Sat.Sep 16, 2023 - Fri.Sep 22, 2023

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New RSV vaccines can be powerful tools, but rollout poses test

Bio Pharma Dive

Public health officials, as well as drugmakers, are trying to raise awareness of RSV among older adults at risk, and convince them to get an additional respiratory shot alongside those for COVID and flu.

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ADDF invest in BrainScope for Alzheimer’s prediction biomarker

Pharmaceutical Technology

The neurotech will receive the investment in Series B equity financing round to invest in Alzheimer’s disease research.

Research 324
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Bioanalysis through automation: Our top four takeaways

Worldwide Clinical Trials

Our team has been working diligently to find a way to revitalize how we use automation, and during WRIB this year, we presented a poster on “Revolutionizing Bioanalysis through Automation: Overcoming Challenges and Unlocking Potential.” In case you missed it, we’ve highlighted the top four takeaways: 1. Instrument Integration: At both hardware and software levels, our integration of multiple bioanalytical instruments created a total laboratory automation (TLA) system for ligand bindi

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September 20, 2023: This Friday’s PCT Grand Rounds Explores the Role of Community Health Workers in Early Childhood Well-Child Care

Rethinking Clinical Trials

In this Friday’s PCT Grand Rounds, Tumaini Rucker Coker of the University of Washington and Seattle Children’s Hospital will present “Community Health Workers in Early Childhood Well-Child Care.” The Grand Rounds session will be held on Friday, September 22, 2023, at 1:00 pm eastern. Coker is the chief of general pediatrics and a professor of pediatrics at the University of Washington School of Medicine and Seattle Children’s Hospital.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Startup AIRNA emerges from stealth to bring RNA editing to a rare disease

Bio Pharma Dive

AIRNA is one of several biotechs to debut plans for target alpha-1 antitrypsin deficiency in recent years, with competitors such as AlveoGene, Wave Life Sciences and Arrowhead Pharmaceuticals.

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FDA accepts Takeda’s NDA resubmission for eosinophilic esophagitis therapy

Pharmaceutical Technology

The US FDA has accepted Takeda’s NDA resubmission for TAK-721 for the short-term treatment of eosinophilic esophagitis (EoE), for review.

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Anthos Stops Mid-Stage Atrial Fibrillation Trial Due to ‘Unprecedented’ Efficacy

BioSpace

After evidence of “overwhelming reduction” in bleeding compared to Bayer and J&J’s Xarelto, Anthos Therapeutics has ended its Phase II atrial fibrillation study for abelacimab ahead of schedule.

Trials 127
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PBMs, PhRMA trade blame over drug costs in House hearing

Bio Pharma Dive

Pharmacy benefit manager lobby PCMA and drugmaker lobby PhRMA pointed fingers over problems in the prescription supply chain during the House committee's second hearing on the PBM industry.

Pharmacy 273
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Signal: Illumina leads $15m investment in Broken String Biosciences

Pharmaceutical Technology

Embattled biotech giant Illumina has led series A funding into genomics mapping company Broken String Biosciences.

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9 common misconceptions about clinical trial participation

Antidote

Connecting patients with clinical research opportunities is our mission here at Antidote, but often, we find that misconceptions can serve as barriers to achieving this goal. It’s important to carefully weigh the pros and cons of participating in a clinical trial but to do this effectively, it’s critical to have accurate information.

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Merck and Eisai's Keytruda-Lenvima combo chalks up 2 more losses, this time in non-small cell lung cancer

Fierce Pharma

Merck and Eisai’s Keytruda-Lenvima tag team can’t seem to catch a break. | Merck and Eisai’s Keytruda-Lenvima tag team can’t seem to catch a break. Following a series of trial shortfalls this year in melanoma, colorectal cancer and head and neck squamous cell carcinoma, the duo has missed the mark in yet another set of clinical trials—this time in non-small cell lung cancer.

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Genentech takes up a deal to make ‘molecular glue’ drugs

Bio Pharma Dive

Targeted protein degradation has emerged as one of the more competitive areas of pharmaceutical research in recent years as scientists develop new ways to reach difficult-to-drug targets.

Drugs 263
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Kinnate Biopharma announces 70% layoffs and pipeline restructuring

Pharmaceutical Technology

The company will suspend the development of three assets, considering strategic alternatives for two clinical programmes.

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10 Promising Therapies for Hard-to-Treat Cancers

BioSpace

In honor of World Cancer Research Day, BioSpace takes a deep dive into 10 therapeutic candidates with the potential to change the treatment landscape in lung, breast, colorectal cancer and more.

