Latest in Regulatory

FDA escalates action against Dabur India over systemic data-integrity and cGMP failures

The US FDA has issued a warning letter to Dabur India following an inspection that identified falsified records, missing laboratory data, inadequate cleaning and process validation and weaknesses in quality-unit oversight, saying the company's response failed to address the systemic nature of the deficiencies

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FDA escalates action against Dabur India over systemic data-integrity and cGMP failures

Loftware and RiseNow partner to strengthen supply chain traceability and compliance in healthcare settings

Loftware and RiseNow partner to strengthen supply chain traceability and compliance in healthcare settings

The alliance pairs Loftware's SAP-integrated product identification platform with RiseNow's procurement and supply chain advisory services, delivering end-to-end...
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Aravax secures FDA Fast Track designation for peanut allergy immunotherapy PVX108

Aravax secures FDA Fast Track designation for peanut allergy immunotherapy PVX108

The designation accelerates development of the peptide-based immunotherapy, which is designed to retrain immune tolerance to peanuts without triggering acute allergic reactions — with Phase II data expected later this year
AstraZeneca’s Trixeo recommended for EU approval in asthma, expanding triple therapy use

AstraZeneca’s Trixeo recommended for EU approval in asthma, expanding triple therapy use

The recommendation is based on KALOS and LOGOS Phase III trials demonstrating statistically significant and clinically meaningful benefits of AZ's single-inhaler fixed-dose triple therapy compared with inhaled dual therapy
Pace Life Sciences' Research Triangle Park facility passes FDA inspection

Pace Life Sciences' Research Triangle Park facility passes FDA inspection

The successful outcome reinforces the CDMO's compliance credentials across stability testing, extractables and leachables, as well as analytical method development and validation for small and large molecule programmes
FDA panel backs six peptides for pharmacy compounding

FDA panel backs six peptides for pharmacy compounding

FDA advisers have recommended allowing six peptides onto the US 503A compounding list, potentially opening a new route to regulated supply — despite concerns around safety, efficacy and manufacturing quality
What’s changing at the FDA? Dr. Julia Marré explains the new U.S. regulatory landscape

What’s changing at the FDA? Dr. Julia Marré explains the new U.S. regulatory landscape

From shifting expectations around submissions to evolving agency–industry interactions, Dr. Marré breaks down what companies need to know to stay compliant, competitive, and prepared
Generic drugs to face 100% and 200% tariffs after 2028, says Trump

Generic drugs to face 100% and 200% tariffs after 2028, says Trump

The President said all generic drugs coming into the US will have a tariff rate of 100% after 2028, rising to 200% in 2029 in an effort to reshore drugmaking into America
MHRA approves Chiesi's low carbon inhalers for UK use

MHRA approves Chiesi's low carbon inhalers for UK use

The inhalers use a new propellant which can reduce the carbon footprint by up to 90%, while maintaining the same clinical benefits, familiar device and usability for both patients and healthcare professionals
Safety in pharmaceutical manufacturing: why a trusted partner makes all the difference

Safety in pharmaceutical manufacturing: why a trusted partner makes all the difference

By taking a three-tiered approach to protecting patients and personnel and ensuring plant compliance, GEA adopts a consultative approach to helping its customers navigate the responsibilities of pharmaceutical manufacturing safety with confidence

Latest posts in Regulatory

Early phase analytical strategy for biosimilars in a shifting regulatory landscape

Early phase analytical strategy for biosimilars in a shifting regulatory landscape

As FDA and EMA guidance continues to reinforce analytical comparability as the foundation of biosimilar development, investing in comprehensive early-stage characterisation is becoming essential to reduce uncertainty and improve development outcomes, says Dr Andrew J. Reason, CEO at BioPharmaSpec
AI in pharma: Practical use cases transforming research, regulatory and medical affairs

AI in pharma: Practical use cases transforming research, regulatory and medical affairs

AI and digital transformation expert Sarah Chan explores the rapidly expanding role of artificial intelligence across the pharmaceutical value chain
Nucleome Therapeutics secures US patent for Micro Capture-C 3D genomics technology

Nucleome Therapeutics secures US patent for Micro Capture-C 3D genomics technology

The USPTO grant strengthens Nucleome's global IP position around its Oxford-licensed MCC platform, which deciphers non-coding genetic variants to identify first-in-class drug targets — with lead inflammatory disease antibody NTP464 entering IND-enabling studies
Sanofi offers EU commitments for flu vaccine disparagement claims

Sanofi offers EU commitments for flu vaccine disparagement claims

Sanofi has proposed remedies to EU antitrust regulators after allegations it disparaged rival CSL Seqirus's Fluad vaccine in Germany and France since 2024
Nicox’s NCX 470 new drug application submitted in the United States by Kowa

Nicox’s NCX 470 new drug application submitted in the United States by Kowa

The submission is based on positive results from two Phase III clinical trials (Mont Blanc and Denali)
Cellares accepted to FDA's inaugural manufacturing precheck cohort

