All Industry Insight articles – Page 42
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NewsRoche to gain rights to novel antibody for IBD
Roche is set to gain rights to develop, manufacture and commercialise a novel antibody treatment with first-in-class and best-in-disease potential for inflammatory bowel disease (IBD), under a new acquisition agreement.
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NewsCould Eli Lilly deliver first-line atopic dermatitis treatment?
Strong evidence of long-term efficacy of the IL-13 inhibitor lebrikizumab for atopic dermatitis has been demonstrated in Eli Lilly’s two-year extension trial.
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NewsSustainability crucial for pharma's supply chain future
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.
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NewsCounterfeit diabetes pens identified in EU and UK
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.
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NewsSweden gets new pharmaceutical aseptic filling line
Sever Pharma Solutions’ new aseptic filling line designed for high potent injectable drugs, features the latest automated systems.
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NewsFirst-in-class phosphate absorption inhibitor approved by FDA
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.
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NewsSanofi 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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NewsNICE 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.
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NewsFDA issues draft guidance on alternative tools for facility assessments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.
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NewsNovo 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.
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NewsLonza 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.
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NewsResearch 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.
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ArticleKey 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.
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NewsNew 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.
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NewsPharma pushes for UK medicine scheme revision
If proposed changes to the UK’s Statutory Scheme for branded medicines is implemented, there will be “a negative impact on new product launches, despite any initial exemption in the first three years,” says Astellas.
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NewsLife Sciences Innovation Day - Accelerating Digital Transformation Ambition
On 18 October 2023, Schneider Electric’s unique event brings together six leading speakers who will explore the future of biotechnology and personalised medicine using AI & digital transformation in life sciences.
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NewsMSD medicine accepted for use in Scotland
Scotland is the first European country to accept the HIF-2α inhibitor WELIREG® (belzutifan) for eligible adults with von Hippel-Lindau (VHL) disease.
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NewsBristol Myers Squibb agrees nearly $6bn oncology merger
In an agreed merger with Mirati Therapeutics, Bristol Myers Squibb will gain rights to a best-in-class treatment for advanced non-small cell lung cancer (NSCLC) with a KRASG12C mutation.
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NewsIndia joins mission to harmonise pharmacopoeial standards
As a “major manufacturer of the world’s medicines”, the Indian Pharmacopoeia Commission (IPC) has joined the Pharmacopoeial Discussion Group (PDG) to contribute to the harmonisation of quality standards.
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NewsModerna reveals optimistic data for influenza-COVID-19 vaccine
Strong influenza and COVID-19 immunogenicity compared to approved standalone vaccines has been demonstrated in Moderna’s combination vaccine, interim Phase I/II trial data shows.