COVID-19 NEWS

CALL FOR HELP IN THE FIGHT AGAINST COVID-19! BUSINESSES UNITE TO SUPPLY 15,000 FACE VISORS A DAY TO NHS

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.

DEVICE DESIGN CONSULTANCIES JOIN FORCES, STEP-UP TO THE COVID-19 VENTILATOR CHALLENGE

DEVICE DESIGN CONSULTANCIES JOIN FORCES, STEP-UP TO THE COVID-19 VENTILATOR CHALLENGE

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.

Development of IMV’s DPX-COVID-19 Vaccine Progresses Apace

Development of IMV’s DPX-COVID-19 Vaccine Progresses Apace

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.

Aquavit Developing Microchannel Drug Delivery Device / Novel Compositions for Vaccine Against COVID-19

Aquavit Developing Microchannel Drug Delivery Device / Novel Compositions for Vaccine Against COVID-19

Aquavit Pharmaceuticals is applying its AQUAGOLD® microchannel drug delivery device in the development of a self-administered dermal vaccine against COVID-19 caused by the SARS-CoV-2 coronavirus.

How the current pandemic will shape healthcare innovation for the next decade

How the current pandemic will shape healthcare innovation for the next decade

In its COVID-19 announcement, Ximedica has confirmed that its manufacturing facility remains open under the “essential service” classification and that is focusing on US national efforts to help address the challenges surrounding ventilator and PPE supplies. It also highlighted its core strength in engineering, with more than 200 engineers who have established several highly effective means of remote collaboration.

Oramed Pharmaceuticals Highlights Potential Suitability of its Platform Technology for COVID-19 Vaccine

Oramed Pharmaceuticals Highlights Potential Suitability of its Platform Technology for COVID-19 Vaccine

In a letter to shareholders issued as an update relating to COVID-19, Oramed Pharmaceuticals has highlighted the suitability of its platform technology for protein-based vaccines, including potentially a vaccine against COVID-19, and the potential for partnerships for such a project.

EUROFINS CDMO Launches “Direct To Patient” Service for Continuity of Treatment for Customers’ Clinical Trial Patients

EUROFINS CDMO Launches “Direct To Patient” Service for Continuity of Treatment for Customers’ Clinical Trial Patients

CDMO Eurofins has launched a Direct to Patient service to assure the continued supply of treatments to its customers' clinical trial patients.

Stabilitech to have oral coronavirus vaccine ready for preclinical evaluation in 3 months

Stabilitech to have oral coronavirus vaccine ready for preclinical evaluation in 3 months

UK biopharma company Stabilitech is developing OraPro-COVID-19, applying its OraPro technology with the aim of developing a viral vector with six weeks, and having a capsule ready for animal testing within 12 weeks.

Vero Biotech gets okay for expanded access to its Genosyl DS iNO system to treat COVID-19 patients

Vero Biotech gets okay for expanded access to its Genosyl DS iNO system to treat COVID-19 patients

The US FDA has granted “Expanded Access Emergency Use” to Vero Biotech immediately to use its proprietary inhaled nitric oxide (iNO) delivery system, GENOSYL DS, in the treatment of cardiopulmonary symptoms associated with COVID-19. The agency recently approved GENOSYL (NO) gas, for inhalation for the treatment of persistent pulmonary hypertension of the newborn.

N4 demonstrating utility of Nuvec<sup>®</sup> vaccine delivery system in COVID-19 vaccines using COVID-19 DNA plasmid

N4 demonstrating utility of Nuvec^® vaccine delivery system in COVID-19 vaccines using COVID-19 DNA plasmid

N4 Pharma has initiated a proof of concept project using a Covid-19 DNA plasmid to demonstrate the utility of its Nuvec® silica nanoparticle vaccine delivery system for potential collaboration partners developing Covid-19 DNA or RNA vaccines.

Springboard offers medical device expertise to tackle COVID-19

Springboard offers medical device expertise to tackle COVID-19

Springboard is now offering: design reviews / risk assessments of COVID-19 related medical devices at no charge; answering ad hoc requests for advice on devices relevant to COVID-19 at no charge; device development expertise, including a willingness to tackle short term projects on a not-for profit basis; submission of services to the UK Gov call for businesses to help make NHS ventilators.

UPDATE AND NEWS FROM ONDRUGDELIVERY’S PUBLISHER IN RESPONSE TO COVID-19

UPDATE AND NEWS FROM ONDRUGDELIVERY’S PUBLISHER IN RESPONSE TO COVID-19

The world, and our industry with it, has entered an unfamiliar and difficult period. I would like to take this opportunity to update you on how ONdrugDelivery can and will continue to provide its services uninterrupted, and tell you about some specific initiatives we're launching to help our readers, authors and clients across the global industry.

