Sarepta gene therapy for Duchenne misses main goal of key study
Bio Pharma Dive
OCTOBER 30, 2023
Yet Sarepta said it still plans to ask the FDA to expand regulatory clearance of Elevidys, which was granted an accelerated approval by the FDA in June.
Mon.Oct 30, 2023
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‘Grave Consequences’: Scientists Warn of Extreme Bias in Brain Aging Research
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 30, 2023
The risk of Alzheimer’s disease and depression differs significantly between male and female bodies, and yet the vast majority of research on the human brain does not reflect that. Instead, male anatomy is too often considered ‘the norm’ against which all other human brains are measured.
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Abingworth raises $356M to invest in late-stage drug development
Bio Pharma Dive
OCTOBER 30, 2023
The venture firm has supported a number of approved medicines with its co-development strategy, including Pfizer’s Besponsa and Apellis’ Empaveli.
FDA warns of infection risks from over-the-counter eye drops
Pharmaceutical Technology
OCTOBER 30, 2023
The US FDA has issued a warning against the use of 26 over-the-counter eye drop products due to potential eye infection risks.
Why prospective real-world studies hold so much promise for clinical research
Bio Pharma Dive
OCTOBER 30, 2023
PrwS studies can reach beyond the limitations of today’s RWE studies and expand the role of RWD across the entire drug development cycle.
EMA dismisses thyroid cancer link with anti-obesity GLP-1 receptor agonists
Pharmaceutical Technology
OCTOBER 30, 2023
An EMA safety panel concluded that available evidence does not prove that GLP-1 receptor agonists cause thyroid cancer.
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AI skills can increase worker salary as much as 40%, says study
Pharmaceutical Technology
OCTOBER 30, 2023
A new study published by the Oxford Internet Institute has found that AI skills and knowledge can increase a worker’s salary as much as 40%.
A brain-focused biotech raises $225M to develop drugs for schizophrenia, Parkinson’s
Bio Pharma Dive
OCTOBER 30, 2023
MapLight Therapeutics’ Series C round saw participation from existing backers as well as new ones like Novo Holdings, 5AM Ventures and Cowen Healthcare Investments.
India needs biometric cards for pharmacists to implement efficient drug dispensing model: Dr BR Jagashetty
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 30, 2023
India can transform the landscape of drug dispensing across its 800,000 pharmacy outlets in a safe and efficient manner if the Union government brings out biometric cards for registered pharmacists pan-India.
Coherus and Junshi’s PD-1 inhibitor approved for nasopharyngeal carcinoma
Pharmaceutical Technology
OCTOBER 30, 2023
A Loqtorzi/chemotherapy combination has been approved as a first-line therapy in adults with metastatic or recurrent locally advanced NPC.
The New Age of Decentralized Clinical Trials
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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
Novartis bet on kidney disease drug yields positive study data
Bio Pharma Dive
OCTOBER 30, 2023
The pharma paid more than $3 billion this summer to acquire Chinook Therapeutics and a therapy that just met its goal in a Phase 3 trial.
How To Effectively Engage With Indonesian Authorities For Medical Device Approval
Pharma Mirror
OCTOBER 30, 2023
Indonesia, being the fourth most populous country in the world, presents a significant market opportunity for medical device manufacturers. The Indonesia medical device registration process is a necessary pathway for any foreign manufacturer looking to supply their products in this burgeoning market. The growth potential is immense due to the increasing healthcare expenditure and growing awareness about advanced medical technologies among the population.
Will mobile visits help the clinical trials industry meet its diversity goals?
Pharmaceutical Technology
OCTOBER 30, 2023
Lowering barriers to participation could boost the diversity of patients in clinical trials. We analyze gender, race and ethnicity data to understand the differences that mobile visits from a certified mobile research nurse can make.
UPDATED: Pfizer plans to shutter New Jersey site, discloses layoffs amid $3.5B cost-cutting drive
Fierce Pharma
OCTOBER 30, 2023
Editor's note: This story has been updated with a comment from Pfizer. An earlier version of the story stated that nearly 800 jobs would be affected. | After plunging COVID revenues prompted Pfizer to embark on a cost-cutting crusade, more details about the company's savings efforts are coming into focus.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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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
Intas licenses Helnius’s antibody for marketing in Europe and India
Pharmaceutical Technology
OCTOBER 30, 2023
Helinus will receive €42m upfront and will be in line to receive up to €143m in regulatory and sales-based milestone payments.
Understanding primary sclerosing cholangitis symptoms
Antidote
OCTOBER 30, 2023
Primary sclerosing cholangitis (PSC) is an autoimmune disease that mainly targets bile ducts in the liver. PSC is a rare condition, impacting about 1 in 10,000 people worldwide , and it is diagnosed twice as frequently in men as it is in women.
