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.
Worldwide Clinical Trials
DECEMBER 20, 2023
In November 2023, at Outsourcing Clinical Trials Dach in Zurich, our Executive Director, Oncology Strategy Lead, Matt Cooper , presented “Delivering Oncology Studies – Challenges and Considerations.” His presentation covered various aspects of oncology clinical programs, focusing on study design trends, with reference to both the recently implemented FDA Project Optimus guidance and studies we have seen from sponsors.
Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.
The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven
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 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.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
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.
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
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
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
NIVI aims to create new or improve vaccines to combat deadly airborne infections - News - PharmaTimes
Pharmaceutical Technology
DECEMBER 20, 2023
PDS-01ADC is under clinical development by PDS Biotechnology and currently in Phase II for Colorectal Cancer.
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
The EC has revoked marketing authorisations for Tecfidera generics, granting the drug marketing protection until February 2025.
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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
XTalks
DECEMBER 20, 2023
As we step into 2024, the life sciences continue to evolve at an unprecedented pace, driven by technological innovation, a deeper understanding of human biology and the application of new technologies in areas like drug development and health wearables. Below are some of the key trends that will be shaping the future of the life sciences in 2024 and beyond.
Pharmaceutical Technology
DECEMBER 20, 2023
The EU’s “Union list of critical medicines” stole many pharma-related headlines this week. Its publication is significant, but the impact has been overblown in some quarters.
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
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.
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
Bluebird bio will secure up to $250m after a surprise decision from the FDA to hold back a priority review voucher.
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
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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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.
pharmaphorum
DECEMBER 20, 2023
GSK has turned to China’s Hansoh for another antibody-drug conjugate (ADC), licensing B7-H3-targeting HS-20093 for $185 million upfront.
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.
Fierce Pharma
DECEMBER 20, 2023
In 2020, Palatin Technologies paid $12 million to regain the rights in North America to its struggling female libido drug Vyleesi. | In 2020, Palatin paid $12 million to regain the rights in North America to its struggling female libido drug Vyleesi. Three years later, the New Jersey company has sold the treatment for the same up-front figure—$12 million—in a deal that indicates the medicine is unlikely to ever make a significant impact in the market.
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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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
pharmaphorum
DECEMBER 20, 2023
FDA OKs test to spot patients at risk of opioid use disorder Phil.
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.
pharmaphorum
DECEMBER 20, 2023
Aclaris will cut 46% of its workforce after stopping development of MK2 inhibitor zunsemetinib (ATI-450) for immuno-inflammatory diseases.
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.
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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.
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