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AstraZeneca heads to regulators after Airsupra asthma trial stops early thanks to 'overwhelming efficacy'

Fierce Pharma

After winning a first-in-class nod for its two-drug inhaler Airsupra l | After winning a first-in-class nod for its two-drug inhaler Airsupra last January, AstraZeneca is bolstering the rescue treatment’s clinical package with new data showing it can cut the risk of asthma exacerbations regardless of patients’ disease severity.

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Single-Arm Trials Using Real-World Evidence for Rare Disease Product Development

Camargo

Often, to gain clinical trial design insights, a sponsor reviews the physician package inserts from approved New Drug Applications (NDAs) and Biologics License Applications (BLAs) with similar indications or in the same therapeutic area. What is the FDA’s current thinking on the use of single-arm trials?

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How the Ukrainian clinical trial industry is overcoming disruption

Pharmaceutical Technology

Clinical trials were thrown into turmoil on the morning of 24 February 2022, along with every aspect of life in Ukraine. In July, approximately a third of companies had paused a trial in the country. By August, 28 foreign-sponsored, multi-country trials were affected, almost half with sites in Ukraine and Russia. [1].

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Clinical Trial Manager Jobs: What You Should Know

XTalks

Clinical trial manager jobs are vital for the development and execution of clinical trials, which are essential for developing new treatments for diseases. In this article, we discuss the job duties, education and experience requirements, outlook and salary expectations for clinical trial managers.

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CMO Moves: Regulatory catalysts for drug manufacturing-December

Pharmaceutical Technology

In this last 2022 edition of the series, which started in June , Pharmaceutical Technology is tracking major trial announcements and decisions by regulators and reimbursement agencies that have occurred since mid-October, as well as their potential impact on manufacturing plans. Regulatory decisions and clinical trial news.

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25 Reasons Why Pharmaceutical Companies Need a Unified Clinical Trial Management Platform

Cloudbyz

Clinical trials are the backbone of drug development, and managing these trials efficiently is paramount. In recent years, the need for a unified clinical trial management platform has become increasingly evident. Cost Efficiency: Centralized data management reduces administrative overhead, minimizing trial costs.

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Breaking: Sharp acquires Berkshire Sterile Manufacturing

BioPharma Reporter

Sharp, a commercial pharma packaging and clinical trial supply services firm, has acquired Berkshire Sterile Manufacturing (BSM), a Massachusetts-based fill finish contract development and manufacturing organization (CDMO).