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There are significant interpretational differences between the European Medicines Agency (EMA) and US Food and Drug Administration (FDA)’s guidance on active pharmaceutical ingredient (API) starting materials. In this article, Dave Elder explores the ambiguity in guidance from both agencies and addresses why industry struggles to identify and justify starting materials…
A Phase I clinical trial of remestemcel-L delivered by an endoscope to patients with Crohn’s disease and ulcerative colitis has commenced.
The increasing use of subcutaneous administration stems from the significant advances in biological drug development, as well as the rising trend of self-administration.
Hosted online from 11 – 12 November, Chemspec Digital 2020 provides an interactive networking event for the fine and speciality chemicals community. From all over the world, industry experts will have the opportunity to meet, conduct business, discover innovative substances and learn about the latest trends and developments.
Introduction to BioPhorum (BPOG) raw materials risk assessments tool and an overview on risk assessment regulations for raw materials.
21 October 2020 | By Lonza Pharma & Biotech
Watch our on-demand webinar to learn about liquid-filled hard capsule technology has a proven record for addressing complex active pharmaceutical ingredient (API) formulation challenges, including bioavailability enhancement.
Researchers have developed a monoclonal antibody called AR-711 that is highly neutralising against COVID-19 in an inhaled formulation.
A new report has predicted that the COVID-19 pandemic will drive demand for pharmaceutical spray drying, boosting the market.
Find out how to streamline your pharmaceutical operations in a COVID-19 environment.
A Phase I clinical trial to test VXA-CoV2-1, an oral tablet COVID-19 vaccine candidate, has been initiated with the first patient dosed.
Researchers have shown that mucoadhesive buccal films containing simvastatin inclusion complex and drug mixed micelles can improve the drug's bioavailability.
Researchers have developed a novel tablet formulation of ibandronate which increases the oral bioavailability of the drug by releasing it from a hydrogel raft formed in the stomach.
Watson-Marlow Fluid Technology Group discusses how the biopharma community is coming together to solve the global vaccine development challenge.
A Phase I clinical trial to test an intranasal COVID-19 vaccine spray has been given regulatory approval in China and is expected to begin in November.
A clinical trial has shown that antibiotics administered orally are just as effective at killing Pseudomonas aeruginosa in cystic fibrosis patients as intravenous antibiotics.
