November, 2023

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Patient perspectives: Clinical trials and Diabetes Awareness Month

Antidote

Each November is designated as Diabetes Awareness Month , an event that highlights the importance of spreading awareness about diabetes and the health issues it can cause.

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Paper details Astellas gene therapy study that led to patient deaths

Bio Pharma Dive

The company, which is working with regulators to lift a clinical hold, said the treatment could still help people with X-linked myotubular myopathy.

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IO Biotech enrolls 380 Patients in phase 3 advanced melanoma trial

BioPharma Reporter

IO Biotech, a clinical-stage biopharma company developing therapeutic cancer vaccines, has completed enrollment in its phase 3 trial for IO102-IO103, in combination with KEYTRUDA (pembrolizumab), Merckâs anti-PD-1 therapy, in patients with advanced melanoma.

Trials 102
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Successful clinical trial for re-engineered Covid vaccine 

Drug Discovery World

The University of Queensland’s re-engineered clamp platform has produced a vaccine that is equally safe and virus-neutralising as an approved Covid vaccine considered among the best in its class. The pivotal proof-of-concept testing clears the way to progress the Clamp2 technology in a range of research programmes. Project leader, Associate Professor Keith Chappell, said the preliminary clinical trial results were an ‘exciting reward’ for the team’s continued dedication and the community’s wi

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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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Investigating Industry Involvement in Modern Clinical Trials

Pharmaceutical Commerce

Study aims to find ways industry gets involved in the most influential clinical trials, and how transparent these trials are.

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Exploring the impact of patient flow forecasting on the patient and the HCP

pharmaphorum

Exploring the impact of patient flow forecasting on the patient and the HCP Mike.

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What if a CRISPR cure isn’t such an easy choice?

Bio Pharma Dive

A gene editing therapy developed by Vertex Pharmaceuticals and CRISPR Therapeutics can mute sickle cell disease’s most damaging symptoms. Yet treatment may not be as simple as its dramatic benefit makes it seem.

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Texas AG sues Pfiz­er and Tris Phar­ma for adul­ter­at­ed ADHD drug

Pharmaceutical Technology

Texas AG has sued Pfizer and Tris Pharma for providing adulterated attention-deficit/hyperactivity disorder drug, Quillivant XR, to children.

Drugs 353
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Pfizer site in Connecticut in line for layoffs amid $3.5B cost-cutting campaign

Fierce Pharma

With layoffs hitting employees on both sides of the Atlantic, Pfizer’s $3.5 billion cost-cutting spree has kicked it into high gear this month. | The company's Groton, Connecticut, research site is the latest to fall victim to job cuts as part of Pfizer's massive $3.5 billion cost-cutting mission, following layoffs across the U.S. and the U.K.

Research 145
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Legalized medical cannabis five years on - Releaf discusses how far the industry hasn't come

BioPharma Reporter

It is five years this month since a ground-breaking change in UK healthcare history happened â with doctors being able to prescribe cannabis-based medicines for the first time.

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Roles and Responsibilities of Specialized Clinical Supply Experts

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.

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What to know about colon cancer stages

Antidote

Despite the fact that colorectal cancer cases have been declining in the United States since the mid-1980s, it is still the third most common cancer diagnosed each year excluding skin cancer. Often shortened to colon cancer, colorectal cancer occurs when cells in the colon and/or the rectum begin to grow uncontrollably and eventually spread to other parts of the body.

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BMS Expands Cardio Partnership with Avidity in Potential $2.3B Deal

BioSpace

Building on a previous 2021 collaboration, Bristol Myers Squibb is paying $100 million upfront for the development of five cardiovascular targets utilizing Avidity Biosciences’ antibody oligonucleotide conjugates.

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Pharma benefited from basing business overseas. An international tax effort could spur a rethink.

Bio Pharma Dive

U.S. tax law changes enacted six years ago slashed large pharma companies' rates and saved them billions. Now, a push for an international floor could disrupt their R&D accounting.

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Health Canada approves Jazz’s cannabis derived seizure therapy

Pharmaceutical Technology

Epidiolex has been approved as an adjunct therapy for seizures associated with three rare forms of epilepsy in patients aged two and older.

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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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FDA investigates 'serious risk' of secondary cancer following CAR-T treatment

Fierce Pharma

In a blow to CAR-T therapies, the FDA is investigating a “serious risk” of patients developing new cancers after treatment with these highly efficacious oncology drugs. | In a blow to CAR-T therapies, the FDA is investigating a “serious risk” of patients developing new cancers after treatment with these highly efficacious oncology drugs.

