AstraZeneca commits to supply Europe with 400 million doses of COVID-19 vaccine candidate

AstraZeneca has announced that it has reached an agreement with Europe’s Inclusive Vaccines Alliance (IVA) to supply the continent with up to 400 million doses of the University of Oxford’s COVID-19 vaccine candidate (ChAdOx1 nCoV-19, now known as AZD1222), with deliveries starting by the end of 2020. With the new agreement, the IVA aims to accelerate the supply of the vaccine and to make it available to other European countries that wish to participate in the initiative.  AstraZeneca is now seeking to expand manufacturing capacity further and is open to collaborating with other companies to ensure it meets its commitment to support access to the vaccine at no profit during the pandemic.

The company has also recently completed similar agreements with the UK, US, the Coalition for Epidemic Preparedness Innovations (CEPI) and Gavi the Vaccine Alliance for 700 million doses and it agreed on a license with the Serum Institute of India for the supply of an additional one billion doses, principally for low- and middle-income countries. Total manufacturing capacity currently stands at two billion doses. AstraZeneca recognizes that the vaccine may not work but is committed to progressing the clinical program with speed and scaling up manufacturing at risk.

 

Retrenchments start in SA’s aviation supply chain as Covid-19 lockdown bites

A subsidiary of Bidvest Group that provides services at SA’s major airports – including operating airport lounges, cargo handling, and passenger chauffeuring – plans to lay off thousands of workers after a large drop in business during the Covid-19 pandemic. Bid Air Services, a subsidiary of JSE-listed Bidvest that employs about 5,000 people across its airport and travel services divisions, has begun steps to retrench more than half of its workforce. Bid Air told its workers in a letter dated 10 June 2020, which Business Maverick has seen, that it would issue them with Section 189 notices under the Labour Relations Act.

Bid Air said even when airports reopen – as they have during a Level 3 lockdown – the company’s “services will remain constrained”. During the Level 3 lockdown, few airports have reopened their doors, and airline companies are allowed to operate business flights, but only between Cape Town, Johannesburg, and Durban. This means airports and airlines are facilitating the travel of fewer passengers and operating limited flight schedules, which affects Bid Air’s profitability because its lounges at major airports are still closed and its airport handling services (cargo, passengers, and ramp) are not operating at full capacity. And with demand for air travel expected to remain low post the Covid-19 period, Bid Air’s operations will likely struggle for a while.

 

After COVID, developing the right digital supply chain talent will be harder than ever

A digital supply chain requires companies to organize and behave in ways significantly different from the past. New business models, new data sources, new technologies, enhanced processes and increased risks all contribute to an operational landscape that requires new ways of working, and most importantly, new skills to match. But finding and recruiting new talent is not enough. Where can traditional firms uncover and attract digital talent? Are your recruiting strategies updated to account for your more digital competitors? Firms also face the reality that bringing bright new digital skills into traditional processes may not necessarily deliver improvements in supply chain performance and may meet resistance.

In our annual Digital Supply Chain survey, a majority of firms acknowledged that their current talent pool is inadequate to execute their digital business strategies. At the same time, respondents also noted they were either unable to or haven’t taken significant actions to close the digital talent gap. Further, in our conversations with supply chain leaders, we found that the digital skills gap was top of mind, yet few firms had begun to address the challenge.

 

Google Cloud Designed to Keep Supply Chain Managers in the Loop

While the full impact of COVID-19 is still unknown, many factories are already experiencing decreases in workforce capacity and resources, notes Dominik Wee, Managing Director, Manufacturing and Transportation, Google Cloud. In this exclusive interview, he outlines how his company is enabling supply chain managers in various industry sectors.

 

Supply Chain Management Review: Did Google anticipate the massive move to remote workplaces before COVID-19?

Dominik Wee: No one could have predicted the sheer impact that COVID-19 would have on economies, industries, and workforces. Google Cloud has been well-positioned to support remote work at scale, though, through our collaboration and productivity apps, namely G Suite. Some of our customers were already ahead of this trend. For example, Koenig & Bauer, the world’s oldest printing press manufacturer, began migrating to G Suite earlier this year. That timely switch enabled its workplaces to stay connected and boost collaboration, irrespective of the time zone.