Research 117
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How Machine Learning Drives Clinical Trial Efficiency

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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Talk of the Towne episode 08: ZERO Prostate Cancer

Antidote

Antidote’s podcast, Talk of the Towne , hosted by Antidote’s Senior Clinical Informatics Manager, Dr. Richard Towne, is an interview series featuring members of Antidote's partner network. During each episode, Rich and his guests take a closer look at particular therapeutic areas, the latest research developments, and specific pain points that impact the patient population.

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Making us more human: Applying artificial intelligence to your clinical resourcing and talent acquisition strategy

Bio Pharma Dive

With the rise of ChatGPT and artificial intelligence (AI), there are many ways the clinical staffing industry can use AI advantageously while removing the stigma that the rise of technology can be dehumanizing.

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Pelican and Primordial Genetics merge to form biotech company Primrose Bio

Pharmaceutical Technology

Pelican Technology has combined business with Primordial Genetics under a deal to create a private biotechnology company Primrose Bio.

Genetics 263
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Pfizer’s Vydura recommended by NICE for acute migraines

Pharma Times

The treatment is the first oral GPCR receptor antagonist class recommended for NHS use - News - PharmaTimes

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

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.

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Inside the FDA's Form 483 findings at Novo Nordisk's North Carolina semaglutide plant

Fierce Pharma

Novo Nordisk’s shares continued to trend downward Tuesday after reports surfaced that the FDA had recently flagged manufacturing shortfalls at the Danish drugmaker’s Clayton, North Carolina product | After inspecting Novo’s Clayton, North Carolina, facility between July 6 and July 13, 2023, the FDA officially chided the company for a pair of quality control lapses, according to a Form 483 seen by Fierce Pharma.

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Orchard nears FDA decision on rare disease gene therapy

Bio Pharma Dive

Three years after gaining European approval, Libmeldy is now under U.S. review with a deadline set for March.

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FDA revises biosimilar guidelines for clearer drug labelling

Pharmaceutical Technology

The FDA released a draft guidance giving advice on the correct labelling of biosimilar and interchangeable biosimilar products.

Drugs 264
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Advancements in Blood-Based Biomarker Tests for NASH — Interview with Dr. Tania Kamphaus and Tony Villiotti – Xtalks Life Science Podcast Ep. 128

XTalks

This episode features an interview with Dr. Tania Kamphaus and Tony Villiotti about new research on the utility and promise of blood-based biomarker tests for the diagnosis of liver diseases like non-alcoholic steatohepatitis (NASH). The research is particularly timely because the American Diabetes Association (ADA) recently called for liver disease screening for all adults with type 2 diabetes.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

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

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Novadiscovery’s trial simulation predicts AstraZeneca phase 3 results

Outsourcing Pharma

The French-U.S. company Novadiscovery has hailed a âwatershed moment for clinical trial designâ as its trial simulation tool successfully predicted the outcome of a phase 3 oncology trial run by AstraZeneca.

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FDA approves GSK’s new bone cancer drug, helping validate a billion-dollar bet

Bio Pharma Dive

The drug, known scientifically as momelotinib, is now cleared to treat myelofibrosis and will compete against rival medicines sold by Incyte and Bristol Myers Squibb.

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JURA Bio and Syena partner to develop TCR-based therapies

Pharmaceutical Technology

JURA Bio has entered into a research collaboration with Replay cell therapy product company Syena for the development of TCR based therapies.

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Maximizing Drug Patents’ Value: Strategies for Biomedical Companies

Drug Patent Watch

The article “Maximizing the Value of Drug Patents Before Losing Exclusivity” discusses strategies for biomedical companies to maximize the value of their drug patents before the exclusivity period expires. In… The post Maximizing Drug Patents’ Value: Strategies for Biomedical Companies appeared first on DrugPatentWatch - Make Better Decisions.

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The New Age of Decentralized Clinical Trials

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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FDA approves Pfizer/BioNTech and Moderna’s adapted COVID-19 vaccines

Pharma Times

The updated vaccines more closely target current circulating variants - News - PharmaTimes

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AstraZeneca and Daiichi’s next cancer medicine scores in breast tumors

Bio Pharma Dive

Results show that the medicine helped patients who progressed on earlier-line treatments live longer than those receiving chemotherapy without their disease getting worse, according to a Friday announcement.

Medicine 164
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How pharma wants to break the efficacy ceiling in IBD

Pharmaceutical Technology

Despite major shifts in the IBD landscape, most approaches that go beyond targeting inflammation remain in the earlier stages of development.

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New UK network launches to boost advanced therapies across the north  

Drug Discovery World

A new cooperative network designed to foster collaboration and boost the sharing of knowledge and expertise for the UK’s advanced therapies sector has been launched. The ‘ Scottish Advanced Therapy Medicinal Products (ATMP) and Vaccines Network ’ specifically targets researchers in the north of the UK and will coordinate events, talks from industry leaders and networking opportunities for the advanced therapies industry.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

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.