Cellares accepted to FDA's inaugural manufacturing precheck cohort

The pilot gives Cellares direct, ongoing engagement with the FDA during facility development and application submission periods, compressing regulatory timelines and derisking the path to commercial-scale production for drug sponsors building on the company's platform.
ten23 health obtains ATMP manufacturing GMP licenses from Swissmedic for its Basel and Visp facilities

ten23 health obtains ATMP manufacturing GMP licenses from Swissmedic for its Basel and Visp facilities

ten23 health has successfully obtained GMP certifications for the manufacturing and testing of advanced therapy medicinal products(ATMPs) in its facilities in Basel and Visp, Switzerland
AbbVie receives positive CHMP opinion for Upadacitinib (RINVOQ) to treat adults and adolescents with non-segmental vitiligo

AbbVie receives positive CHMP opinion for Upadacitinib (RINVOQ) to treat adults and adolescents with non-segmental vitiligo

If approved, upadacitinib is expected to be the first systemic medication for patients with non-segmental vitiligo, addressing important treatment needs for those living with the chronic, unpredictable autoimmune disease
Sanofi expands vaccine manufacturing in Abu Dhabi as NICE backs its diabetes therapy

Sanofi expands vaccine manufacturing in Abu Dhabi as NICE backs its diabetes therapy

Sanofi advances on two fronts: a new Abu Dhabi vaccine innovation centre with AI and mRNA capabilities and UK NICE backing for teplizumab, the first disease-modifying treatment for type 1 diabetes
Cogent Skills research exposes specialist skills gaps holding back UK medicines manufacturing SMEs

Cogent Skills research exposes specialist skills gaps holding back UK medicines manufacturing SMEs

The Office for Life Sciences-funded report identifies acute gaps in commercial, R&D and digital competencies, recommending simplified apprenticeships and GMP-ready micro-credentials to support sector growth
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What Operation TrialBlazer means for CDMOs and CMC strategy

What Operation TrialBlazer means for CDMOs and CMC strategy

The FDA's new framework cuts Phase I data requirements, opens platform manufacturing data reuse and creates a new CRO/CDMO review role as HHS moves to close the gap with China's faster clinical trial pipeline — but how will this affect the pharma sector?

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Meet growing chemical containment demands with ControlTech

Meet growing chemical containment demands with ControlTech

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Tasrif Pharmaceutical granted second US patent for CD155-targeting antibody developed with Abzena's humanisation and immunogenicity platforms

Tasrif Pharmaceutical granted second US patent for CD155-targeting antibody developed with Abzena's humanisation and immunogenicity platforms

Expanded intellectual property supports development of humanised anti-CD155 antibody and next-generation cancer immunotherapy modalities
Promatix secures Innovate UK grant to advance cis-bispecific ADC programme

Promatix secures Innovate UK grant to advance cis-bispecific ADC programme

Funding will support manufacturing scale-up, preclinical studies and IND-enabling safety work for PBS293-exatecan
Why FDA inspectors focus on senior management oversight and quality culture

Why FDA inspectors focus on senior management oversight and quality culture

Learn why executive oversight matters, how inspectors evaluate quality culture, and what organisations should do before an inspector arrives on site
Advanced mass spectrometry technique breaks free from specialist hardware

Advanced mass spectrometry technique breaks free from specialist hardware

Researchers at the University of Warwick and spin-out company Verdel Instruments have successfully demonstrated two-dimensional mass spectrometry (2DMS) on a benchtop...
Complex APIs demand a new generation of CDMO partnerships

Complex APIs demand a new generation of CDMO partnerships

Modern API complexity and geopolitical pressures are driving deeper, integrated sponsor–CDMO partnerships built on early scientific alignment, resilient supply, and...
How the EU PPWR shifts blister packaging decisions upstream

How the EU PPWR shifts blister packaging decisions upstream

The difference in moisture permeation of pharmaceutical blister packaging materials can be as wide as 259-fold.(1) Historically, the cost of over-specifying packaging was...
FDA inspection readiness: How to prepare for surveillance and pre-approval inspections

FDA inspection readiness: How to prepare for surveillance and pre-approval inspections

Learn how to prepare for surveillance and pre-approval inspections, build a culture of continuous compliance and reduce regulatory risk
Beckman Coulter expands Alzheimer’s testing portfolio with CE-marked p-Tau217 assay

Beckman Coulter expands Alzheimer’s testing portfolio with CE-marked p-Tau217 assay

New blood-based assay and research test aim to improve clinical evaluation and biomarker research for Alzheimer’s disease
FDA inspection outcomes explained: Form 483, VAI, OAI, and effective regulatory responses

FDA inspection outcomes explained: Form 483, VAI, OAI, and effective regulatory responses

Learn what a Form FDA 483 means, how to develop an effective response within 15 business days, and how FDA evaluates inspection outcomes and regulatory risk
LogiPharma Digital Supply Chain Connect announces 2026 agenda for pharma supply chain summit

LogiPharma Digital Supply Chain Connect announces 2026 agenda for pharma supply chain summit

Exclusive Frankfurt event to bring together senior pharma supply chain leaders, digital transformation specialists and technology partners
Guardtech delivers cleanroom solutions for the aerospace sector’s next frontier

Guardtech delivers cleanroom solutions for the aerospace sector’s next frontier

Specialist contamination control environments support precision manufacturing, from aircraft components to space technologies

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