FDA approves world’s most expensive drug at $2.1M

A new drug to treat spinal muscular atrophy (SMA) approved by the Food and Drug Administration (FDA) on Friday will come with a price tag of $2.1 million, making it the most expensive medicine in the world.

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AI could spot lung cancer before radiologists

Artificial Intelligence (AI) ‘deep learning’ has been found to detect malignant lung nodules on low-dose chest computed tomography (LDCT) scans sooner than radiologists.

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Amgen offers $167m

Amgen has agreed to buy Swedish biotech Nuevolution for around $167 million to boost its drug pipeline after an R&D collaboration showed promise.

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FDA approves new device for treating patients with CHF

  • The Optimizer Smart System, created by Impulse Dynamics, monitors heart activity and delivers non-excitatory electrical signals to the right heart valve.

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Sun Pharma receives 483 for Baska facility

India’s largest drug maker Sun Pharma on Monday said that it has received letter 483 (an observation of deviation in manufacturing practice) from the US Food and Drug Administration for its manufacturing plant in Baska Gujarat. Read more

Bayer, J&J settle thousands of U.S. Xarelto lawsuits for $775 million

Bayer AG and Johnson & Johnson have agreed to settle more than 25,000 U.S. lawsuits alleging that their blockbuster blood thinner Xarelto caused unstoppable and in some cases fatal bleeding for a total of $775 million (588 million pounds), court documents on Monday showed

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Knock – Knock. Who’s There? Is it FDA?

Companies that do not have much knowledge about how the FDA conducts inspections or are not ready for an audit always have difficulty. FDA inspections, announced ahead of time or not provide great opportunities to carefully examine the GMP compliance of pharmaceutical, biotechnology and medical device companies.

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Internal Audits & Auditee Games

One part of an internal auditor’s life is the eventual (in some cases constant) contact with an auditee who plays some type of game. The reasons for auditee games are varied, but mostly they occur because the auditee believes (or knows) that the audit will not go well. Despite what we say, and do, most auditees equate a nonconformance with failure of them, or their department. Senior management often exacerbates the problem by placing internal audit performance in manager’s overall performance evaluation.

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What Does This Map Tell You About PIC/S Members?

Almost entire Asia and Africa and major part of Latin America are out of the up to date PIC/S Guidelines and Aide Memoirs?


Expertise Trainings for Recognized GXP Auditors

Regula Inspection Services would like to share its comprehensive experience with you by providing expertise trainings for GXP Auditors.

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  • Packaging and Labeling for GXP Auditors (2 Days)
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  • Data Integrity for GXP Auditors (2 Days)
  • Equipment Qualification for GXP Auditors (2 Days)
  • Pharmaceutical Water System for GXP Auditors (2 Days)
  • GMP Compliance & QA for GXP Auditors (2 Days)
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  • Process Validation for GXP Auditors (2 Days)
  • Stability for GXP Auditors (2 Days)
  • Sterilization for GXP Auditors (2 Days)
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  • CSV for GXP Auditors (2 Days)
  • Utilities for GXP Auditors (2 Days)
  • Sterile Manufacturing for GXP Auditors (2 Days)