 

Covid-19 has exposed cracks in the global medicines supply chain. We need to fix them

The Covid-19 pandemic has upended the normal ways of doing everything from going to school to making sure countries have the medications their citizens need. It has also exposed vulnerabilities in the global medicine supply chain, leading to uncertainty, drug shortages, quality issues, and price volatility. Strengthening the supply chain to ensure an uninterrupted supply of essential medicines that are safe, meet standards for quality, and are beneficial to health — something the U.S. Senate’s Finance Committee will be discussing at a hearing Tuesday afternoon — should be seen as a public health priority.

The dependence of Americans on medicines and their active ingredients mostly made in a handful of countries outside the U.S. raises concerns about supply-chain disruptions and our ability to ensure the availability of essential medicines. This was evident earlier this year when cities in China shut down and the production of some medicines was halted as India was restricting the export of certain medicines.

BioSerenity, Leader in Healthcare as a Service (HaaS), Helps Advance Understanding of COVID-19 Neurological Impact

BioSerenity offers EEG services using remotely connected equipment enabling testing outside of traditional departments.   Hospitals in France requested BioSerenity to perform EEGs in Intensive Care Units (ICUs) during the initial surge of Covid-19 patients. The data was reviewed remotely by BioSerenity’s specialists and shared with the hospitals’ medical staff. Via these collaborations, we were one of the first to discover EEG anomalies likely associated with Covid-19. BioSerenity will provide data to help physicians diagnose over 30,000 patients suffering from neurological disorders this year.   We are excited to report our discovery to assist medical professionals in treating COVID-19 patients. 

According to Dr. Bruce Lavin, Chief Medical Officer, “This report highlights the importance of obtaining EEGs in patients with COVID-19 who present with cognitive impairment to identify possible brain injury, directly or indirectly due to the virus.” Samir Medjebar, Ph.D., GM BioSerenity France adds, “BioSerenity has demonstrated that our scale and scope of services allow us to provide 24/7 hospital assistance during a crisis and the ability to detect new EEG findings.”

Louis Maillard, Professor at Lorraine University, France, commented that “This study gives a possible explanation for the comas, delayed awakening and arousal observed in some of the most severe cases of Covid-19 infections. It shows the importance of EEG, an old but still relevant exam that can be done at the patient bedside and the only exam that allows for the functional state evaluation of the brain.”

Cell therapy weekly: FDA approves Phase I trial of cryopreserved, cord blood-derived, T-regulatory cells for COVID-19-associated ARDS

Cellenkos® Inc. (TX, USA) has announced it has received US FDA clearance to initiate a double-blinded, placebo-controlled, Phase I clinical trial to assess the safety and preliminary efficacy of CK0802 – an off-the-shelf, cord blood-derived, allogeneic T-regulatory cell product – in hospitalized patients with COVID-19-associated acute respiratory distress syndrome (ARDS).

Elizabeth Read, Chief Technology Officer at Cellenkos Inc., commented: “We appreciate FDA’s expedited review of our plans to evaluate CK0802 in critically ill, intubated patients suffering from ARDS, a deadly complication of COVID-19…In the forthcoming Phase I randomized trial, CK0802 will be assessed for both toxicity and 28-day treatment success, as co-primary outcomes.”

 

A cheap steroid is the first drug shown to reduce death in COVID-19 patients

After months of dire news about the spread of the novel coronavirus and a mounting global death toll, a glimmer of hope arrived today: Researchers announced that dexamethasone, a cheap, widely available corticosteroid, significantly reduced deaths of severely sick COVID-19 patients in a major clinical trial. Although full trial data have not yet been released, several outside commentators hailed the result as a “breakthrough.”

“These are really surprising, but really very convincing results,” says Martin Landray of the University of Oxford, one of the principal investigators of the Recovery trial in the United Kingdom that evaluated the steroid. If they hold up, adds Devi Sridhar, an expert on global public health at the University of Edinburgh, they could be a game-changer for critical patients, as the drugs are accessible even in lower-income countries. Dexamethasone’s effect is seemingly much stronger than that of redeliver, the only other drug so far shown to help COVID-19 patients in a randomized clinical trial. That antiviral reduced the number of days critical patients were hospitalized, but it did not clearly reduce deaths.

 

Convalescent Plasma Therapy Found Safe For COVID-19 Patients

The country’s first peer-reviewed study of a COVID-19 treatment that transfuses blood plasma from recovered patients into critically ill patients found about 76 percent of patients improved. Collaborators at The University of Texas at Austin (UT-Austin) developed an antibody test and selected recovered patients with the highest levels of antibody response for donation. With no adverse side effects caused by the plasma transfusion, this study concluded that convalescent plasma therapy is a safe treatment option for patients with severe COVID-19 disease.

