR issues comprehensive guidance on ethical requirements for laboratory validation testing
AuroBlog - Aurous Healthcare Clinical Trials blog
FEBRUARY 12, 2024
In a significant move aimed at upholding ethical standards in the realm of medical research, the Indian Council of Medical Research (ICMR) has recently released detailed guidelines on the ethical requirements for laboratory validation testing.
Alys launches with $100M and a pipeline of skin disease drugs
Bio Pharma Dive
FEBRUARY 12, 2024
European venture firm Medicxi built the startup by combining six of its portolio companies, similar to when it merged 10 startups to form Centessa Pharmaceuticals in 2021.
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Innovate UK grants funds for breast cancer therapy project
Pharmaceutical Technology
FEBRUARY 12, 2024
Innovate UK has awarded £1m grant for a collaborative initiative called AI-VISION to aid in adopting treatment decisions for breast cancer.
CSL heart drug misses goal in large study
Bio Pharma Dive
FEBRUARY 12, 2024
The failure of CSL’s plasma-derived infusion, which contains a protein in “good” cholesterol, follows a similar path as pills from Lilly, Merck, Pfizer and Roche.
FDA grants breakthrough status to J&J’s nipocalimab for HDFN
Pharmaceutical Technology
FEBRUARY 12, 2024
The FDA granted breakthrough therapy status for J&J's nipocalimab for pregnant people at risk of haemolytic disease of the foetus and newborn.
2024 predictions: Experts comment on AI, ML and automation
Drug Discovery World
FEBRUARY 12, 2024
DDW’s Megan Thomas spoke to experts from the drug discovery industry about their predictions on what 2024 holds for our sector. This is part of a series of predictions based on different themes. Here, experts weigh in on the impact of artificial intelligence (AI), machine learning (ML) and automation in the sector. Updesh Dosanjh, Practice Leader for Pharmacovigilance Technology Solutions, IQVIA “In 2024, the traditional pain points of the pharmacovigilance (PV) space will not disappear.
The New Age of Decentralized Clinical Trials
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
The opioid crisis: Different delivery systems tackle treatment needs
Pharmaceutical Technology
FEBRUARY 12, 2024
What is the outlook for existing approaches and other pharmaceuticals in managing the opioid crisis?
Women’s health is a priority not a charity
pharmaphorum
FEBRUARY 12, 2024
Investing in women's health research and funding is not a charity, but a priority. Discover the importance of allocating resources and supporting initiatives that promote women's health and well-being.
How AI data management can transform your clinical trial
Pharmaceutical Technology
FEBRUARY 12, 2024
Vast quantities of data are only useful to researchers if that data can be easily understood and simply managed. How can AI help?
Who Won the Super Bowl and More Importantly Why?
Intouch Solutions
FEBRUARY 12, 2024
The Super Bowl is a wonderfully flat playing field for advertisers, with all brands given their $7 million shot to try to capture the truly last mass media event in American culture. Because media spend is relatively equal, it’s an opportunity to see how creativity can be used to make the most of that investment. True, consumer understanding and insight are critical.
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
CSL’s ‘big’ post-heart attack drug fails in Phase III trial
Pharmaceutical Technology
FEBRUARY 12, 2024
CSL’s post-MI drug failed to meet its primary endpoint of reducing the risk of major adverse cardiovascular events.
UK university partnership wins £1.8m for drug discovery research
Drug Discovery World
FEBRUARY 12, 2024
A team from Aston University and the University of Warwick has secured a £1.8 ($2.2) million grant to engineer microbial cell factories to produce membrane proteins which will support future drug screening and sustainable chemical production. The Engineering Biology Mission Award was given by UK Research and Innovation (UKRI). Membrane proteins are crucial molecules on the surface of cells with numerous biological functions, such as sensing hormones or cell communication.
First targeted alpha therapy wins FDA breakthrough device designation
Pharmaceutical Technology
FEBRUARY 12, 2024
RadioMedix and Orano Med’s radioligand therapy AlphaMedix (lead-212-Dotamtate) is currently in a Phase II trial.
