Latest in Regulatory

Amcor’s Winterbourne site achieves ISO 13485 certification, strengthening its position and capabilities in healthcare

ISO 13485:2016 is an internationally recognised quality management standard specifically for medical devices.

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Applied Biopharm Consulting secures IP grant to protect AI-driven viral capsid engineering innovations

Irish biotech consultancy Applied Biopharm Consulting has received an IP Start Grant from Enterprise Ireland to develop a formal patent strategy around its AI-powered...
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Roche wins CE mark for first blood-based immunoassay to identify ApoE4 Alzheimer's risk variant

Roche's Elecsys ApoE4 test has received CE mark approval as the first in-vitro diagnostic immunoassay to detect the ApoE4 genetic variant from a simple blood sample, potentially eliminating the need for confirmatory DNA testing in Alzheimer's patients who do not carry the variant

Orphan drug sales to exceed $400bn by 2032, Evaluate report finds

Despite FDA policy shifts and the rise of blockbuster obesity drugs, a new Evaluate report confirms rare disease therapies are on track to claim more than a fifth of all global prescription drug sales within a decade

Shilpa Biologicals and mAbTree secure FDA Orphan Drug Designation for rare blood cancer biologic

The FDA has granted Orphan Drug Designation to the pair's investigational monoclonal antibody for Essential Thrombocythemia and Polycythemia Vera, two rare chronic blood cancers with significant unmet treatment need

CBA releases statement welcoming government's decision to incude biocides in post-Brexit negotiations

Biocides have now been officially included in the scope of negotiations, which the association has called an "important and practical step towards cutting red tape and restoring clarity for businesses," though the "reality is that much more still needs to be done"

Orbia Fluor & Energy Materials registers US DMF file for low-GWP propellant

The fluor-based product manufacturer announced the creation of a US Type IV Drug Master File (DMF) for the low-GWP excipient Zephex 152a, with pharma companies now able to reference the data package for faster, lower-risk FDA reviews for pMDIs

FDA rejects uniQure Huntington's gene therapy AMT-130, demands randomised trial

The US regulator has refused to accept uniQure's Phase I/II data for AMT-130 as sufficient for approval, calling for a placebo-controlled study and accusing the company of using a 'distorted' external comparator — a decision that could delay any approval by years

Ipsen withdraws Tazverik worldwide after safety signal in SYMPHONY-1 trial

Ipsen has voluntarily withdrawn the EZH2 inhibitor Tazverik (tazemetostat) from all markets following safety concerns in a Phase Ib/III trial that linked the therapy to secondary haematologic malignancies

Mastering precision: overcoming production hurdles for inhalable dry powder manufacturing

From high-shear blending mechanics to the impact of particle size and distribution, this article explores the key factors that define effective inhalable powder formulations and how innovative processing methods are enhancing stability, performance and scalability

Latest posts in Regulatory

Upperton submits MHRA application for new sterile manufacturing facility in Nottingham

UK CDMO Upperton Pharma Solutions has filed for regulatory approval from the MHRA for its new 7000 sqft sterile manufacturing facility, designed to meet updated EU GMP Annex 1 standards and expand early-phase clinical manufacturing capacity

UK unveils regulatory pathway to bring space-manufactured medicines to market

The UK Space Agency and MHRA have outlined new guidance, case studies and a regulatory sandbox to support companies developing pharmaceuticals in microgravity, aiming to accelerate the path from in-orbit manufacturing to patient access

Ananda Pharma receives MHRA and HRA approval for Phase II ENDOCAN trial in endometriosis

UK biopharmaceutical company Ananda Pharma has received regulatory and ethics approval to begin a Phase II clinical trial investigating its proprietary cannabidiol (CBD) therapy for the management of endometriosis-associated pain

FDA Class I recall: Fresenius Kabi issues urgent software correction for Ivenix infusion pumps

US Food and Drug Administration classifies the recall of Ivenix Large Volume Pump software as Class I after anomalies linked to therapy interruptions and two serious injuries
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Beyond borders: how geopolitical shifts are redefining pharma and medical device development

Structural shifts in pricing, regulation and commercial models are forcing pharmaceutical and medical device companies to rethink how therapies are developed, manufactured and delivered worldwide

CStone's sugemalimab approved by MHRA for Stage III NSCLC

The MHRA's decision marks the biopharma's second indication approved for the product in the UK, with a global commercial rollout for sugemalimab now actively underway

American Chemistry Council's statement to Trump: make chemistry in America again

The Council has released a statement ahead of the President's State of the Union Address, asking for policies that unlock domestic production and address unfair foreign practices

Johnson & Johnson files FDA application for IMAAVY in wAIHA

Johnson & Johnson has submitted an sBLA to the US Food and Drug Administration seeking approval of IMAAVY as the first-ever treatment for warm autoimmune haemolytic anaemia, supported by Phase II/III ENERGY trial data showing rapid and durable haemoglobin response

NICE approves Opzelura cream as first UK treatment for non-segmental vitiligo

Incyte Biosciences UK has secured NICE approval for Opzelura (ruxolitinib) cream, granting eligible NHS patients with non-segmental vitiligo access to the first and only approved therapy in England shown to support facial re-pigmentation

CDA-AMC rejects Leqembi reimbursement despite Health Canada approval

After expressing disappointment about a separate insomnia ruling, Eisai has criticised a draft decision by Canada's drug agency not to recommend public reimbursement of Leqembi for early Alzheimer's disease

Shield Therapeutics’ ACCRUFeR becomes first FDA-approved oral iron for children 10+

The FDA's approval for ACCRUFeR (ferric maltol) to treat iron deficiency in children aged 10 and older makes it the first and only prescription oral iron therapy specifically approved for this pediatric population

Sponsor content

Lonza and Genetix extend commercial manufacturing agreement for ZYNTEGLO™

Expanded collaboration will support growing demand for FDA-approved gene therapy for beta-thalassemia

BIXOLON introduces healthcare-optimised desktop printers with advanced safety and hygiene features

New XD5-40II models support patient safety, regulatory compliance and operational efficiency in European clinical environments

Compliance podcast: How EU law, AI and decentralised manufacturing are redefining the QP role

On the NSF Life Sciences Compliance Podcast, Dr Peter Gough speaks on where pharmaceutical quality is headed next

The Global AI Regulation Shift in Pharma Biotech

How life science leaders must prepare for AI-enabled regulators across the EU, UK and the United States

Navigating AI regulation for digital medical devices in global markets

New whitepaper outlines regulatory pathways for AI-powered medical technologies in the UK, US and EU

NJM introduces next-generation Bronco 4 pressure-sensitive labeler

New system simplifies labeling for pharmaceuticals, nutraceuticals and cosmetics

Extract Technology fully integrates into Dec Group and unveils new company name

Dec Group UK reflects unified vision and strengthened capabilities for global customers

testo Saveris 1 update automates environmental monitoring workflows for pharma compliance

Testo Saveris, global leader in measurement solutions, has announced the latest software update for its testo Saveris 1 Environmental Monitoring System, designed to...

New thermal inkjet printer expands AM Labels’ coding portfolio

M2 system delivers high resolution variable data printing at production-line speeds

Why aseptic processing is critical for microsphere drug manufacturing

As microsphere-based drug delivery systems move from niche innovation to commercial reality, manufacturers face growing pressure to guarantee sterility without...

ten23 health QC lab to support commercial product testing for US customer following FDA approvals

This pivotal regulatory milestone enables FDA-compliant release and stability testing for injectable drug products throughout the clinical and commercial phases, in...

Autopack launches modular semi-automatic bucket line

Flexible system helps manufacturers improve efficiency and reduce costs

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