This rapid approval granted by the FDA opened access to convalescent plasma treatment for COVID-19 patients. Additional findings during this trial revealed patient outcomes after plasma therapy were similar to recently published results of patients treated on a compassionate-use basis with the antiviral drug redeliver. The research team also concluded that any observed complications were consistent with findings reported for COVID-19 disease progression and did not result from the plasma transfusions.

 

Cancer Immunotherapy Tools Identify Coronavirus Vaccine Options

Cancer researchers at Children’s Hospital of Philadelphia (CHOP) have harnessed tools used for the development of cancer immunotherapies and adapted them to identify regions of the SARS-CoV-2 virus to target with a vaccine. These CHOP researchers are employing the same approach used to elicit an immune response against cancer cells to stimulate an immune response against the virus.

“In many ways, cancer behaves like a virus, so our team decided to use the tools we developed to identify unique aspects of childhood cancers that can be targeted with immunotherapies and apply those same tools to identify the right protein sequences to target in SARS-CoV-2,” said senior author John M. Maris, M.D., a pediatric oncologist in CHOP’s Cancer Center and the University of Pennsylvania. The researchers looked for regions that would stimulate a memory T-cell response that, when paired with the right B cells would drive memory B cell formation and provide lasting immunity and do so across the majority of human genomes.

“A subset of the sequences selected in our study is derived from viral regions that are very similar to other coronaviruses, and thus our approach, if successful, could lead to protection against not only SARS-CoV-2 but also other coronaviruses that might emerge in the future.”

 

EU unveils coronavirus vaccine strategy to accelerate the development

The European Commission (EC) has set out a number of objectives for a new European coronavirus vaccine strategy, noting that “time is of the essence”. These include ensuring the quality, safety, and efficacy of vaccines; securing swift access to vaccines for member states; and ensuring equitable access to an affordable vaccine as soon as possible. This, the EC said, would be achieved by securing the production of vaccines in the EU through advanced purchase agreements with vaccine producers using the €2.7bn Emergency Support Instrument. In return for the right to buy a specified number of vaccine doses in a given timeframe, the EU will finance part of the upfront costs faced by vaccine producers.

The strategy will also look to adapt existing regulatory frameworks around vaccines, including an accelerated procedure for authorization, flexibility in relation to labeling and packaging. There is also a proposal to provide temporary derogations from certain provisions of the GMO legislation to speed up clinical trials of Covid-19 vaccines and medicines containing genetically modified organisms.

Israeli Researchers Say Medical Cannabis Could Effectively Treat Some COVID-19 Symptoms

Israeli researchers from The Medical Cannabis Research and Innovation Center at Haifa’s Rambam Health Care Campus are leading research that suggests the effects of medical cannabis could be used as a method for treating some symptoms of seriously ill COVID-19 patients. As the novel coronavirus continues to spread, clinical trials at Rambam hospital for the use of medical marijuana in treating and preventing the rapid, life-threatening inflammation in patients with COVID-19 are scheduled to begin in the next few months. Preliminary investigations have already indicated as much, according to the hospital. The researchers aim to prove these theories with evidence-based trials.

Researchers of the cannabis research center investigated multiple cannabis strains and were able to narrow the field to about 15 species strains that appear to have the ability to prevent the intense inflammatory response experienced by some COVID-19 patients. “We detected signs that cannabinoids contribute to the sophisticated fabric network of intercellular communications,” Dr. Louria-Hayon explained. “Intercellular communication based on cannabis-like substances also exists in the immune system. If we understand how cannabinoid components are used in intercellular communication, we can help influence this communication in the event of a disease, to disrupt it or empower the communication to convey desired messages.”

 

Malta’s COVID-19 response secures cannabis industry growth

Even from an economic point of view, Malta has been praised for the way in which we have handled the situation and supported the local industry in this time of need. In its report titled ‘The great lockdown’, the International Monetary Fund predicts that, of the EU Member States, Malta will be the jurisdiction to suffer the least. The GDP contraction for Malta is expected to be the lowest amongst the EU28, standing at -2.8% in comparison to the average EU contraction of -7.5%. In the post-virus economic landscape, Malta is predicted to grow its GDP by 7% in 2021.