Pfizer Airs ‘Here’s to Science’ Commercial at Super Bowl 2024 Celebrating Scientists and 175 Years of Pfizer
XTalks
FEBRUARY 12, 2024
Pfizer was in attendance at Super Bowl 2024 to tell the story of science with its TV commercial ‘Here’s to Science.’ The ad pays homage to notable scientists throughout the times and also celebrates 175 years of Pfizer’s contributions to scientific innovation. Taking viewers back to the scientific principles of Hippocrates to Sir Isaac Newton’s foundational work on gravity, Rosalind Franklin’s key role in the discovery of the structure of DNA to Pfizer scientist Kena Swanson’s work on the world’
The New Age of Decentralized Clinical Trials
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This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.
Alys Pharmaceuticals announces launch with $100m funding
Pharmaceutical Technology
FEBRUARY 12, 2024
Alys Pharmaceuticals has announced its launch with a R&D pipeline, backed by a $100m financing from Medicxi.
In stunning reversal, Takeda snags FDA approval for once-snubbed Eohilia after ‘significant grassroots support’
Fierce Pharma
FEBRUARY 12, 2024
Eohilia, an oral suspension formulation of the corticosteroid budesonide, has surprisingly won over the FDA even after the drug’s developer, Takeda, had at one point abandoned the program following | Takeda's Eohilia has surprisingly won over the FDA even after the company had at one point abandoned the program following an FDA rejection. But the first FDA-approved oral eosinophilic esophagitis therapy comes with a limitation.
Science and menopause under the spotlight during the Super Bowl
Pharmaceutical Technology
FEBRUARY 12, 2024
Super Bowl LVIII saw Astellas run awareness for hot flashes and Pfizer touchdown with the history of science.
First UK patients receive experimental mRNA therapy for cancer in global trial
Pharma Times
FEBRUARY 12, 2024
The phase 1/2 Mobilize trial is evaluating the safety and efficacy of mRNA-4359
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.
Q4 2023 update: renewable energy related M&A activity in the pharmaceutical industry
Pharmaceutical Technology
FEBRUARY 12, 2024
In the global pharmaceutical industry, there were 2 M&A deals announced in Q4 2023, worth a total value of $161.4m, according to GlobalData's Deals Database.
PTC's Emflaza to face generics this month after Aurobindo's final FDA nod
Fierce Pharma
FEBRUARY 12, 2024
After a series of regulatory setbacks in Europe, PTC Therapeutics will soon find itself under a generic attack in the U.S. | After a series of regulatory setbacks in Europe, PTC Therapeutics will soon find itself under a generic attack in the U.S.
Q4 2023 update: energy transition related M&A activity in the pharmaceutical industry
Pharmaceutical Technology
FEBRUARY 12, 2024
In the global pharmaceutical industry, there were 3 M&A deals announced in Q4 2023, worth a total value of $161.4m, according to GlobalData's Deals Database.
Apple devices enrich patent data in arthritis trial
pharmaphorum
FEBRUARY 12, 2024
Study finds that monitoring of rheumatoid arthritis patients with an Apple Watch and iPhone and AI algorithm improves on standard practices.
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.
Q4 2023 update: immuno-oncology related M&A activity in the pharmaceutical industry
Pharmaceutical Technology
FEBRUARY 12, 2024
In the global pharmaceutical industry, there were 14 M&A deals announced in Q4 2023, worth a total value of $1.9bn, according to GlobalData's Deals Database.
Scientists develop micofluidic chip to make cell therapy safer
Pharma Times
FEBRUARY 12, 2024
The chip removes cells, which could become tumours, before they are implanted in a patient
Q4 2023 update: microbiome related M&A activity in the pharmaceutical industry
Pharmaceutical Technology
FEBRUARY 12, 2024
In the global pharmaceutical industry, there were 3 M&A deals announced in Q4 2023, worth a total value of $511.6m, according to GlobalData's Deals Database.
Phesi’s AI-driven Trial Accelerator platform contains over 100 million patients
Pharma Times
FEBRUARY 12, 2024
The platform delivers digitalised patient data to improve clinical trials and development
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.
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