Manufacturing

Why Is Integrated CMC Key to Pharmaceutical Development?
Management & Regulatory Why Is Integrated CMC Key to Pharmaceutical Development?

Modern pharmaceutical development frequently stalls when chemists deliver a bulk powder that formulation scientists cannot effectively process into a stable dosage form. This persistent challenge is largely a relic of outdated, siloed organizational structures where drug substance synthesis and

Industry Leaders Urge FDA to Expand Prior Knowledge Guidance
Research & Development Industry Leaders Urge FDA to Expand Prior Knowledge Guidance

Industry groups are requesting concrete examples of how prior clinical data can be used to optimize dosing and streamline trial designs for rare disease therapies. This collective push follows the release of the Food and Drug Administration's draft guidance concerning the use of prior knowledge in

Are Autoimmune CAR-T Therapies Safe for Patients?
Research & Development Are Autoimmune CAR-T Therapies Safe for Patients?

The medical landscape is currently grappling with a profound paradox as the most promising frontier in immunology faces an unprecedented crisis of confidence. The biopharmaceutical sector must now determine if the high levels of toxicity tolerated in oncology are an acceptable trade-off for

Piramal Pharma Highlights ESG Success in New Sustainability Report
Management & Regulatory Piramal Pharma Highlights ESG Success in New Sustainability Report

Piramal Pharma is currently evaluating 38% of its critical suppliers against strict environmental, social, and governance criteria to ensure sustainability throughout the entire value chain. This initiative represents a fundamental shift in how the pharmaceutical industry approaches procurement,

Can a Cyberattack Disrupt Medical Device Manufacturing?
Management & Regulatory Can a Cyberattack Disrupt Medical Device Manufacturing?

While cloud-based applications remained secure, the compromise of on-premises systems halted the ability of a major manufacturer to fulfill essential medical hardware orders. This incident sent immediate shockwaves through the global healthcare sector, highlighting the precarious dependency on

Gland Pharma Hits Regulatory and Financial Milestones
Management & Regulatory Gland Pharma Hits Regulatory and Financial Milestones

Gland Pharma's Visakhapatnam Special Economic Zone Sterile Oncology Facility recently achieved a No Action Indicated status following a USFDA inspection with zero Form 483 observations. This significant regulatory outcome underscores the firm’s commitment to maintaining the highest quality

Loading

Subscribe to our weekly news digest.

Join now and become a part of our fast-growing community.

Invalid Email Address
Thanks for Subscribing!
We'll be sending you our best soon!
Something went wrong, please try again later