Pion Offers Its Analytical Services Pro Bono if used in the fight against COVID-19

Pion Offers Its Analytical Services Pro Bono if used in the fight against COVID-19

Pion has offered its analytical services pro bono to assist in the development of vaccines and therapeutics for use in the fight against COVID-19. Its Scissor SubCutaneous Injection Site Simulator assays "simulate the stress conditions and environmental transitions of a biopharmaceutical drug when injected SC".

COVID-19, what’s left to be said and done?…well, everything!

COVID-19, what’s left to be said and done?…well, everything!

John Cahill, Director, Senior Consultant, Quality & Compliance, PharmaLex Ireland, provides an update on the status of several COVID-19 vaccine and therapeutic development programmes, emphasising the considerable efforts being made by industry, regulatory agencies and others, to accelerate development in what is normally, due to the need for stringent regulation, a notoriously slow-moving sector.

Ampio to Study Nebulised Ampion Anti-Inflammatory Biologic in COVID-19 Patients

Ampio to Study Nebulised Ampion Anti-Inflammatory Biologic in COVID-19 Patients

Ampio Pharmaceuticals is preparing an expanded access US FDA protocol to study potential benefit of nebulised treatment with Ampion in COVID-19-induced acute respiratory distress syndrome (ARDS), an immediately life-threatening condition.

Windtree Therapeutics to study its KL4 surfactant for COVID-19 pulmonary effects

Windtree Therapeutics to study its KL4 surfactant for COVID-19 pulmonary effects

Windtree Therapeutics plans a pilot study to assess its KL4 surfactant's ability to impact key respiratory parameters in ventilated COVID-19 patients. The COVID-19 virus infects the specific cells that make pulmonary surfactant and is believed to result in inadequate levels of functional surfactant.

eTheRNA launches international consortium, starts development of cross-strain protective CoV-2 mRNA vaccine

eTheRNA launches international consortium, starts development of cross-strain protective CoV-2 mRNA vaccine

An international consortium is pooling resources to develop a nasally delivered, cross-strain protective CoV-2 mRNA vaccine. Clinical testing is scheduled for early 2021. Organisations involves include eTheRNA, EpiVax, REPROCELL, Nexelis, and CEV

Gerresheimer part of critical infrastructure, products include vital drug delivery devices

Gerresheimer part of critical infrastructure, products include vital drug delivery devices

In its COVID-19 announcement, Gerresheimer has stated that it is part of the critical infrastructure of the countries in which it operates, producing vital packaging for medicines, drug delivery devices and packaging for food, beverages and hygiene and personal care products.

Catalent Responds to the Global Outbreak of COVID-19

Catalent Responds to the Global Outbreak of COVID-19

Catalent has noted that many governments of the countries where it operates have recognised its work as essential meaning all Catalent operating facilities remain open. The company also said it was working with several customers on COVID-related antivirals, vaccines, and treatments for symptoms and effects of the disease.

With precision metal components being used in inhalers & similar devices, Advanex acknowledges critical role in supply chain

With precision metal components being used in inhalers & similar devices, Advanex acknowledges critical role in supply chain

Advanex acknowledges critical role in supply chains with precision metal components being used in inhalers & similar devices, and commits to maintaining supply during turbulent period.

Elcam Medical facilities Recognised by local authorities as essential, enabling continuation of production

E3D – Elcam Drug Delivery Devices

Elcam Medical facilities Recognised by local authorities as essential, enabling continuation of production

All Elcam facilities have been recognised by the local authorities as an essential facility to enable the continuity of production. (See statement by the Israeli Ministry of Economy and Industry). Currently the company does not foresee any disruption to our operation.

Digital RDD 2020 starts April 26, replaces cancelled RDD California

Digital RDD 2020 starts April 26, replaces cancelled RDD California

For 2020, RDD is going digital. The organisers, focused on quality, have committed to providing delegates a digital conference venue open 24/7 with the following features: Digital Auditorium; Digital Platinum Sponsor Sessions; Digital Scientific Poster Session; Posters on the Digital Podium; Digital Exhibition; Digital Networking; Digital Library; Digital Personal Proceedings.

Lexaria Bioscience Expands Pharma Division for development of Lipophilic Antivirals against COVID-19

Lexaria Bioscience

Lexaria Bioscience Expands Pharma Division for development of Lipophilic Antivirals against COVID-19

Lexaria is to investigate how its patented DehydraTECH drug delivery technology could enhance delivery and effectiveness of certain antiviral drugs in the fight against coronavirus disease COVID-19. Lexaria intends to expand collaboration with leading laboratories as soon as possible.

