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We are happy to announce that Nelson Labs will be exhibiting at the Respiratory Drug Delivery (RDD) conference in Lisbon, Portugal. The 20th edition of RDD will be held on May 6-9, 2025.
Be sure to visit our booth, our consultants are happy to answer any testing and/or compliance questions you may have!
Register now: https://www.rddonline.com/rdd/r

Respiratory Drug Delivery Conference

Dealing with risks in a planned manner is associated with a variety of opportunities and advantages for a company. This includes not only technical, but also entrepreneurial and business management aspects.
[GMP Compliance Adviser, 19. A]
You can find out more about this topic:
The GMP Compliance Adviser is the world's largest knowledge portal for

What advantages does quality risk management have for the company?

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The Prime Minister met President Zelenskyy in Rome.
From:
Prime Minister's Office, 10 Downing Street and The Rt Hon Sir Keir Starmer KCB KC MP
Published
26 April 2025
The Prime Minister met President Zelenskyy in Rome this afternoon.
They discussed positive progress made in recent days to secure a just and lasting peace in Ukraine.
They agreed to m

PM meeting with President Zelenskyy of Ukraine: 26 April 2025

Final Membrane Filter for Microbial Reduction

Sr AD, Medical Customer Engagement - Cardio Renal Metabolic (Remote)

Dear EMA On behalf of we have reviewed your consultation document regarding risk proportionate approach to clinical trials. We are in agreement with your assessment of the risk proportionate approach and the mitigations available to sponsors to ensure the safe and robust conduct of clinical trials. We are in agreement that the two main risks to the

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This episode of Drug Digest will discuss where the significant bottlenecks are in the development and manufacturing of new molecules resulting from progressive technologies, such as AI and ML, and how best to approach these challenges.
WhiteBlackRedGreenBlueYellowMagentaCyanOpaqueSemi-TransparentBlackWhiteRedGreenBlueYellowMagentaCyanOpaqueSemi-Tra

Drug Digest: Keeping Pace with Progressive Technologies in Biopharma Development

Jazz Pharmaceuticals, headquartered in Dublin, Ireland, announced on April 25, 2025 that the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion to recommend conditional marketing authorization for zanidatamab, a dual human epidermal growth factor receptor 2 (HER2)-targeted bispecific an

CHMP Recommends Jazz Pharmaceuticals Therapy for Biliary Tract Cancer

At some point in their career, nearly everyone believes that leadership is about guiding every situation with complete balance and control. It’s natural to think that strength comes from always having the answers. For me, real life changed that view.
After years of IVF, I was finally expecting my son at the age of 41. Late in pregnancy, I developed

Why Empathy Is Your Most Powerful Leadership Tool

The U.S. Food and Drug Administration has approved a second drug product manufacturing facility for Ferring Pharmaceuticals’ Adstiladrin (nadofaragene firadenovec-vncg), a non-replicating gene therapy for bladder cancer.
The approved site is located in Parsippany, New Jersey, and joins Ferring’s existing facilities in Kuopio, Finland. The expansion

FDA clears second US manufacturing site for Ferring's gene therapy

The U.S. Food and Drug Administration (FDA) has approved Akeso Inc.’s differentiated PD-1 monoclonal antibody, penpulimab-kcqx, in combination with cisplatin or carboplatin and gemcitabine for the first-line treatment of adult recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC). The FDA also approved penpulimab-kcqx as a single

FDA Approves Akeso's Penpulimab for Nasopharyngeal Carcinoma

How hard is it for a consumer to open your company's packaging? Healthcare Packaging Editor-in-chief Elisabeth Cuneo sits down with Deb Gokie from the Arthritis Foundation to discuss how inclusive and easy-to-open packaging can benefit all consumers.
Apr 25, 2025
Follow this podcast on your favorite streaming platform - links can be found by clicki

Through the Line Podcast: Inclusive Design in Packaging

Dear Nitrosamines Exchange Community,
I am thrilled to announce the launch of our Analytical Hub expansion, a central resource designed to bring together our collective knowledge and expertise on nitrosamines testing methods. Over the past year, our community has grown rapidly in both membership and expertise, showcasing a remarkable dedication to

OTC Market Withdrawal of Diphenhydramine

Friday, April 25, 2025
Isolere Bio by Donaldson, an innovative bioprocessing technology provider, proudly announces the availability of its manufacturing- grade IsoTag™ AAV reagent for the purification of Adeno-associated Virus (AAV) vectors. As indicated during the launch of the research-grade reagent in October 2024, this final advancement in pro

Isolere Bio by Donaldson Passes Most Significant Milestone To-Date, Announces Availability of Manufacturing-Grade IsoTag™ AAV Reagent

This webinar explores validation of rapid microbial methods with ready-to-use reference materials, a new industry standard in microbial QC testing.
SPEAKERS
Owen Griffin, Senior Director, Microbiology, Rapid Micro Biosystems
Owen is Senior Director, Microbiology at Rapid Micro Biosystems. He has 15 years of experience working in and leading laborat

Achieving rapid microbial method validation with precise reference standard quantification

Proposed Update to USP <1058> on Analytical Instrument Qualification
Apr 25, 2025 Compliance Regulatory Affairs
The proposed revision to USP <1058> introduces a significant change in the approach to analytical instrument and system qualification (AISQ). Instead of considering qualification as a series of isolated events, the updated chapter adopts