Drug Patent Watch
JUNE 6, 2024
In a recent study published in the Expert Review of Medical Devices, researchers investigated the utilization of patent term extensions (PTEs) to extend regulatory timeframes for medical devices in the… Source
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 4, 2024
Though one in two people will develop some form of cancer in their lifetime, there’s still much we don’t know about this disease. But thanks to continued research efforts, we keep learning more about the biology of cancer. One of these recent discoveries could even transform our understanding of how cancers develop.
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Bio Pharma Dive
JUNE 4, 2024
A group of independent experts wasn't convinced by clinical trial data from company Lykos Therapeutics, which is seeking FDA approval of MDMA-assisted treatment for post-traumatic stress disorder.
Fierce Pharma
JUNE 5, 2024
The scope of Bristol Myers Squibb’s $1.5 billion savings drive is beginning to come into focus. | Starting this month, BMS will begin the process of laying off around 863 employees in Lawrenceville, New Jersey, according to a Worker Adjustment and Retraining Notification (WARN) alert from the state. The move forms part of BMS’ campaign to shave off $1.5 billion in costs by the end of 2025, a company spokesperson said over email.
Pharmaceutical Technology
JUNE 4, 2024
Monday saw a 9% drop in GlaxoSmithKline’s (GSK) share price on the London Stock Exchange (LSE) following a Delaware judge’s ruling on 31 May that over 72,000 lawsuits over discontinued heartburn drug Zantac, known generically as ranitidine, could go ahead.
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 3, 2024
Researchers at the Indian Institute of Science (IISc) have found that Pranlukast have the potential applications in tuberculosis (TB) therapy. The researchers are of the view that it could enhance the healing process of lung tissues infected with TB.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Rethinking Clinical Trials
JUNE 5, 2024
Dr. Russell Rothman and Dr. Jason Block In this Friday’s PCT Grand Rounds, Russell Rothman of Vanderbilt University Medical Center and Jason Block of Harvard Medical School will present “The NIH COvid-19 and Diabetes Assessment (CODA) Study: Leveraging PCORnet for a Novel Cohort Study.” The Grand Rounds session will be held on Friday, June 7, 2024, at 1:00 pm eastern.
Pharmaceutical Technology
JUNE 4, 2024
A June 2024 literature review has revealed that climate change has the potential to intensify MS symptoms, as well as the incidence, prevalence, and severity of other major neurological disorders.
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 5, 2024
Drugs Controller General of India (DCGI) Dr Rajeev Singh Raghuvanshi has emphasised that the medical devices and in-vitro diagnostics (IVD) sold in the county should be tested for the standards prescribed by the Bureau of Indian Standards (BIS) for its quality and performance in the country.
Bio Pharma Dive
JUNE 7, 2024
A vote against MDMA-assisted therapy set back a high-profile treatment. Proponents argue the panel offered few solutions to longstanding problems, making the path forward unclear.
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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
Fierce Pharma
JUNE 7, 2024
Once hailed as an anti-aging magic bullet, telomerase has failed to live up to the hype as it was profiled in a | The FDA has approved Geron Corporation's Rytelo (imetelstat) to treat a group of bone marrow disorders called myelodysplastic syndrome (MDS). The approval is the first for the 33-year-old California biotech.
Pharmaceutical Technology
JUNE 6, 2024
While the potential for using AI to develop mRNA therapeutics is now a real possibility, accurate and diverse data is needed to make it a reality.
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 6, 2024
India’s is now a key hub for lifesciences Global Capability Centers (GCCs). This according to multinational majors like Amgen, GSK, Eli Lily, Bayer, Mylan, AstraZeneca among others indicated that it underscores India’s importance in R&D and clinical trials.
Bio Pharma Dive
JUNE 5, 2024
How can small and mid-sized biotech companies better manage pharmacovigilance during clinical trials? Listen to the podcast to learn how strategic alliances are helping.
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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.
BioSpace
JUNE 7, 2024
Both Eli Lilly and the partnered companies Boehringer Ingelheim and Zealand Pharma have mid-stage data readouts this week, fueling the race in metabolic dysfunction-associated steatohepatitis.
Pharmaceutical Technology
JUNE 4, 2024
Scientists at the NIH have introduced an AI tool to predict the response to immune checkpoint inhibitors for cancer patients.
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 2, 2024
The bitter peel of an orange is there to protect the fruit, and it could protect our own insides, too, if only we stopped throwing the rinds away. The zest of oranges has now been found to contain a novel, bioactive compound, called feruloylputrescine (FP), that could benefit heart health when eaten.
Bio Pharma Dive
JUNE 2, 2024
Study results showed the antibody-drug conjugate helped stave off disease progression better than a standard treatment. But eye-related side effects remained common.
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.
BioSpace
JUNE 7, 2024
After rejecting a previous takeover offer from Future Pak, Vanda Pharmaceuticals is now fielding another acquisition proposal from Cycle Pharmaceuticals, which values the biotech at $8 per share.
Pharmaceutical Technology
JUNE 4, 2024
Alligator Bioscience’s CEO says that its pancreatic cancer drug may mark a meaningful improvement on current treatment standards.
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 4, 2024
With the effective implementation of its flagship e-governance programme, Gujarat Food and Drug Control Administration (FDCA)’s online WHO-GMP certificate verification is all poised to boost pharma exports, informs Gujarat FDCA commissioner Dr H G Koshia. Good Manufacturing Practice (GMP) is a critical concept in the pharmaceutical industry.
Bio Pharma Dive
JUNE 3, 2024
Shares in the company soared by more than 50% as study data showed the pill led to similar levels of weight loss as a rival drug being developed by Eli Lilly.
BioSpace
JUNE 7, 2024
Approved for patients with low- to intermediate-risk myelodysplastic syndromes, Geron’s Rytelo is the first telomerase inhibitor to hit the market and the company’s first approved drug after 34 years in business.
Pharmaceutical Technology
JUNE 6, 2024
I-Mab has agreed with Bristol Myers Squibb (BMS) to assess the givastomig regimen for advanced gastric and oesophageal cancers.
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 3, 2024
Taking blood pressure medication at a time that aligns with your personal chronotype – the way your body’s circadian rhythm affects when you go to sleep and get up – could help to protect the heart against the risk of heart attack, a new study shows.
Bio Pharma Dive
JUNE 3, 2024
The number of oral cancer medications is increasing, opening new possibilities for improved convenience, but some studies show much lower adherence rates with oral oncolytics.
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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
JUNE 5, 2024
Moderna on Thursday said its investigational mRNA-based therapy for methylmalonic acidemia has been selected for the FDA’s accelerator program for rare diseases, dubbed START.
Pharmaceutical Technology
JUNE 6, 2024
ArriVent BioPharma has entered a partnership with Jiangsu Alphamab Biopharmaceuticals for developing new ADCs to treat cancer.
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 5, 2024
Scientists are learning about the pros and cons of Ozempic in real-time, as prescriptions of the appetite-suppressing drug explode into the millions worldwide.
Bio Pharma Dive
JUNE 3, 2024
Liquid biopsy has emerged as a revolutionary tool for clinical trials, offering cellular and cell-free methods that provide valuable insights into disease progression and treatment response.
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Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.
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