Sat.May 18, 2024 - Fri.May 24, 2024

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European Commission, in ‘unprecedented’ move, declines to revoke approval of PTC Duchenne drug

Bio Pharma Dive

Rather than endorse the recommendation of the EMA, the commission called for a new review for Translarna that considers “the totality of the evidence” compiled to date.

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Final report says UK infected blood scandal “should have been avoided”  

Pharmaceutical Technology

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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Alzheimer’s Could Be Caused by Brain Cells That Age Too Fast

AuroBlog - Aurous Healthcare Clinical Trials blog

Different types of brain cells could age at different speeds, and that may help explain the development of Alzheimer’s disease.

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May 20, 2024: BeatPain Utah and AIM-Back Trials Offer Insights Into Telehealth Delivery of Physical Therapy

Rethinking Clinical Trials

Dr. Julie Fritz, principal investigator for BeatPain Utah In a new article, investigators from 2 pragmatic clinical trials of telehealth-delivered physical therapy share insights into the challenges they faced in implementing the study interventions, especially in historically underserved communities. The article was published last month in Frontiers in Pain Research.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Therapies designed to dismantle cancer’s escape mechanisms show promise for patients

Bio Pharma Dive

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.

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Pfizer wins cancer drug patent case against AstraZeneca

Pharmaceutical Technology

The US District Court of Delaware has ordered AstraZeneca to pay $107.5m to Pfizer in damages for infringing patents related to Tagrisso.

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Pfizer unit wins $107.5M verdict in cancer-drug patent case against AstraZeneca

Fierce Pharma

A Delaware federal jury has ordered AstraZeneca to fork over $107.5 million to Pfizer for infringing two of the latter company's patents with its marketing of blockbuster oncology med Tagrisso. | Pfizer's Wyeth subsidiary and licensee Puma Biotechnology sued AstraZeneca in 2021 for alleged patent infringement related to AZ's marketing of cancer blockbuster Tagrisso.

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Dyne shares jump on trial data for muscle disease drugs

Bio Pharma Dive

Updated study results for the biotech’s medicines for myotonic dystrophy Type 1 and Duchenne muscular dystrophy appeared to impress analysts and investors on Wall Street.

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Parenteral Solutions in Contract Manufacturing for the Pharmaceutical Industry 

Pharmaceutical Technology

Discover what industry professionals seek in contract manufacturing for parenteral solutions. Ensure quality, compliance, and innovation with our comprehensive guide. Click to learn more.

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GLP-1 Receptor Agonist Market to Reach $125B by 2033: GlobalData

BioSpace

While Eli Lilly and Novo Nordisk currently dominate the GLP-1 receptor agonist space, there are more than 50 candidates in clinical development for obesity and type 2 diabetes, according to analytics firm GlobalData.

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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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As Stelara nears patent cliff, J&J fortifies Tremfya for upcoming ulcerative colitis showdown

Fierce Pharma

The biologics market for inflammatory bowel disease is continually getting more competitive, and now Johnson & Johnson’s Tremfya is the latest medicine angling to make a mark in the space. | The biologics market for inflammatory bowel disease is continually getting more competitive, and now Johnson & Johnson’s Tremfya is the latest medicine angling to make a mark in the space.

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Forbion-backed biotech Progentos debuts with $65M for MS drug

Bio Pharma Dive

Progentos says the money will go toward expanding its pipeline and pushing an experimental treatment for multiple sclerosis through "proof of concept” testing.

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Rucaparib camsylate by Pharmaand for Adenocarcinoma Of The Gastroesophageal Junction: Likelihood of Approval

Pharmaceutical Technology

Rucaparib camsylate is under clinical development by pharmaand and currently in Phase II for Adenocarcinoma Of The Gastroesophageal Junction.

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Moderna Gets Win in COVID-19 Patent Dispute with Pfizer, BioNTech

BioSpace

The European Patent Office last week upheld one of Moderna’s key patents, handing the biotech an important victory in its protracted COVID-19 vaccine battle with Pfizer and BioNTech.

