Bio Pharma Dive
DECEMBER 20, 2023
The Healey center is at the front of ALS research and care, earning acclaim from patients, doctors and scientists. Still, the complexities of the disease and of drug development have brought hard-felt losses.
Pharmaceutical Technology
DECEMBER 20, 2023
The FDA accepted the filing based on NIH-funded Phase III trial interim results, with an approval decision expected in Q1 2024
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AuroBlog - Aurous Healthcare Clinical Trials blog
DECEMBER 20, 2023
In recent years, a growing number of scientific studies have backed an alarming hypothesis: Alzheimer’s disease isn’t just a disease, it’s an infection. While the exact mechanisms of this infection are something researchers are still trying to isolate, numerous studies suggest the deadly spread of Alzheimer’s goes way beyond what we used to think.
Bio Pharma Dive
DECEMBER 20, 2023
The Dutch biotech’s star product has lost some luster after a second failed Phase 3 trial in two months, this time for a skin condition called pemphigus.
AuroBlog - Aurous Healthcare Clinical Trials blog
DECEMBER 20, 2023
The HoD of the Department of Pharmacy Practice at the CL Baid Mehta College of Pharmacy in Chennai, Prof. Guruprasad Mohanta has been bestowed with the prestigious Acharya P C Ray Gold Medal Award 2023 instituted by the Bengal branch of the Indian Pharmaceutical Association (IPA).
Bio Pharma Dive
DECEMBER 20, 2023
The deal with Hansoh Pharma, GSK’s second this year, gives the company an antibody-drug conjugate in testing for solid tumors like lung cancer.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Rethinking Clinical Trials
DECEMBER 20, 2023
Speaker Roxana Mehran, MD, FACC, FAHA, MSCAI, FESC Mount Sinai Endowed Professor of Cardiovascular Clinical Research and Outcomes Professor of Medicine (Cardiology), and Population Health Science and Policy Director, Interventional Cardiovascular Research and Clinical Trials Director, Women’s Heart and Vascular Center at Mount Sinai Heart Icahn School of Medicine at Mount Sinai Slides Keywords Cardiovascular Health, Interventional Cardiovascular Research, Diversity, Health Di
Pharmaceutical Technology
DECEMBER 20, 2023
In Teva Pharmaceutical’s third quarter (Q3) 2023 report, the company reported a significant 7% increase in global revenues, bringing its Q3 sales to $3.9bn.
Fierce Pharma
DECEMBER 20, 2023
Seven months after Krystal Biotech became the first company to gain FDA approval to treat the rare, devastating skin disease epidermolysis bullosa (EB), Chiesi Farmaceutici has followed suit. | Seven months after Krystal Biotech became the first company to gain FDA approval to treat the rare, devastating skin disease epidermolysis bullosa (EB), Chiesi Farmaceutici has followed suit.
Pharmaceutical Technology
DECEMBER 20, 2023
AI is delivering hugely promising results in oncology, from enhancing drug development to improving the detection of early-stage cancers.
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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
BioSpace
DECEMBER 20, 2023
Clene disclosed Thursday the FDA has determined that biomarker Neurofilament Light Chain reduction in its Phase II programs “were insufficient to support accelerated approval at this time.
Pharmaceutical Technology
DECEMBER 20, 2023
Gilead Sciences has signed a licence agreement for Compugen’s pre-clinical antibody programme against IL-18 binding protein for $848m.
BioSpace
DECEMBER 20, 2023
The regulator’s Complete Response Letter on Wednesday said Merck’s data package for gefapixant “did not meet substantial evidence of effectiveness.” The FDA also rejected the drug in 2022 due to a lack of efficacy evidence.
Pharmaceutical Technology
DECEMBER 20, 2023
Andrew Griffiths, a director at Planet Mark, tells a GlobalData COP28 podcast about the need to bring back down the 1.5°C overshoot.
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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
BioSpace
DECEMBER 20, 2023
The oral formulation of budesonide, marketed as Tarpeyo, is the only FDA-approved therapy that significantly reduces the loss of kidney function in immunoglobulin A nephropathy patients.
Pharmaceutical Technology
DECEMBER 20, 2023
Andrew Griffiths, a director at Planet Mark, tells a GlobalData COP28 podcast about the need to bring back down the 1.5°C overshoot.
pharmaphorum
DECEMBER 20, 2023
Shares in CureVac have plummeted after a German court ruled that a patent it holds on mRNA-based COVID-19 vaccines was invalid. The validity of the patent is at the heart of patent litigation between CureVac and fellow German biotech BioNTech and its partner Pfizer, claiming infringement by their Comirnaty coronavirus shot.
Pharmaceutical Technology
DECEMBER 20, 2023
The US FDA has accepted the new BLA for Merck’s investigational 21-valent pneumococcal conjugate vaccine, V116, for priority review.
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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.
BioSpace
DECEMBER 20, 2023
How can startup leaders support long-term sustainable growth and investment? BioSpace’s Lori Ellis speaks with venture capital guests Ansbert Gadicke, Martin Gershon and Mike Goguen for their advice and recommendations on how biopharma startups should approach funding.
Pharmaceutical Technology
DECEMBER 20, 2023
Neurogene has concluded its merger deal with Neoleukin Therapeutics to develop genetic therapies for complex neurological ailments.
BioSpace
DECEMBER 20, 2023
A study finds that employees are more likely to view pay for performance positively—and rise to the challenge of performing well—when they view their managers as friendly and good at their jobs.
Pharmaceutical Technology
DECEMBER 20, 2023
The EC has revoked marketing authorisations for Tecfidera generics, granting the drug marketing protection until February 2025.
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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.
Fierce Pharma
DECEMBER 20, 2023
Two years after securing an accelerated approval for its primary immunoglobulin A nephropathy (IgAN) therapy Tarpeyo (budesonide), Calliditas Therapeutics has
Pharmaceutical Technology
DECEMBER 20, 2023
MYK-224 is under clinical development by Bristol-Myers Squibb and currently in Phase II for Diastolic Heart Failure (HFpEF).
Pharma Times
DECEMBER 20, 2023
The findings could lead to new treatments to target the mTOR and ease PD symptoms - News - PharmaTimes
Pharmaceutical Technology
DECEMBER 20, 2023
GLB-001 is under clinical development by GluBio Therapeutics and currently in Phase I for Relapsed Acute Myeloid Leukemia.
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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.
XTalks
DECEMBER 20, 2023
The market for pain management is both complex and substantial, driven by a growing patient population and evolving medical needs. Chronic pain affects millions of people worldwide, significantly impacting their quality of life and posing a substantial economic burden on healthcare systems. The global market for pain management is substantial, driven by an aging population, increased prevalence of chronic diseases and a rising number of surgical procedures.
Pharmaceutical Technology
DECEMBER 20, 2023
Admilparant is under clinical development by Bristol-Myers Squibb and currently in Phase III for Pulmonary Fibrosis.
BioSpace
DECEMBER 20, 2023
Now designated as a Tech Hub by the White House, Alabama’s nonprofit Southern Research is winnowing its focus and investing in healthcare solutions.
Pharmaceutical Technology
DECEMBER 20, 2023
Bluebird bio will secure up to $250m after a surprise decision from the FDA to hold back a priority review voucher.
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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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