Latest in Regulatory

BIOSECURE Act on track to curb Chinese biotech investment in the US

The amended Act was included in the annual defence bill after failing to pass muster in the last key defence spending bill, but has some notable omissions

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Grace and Molecule.One join forces to transform peptide building block synthesis with AI

The pair have entered into a multi-year strategic agreement to accelerate drug development timelines, strengthen US manufacturing capabilities and help bring lifesaving...
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One in four European pharma companies at risk of regulatory breaches according to NSF research

The independent survey exposed significant gaps in quality systems, supply chain oversight and data integration, just as EU GMP regulations continue to tighten

NICE raises cost-effectiveness thresholds to boost UK pharma innovation

The UK government has confirmed that NICE will increase its cost-effectiveness thresholds to £25,000-£35,000 per QALY from April 2026, with the aim to support pharmaceutical companies and unlock patient access to new medicines

BIA urges new UK access pathway to speed innovative rare disease medicines to NHS patients

The BioIndustry Association (BIA) has called for a connected, flexible UK pathway to improve access to innovative rare disease medicines, as outlined in a new report released in London

AstraZeneca's New Drug Application for hypertension drug accepted under FDA Priority Review

Baxdrostat has had positive Phase III trial results and, if approved, could be the first aldosterone synthase inhibitor to receive regulatory authorisation

NOAH calls for Veterinary Medicines Agreement amid concerns over Northern Ireland veterinary medicines supply changes

With EU regulations set to apply fully from 1 January 2026, Northern Ireland could see 10-15% of veterinary medicines discontinued. Industry and government are working on mitigation schemes to protect animal health and ensure continued access to essential treatments

UK-US pharma deal removes tariffs and boosts access to innovative medicines

The UK has secured a zero-tariff agreement on pharmaceutical exports to the US, alongside major reforms to accelerate NHS access to new treatments

EU approves Sanofi and Regeneron’s Dupixent as first targeted CSU treatment in more than a decade

The European Commission has authorised Dupixent for moderate-to-severe chronic spontaneous urticaria in patients aged 12+, offering the first new targeted option in more than ten years

Aseptic spray drying: Transforming biotherapeutics for a new era

With interest in aseptic spray drying on the rise in the pharmaceutical industry, Dr Kevin Robinson spoke to GEA’s David Costes about how the company is combining process, engineering and technological expertise with market insights to provide a safe, reliable and high-performance technology for advanced biotherapeutic powder applications

Latest posts in Regulatory

FDA grants Medivir’s MIV-711 Orphan Drug Designation for Osteogenesis Imperfecta treatment

The FDA has awarded Orphan Drug Designation to Medivir’s selective cathepsin K inhibitor MIV-711 for Osteogenesis Imperfecta, a rare genetic bone disorder, after preclinical and clinical data suggests the therapy may strengthen bone

European Commission approves Teva denosumab biosimilars PONLIMSI and DEGEVMA

The two biosimilars to Prolia and Xgeva will expand access to important bone health treatments across Europe and bolster Teva's strong biosimilars portfolio
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From stockpiles to smart supply chains: how industry wants to fix Europe’s drug shortages

An EU-level stockpile may work, but only if it’s flexible, closely monitored and built with logistics in mind. Industry players say drug security will depend less on volume and more on data, digital oversight and early collaboration throughout the supply chain

FDA gives approval to Novartis' SMA gene replacement therapy Itvisma

Phase III studies demonstrated that a one-time dose of Itvisma improved motor function and stabilisation in patients, potentially reducing the need for chronic spinal muscular atrophy (SMA) treatment

QInscribe unveils AI-powered medical writing to revolutionise regulatory submissions

New medical writing service provider QInscribe reduces the time to generate a draft clinical study report (CSR) by 90% with a generative AI solution

Texas sues Bristol Myers Squibb and Sanofi for the alleged deceptive marketing of Plavix

The State of Texas has filed a lawsuit claiming the drugmakers misled patients and healthcare programmes about Plavix’s effectiveness, particularly for minority populations, risking patient safety

Poolbeg Pharma granted European patent for flu drug

POLB 001 targets the body's inflammation machinery and prevents dangerous immune overreactions. The drug could also be used in the treatment of other inflammation-based diseases, such as Cytokine Release Syndrome

BCMPA warns Chancellor: avoid new tax burdens on SMEs in upcoming Budget

The BCMPA is urging the UK Government to ease pressure on small manufacturers by reducing National Insurance costs, cutting red tape and considering SME impact assessments, warning that rising costs and uncertainty are stalling investment and growth

UK pharma shifts as Merck and AstraZeneca scale back: can CDMOs fill the gap?

Recent major site withdrawals and investment pauses have raised concerns about the UK’s industrial strength. But CDMOs say agility, innovation and technical expertise could redefine how and where drugs are made

HHS removes long-standing FDA menopause HRT warnings in landmark move for women’s health in the US

The US Department of Health and Human Services has announced the removal of broad FDA boxed warnings from menopause hormone replacement therapy, following a full scientific review

TrakCel launches CGT Gateway to streamline cell and gene therapy access for healthcare providers

The gateway will be a single sign-on platform designed to reduce portal fatigue and simplify how healthcare professionals manage cell and gene therapy products, supporting smoother coordination across clinics, networks and stakeholders

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Autopack launches modular semi-automatic bucket line

Flexible system helps manufacturers improve efficiency and reduce costs

A-Z Color advances automated quality control in pharmaceutical label production

EyeC inspection systems help deliver zero-error labels and GMP-compliant reliability

ASTM acquires Insight SQC from Sabine River Partners

ASTM International has announced its acquisition of the Insight SQC platform and its customers through an agreement signed in October 2025

Work safely with hazardous substances – new Asecos catalogue available now

Asecos cabinets help minimise risks when storing flammable substances

Piramal Pharma Solutions’ bioconjugates facility in Grangemouth, UK, receives updated MHRA GMP certificates

These certificates cover all activities conducted in the site’s Helix building, including its supporting warehouse and laboratory areas

Updated MHRA GMP certificates strengthen Piramal’s bioconjugates capabilities at Grangemouth

Certification renewal supports clinical and commercial ADC development and manufacturing

Redefining QP training for today’s professionals

How NSF is making specialist learning more flexible and accessible

NSF’s QP training program combines technical skill with personalised guidance

A mentoring-led approach supporting delegates through every stage of the QP journey

Breaking down silos and building in seamless scale

A Q&A with Kindeva's Tommy Schornak on the Bridgeton facility, Annex 1 compliance and scaling sterile injectable production

TurboFil offers industry-leading glove testing systems

Partnership with RAVONA delivers precision and compliance in aseptic environments

How to execute a successful remediation strategy

NSF’s experts share guidance on building sustainable compliance and avoiding quick fixes

How to optimise your quality culture and maturity for success

NSF outlines how aligning culture, leadership and systems can strengthen compliance and performance

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