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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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KCL researchers identify key features of autoimmune diseases present in the gut

Pharma Times

Globally affecting 4% of the population, autoimmune diseases mistakenly attack healthy cells, tissues and organs in the body

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BIO to restructure, lay off staff in shakeup of lobbying group

Bio Pharma Dive

Thirty employees will leave as part of the reorganization, which the group said is meant to bring "stronger focus and greater impact" to its work.

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How to identify and remove CNS assessment errors to avoid jeopardising a trial

Pharmaceutical Technology

Integrating speech analysis for automated quality assurance provides can help identify CNS assessments at risk of quality inconsistencies.

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AstraZeneca to Pay Pfizer $107.5M in Damages in Tagrisso Patent Tussle

BioSpace

Pfizer’s Wyeth unit notched a legal victory over AstraZeneca on Friday as a federal jury found the British-Swedish company violated two key patents in developing and marketing its lung cancer drug Tagrisso.

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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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ATS: Amgen, AZ say data backs Tezspire’s role in COPD

pharmaphorum

Amgen and AstraZeneca have said their severe asthma therapy Tezspire could have a role to play in chronic obstructive pulmonary disease (COPD) – a key target indication for the drug – despite missing its primary objective in a clinical trial.

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The ABCs of SDOH: Meaningful strategies to improve patient outcomes

Bio Pharma Dive

As biopharmaceutical and medical device companies increasingly recognize the impact of SDOH, a question emerges: how can these sponsors effectively integrate SDOH data into clinical trial recruitment and real-world evidence strategies?

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Cold chain storage and distribution for the pharmaceutical industry

Pharmaceutical Technology

Download our comprehensive list of leading cold chain storage and distribution solution providers to make an informed purchasing decision.

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Rapport Therapeutics and Telix Pharma File IPOs as Number of Biotechs Going Public Slows

BioSpace

Neuroscience-focused Rapport Therapeutics and radiopharma developer Telix Pharma announced their respective plans Friday for initial public offerings on the Nasdaq for undisclosed dollar amounts.

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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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Drug Patent Expirations for the Week of May 19, 2024

Drug Patent Watch

ADASUVE (loxapine) Alexza pharms Patent: 9,370,629 Expiration: May 20, 2024 See More … For more information on how DrugPatentWatch can help with your pharmaceutical business intelligence needs, contact admin@DrugPatentWatch.

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Vicore and Endeavor’s therapies show promise in treating IPF

Pharma Times

Both drugs have the potential to offer a disease-modifying approach to the lung disease

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EMA recommends suspension of 17-OHPC medicines in EU

Pharmaceutical Technology

The EMA's PRAC has advised suspension of marketing authorisations for therapeutics containing 17-OHPC in the European Union (EU).

Medicine 130
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Gilead Touts Phase III Results for Liver Disease Drug Ahead of PDUFA Date

BioSpace

Seladelpar, which Gilead acquired when it bought CymaBay in February for $4.3 billion, showed positive results for reducing pruritus in primary biliary cholangitis patients and reducing inflammation.

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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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Sanofi and Regeneron update trial data, strengthening case for Dupixent in COPD

Fierce Pharma

At the American Thoracic Society international conference in San Diego, one of the major themes is the advance of new therapies for chronic obstructive pulmonary disease (COPD). | At the American Thoracic Society international conference, one of the major themes is the advance of new therapies for COPD. On Monday, Sanofi and Regeneron had their answer to Amgen and AstraZeneca's presentation from the day before.

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Drug Patent Expirations for the Week of May 19, 2024

Drug Patent Watch

ADASUVE (loxapine) Alexza pharms Patent: 9,370,629 Expiration: May 20, 2024 See More … For more information on how DrugPatentWatch can help with your pharmaceutical business intelligence needs, contact admin@DrugPatentWatch.

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Pharmaceutical Lyophilization Manufacturers, Companies and Solutions

Pharmaceutical Technology

Discover what to look for in pharmaceutical lyophilization manufacturers and stay ahead with the latest in freeze-drying technology.

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AstraZeneca to Build $1.5B ADC Manufacturing Plant in Singapore

BioSpace

To support its growing antibody-drug conjugate portfolio, AstraZeneca on Monday said it is investing $1.5 billion in a Singapore production site that will include all steps of the ADC manufacturing process.

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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.