The local manufacturing industry has weathered the first part of this crisis very well. Our sturdy manufacturing ecosystem, which operates in different niches, exports to different markets, and trades in different international currencies, has managed to overcome the initial impact of COVID-19. In no uncertain terms, this has been supported by the fact that the country never went into total lockdown, resulting in no days lost from production. In fact, some manufacturers effectively increased production and are now further expanding their operations.

This is very reassuring news to the booming and evolving medical cannabis sector, which is currently setting up its operations on this Mediterranean island. In fact, Malta’s cannabis sector has continued its activities as planned and predicted, with five projects that have set up their facilities and applied for the requisite license from the Malta Medicines Authority. Later on this year we should be seeing the first exports of medical cannabis originating in Malta.

 

New Australian law looks to boost cannabis exports after COVID-19 threat passes

Australia has amended pertinent laws in an effort to put its medical marijuana and hemp exporters in a position to “come out firing” after the COVID-19 crisis eases, the country’s agriculture minister said. The Export Control Legislation Amendment (Certification of Narcotic Exports) Bill 2020 was approved in the House of Representatives on June 10 and in the Senate on June 17.

 “The amendments will remove unnecessary and unintended regulatory barriers imposed on Australia’s exports,” according to the bill’s explanatory memorandum. “This will facilitate trade and the growth of Australia’s legitimate export markets for low-THC hemp, medicinal cannabis industries, as well as other legitimate narcotic goods exports. “Agriculture Minister David Littleproud said the bill broadens current legislation to allow for certification of medical marijuana and hemp exports.

 

The Health Benefits of Medical Marijuana As Reported by Users

Using cannabis for medical reasons has been linked in a study to outcomes including better sleep, less anxiety, and taking fewer prescription medications. The paper, published in Cannabis and Cannabinoid Research, involved 1,276 people recruited from the registry and social media pages of the Realm of Caring Foundation, a non-profit that focuses on therapeutic cannabis research and education. Of the total respondents, 808 were defined as cannabis users, either being patients with a health condition who took the substance (524) or their carers (284). The remaining 468 who acted as the control group were made up of 271 people considering using medicinal cannabis, and 197 careers thinking of giving it to a dependent child or adult.

Between April 2016 and February 2018, the researchers invited participants to complete online surveys every three months, with 33 percent doing one or more follow-up. In the study, the researchers referred to all those who filled out the surveys as participants, and those who had health conditions as patients.

 

Vaping Market Could See a Boom This Summer Post-COVID, Say Experts

Last year, the cannabis sector took a big hit due to the vaping crisis, which ironically emanated from the illicit market. As a result, companies have been on high alert, making safety a priority when crafting vape products. With COVID-19 still a reality, experts are foreseeing a boom in the vaping market this summer. So, what else do they see in their crystal ball post-COVID-19? Find out below. Among those weighing in are Tom Brooksher, CEO of Clear Cannabis Inc; Cortney Smith, CEO and founder of DaVinci; Dan Gardenswartz, the chief financial officer of Spherex; and Elizabeth Hogan, vice president of brands at GCH Inc (parent company of Willie’s Remedy and Willie’s Reserve).  This Q&A has been edited for conciseness and clarity.

 

Iris Dorbian: Why do you think the vape market will see a boom in the summer?

Tom Brooksher: Traditionally, summer is a strong season for cannabis sales as people purchase our products to enhance their vacations and time spent outdoors. As restrictions are lifted, we expect pent-up demand for cannabis products that can be conveniently used in conjunction with outdoor activities. We also expect the phased reopening of tourism in key tourist/cannabis markets, such as Nevada, California, Colorado, and Florida, to positively impact vape product sales.

Redhill Biopharma Expands Opaganib COVID-19 Phase 2/3 Study with Clinical Trial Applications in Italy and UK

Redhill Biopharma Expands Opaganib COVID-19 Phase 2/3 Study with Clinical Trial Applications in Italy and UK

Mark L. Levitt, M.D., Ph.D., and Medical Director at Redhill, said: “We are quickly advancing the preparations for a global, multi-center powered Phase 2/3 study with opaganib for COVID-19. In line with the global shift from a focus on compassionate use programs to adequately controlled clinical studies, our highest priority is on generating robust data in a controlled setting for regulatory purposes. Following our submission of the Clinical Trial Application in Russia last week, we have submitted similar applications in the UK and Italy, and we are looking to expand the study to additional countries and start treating patients soon. This study, along with the ongoing Phase 2a study in the U.S., should allow us to enroll patients faster to evaluate the efficacy of opaganib against COVID-19 and bring this promising therapy one step closer to those who need it.”

