A NOVEL PREFILLABLE SYRINGE WITH A GLASS PRIMARY CONTAINER BUT NO NEED FOR EXTREME THERMAL REFORMING
Stephen Shue introduces a proprietary prefillable syringe, the SMPFS, whose novel glass-tube-plus-plastic-sheath design enables the use of a standard glass tube primary drug container, but avoids the need for the extreme thermal reforming process that conventional glass prefillable syringes must undergo.
Covis Pharma's inhaled glucocorticoid, Alvesco (ciclesonide), has entered a US multicentre, randomised, double-blind, placebo-controlled Phase III safety and efficacy trial in 400 non-hospitalised patients 12 years of age and older with symptomatic COVID-19. The product is delivered twice daily via a pMDI.
Stabilitech Recognised by WHO, seeks £6m funding to make oral SARS-COV-2 vaccine available by end of 2020
Stabilitech Biopharma, which is developing OraPro-COVID-19, an oral coronavirus vaccine, has been formally recognised on the international stage by the WHO as a vaccine developer, and seeks £6 million to fund clinical trials and manufacturing required to make the vaccine available by the end of 2020.
Bavarian Nordic has entered into an exclusive head of terms agreement to license AdaptVac’s proprietary capsid virus like particle (VLP)-based SARS-CoV-2 subunit vaccine technology, to help a European consortium, PREVENT-nCoV, move towards clinical proof of concept. Bavarian Nordic takes responsibility for clinical development and global commercialisation of the vaccine.
A new testing model from MedPharm supports pharmaceutical development programmes targeting coronavirus treatments, meaning companies can assess the therapeutic effectiveness of their anti-COVID-19 candidate compounds in nasal, airway (bronchial), and deep lung (alveolar) epithelia against members of the Coronaviridae family.
Nanoparticles developed by researchers from Galien Institute at Paris-Saclay University and the Federal University of Rio de Janeiro, made by conjugating squalene to adenosine and then encapsulating α-tocopherol, a natural antioxidant, have shown potential against the uncontrolled inflammatory processes associated with severe SARS-COV-2 infection.
Bioavanta-Bosti has developed of a 48-hour manufacturing process, using its Novochizol chitosan polysaccharide nanotechnology to encapsulate APIs – small molecules or biologics – for localised delivery and sustained release, to generate intra-pulmonary drug delivery formulations suitable for treating COVID-19 patients.
A novel inhaled formulation of the approved antihelminthic drug, niclosamide, is under development at the College of Pharmacy at The University of Texas at Austin for COVID-19. The compound was recently confirmed to exhibit antiviral efficacy in SARS-COV-2 infected cells and indeed was more potent compared with chloroquine, lopinavir and remdesivir, the group said.
Nicolas Schwenck and Michael Hahn summarise the critical success factors for bringing a new vibrating membrane nebuliser for a drug-device combination product to the market. They highlight opportunities and pitfalls – starting from the evaluation phase, through the development phase and finally during commercialisation.