Bio Pharma Dive
MAY 20, 2024
Hear from IO Biotech CEO Dr. Mai-Britt Zocca about the potential of therapeutic vaccines to strip the defenses used by cancer cells to keep the immune system at bay.
Pharmaceutical Technology
MAY 20, 2024
Nearly 30,000 people, including children in clinical trials, were infected with hepatitis C and HIV from contaminated blood products in the 1970s and 1980s.
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Pharmaceutical Technology
MAY 16, 2024
Docetaxel albumin bound is under clinical development by CSPC Pharmaceutical Group and currently in Phase II for Hypopharyngeal Cancer.
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 15, 2024
Miniscule fragments of plastic pollution invade the human body every day without our knowing it, not just from eating and drinking but from simply breathing. By some estimates, the average person inhales a credit card’s worth of plastic every week with unknown health effects.
Worldwide Clinical Trials
MAY 14, 2024
By: Amy Raymond, Derek Ansel, Nathan Chadwick, & Juliane Mills When choosing a CRO for a rare disease study, what truly sets them apart is their methodology: the CRO’s mindset, their approach to each unique study, and their agility in navigating the inherent complexities of rare disease research. The team’s ability to apply insights and proven strategies from their experience in rare disease research brings concepts to reality, getting medications to patients faster.
Rethinking Clinical Trials
MAY 16, 2024
According to a report from the NIH Pragmatic Trials Collaboratory Coordinating Center, journal editors and peer reviewers were familiar with pragmatic clinical trials and their designs and analytic approaches, but they often asked for more information about intervention implementation. The report was published this week in the Living Textbook of Pragmatic Clinical Trials.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
MAY 16, 2024
Docetaxel albumin bound is under clinical development by CSPC Pharmaceutical Group and currently in Phase II for Oropharyngeal Cancer.
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 14, 2024
A Subject Expert Committee (SEC), which advices the national drug regulator on approvals and clinical trials related to Covid-19 vaccines, has recommended grant of permission to Serum Institute of India (SII) for Omicron XBB 1.5 variant Covid-19 vaccine with local clinical trial waiver, for restricted use in emergency situation subject to conditions.
BioSpace
MAY 16, 2024
Bolstered by promising response data from its Phase II study, Amgen announced Thursday it got the FDA’s green light for its first-in-class bi-specific T-cell engager Imdelltra for extensive-stage small lung cancer.
Fierce Pharma
MAY 14, 2024
With new four-year data in hand, Novo Nordisk can make a case for its popular obesity med Wegovy to be used as a long-term treatment. | An analysis unveiled at the European Congress on Obesity showed that Wegovy patients lost 10% of their weight, on average, over a 4-year span.
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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
Bio Pharma Dive
MAY 15, 2024
The annual forecast, which comes as Eisai and Biogen have begun submitting a more convenient form of Leqembi for approval, looks “more realistic” than previous guidance, according to Jefferies analysts.
Pharmaceutical Technology
MAY 16, 2024
Docetaxel albumin bound is under clinical development by CSPC Pharmaceutical Group and currently in Phase II for Laryngeal Cancer.
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 15, 2024
The Pharmacy Council of India (PCI) has issued guidelines for the institutions related to the inspection process for the academic year 2024-25, mandating that the students and the faculties should have their smart cards and the infrastructure of the institutions should have mandatory active Quick Response (QR) code at the time of inspection.
BioSpace
MAY 15, 2024
Following back-to-back approvals in lymphocytic leukemia, Bristol Myers Squibb’s CAR-T therapy Breyanzi on Wednesday won the FDA’s green light for relapsed or refractory follicular lymphoma.
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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.
Fierce Pharma
MAY 16, 2024
The momentum the biopharma industry showed in the fourth quarter of 2023 has continued into this year. | The momentum the biopharma industry showed in the fourth quarter of 2023 has continued into this year. With 18 of the industry’s top 25 companies achieving year-over-year revenue gains, Q1 came close to matching the final quarter of last year, when 21 of the top 25 companies showed increases.
Bio Pharma Dive
MAY 16, 2024
While results indicated the drug works as intended, it didn’t have enough of an effect on a protein that’s become integral to many ALS research programs.
Pharmaceutical Technology
MAY 16, 2024
The US National Opioid Settlement is distributing more than $54 billion to communities grappling with the opioid crisis.
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 19, 2024
Different types of brain cells could age at different speeds, and that may help explain the development of Alzheimer’s disease.
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
MAY 16, 2024
Since taking the helm in 2023, Anderson has embarked on a radical departure from the traditional structure of large pharma companies. Will getting rid of management layers fix Bayer?
pharmaphorum
MAY 14, 2024
The Institute for Clinical and Economic Review (ICER) typically focuses on the cost-effectiveness of new therapies, but in an unusual move has sharply criticised the design and conduct of clinical trials of Lykos Therapeutics psychedelic therapy for post-traumatic stress disorder (PTSD).
Bio Pharma Dive
MAY 16, 2024
Full study results disclosed ahead of a medical meeting showed elinzanetant consistently reduced the frequency and severity of hot flashes.
Pharmaceutical Technology
MAY 16, 2024
Chenodiol is under clinical development by Leadiant Biosciences and currently in Phase II for Cerebrotendinous Xanthomatosis.
Advertiser: FourKites
A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.
Fierce Pharma
MAY 17, 2024
Following a controversy over Covis’ preterm birth drug Makena in the U.S. last year, the European Medicines Agency (EMA) is cracking down on hydroxyprogesterone caproate therapies across the pond. | A committee of the European Medicines Agency on Friday called for the withdrawal of preterm birth drugs containing 17-hydroxyprogesterone caproate (17-OHPC), citing safety and efficacy concerns.
BioSpace
MAY 16, 2024
Disappointed with Phase I/II results for two Ionis-partnered programs, one for amyotrophic lateral sclerosis and another for Angelman syndrome, Biogen has opted to not proceed with their development.
pharmaphorum
MAY 16, 2024
Explore innovation, investment, and policies at the US Pharma and Biotech Summit 2024. Join industry leaders, regulators, and investors to discuss trends shaping healthcare.
Bio Pharma Dive
MAY 16, 2024
The biotech, tentatively named Hercules CM Newco, has rights to three incretin drugs discovered by Jiangsu Hengrui Pharmaceuticals, two of which are in clinical testing.
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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
Pharmaceutical Technology
MAY 15, 2024
The US agency rejected the expanded use of Dynavax’s vaccine for adults on haemodialysis, citing insufficient efficacy and safety data.
Fierce Pharma
MAY 14, 2024
When Bayer unveiled a restructuring in January, the company didn’t provide specifics on the number of planned job cuts. | When Bayer unveiled a restructuring in January, the company didn't provide specifics on the number of planned job cuts. Now, the size of the initial round of cuts shows that CEO Bill Anderson means business.
BioSpace
MAY 14, 2024
Applications of the technology range from data collection to drug design to raising the alarm on product safety, but its adoption is also creating some anxiety.
pharmaphorum
MAY 15, 2024
GSK has become the first founding partner of the new Fleming Initiative, which aims to tackle the rising threat of antimicrobial resistance (AMR) and is also backed by the UK government.
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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.
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