Biogen, Ionis shelve ALS drug following study failure
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.
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
Docetaxel albumin bound is under clinical development by CSPC Pharmaceutical Group and currently in Phase II for Hypopharyngeal Cancer.
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Bio Pharma Dive
MAY 13, 2024
Goldman Sachs and Eli Lilly are among those backing the startup, which claims its prospect could be more potent than the myelofibrosis therapies that have come to market in recent years.
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 12, 2024
Running 10 hours a week for more than 120 km (75 miles) is extreme exercise, to be sure. Yet far from pushing the body beyond its limits, a new study suggests some professional athletes are adding years to their lives with such brutal routines.
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 Laryngeal Cancer.
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 14, 2024
The last thing anyone wants is for sex to be a headache. For some people, though, an increase in sexual excitement can be a real pain in the neck. Primary headache associated with sexual activity (PHASA) describes at least two bouts of pain in the head or neck brought on by sexual activity.
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.
BioSpace
MAY 12, 2024
The race is on to develop therapeutic cancer vaccines that could give immunotherapies an edge, and late-stage trials could soon provide more-robust data about candidates’ efficacy and safety.
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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
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 13, 2024
As treatments for multiple sclerosis (MS) continue to improve, scientists are looking for ways to spot the condition before symptoms set in. With nothing more than a drop of blood, medical specialists could soon have years of advance warning that the disease is developing.
pharmaphorum
MAY 13, 2024
Takeda has made a strong play for a stake in the Alzheimer’s disease market, paying $100 million upfront for an option on AC Immune’s amyloid-targeting immunotherapy. The option fee could be followed by another up to $2.1 billion in potential milestones if Takeda takes global rights to the programme, currently headed by ACI-24.060 which is in a phase 1b/2 trial with new data due in the next few weeks.
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.
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.
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.
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.
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.
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.
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 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.
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.
BioSpace
MAY 15, 2024
Belgian biotech Galapagos is teaming with Blood Centers of America to help deploy its decentralized CAR-T therapy manufacturing platform closer to treatment centers across the U.S.
pharmaphorum
MAY 14, 2024
Bayer's first-quarter results update shows its headcount has shrunk by around 1,500 since the start of the year, suggesting promised job cuts are starting to take hold
Bio Pharma Dive
MAY 13, 2024
The deal — worth $100 million up front and potentially billions more later on — gives Takeda an exclusive option to license an Alzheimer’s vaccine and other “active immunotherapies.
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.
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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
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.
BioPharma Reporter
MAY 14, 2024
Anti-obesity jabs could reduce the risk of heart attacks, strokes or heart failure in obese people irrespective of the amount of weight they lose while using the medication, according to a new study.
pharmaphorum
MAY 15, 2024
The FDA has approved Roche's HPV self-sampling solution that the company says can tackle unequal access to screening that can put women at risk of cervical cancer
Bio Pharma Dive
MAY 16, 2024
The results, which showed Lilly’s drug was as effective at controlling blood sugar as standard injections, come as Novo Nordisk seeks approval for a competing once-weekly insulin.
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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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