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EU MDR DEADLINE DELAY: WHAT DOES IT MEAN FOR THE MEDICAL DEVICE INDUSTRY?

EU MDR DEADLINE DELAY: WHAT DOES IT MEAN FOR THE MEDICAL DEVICE INDUSTRY?

With the compliance deadline for the EU Medical Device Regulation recently delayed by a year due to the novel coronavirus pandemic, Beth Crandall looks at what it means for the medical device industry.

SILICA RE-EMERGES AS POTENTIAL NUCLEIC ACID DELIVERY VECTOR

SILICA RE-EMERGES AS POTENTIAL NUCLEIC ACID DELIVERY VECTOR

Nigel Theobald looks at the challenges of oligonucleotide delivery and explores approaches to overcome them.

Senzer to Create Targeted Inhaled Antivirals for COVID-19

Senzer to Create Targeted Inhaled Antivirals for COVID-19

Senzer Pharmaceuticals has launched a Critical Care Division, which will utilise its expertise in respiratory pharmaceuticals to create targeted antiviral treatments for covid-19.

Covis Pharma’s Alvesco (ciclesonide) Inhaler Enters Phase III COVID-19 Trials

Covis Pharma’s Alvesco (ciclesonide) Inhaler Enters Phase III COVID-19 Trials

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 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.

Telemedicine gains acceptance amid the Covid-19 pandemic

Telemedicine gains acceptance amid the Covid-19 pandemic

Noble highlights how telemedicine is poised to become a mainstream alternative to the traditional in-person methods of care delivery, with the covid-19 pandemic easing barriers to acceptance and introducing patients to the safety and convenience of telehealth technology.

RedHill’s US IND Approved for Opaganib SARS-COV-2 trial; positive results from Israeli trial

RedHill’s US IND Approved for Opaganib SARS-COV-2 trial; positive results from Israeli trial

RedHill Biopharma has received US FDA of its IND for a Phase IIa clinical trial of opaganib (Yeliva^®, ABC294640) in 40 hospitalised SARS-COV-2 patients, and has reported positive preliminary results from a trial of the product in six patients in Israel.

BAVARIAN NORDIC ENTERS AGREEMENT WITH ADAPTVAC TO ADVANCE COVID-19 VACCINE

BAVARIAN NORDIC ENTERS AGREEMENT WITH ADAPTVAC TO ADVANCE COVID-19 VACCINE

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.

ARTES USING METAVAX<sup>®</sup> AND SplitCore VLP PLATFORM FOR SARS-CoV-2 vaccine

ARTES USING METAVAX^® AND SplitCore VLP PLATFORM FOR SARS-CoV-2 vaccine

ARTES Biotechnology has begun development of SARS-CoV-2 vaccine candidates based on its virus-like particle (VLP)-based platform technologies METAVAX^® and SplitCore.

MedPharm Develops Model to Support Coronavirus Pharmaceutical Development

MedPharm Develops Model to Support Coronavirus Pharmaceutical Development

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.

Squalene-based nanoparticles for the treatment of uncontrolled inflammatory processes

Squalene-based nanoparticles for the treatment of uncontrolled inflammatory processes

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.

Chitosan nanoparticles suitable for aerosol treatment of Covid-19 patients

Chitosan nanoparticles suitable for aerosol treatment of Covid-19 patients

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.

ANSYS simulations to help provide insights in fight against COVID-19

ANSYS simulations to help provide insights in fight against COVID-19

ANSYS, Inc, has posted sample clips of various simulations on its webpage, for others to use to gain insights in the fight against COVID-19. The simulations, which can be viewed here, offer various insights on aspects.

NanoPass Sharing Microneedle Device with Pharma Partners for COVID-19 Vaccine

NanoPass Sharing Microneedle Device with Pharma Partners for COVID-19 Vaccine

NanoPass is sharing its proprietary MicronJet microneedle device with vaccine and immunotherapy companies to help in the efforts to develop a safe, effective and affordable vaccine against SARS-COV-2, novel coronavirus.

Pulmonary Delivery Could Make Niclosamide Effective Against COVID-19

Pulmonary Delivery Could Make Niclosamide Effective Against COVID-19

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.

IS NOW THE TIME TO SHAKE UP THE pMDI ENVIRONMENT?

IS NOW THE TIME TO SHAKE UP THE pMDI ENVIRONMENT?

Chris Baron explores how the use of propellants in pressurised metered dose inhalers has evolved – and how alternative propellants could be a catalyst for greater patient adherence.

NEW DRUG-NEBULISER COMBINATION PRODUCTS: CONSIDERATIONS BEYOND PERFORMANCE

Dr Nicolas Schwenck

NEW DRUG-NEBULISER COMBINATION PRODUCTS: CONSIDERATIONS BEYOND PERFORMANCE

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.

OPTIMISING NASAL DRUG PRODUCTS FOR SYSTEMIC DELIVERY

Intertek Pharmaceutical Services

OPTIMISING NASAL DRUG PRODUCTS FOR SYSTEMIC DELIVERY

David Ward discusses the benefits of systemic nasal delivery, describes a number of formulation strategies, and explains how to optimise absorption through properly informed formulation and device selection.

RETRONOSE: IMPROVING NASAL DELIVERY THROUGH A NEW AND IMPROVED DEVICE

Dr Laurent Vecellio

RETRONOSE: IMPROVING NASAL DELIVERY THROUGH A NEW AND IMPROVED DEVICE

Laurent Vecellio, Déborah Le Pennec, Guillaume Grevin and Alain Regard evaluate the performance of the RetroNose nasal drug delivery device.

OFF-THE-SHELF OR CUSTOM-MADE? CHOOSING A DRY POWDER INHALER

Dr Philippe Rogueda

OFF-THE-SHELF OR CUSTOM-MADE? CHOOSING A DRY POWDER INHALER

Philippe Rogueda discusses the manifold factors that need to be taken into account when choosing a dry powder inhaler – beyond just the target disease, formulation and patient population.

THE IMPORTANCE OF TRAINING AND ONBOARDING FOR INTRANASAL RESCUE THERAPIES

THE IMPORTANCE OF TRAINING AND ONBOARDING FOR INTRANASAL RESCUE THERAPIES

With a recent resurgence in nasal drug repurposing, Joe Masci looks at the importance of training and onboarding for intranasal rescue therapies.

RESPIRATORY DRUG DELIVERY: THEN, NOW AND SOON

RESPIRATORY DRUG DELIVERY: THEN, NOW AND SOON

Brennan Miles takes a look back at respiratory drug delivery over the last few decades to see what we can learn from the past – and looks ahead to what the future might look like, covering sustainability, device regulation, and formulation milestones.

PUBLIC INTEREST & INCENTIVES FOR INNOVATORS OF INHALED PRODUCTS

PUBLIC INTEREST & INCENTIVES FOR INNOVATORS OF INHALED PRODUCTS

Igor Gonda, David Cipolla and Philippe Rogueda discuss the changes needed to increase the number of approved generic orally inhaled drug products (OIDPs) whilst providing additional incentives to innovators to meet the needs of the general public.

ADVANCING ASPRIHALE<sup>®</sup> TO PIVOTAL PK/PD STUDY

Mark Stansfield

ADVANCING ASPRIHALE^® TO PIVOTAL PK/PD STUDY

Mark Stansfield and Kambiz Yadidi discuss results of their pilot Phase I clinical study of dry-powder inhalation of aspirin.

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