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.
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Drug Delivery Systems
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
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.
news
MHRA authorises novel pre-filled pen injector
Adtralza®(tralokinumab) has been granted a UK marketing authorisation by the Medicines and Healthcare Products Regulatory Agency (MHRA) to treat atopic dermatitis, halving the number of injections required.
whitepaper
Technical document: Introducing: Ami Polymer’s Sterile Sampling Systems
Next-Gen Sterile Sampling System: Pinnacle Compliance - USP Standards 87, 88, 85, 661.1, 788, 71, and ISO 11737-1 for Unparalleled Pharma & Biopharma
whitepaper
Application note: Chemical characterisation & databasing at medtronic
Medtronic has created a data-handling workflow for chemical characterisation & database curation using MS Structure ID Suite.
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Roche subcutaneous cancer immunotherapy granted MHRA approval
The first subcutaneous anti-PD-(L)1 cancer immunotherapy available to patients in Great Britain on the NHS reduces treatment time to under ten minutes.
whitepaper
Whitepaper: Are nitrosamines a concern for biologic manufacturers?
Nitrosamine genotoxins in several pharmaceuticals has led to monitoring of manufacturing practices for products considered at risk.
whitepaper
Whitepaper: Navigating nitrosamine impurity testing
Nitrosamine impurities have become a concern in the bio/pharmaceutical industries, due to their carcinogenic properties and presence in medications.
news
CDMO to manufacture SARS-CoV-2 intranasal vaccine
In a collaboration between the Institutes of Health (NIH) and CDMO Exothera, an intranasal vaccine for SARS-CoV-2 will be manufactured for use in a clinical Phase I/II trial in Africa and the US.
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CPHI to return to Milan in 2024
CPHI, the global pharmaceutical exhibition will take place in Milan, Italy from 8-10 October 2024.
news
Buccal drug delivery market to reach $7.1b by 2030
Growth of the buccal drug delivery market is driven by the high bioavailability of buccal formulations as well as the ageing population, smoking addiction and increased R&D.
article
ATRAG formulations for lung disease
Carl-Johan Dalsgaard, CEO of Vicore Pharma speaks to EPR about clinical trials of C21, an angiotensin II type 2 receptor agonist developed to treat rare lung diseases – and the first ever ATRAG to reach clinical-stage development.
news
Next-gen sustainable inhalers on the horizon
Global development and manufacture of the next generation of green inhalers is positioned to be accelerated by a new joint £33 million government-industry investment.
news
Ten-minute subcutaneous injection shows promise for MS
A Phase III trial for the only therapy approved for both relapsing and primary progressive multiple sclerosis (MS) met its clinical endpoints, Genentech has announced.