In parallel, a randomized, double-blind, placebo-controlled Phase 2a clinical study with opaganib in the U.S. is open for recruitment (NCT04414618). This study is set to enroll up to 40 patients with severe COVID-19 pneumonia requiring hospitalization and supplemental oxygen. This clinical trial is not powered for statistical significance. To date, a total of 141 subjects have been dosed with opaganib in ongoing and completed Phase 1 and Phase 2 clinical studies in oncology indications, in pharmacokinetic studies in healthy volunteers in the U.S., under the existing U.S. Food and Drug Administration (FDA) approved expanded access requests for oncology patients and under the expanded access for COVID-19 patients in Israel, establishing safety and tolerability in humans both in the U.S. and ex-U.S.

TransCelerate Expands COVID-19 Clinical Trial Data Sharing to Include All Biopharma Companies and Biomedical Research Institutions

TransCelerate will expand the type of data shared to include data from both the investigational product and control arms of COVID-19 clinical trials. This announcement comes quickly following a decision last month to utilize the DataCelerate® platform to share control arm data from ongoing and planned COVID-19 clinical studies. DataCelerate® is a global cloud-based data-sharing platform that allows for de-identified, anonymized pre-clinical, and clinical data types to be requested and voluntarily shared. The DataCelerate® system and accompanying legal agreements provide an internationally compliant system protecting privacy rights in clinical data. COVID-19-related clinical data will accumulate in the DataCelerate platform and will be available for complimentary access to qualifying biopharmaceutical companies and biomedical research agencies.

TransCelerate BioPharma Inc. is a non-profit organization dedicated to improving the health of people around the world by simplifying and accelerating the research and development (R&D) of innovative new therapies. The organization’s mission is to collaborate across the global biopharmaceutical R&D community to identify, prioritize, design, and facilitate the implementation of solutions intended to drive the efficient, effective, and high-quality delivery of new medicines.

Low-cost dexamethasone hits the mark in COVID-19 study

The initial results from the study demonstrated that dexamethasone reduced deaths by one-third in patients on ventilation, and by one-fifth in patients receiving oxygen only. According to researchers, this means that one death would be prevented by dexamethasone treatment in around eight ventilated patients or around 25 patients requiring oxygen.

“Dexamethasone is the first drug to be shown to improve survival in COVID-19. This is an extremely welcome result,” said Peter Horby, professor of Emerging Infectious Diseases at the Nuffield Department of Medicine, University of Oxford, and one of the chief investigators for the trial. “This is a ground-breaking development in our fight against the disease, and the speed at which researchers have progressed in finding an effective treatment is truly remarkable. It shows the importance of doing high-quality clinical trials and basing decisions on the results of those trials,” he added.

Biopharma Launches Trial Testing Nitric Oxide as COVID-19 Treatment

“Nitric oxide has shown potential against viruses through blocking both RNA synthesis and viral replication. Data include in vitro analysis of SARS coronavirus and four patients with coronavirus,” Henry indicated. The analyst described the New York-based company’s open-label study that is to be conducted at two sites. It will involve 20 patients who are hospitalized with COVID-19. To be randomized on a 1:1 basis, patients will receive standard supportive therapy alone or standard supportive therapy plus intermittent treatments of 80 parts per million (80 ppm) of nitric oxide over 40 minutes four times per day. Patients will be treated and evaluated for about seven days and then followed up at 30 days.

Henry highlighted that safety is the main focus of the U.S. study, as the maximum nitric oxide dose to be used in it is 80 ppm, which is “underdosed as antiviral therapy.” The Canadian trial to follow, however, will concentrate on efficacy as it will test nitric oxide doses up to 150 ppm. Data from the Canadian trial are expected sometime in Q4/20.

Moderna Phase III Covid-19 vaccine study to enroll 30,000 participants starting next month

One of the companies in the lead to develop a vaccine against the virus that causes Covid-19 has finalized the design of its protocol for the Phase III study slated to begin next month. Cambridge, Massachusetts-based Moderna gave details Thursday about the design of the protocol of the upcoming Phase III study, based on discussions with the Food and Drug Administration. Its vaccine against SARS-CoV-2, mRNA-1273, is currently in two clinical trials: a Phase I study sponsored by the National Institute of Allergy and Infectious Diseases and a Phase II study that the company itself is running.