ACG releases letter to customers in response to COVID-19

ACG releases letter to customers in response to COVID-19

ACG has released a letter to its customers in response to the COVID-19 outbreak, and reaffirmed its commitment to providing uninterrupted supply of its products and services, and factories in all locations around the world are working at full capacity. ACG has also ensured the supply of its own raw materials for many months.

PFIZER OUTLINES FIVE-POINT PLAN TO BATTLE COVID-19

PFIZER OUTLINES FIVE-POINT PLAN TO BATTLE COVID-19

Pfizer has called on the biopharmaceutical industry to join it in committing to unprecedented collaboration to combat COVID-19, issuing a five-point plan, which includes applying its drug development expertise, especially to help smaller companies, and offering its manufacturing capabilities.

Nemera highlights obligation to provide life-saving devices to most vulnerable – including the elderly, asthmatics, diabetics

Nemera highlights obligation to provide life-saving devices to most vulnerable – including the elderly, asthmatics, diabetics

PRESS RELEASE In its COVID-19 press update, Nemera has highlighted its obligation to provide life-saving […]

The world in a state of emergency: How Sensirion helps save lives worldwide

The world in a state of emergency: How Sensirion helps save lives worldwide

Sensirion is lending its support to manufacturers of respiratory devices around the world to ensure their equipment is fitted with exceptionally accurate sensor technology allowing for time-resolved flow and volume measurements.

Stevanato guarantees primary packaging supplies for pharma glass containers and integrated medical device solutions

Stevanato Group

Stevanato guarantees primary packaging supplies for pharma glass containers and integrated medical device solutions

In its COVID-19 announcement, Stevanato Group has confirmed that as a major manufacturer of glass containers for pharma and a supplier of integrated solutions for medical devices is guaranteeing primary packaging supplies to support patient care worldwide.

Aptar Group Releases COVID-19 Update for its Customers and Partners

Aptar Group Releases COVID-19 Update for its Customers and Partners

Aptar Pharma has released a message from its President and Chief Executive Officer to provide a COVID-19 update to inform its customers and partners of the measures the Group is taking in regards to the evolving coronavirus pandemic in order to continue to support our customers.

AS DEMAND SURGES, NEPHRON PREPARED TO MEET AMERICA’S NEEDS FOR RESPIRATORY MEDS

AS DEMAND SURGES, NEPHRON PREPARED TO MEET AMERICA’S NEEDS FOR RESPIRATORY MEDS

Nephron Pharmaceuticals has released a statement detailing how current demand for its medications - inhalation solutions and suspension products that treat respiratory conditions - is surging and the company is shattering sales records.

Synairgen to start trial of SNG001 in COVID-19 imminently

Synairgen to start trial of SNG001 in COVID-19 imminently

Synairgen has announced that it has received expedited approvals from the UK Medicines and Healthcare products Regulatory Agency (MHRA) and Health Research Authority (HRA) to conduct a trial of SNG001 (inhaled formulation of interferon-beta-1a) in COVID-19 patients to assist with the global outbreak of the virus.

US FDA Issues Guidance for Conducting Clinical Trials during the COVID-19 pandemic.

US FDA Issues Guidance for Conducting Clinical Trials during the COVID-19 pandemic.

“With this guidance issued today, the FDA is helping industry and investigators navigate the COVID-19 […]

MannKind Refocuses Pipeline Resources in Response to COVID-19 Pandemic

MannKind Refocuses Pipeline Resources in Response to COVID-19 Pandemic

MannKind Corporation is adjusting R&D resources that were reserved for its pipeline of investigational products for treating serious lung diseases, with the goal of prioritising work on new compounds that may have the potential to address the morbidity and mortality associated with respiratory viral infections, such as COVID-19.

PBOA Members Committed To Continuing To Reliably Manufacture Drug and Vaccine Products

PBOA Members Committed To Continuing To Reliably Manufacture Drug and Vaccine Products

PBOA reports how its member companies remain committed to serving patients by manufacturing effective, quality products for their customers, during this global health crisis, and report no material disruptions to their operations.

Insmed Provides Covid-19 Business Update

Insmed Provides Covid-19 Business Update

Insmed implements corporate initiatives in response to the novel coronavirus (SARS-CoV-2) global pandemic including a remote working policy to allow infectious disease specialists and pulmonologists to focus on treating patients and containing the virus. Arikares trainers will now offer remote training and onboarding for patients who initiate treatment with ARIKAYCE.

Beyond Air Submits Investigational Device Exemption to FDA for the Treatment of COVID-19

Beyond Air Submits Investigational Device Exemption to FDA for the Treatment of COVID-19

Beyond Air has submitted an IDE to the US FDA for use of its LungFit™ BRO system in the treatment of COVID-19 patients stating that a mounting body of evidence that NO is safe and well tolerated and in vitro evidence points to inhibition of viral replication in coronaviruses.

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