news
Sanofi treatment could slow type 1 diabetes progression
New Sanofi Phase III trial data adds to evidence of the treatment potential for the first disease modifying therapy in type 1 diabetes.
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Biopharmaceuticals
news
NICE recommends Roche biologic for lymphoma
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.
news
FDA issues draft guidance on alternative tools for facility assessments
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Biosimilar User Fee Act (BsUFA) reauthorisation negotiations, the US Food and Drug Administration (FDA) has issued new draft guidance on alternative tools for assessing drug manufacturing facilities.
news
Novo Nordisk agrees $1.3bn hypertension acquisition
Novo Nordisk has set its sights on acquiring a medicine with best-in-class potential for hypertension from KBP Biosciences.
news
Lonza to enhance commercial antibody-drug conjugate supply capacity
A new cGMP filling line is set to be built at Lonza’s Stein site in Switzerland, expanding filling capacity and enabling the handling and filling of bioconjugates for commercial supply.
news
Follicular lymphoma BTK inhibitor recommended by CHMP
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.
news
Study reports rapid method for microbial contaminant detection
Research using fluorescent optical respirometry (FOR) illustrated successful detection of aerobic bacteria three hours after setting samples.
whitepaper
Whitepaper: Changing regulatory environment for nitrosamine impurities
This whitepaper provides an overview of the regulatory challenges posed by the detection of nitrosamine impurities in pharmaceutical products.
whitepaper
Technical bulletin: Streamline your drug development pathway from preclinic to FIH/POC
No matter the industry, collaborations between multiple parties throughout a project pipeline can prove challenging.
news
Research predicts 2029 small molecule oncology market leaders
With over $7 billion sales predicted by 2029, AstraZeneca’s Tagrisso is set to lead the lung cancer small molecule treatment market, according to GlobalData.
article
Key developments in pharmaceutical manufacturing – September 2023
This article outlines the recent progress of several major new manufacturing facilities that will be central in supporting the production of innovative therapies in Europe.
news
MHRA regulation overhaul: new scheme for lowest-risk UK clinical trials
The Medicines and Healthcare products Regulatory Agency (MHRA) states its new scheme enables a more streamlined approach to processing Clinical Trial Authorisations (CTAs) for initial applications in late-stage clinical trials.
news
New acquisition to accelerate microbiome therapeutics manufacture
Clinical development and manufacture of microbiome-based therapeutics is set to be accelerated through Kanvas Biosciences’ new acquisition of key assets from Federation Bio.
news
Roche multiple sclerosis subcutaneous injection: late-breaking data
OCREVUS subcutaneous injection was comparable to intravenous (IV) infusion in providing near-complete suppression of multiple sclerosis brain lesions over 24 weeks, Phase III study data shows.
webinar
How to implement single temperature incubation in your environmental monitoring routine
11 October 2023 | By bioMérieux
Watch this webinar to hear Laurent Leblanc explore the challenges and benefits of implementing the “one media / one temperature” approach for routine environmental monitoring.
