Latest in Regulatory

Merck jumps on the GLP-1 therapeutic bandwagon by licensing Hansoh Pharma's HS-10535

Merck will be responsible for the development, manufacture and commercialisation of the investigational preclinical oral GLP-1 receptor agonist

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Industrial data mastery: navigating the 2025 landscape

As industrial manufacturers contend with the ever-increasing volume and variety of operational data, the year ahead promises both complexity and opportunity
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Bayer's acoramidis recommended for approval by the EMA's CHMP for cardiomyopathy

The orally administered transthyretin (TTR) stabiliser is suitable for patients with transthyretin amyloid cardiomyopathy, demonstrating at least a 90% TTR stabilisation capacity and a reduction in cardiovascular-related hospitalisations
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Why quality control should be intimately combined with sterile product development, manufacturing and the overall product supply chain

With sponsor companies increasingly needing to create and launch differentiated, stable, usable and safe injectable treatments for patients, experts at ten23 health are keen to promote the importance of integrating development and/or manufacturing with quality control services

Accumulus Synergy teams up with CEPI to expedite the vaccine regulatory approval process

Through Accumulus' cloud-based technology, the two organisations aim to accelerate the accessibility of data for the regulatory approval process of vaccines globally, enhancing the world's pandemic 'preparedness'

AstraZeneca's Imfinzi gains FDA approval for limited-stage small cell lung cancer

The immunotherapy has been approved based on the results of the Phase III ADRIATIC clinical trial, which evaluated the benefits of durvalumab in patients with limited-stage SCLC

Merck's sacituzumab tirumotecan granted Breakthrough Therapy Designation by the FDA

The antibody-drug conjugate (ADC) can be used to treat patients with advanced or metastatic non-small cell lung cancer (NSCLC)

Sigrid Therapeutics' blood glucose-lowering silica, SiPore, attains US patent

The silica-based gel, when taken alongside a meal, can reduce blood glucose levels and reduce the risk of a user developing metabolic syndrome and other obesity-related complications

US Pharmacopeia details mass spectrometry guidelines to advance biologics impurity control

The new chapter aims to standardise the use of mass spectrometry-based analysis in the biopharmaceutical industry, which can be used to detect impurities in cell and gene therapies, antibodies and other biologics

The new F-Gas Regulation and its impact on pharmaceutical freeze-drying

Freeze-drying or lyophilization represents a pivotal process in the life sciences industry. During the past five decades, the technology involved has evolved into a complex, integrated system that balances both technical and biological specifications with economic, safety, and environmental concerns

Latest posts in Regulatory

Merck's Welireg approved for cancers associated with von Hippel-Lindau disease in China

The once-daily drug is the first HIF-2α to be approved in China, exhibiting a 49% objective response rate (ORR)

Ardena's Oss nanomedicine facility gains full GMP approval from the Dutch Healthcare Authority

The pharmaceutical manufacturing facility can produce advanced nanoparticle drug delivery systems, including lipid-based, polymeric and metal oxide nanoparticles

Pfizer gains European Commission approval for haemophilia A and B drug, Hympavzi

The subcutaneous therapeutic is the first and only anti-tissue factor pathway inhibitor approved for the treatment of haemophilia A or B, and is available in an auto-injector format

Syndax Pharmaceuticals' leukaemia drug Revuforj bags FDA approval

The therapeutic is the first and only menin inhibitor to gain FDA approval for acute relapsed or refractory acute leukaemia

AbbVie's Elahere approved for platinum-resistant ovarian cancer by the European Commission

Elahere is the first FRα-targeting antibody-drug conjugate (ADC) to be approved in Europe for platinum-resistant ovarian cancer

PTC Therapeutics' gene therapy Kebilidi bags FDA approval for AADC deficiency

The gene therapy is the first to be approved in the US for direct administration to the brain, and tackles aromatic L-amino acid decarboxylase deficiency (AADC)

Autolus Therapeutics' CAR-T therapy, Aucatzyl, bags FDA approval for ALL

Aucatzyl (obecabtagene autoleucel) is the first CAR-T therapy to receive FDA approval with no risk evaluation mitigation strategy requirement

Navigating regulatory challenges in pharmaceutical packaging: lessons from the past and strategies for the future

To safeguard drug efficacy, maintain strict quality standards and ensure patient safety, pharmaceutical packaging is subject to a wide range of regulations around the world, reports Kun Shing Chan, Director of QA at Tjoapack

Novartis obtains FDA approval for CML drug, Scemblix

The TKI's approval is an important step forward for oncology patients with newly diagnosed chronic myeloid leukaemia, and was based on the results of the Phase III ASC4FIRST trial

Iterum Therapeutics' Orlynvah for uncomplicated UTIs gets FDA seal of approval

Orlynvah is the first oral penem to gain approval in the US, allowing patients access to the treatment outside of a hospital setting

AstraZeneca's Wainzua recommended for EU approval to treat amyloidosis

The neuropathy drug was developed in tandem with Ionis, and has been shown to reduce neuropathy and increase quality of life in the Phase III NEURO-TTransform trial

Astellas' Vyloytm plus chemo gains FDA approval for gastric adenocarcinoma

The drug is the first CLDN18.2 targeted therapy to be approved in the US, and can further extend a patient's PFS and OS compared with chemotherapy alone

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Accelerating and enhancing toxicology assessments

Infographic guides users through ToxHQ’s speedy assessment features

Asahi Kasei Pharma grows its global portfolio with anti-CX3CR1 license

The licensing deal with Chiome enhances its open innovation platform

Solvent recycler SPR-200 boosts sustainability in pharma labs

Recycling up to 90% of solvent in isocratic HPLC improves lab efficiency and sustainability

Thermo Fisher Scientific introduces CTS Detachable Dynabeads for cell therapy production

New products enable precise T cell isolation, advancing CAR-T therapy development

Precision psychiatry in action: How IMed Consultancy helped HMNC Brain Health’s Cortibon programme

AI-driven approach promises a new class of depression treatment

Vetter strengthens senior management team for growth

Three new managing directors to support global sustainable development

IMed Consultancy helps Toby Orthopaedics navigate UK regulations

Regulatory consultancy ensures compliance and confidence for Miami-based company

Cleancube multi: Guardtech’s container facilities support NHS aseptic pharmacies

Award-winning mobile cleanrooms offer fast, flexible solutions for facility upgrades

IMed supports K2 medical systems in their EU MDR transition

Consultancy firm helps K2 navigate the complex regulatory process to achieve Article 97 compliance

New Berry bottle complements preservative-free eye treatment dispensing

Easy-squeeze ophthalmic bottle designed for use with Aptar Pharma’s dispenser

Domino makes it easier than ever for pharmaceutical manufacturers to explore individual dose serialisation

New enhancements to the K600G printing solution streamline integration and usability

Pharmaworks introduces FR1 robotic feeder for blister machines

New system offers superior flexibility and fast changeovers, ideal for drug delivery devices and consumer goods

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