Latest in Regulatory

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

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

FPT launches MediSight AI framework to accelerate pharma digital transformation and regulatory compliance

FPT launches MediSight AI framework to accelerate pharma digital transformation and regulatory compliance

The new AI-powered platform combines autonomous digital workers, interoperable healthcare data and compliance tools to help pharmaceutical manufacturers, medical device...
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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
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
Plan your marketing strategy with Manufacturing Chemist

Plan your marketing strategy with Manufacturing Chemist

Discover upcoming special reports, themed features and commercial opportunities to help you connect with pharmaceutical manufacturing decision-makers throughout the year
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)
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

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?
Pheno Therapeutics gains FDA IND clearance for first-in-class GPR17 antagonist PTD802 in MS

Pheno Therapeutics gains FDA IND clearance for first-in-class GPR17 antagonist PTD802 in MS

The clearance enables a first-in-human trial of the UCB-licensed remyelination candidate, marking the first GPR17 programme to reach clinical development for multiple sclerosis and related demyelinating diseases
FDA approves Utebzi, first oral carbapenem antibiotic, for complicated UTIs

FDA approves Utebzi, first oral carbapenem antibiotic, for complicated UTIs

GSK and Spero Therapeutics' tebipenem pivoxil matches IV imipenem-cilastatin in Phase III trials, offering an outpatient alternative for resistant infections that cost the US healthcare system more than $6bn annually
Why Pharma's supply chain technology investments are falling short of resilience

Why Pharma's supply chain technology investments are falling short of resilience

The pharmaceutical industry has spent the best part of six years reassessing its supply chain
Amphista Therapeutics receives FDA IND clearance for BRD9 degrader AMX-883 in acute myeloid leukaemia

Amphista Therapeutics receives FDA IND clearance for BRD9 degrader AMX-883 in acute myeloid leukaemia

The first-in-class DCAF16-dependent Targeted Glue degrader will enter Phase I dose-escalation trials in H2 2026, targeting relapsed or refractory AML independently of karyotype status
MHRA approves first oral semaglutide tablet for weight loss in the UK

MHRA approves first oral semaglutide tablet for weight loss in the UK

Novo Nordisk's Wegovy tablet becomes the UK's first GLP-1 receptor agonist in oral form for obesity treatment — a significant shift in delivery format as the drug awaits NICE evaluation for NHS access

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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
Mini-data loggers from Testo Saveris GmbH: Precise monitoring of temperature and humidity

Mini-data loggers from Testo Saveris GmbH: Precise monitoring of temperature and humidity

For anyone who needs to document temperature and humidity readings in storage areas, cold rooms or during transport, the testo 174 data loggers provide a reliable...
DNA Script expands access to on-demand DNA synthesis in India through distributor agreement with Imperial Life Sciences

DNA Script expands access to on-demand DNA synthesis in India through distributor agreement with Imperial Life Sciences

Brings decentralised, in-house DNA synthesis capabilities to researchers in a rapidly growing biotechnology market
Boehringer Ingelheim standardises plant maintenance globally with osapiens

Boehringer Ingelheim standardises plant maintenance globally with osapiens

Boehringer Ingelheim has selected the osapiens HUB for Mobile Maintenance for its global, regulated manufacturing operations
Brabender TwinLab B-TSE-S 30/40: Pilot-scale extrusion with lab-level insight

Brabender TwinLab B-TSE-S 30/40: Pilot-scale extrusion with lab-level insight

With throughput up to 100 kg/h, the new twin-screw extruder brings lab-grade process understanding into pilot-scale production, enabling users to validate process...
ATEX zones explained: classifying hazardous areas in chemical manufacturing

ATEX zones explained: classifying hazardous areas in chemical manufacturing

When a dust explosion killed six workers at a US pharmaceutical plant in 2003, the hazard was on file. What was missing was area classification, the foundation of every...
Watlow launches Edge Process Management platform for trusted process records in regulated industries

Watlow launches Edge Process Management platform for trusted process records in regulated industries

The platform is designed as a modular, distributed platform that unifies data, control and automation in a single architecture, enabling manufacturers to move beyond...
Why SLTs fail on the PQS/QMS: The leadership gap undermining quality

Why SLTs fail on the PQS/QMS: The leadership gap undermining quality

Senior leadership teams hold the ultimate responsibility for an effective Pharmaceutical Quality System. Yet across the industry, PQS failures remain one of the most...
FINAT Recognises Digital Security Seal from Schreiner MediPharm

FINAT Recognises Digital Security Seal from Schreiner MediPharm

Schreiner MediPharm, a leading developer and manufacturer of innovative functional labels for the healthcare industry, received the prestigious Group Award for Innovation...
Measurement uncertainty explained – Why it matters more than you think

Measurement uncertainty explained – Why it matters more than you think

In regulated environments, where decisions often depend on whether a result passes or fails a defined limit, understanding measurement uncertainty becomes critical
RFID brings greater visibility to pharmaceutical supply chains

RFID brings greater visibility to pharmaceutical supply chains

From hospital pharmacies to global distribution networks, RFID is adding a new layer of intelligence to pharmaceutical logistics

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