100% Virtual, 10th Injectables Summit. Uniting 120+ senior leaders in parenteral device design, development and engineers to share best practice and lessons learned from pre-filled syringes to autoinjectors. With the rise of emerging formulations and biologics, Injectable Device experts are tasked with new engineering challenges to ensure quality, computability and a human-centric approach to the device design. Join us to learn how your fellows are tackling these obstacles as well as leveraging strategic platforming to minimize development timeline.
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.
Specialist respiratory drug product news publication OINDP News, has reported progress from several intranasal and inhaled COVID-19 vaccine development programmes, including from Altimmune, APEPTICO, a partnership between Neurimmune and Ethris, and a partnership between UW–Madison, FluGen and Bharat Biotech.
Martti Hedman, Chief Executive of Colorcon, has released a statement in which he confirmed that Colorcon is continuing its business activities, which had been categorised as essential and life sustaining by authorities around the world. He noted that Colorcon materials and coatings are used in some of the drugs that are being evaluated for use to treat COVID-19.
Roquette has identified its KLEPTOSE® hydroxypropyl beta-cyclodextrins (HPβCD) as potentially effective to help the joint efforts of the scientific and pharmaceutical communities working on treating and preventing new emerging viruses such as the coronavirus. HPβCD can effectively act as a safe, enabling excipient for solubility enhancement of antiviral drugs, stability improvement of therapeutic monoclonal antibodies, and as a vaccine adjuvant.
MedinCell investigating role of long-acting antivirals to break chain of SARS-COV-2 viral transmission
With evidence indicating that the established antiparasitic ivermectin can kill coronavirus in a laboratory setting in under 48 hours, MedinCell has published data showing that long-acting formulations of ivermectin can be designed with varying doses and durations with its BEPO® technology and is investigating whether a long-acting product could be effective in breaking the chain of viral transmission.
Tiziana Life Sciences has developed a handheld inhaler that will allow the rapid delivery of TZLS-501, its drug to treat inflammation of the lung in COVID-19. The company believes TZLS-501 (anti-IL6R) combined with this newly introduced inhalation technology may rapidly inhibit inflammation in lungs and in combination with intravenous administration may deplete circulating levels of IL-6 and potentially halt progression of COVID-19-mediated lung damage and death.
Theravance Biopharma is advancing TD-0903, a lung-selective nebulised Janus kinase inhibitor (JAKi) into clinical development to assess its utility in preventing the cytokine storm associated with acute lung injury (ALI) in patients hospitalised COVID-19 patients. The goal is the prevention of disease progression to ARDS.
BIOHAVEN GIVEN FDA GO-AHEAD TO BEGIN PHASE II TRIAL OF INTRANASAL VAZEGEPANT IN COVID-19 LUNG INFLAMMATION
Biohaven is to initiate a Phase II trial within weeks of intranasal vazegepant, its third-generation, high-affinity, selective small molecule CGRP receptor antagonist, in pulmonary complications of COVID-19 disease. The clinical trial will assess the potential benefits of CGRP receptor-blockade in mitigating an excessive immune response which in some cases can be fatal in COVID-19.
9th Sep 2020 - 10th Sep 2020
CALL FOR HELP IN THE FIGHT AGAINST COVID-19! BUSINESSES UNITE TO SUPPLY 15,000 FACE VISORS A DAY TO NHS
A growing group of businesses is urgently calling for more companies to join its initiative to put in place an end-to-end supply chain for desperately needed protective face visors for NHS and other workers in the fight against COVID-19. The group aims to achieve volumes of approx. 15,000 units/day.
Leading device design consultancies Cambridge Consultants, PA Consulting, Sagentia, Team Consulting and TTP , with industrial assistance from MetLase, have joined forces to answer the UK government's call for the rapid development and manufacture of vital ventilators for patients suffering with severe symptoms of COVID-19.
Canadian biotech company IMV has made impressively rapid, solid progress on the development of a vaccine candidate against the novel coronavirus, using its lipid-based vaccine delivery platform, DPX. New developments in just two weeks include, include: initiation of peptide candidate manufacturing, cGMP scale-up plans, preclinical models/assays; and Phase I clinical trial design completed, with discussions with Health Canada already underway also.