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Issue #4 2016 – Digital edition
In this issue: Regulation, Environmental Monitoring, Drug Delivery; Microbiology, Track & race, Spectroscopy, HPLC, Mass Spectrometry, and much more...
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Formulation
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The legal framework applicable to biosimilars in the EU
Biosimilars are becoming increasingly important in the European Union’s biopharmaceutical landscape due to the increased growth of biologicals as key therapies and the financial pressure this puts on healthcare budgets.
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Approaches in subcutaneous delivery of monoclonal antibodies
Currently, subcutaneous delivery of therapeutic proteins is a fast-growing field, especially for such established modalities as monoclonal antibodies, which require large quantities of drug to be administrated. Different approaches, including high protein concentration, speciality formulations and drug delivery matrices, as well as devices enabling a more rapid administration of larger…
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Current activities of the USP general chapters
From a microbiological perspective, pharmaceutical products fall into two categories – nonsterile and sterile. For both categories manufacturers must eliminate, or minimise, potential health risks to patients related to microorganisms and the toxins they produce, whilst maintaining product quality. Many contributing factors may affect the quality of a medicine or…
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Lab M launches MMGA pre-poured media plate
Lab M Ltd, a Neogen company, introduces its Pinnacle™ MMGA (ISO), Mineral Modified Glutamate Agar, pre-poured media plate. The new plate is formulation compliant to ISO 16649-1 and performance compliant to ISO 11133 for the recovery of stressed and injured E. coli in food, water and feed samples.
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Onivyde receives positive CHMP opinion for pancreatic cancer treatment
25 July 2016 | By Niamh Louise Marriott, Digital Content Producer
The positive opinion is based on a pivotal Phase 3 study showing that Onivyde combined with chemotherapy significantly increased overall survival in patients with metastatic pancreatic cancer...
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Combining soft-tissue cancer drugs improves survival
21 July 2016 | By Niamh Louise Marriott, Digital Content Producer
Scientists discovered that adding a novel monoclonal antibody therapy to traditional chemotherapy increased survival by nearly a year in patients with advanced sarcoma, a lethal soft-tissue cancer.
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Blood cancer study yields disappointing results
19 July 2016 | By Niamh Louise Marriott
Gazyvaro did not meet its primary endpoint of significantly reducing the risk of disease worsening or death in people with diffuse large B-cell lymphoma...
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Samsung Bioepis seeks EU approval for its biosimilar adalimumab candidate, SB5
18 July 2016 | By Victoria White, Digital Content Producer
At an estimated $4billion a year, the reference product, Humira, is among the European Union's largest single drug expenditures...
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Celltrion Healthcare on Remsima and biosimilars
With Remsima being on the market for a year, European Pharmaceutical Review caught up with Celltrion Healthcare to find out more about biosimilars...
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FDA committee recommends approval of Sandoz’s biosimilar etanercept
14 July 2016 | By Victoria White, Digital Content Producer
The Arthritis Advisory Committee voted unanimously in support of biosimilar etanercept for all five indications of the reference product...
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How the implementation of Exalt™ for evaporative crystallisation studies improves stability and controlled delivery in drug development.
12 July 2016 | By Biopharma Group
Polymorph screening is an important stage of drug development. The aim is to identify the different crystalline structures or polymorphs that a drug may appropriate...
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Sandoz announces EGALITY trial results for biosimilar etanercept
7 July 2016 | By Victoria White, Digital Content Producer
The EGALITY study involved 531 patients and compared the efficacy and safety of biosimilar etanercept with the originator product, Enbrel...
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Celltrion to develop assay for evidence-based decision-making in anti-TNF treatment
5 July 2016 | By Victoria White, Digital Content Producer
Celltrion is to develop laboratory tests that will enable physicians to identify when patients on an anti-TNF drug require a change of dose...
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How & why to build a QbD process to optimise the efficiency of your freeze drying projects
Quality by design (QbD) for lyophilisation is about building a robust process that proactively flags critical points and ensures consistent delivery of the best quality product, not only by minimising risk but also through greater understanding of the process itself...