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Samay’s AI-assisted wearable technology accurately diagnoses COPD

Pharma Times

The device successfully diagnosed COPD in patients with 90% accuracy - News - PharmaTimes

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What’s a corneal epithelial defect?

Antidote

The cornea is the outermost layer of the human eye, serving both as a protective covering and allowing light into the retina. To perform this function, the cornea is made up of several layers, the outermost of which is known as the epithelium.

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Vertex, CRISPR Win World’s First Approval for CRISPR-Edited Therapy from UK

BioSpace

The U.K.’s Medicines and Healthcare products Regulatory Agency on Thursday provided conditional marketing authorization for Vertex Pharmaceuticals and CRISPR Therapeutics’ gene-edited therapy exa-cel.

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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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Moderna adjusts to changing outlook for COVID vaccine demand

Bio Pharma Dive

The company recorded a net loss in the third quarter as it “resizes” its manufacturing footprint, and now expects revenue to come in at low end of its previous guidance.

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Eli Lilly supports Alto Neuroscience in $45m Series C round

Pharmaceutical Technology

The funding will go towards the development of the company's four CNS candidates, with Phase II study data readouts expected by early 2025.

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Moderna loses a COVID vaccine patent in Europe amid heated clash with BioNTech, Pfizer

Fierce Pharma

With litigation spanning many countries, the COVID-19 vaccine giants remain engaged in a heated patent war. | Moderna pledged to appeal after the European Patent Office ruled one of its patents invalid in the intellectual property battle that spans multiple countries.

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Are Predetermined Change Control Plans on the road to Global Harmonization?

FDA Law Blog

By Lisa M. Baumhardt, Senior Medical Device Regulation Expert — In October 2021, FDA and MHRA (United Kingdom’s Medicines and Healthcare products Regulatory Agency) jointly developed 10 guiding principles for the development of Good Machine Learning Practice (GMLP) with the goal of promoting “safe, effective, and high-quality medical devices” that are based on Artificial Intelligence/Machine Learning (AI/ML) technologies.

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2022 Research: The Rapid Rise of Ocean Freight Visibility

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.

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A researcher's perspective: Linking scientific discovery to clinical medicine

Antidote

For Carla Greenbaum, M.D., growing up in the era of space travel and the moon landing kindled a lifelong interest in science. That interest influenced her career trajectory, and she’s now a leading investigator at Benaroya Research Institute where she has studied the natural history of type 1 diabetes (T1D) since 2000. Her work focuses on finding the cause of autoimmunity and developing targets for treatment, which she finds “incredibly exciting and inspiring—like landing on the moon!

Medicine 120
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NHS trials artificial intelligence system to prevent avoidable admissions

Pharma Times

The AI system will identify those most at risk and reduce pressure on the NHS - News - PharmaTimes

Trials 149
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Roche’s Genentech partners with Nvidia in AI drug deal

Bio Pharma Dive

The partnership is another investment by the biotech subsidiary in artificial intelligence for drug discovery and development, continuing an industry trend.

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Japan grants approval for CSL and Arcturus’ Covid-19 vaccine 

Pharmaceutical Technology

Japan’s MHLW has approved CSL and Arcturus Therapeutics’ self-amplifying mRNA (sa-mRNA) Covid-19 vaccine, ARCT-154.

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An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space

Speaker: Steve Goldstein, Sales Leader

Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g

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Novo Nordisk fights back at Lilly with Wegovy combo trial against Zepbound in obesity

Fierce Pharma

In response to an onslaught from Eli Lilly, Novo Nordisk is escalating the obesity market battle with a new head-to-head trial against its archrival. | In response to an onslaught from Eli Lilly, Novo Nordisk is escalating the obesity market battle with a new head-to-head trial against its archrival.

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5 Cancer Vaccines to Watch in 2024

BioSpace

BioSpace takes a deep dive into five investigational therapeutic cancer vaccines that have recently shown efficacy in difficult-to-treat indications.

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What is achondroplasia?

Antidote

Achondroplasia, also known as achondroplastic dwarfism or ACH, is a rare disorder characterized by short stature, a large head, and short arms and legs. It is the most common type of skeletal dysplasia, the umbrella term that identifies hundreds of conditions , and occurs in about one in 15,000 to 35,000 births.

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Innoviva and GARDP reveal positive results for antibiotic to treat gonorrhoea

Pharma Times

Zoliflodacin inhibits the vital bacterial enzyme for bacterial function and reproduction - News - PharmaTimes

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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.