newsUK Clinical Trial Application submitted for amyloid-targeting drug26 October 2023 | By Catherine Eckford (European Pharmaceutical Review)The Clinical Trial Application sent to the MHRA is for a combination drug with the potential to become a cost-effective treatment against early Alzheimer’s disease.
newsNICE recommends first Parkinson’s treatment26 October 2023 | By Catherine Eckford (European Pharmaceutical Review)A new, easy-to-use treatment option for advanced Parkinson’s could benefit around 900 adult patients on the NHS, according to National Institute for Health and Care Excellence (NICE) final draft guidance.
newsFDA approves new therapy for myelodysplastic syndromes25 October 2023 | By Catherine Eckford (European Pharmaceutical Review)The first targeted therapy for certain adults with the rare blood cancer myelodysplastic syndromes, has been approved by the US Food and Drug Administration (FDA).
newsGuidance on machine learning-enabled medical devices published25 October 2023 | By Catherine Eckford (European Pharmaceutical Review)The Medicines and Healthcare products Regulatory Agency (MHRA), US Food and Drug Administration (FDA) and Health Canada have issued guidelines to reduce the regulatory burden for machine learning-enabled medical devices.
newsCPHI selects 2023 Pharma Award winners25 October 2023 | By CPhIProgress, innovation and sustainability across the pharmaceutical supply chain were recognised at the 2023 CPHI Pharma Awards.
newsApproval-first for meningococcal vaccine24 October 2023 | By Catherine Eckford (European Pharmaceutical Review)The first single vaccine to immunise against the five most common meningococcal disease serogroups in adolescents has been approved in the US.
newsSustainability crucial for pharma’s supply chain future20 October 2023 | By Catherine Eckford (European Pharmaceutical Review)Evidence of sustainability metrics is expected to be important for companies in the pharmaceutical industry in the next few years, according to sustainability results of the CPHI Annual Survey 2023.
newsCounterfeit diabetes pens identified in EU and UK19 October 2023 | By Catherine Eckford (European Pharmaceutical Review)Following shortages of the diabetes medicine Ozempic (semaglutide), the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) have confirmed cases of falsely labelled pre-filled pens at UK and EU wholesalers.
newsRegulatory-first for gene editing therapy19 October 2023 | By Catherine Eckford (European Pharmaceutical Review)The world’s first investigational in vivo CRISPR-based gene editing therapy cleared for late-stage clinical development is expected to enter Phase III in late 2023.
newsFirst-in-class phosphate absorption inhibitor approved by FDA18 October 2023 | By Catherine Eckford (European Pharmaceutical Review)A first-in-class treatment with a differentiated mechanism of action has been approved to reduce serum phosphorus in chronic kidney disease (CKD) in individuals for which phosphate binders are not suitable.
newsNICE recommends Roche biologic for lymphoma17 October 2023 | By Catherine Eckford (European Pharmaceutical Review)Glofitamab is the first treatment to be recommended by the National Institute for Health and Care Excellence (NICE) at the same time as it is approved for advanced lymphoma in the UK.
newsFDA issues draft guidance on alternative tools for facility assessments17 October 2023 | By Catherine Eckford (European Pharmaceutical Review)As part of the Prescription Drug User Fee Act (PDUFA) and the Biosimilar User Fee Act (BsUFA) reauthorisation negotiations, the US Food and Drug Administration (FDA) has issued new draft guidance on alternative tools for assessing drug manufacturing facilities.
newsFollicular lymphoma BTK inhibitor recommended by CHMP13 October 2023 | By Catherine Eckford (European Pharmaceutical Review)Following the CHMP’s recommendation of a follicular lymphoma combination treatment, if approved, BRUKINSA will be the first BTK inhibitor to be authorised for follicular lymphoma.
whitepaperWhitepaper: Changing regulatory environment for nitrosamine impurities13 October 2023 | By SGS Life SciencesThis whitepaper provides an overview of the regulatory challenges posed by the detection of nitrosamine impurities in pharmaceutical products.
webinarNavigating challenges in HPAPI development and manufacturing12 October 2023 | By Thermo Fisher Scientific (Patheon)HPAPIs now account for more than half of clinical small molecule NCE drugs. Learn from our experts how to overcome the most common challenges in HPAPI handling.
