Latest in Regulatory

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

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Asymchem develops AI platform to optimise protein design in drug development

Sequence Recommendation via Artificial Intelligence (STAR) addresses key challenges in protein design through intelligent algorithms and data-driven insights
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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

AbbVie's Parkinson's injectable Vyalev approved by the FDA

The drug proved more efficacious than the traditional oral-based regimen in patients with advanced Parkinson's disease

Novo Nordisk's haemophilia A/B drug Alhemo gets positive opinion from the EMA

The subcutaneous, self-administering prophylactic can allow a patient to produce thrombin, a clotting agent, even in the presence of inhibitors

Improving the sustainability of pharmaceutical freeze drying with ECO Mode

Freeze dryers are typically associated with high levels of energy consumption; to counteract this issue, GEA Pharma & Healthcare has introduced the LYOVAC ECO Mode, which optimises the process with dynamic condenser temperature control and mushroom valve regulation

Latest posts in Regulatory

Pfizer's haemophilia A/B therapeutic Hympavzi gains FDA approval

The pharma giant's once-weekly injectable can be administered subcutaneously and is able to significantly reduce annualised bleeding

Roche's breast cancer combination therapy Itovebi bags FDA approval

Itovebi plus palbociclib and fulvestrant reduced the risk of disease progression or death significantly in patients

TurboFil develops automatic assembly and vial-filling system for nasal devices

The UDS Vial Filling & Assembly System can produce up to 100 nasal spray devices per minute

SGS’s Shanghai Health Science laboratory completes US FDA inspection with zero 483 observations

SGS, the world’s leading testing, inspection and certification company, has set a new benchmark for third-party pharmaceutical testing laboratories in China following an outstanding inspection by the US Food and Drug Administration (FDA) of its Shanghai Health Science Laboratory

Enterprise Therapeutics bags RPD designation from the FDA for cystic fibrosis therapy

ETD001 acts as a ENaC inhibitor, allowing for improved lung mucocilliary clearance, resulting in improved lung function

AstraZeneca's Tagrisso obtains FDA approval for use in stage III NSCLC

Tagrisso reduced the risk of disease progression or death by 84% compared to placebo in the Phase III LAURA trial

Thrombolytic Science receives IND application clearance for its mutant prourokinase from the FDA

The therapeutic will be further investigated in two Phase II clinical trials across the US and UK

Zevra Therapeutics' Miplyffa becomes the first FDA-approved therapeutic for Niemann-Pick disease

Miplyffa can now be used to treat type-C Niemann-Pick disease, a rare and progressive neurodegenerative disease

Novartis' Kisqali plus ET bags FDA approval for HR+/HER2- breast cancer

The decision comes off the back of the Phase III NATALEE clinical trial, which diminished the risk of disease recurrence by 25.1%

ten23 health achieves B Corp status

The acknowledgement makes the ten23 the first biotech CDMO to receive this status

Roche's cancer immunotherapy Tecentriq Hybreza bags FDA approval

The drug first and only subcutaneous PD-(L)1 inhibitor available for patients with certain types of lung, skin, liver and soft tissue cancers

How the EU's AI Act of 2024 will impact businesses using the technology

The legally binding rules on AI use aim to enhance the reliability and safety of the technology's implementation globally

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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

TekniPlex Healthcare highlights enhanced capabilities for class III implantable devices

Company showcases bio-based PVC compounds and reinforced paper solutions at Compamed

Machine Solutions Inc. and Taymer International introduce integrated quality control solution

Enhancing cost efficiency and quality of medical braiders with vision-based inspection systems

groninger showcases filling and closing solutions for OTC pharma at Pack Expo

Discover the flexcare 101 and flexfill machines designed for enhanced efficiency and flexibility in pharmaceutical production

Refeyn enhances mass photometry capabilities with new microfluidic chip

Upgraded system streamlines biomolecular analysis workflows for improved efficiency and quality

Innovation and the future of life science at Pharmintech

How Pharmintech by Ipack Ima is driving technological advancements in the pharmaceutical and life sciences industries

Maximise your automatic filling process in hazardous areas

Discover how the IND500x ensures both safety and productivity in Zone 1/21 environments

Natac obtains the GMP certificate to manufacture for the pharmaceutical sector

The GMP certificate will allow the manufacturing site in Hervás, Cáceres to manufaacture active ingredients for the pharmaceutical industry that is based on medicinal...

Alpha Laboratories showcases commitment to sustainability at Lab Innovations 2024

Discover innovative environmental practices and packaging solutions at stand C22

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