UK allocates £100m for AI-powered new drug development
Pharmaceutical Technology
OCTOBER 30, 2023
The UK government has allocated £100m investment in AI-powered drug development for previously incurable conditions
Advancements in In Silico ADMET Modeling: A 20-Year Journey of Machine Learning in Drug Discovery at Bayer Pharma
Drug Patent Watch
OCTOBER 30, 2023
Over the past two decades, Bayer Pharma has developed an in silico absorption, distribution, metabolism, and excretion (ADMET) platform with the aim of generating models for various pharmacokinetic and physicochemical… The post Advancements in In Silico ADMET Modeling: A 20-Year Journey of Machine Learning in Drug Discovery at Bayer Pharma appeared first on DrugPatentWatch - Make Better Decisions.
The New Age of Decentralized Clinical Trials
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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.
Merck partners with Hengrui in deal worth up to $1.48bn
Pharmaceutical Technology
OCTOBER 30, 2023
Merck has gained worldwide rights outside of China for PARP1 trapping inhibitor HRS-1167 and ADC drug SHR-A1904.
New patent for Astrazeneca drug CALQUENCE
Drug Patent Watch
OCTOBER 30, 2023
Annual Drug Patent Expirations for CALQUENCE Calquence is a drug marketed by Astrazeneca and is included in two NDAs. It is available from one supplier. There are eight patents protecting… The post New patent for Astrazeneca drug CALQUENCE appeared first on DrugPatentWatch - Make Better Decisions.
Rishi Sunak addresses existential AI threats ahead of UK safety summit
Pharmaceutical Technology
OCTOBER 30, 2023
UK Prime Minister Rishi Sunak has vowed to tackle fears surrounding AI in a speech ahead of the world’s first AI safety summit next week.
Sarepta Fails Confirmatory Trial for DMD Therapy, Still Eyes Label Expansion
BioSpace
OCTOBER 30, 2023
Despite failing to hit the primary endpoint in the Phase III EMBARK study, the company plans to file for a label expansion for its Duchenne muscular dystrophy gene therapy Elevidys.
Roles and Responsibilities of Specialized Clinical Supply Experts
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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.
EMA validates BMS’ Opdivo application for bladder cancer
Pharmaceutical Technology
OCTOBER 30, 2023
If approved, the combination with chemotherapy would be the first of its kind to receive European authorisation for 1L urothelial cancer.
Sarepta's Elevidys fails on primary endpoint, but executives see path to wider DMD approval anyway
Fierce Pharma
OCTOBER 30, 2023
After Sarepta overcame several regulatory hurdles to finally win | After Sarepta overcame several regulatory hurdles to finally win FDA approval for its DMD gene therapy Elevidys, the company now faces the prospect of more FDA scrutiny because a pivotal study on the drug has failed on the primary endpoint.
Allyx sets Phase II plans in motion after Phase Ia results for Alzheimer’s drug
Pharmaceutical Technology
OCTOBER 30, 2023
ALX-001 is currently being studied in a Phase Ib safety study and designs for a Phase II ALX-001 proof-of-concept study are underway.
New patent for United Therap drug REMODULIN
Drug Patent Watch
OCTOBER 30, 2023
Annual Drug Patent Expirations for REMODULIN Remodulin is a drug marketed by United Therap and is included in two NDAs. It is available from one supplier. There are ten patents… The post New patent for United Therap drug REMODULIN appeared first on DrugPatentWatch - Make Better Decisions.
How Machine Learning Drives Clinical Trial Efficiency
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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.
Signal: UK Biobank raises £32m in funding via public-private partnership
Pharmaceutical Technology
OCTOBER 30, 2023
Eric Schmidt and Ken Griffin have led the UK Biobank funding round, donating a government-matched $10m each that may be used for AI.
Novartis’ $3.2B Chinook Buy Pays Off with Promising Phase III IgAN Data
BioSpace
OCTOBER 30, 2023
Following the recent Chinook Therapeutics acquisition, the Novartis experimental IgA nephropathy therapeutic atrasentan significantly reduced protein in the urine of patients compared to placebo.
AbbVie posts drop in Q3 2023 attributable net earnings
Pharmaceutical Technology
OCTOBER 30, 2023
AbbVie has posted net earnings attributable to the company of $17.78bn in Q3 2023 versus $39.49bn in the same quarter of 2022.
Amgen Axes Prostate Cancer Drug, Takes $650M Write-Down as Q3 Profit Drops
BioSpace
OCTOBER 30, 2023
In its third-quarter results Tuesday, Amgen announced a $650 million write-down after discontinuing AMG 340, a prostate cancer candidate acquired in the $900 million buy of Tenobio in 2021.
Accelerating Clinical Supply Through Integrated Drug Development
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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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