The Phase III trial, which Moderna will conduct under collaboration with NIAID, will be randomized and placebo-controlled, enrolling about 30,000 participants in the U.S. Its primary endpoint will be the prevention of symptomatic Covid-19 disease, while prevention of severe disease and of infection by SARS-CoV-2 will be secondary endpoints. Dosing is expected to start in July, and participants will receive a dose of 100 micrograms, the dose determined based on results of the Phase I study. Moderna also announced data from its Phase I study, showing that participants developed antibodies, though the data only included a very small number of subjects and did not show whether those antibodies would lead to immunity against SARS-CoV-2.

FDA Continues to Accelerate Development of Novel Therapies for COVID-19

Companies Taking Very Different Approaches to ACE2-Focused COVID-19 Therapies

ACE2, which stands for angiotensin-converting enzyme-2, in healthy people, cuts up to two forms of the angiotensin protein to stabilize blood pressure, as well as other functions. SARS-CoV-2 attaches to ACE2, letting itself into the cell, where it then replicates itself in the cell. Usually, ACE2 is found on the lung, kidney, heart, and gut cells. Recently, researchers discovered ACE2 receptors on the cells in the nose.

At least three different biotech companies are working on two ACE2-related drugs to find a solution to the COVID-19 pandemic. They are Vienna, Austria’s APEIRON Biologics, Cambridge, Massachusetts-based Alnylam Pharmaceuticals, and San Francisco-based Vir Biotechnology.

Apeiron’s approach is to flood the body with more ACE2 to confuse the virus. On April 2, the company received the go-ahead from regulators in Austria, Germany, and Denmark to launch a Phase II trial of APN01 to treat COVID-19. APN01 is the recombinant form of the human angiotensin-converting enzyme 2 (rhACE2), which, the company indicates, has the potential to block the infection of the cells by SARS-CoV-2, decreasing lung injury. The trial plans to treat 200 severely infected COVID-19 patients.

Vir and Alnylam’s overall approach is to silence a protein that causes a disease that is the result of an overproduction of the protein. In the case of COVID-19, the focus is on silencing the ACE2 receptor, with the rationale that without it, the virus won’t be able to infect cells.

 

FDA Continues to Accelerate Development of Novel Therapies for COVID-19

There are a large number of companies and researchers developing and evaluating COVID-19 related therapies. Given the urgent nature of the pandemic, under the FDA’s accelerator program, staff from the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research is providing regulatory advice, guidance and technical assistance as quickly as possible. As part of this work, the FDA is triaging requests from developers and scientists seeking to develop a new drug and biologic therapies, getting the relevant FDA staff in touch with them and providing rapid, interactive input to get studies underway quickly. For example, the FDA has reviewed study protocols within 24 hours in many cases and has reviewed single-patient expanded access requests generally within three hours. The FDA is also collaborating with federal partners, developers and researchers to create protocols that can be used across institutions and programs to streamline efforts.

The FDA also recognizes the potential for many different real-world data sources to complement traditional clinical studies and speed the process of evaluating the impact of potential COVID-19 therapies. To that end, the agency is advancing relationships with partners in the public and private sectors to rapidly collect and analyze information in areas such as illness patterns and treatment outcomes.

 

Feinstein Institutes to Collect COVID-19 Patient Plasma, Research Antibodies Therapy

The Feinstein Institutes will initiate a clinical trial to investigate the therapeutic benefit and safety of donated plasma that contains antibodies to SARS-CoV-2 (the virus that causes COVID-19) from a convalescent – someone who has recovered from the virus. Plasma carries blood components within the human body and, when separated, is a light yellow liquid. This plasma will be injected into someone who is being hospitalized with COVID-19 and being treated at North Shore University Hospital (NSUH) or Long Island Jewish Medical Center (LIJ), in hopes the infused antibodies will ward off infection. Additional Northwell Health hospitals will be able to administer plasma soon.

Additionally, for Feinstein Institutes scientists to better understand the immune system response to COVID-19 for future research, including the investigation of a potential vaccine, those who visit the Convalescent Coronavirus Patient Registry at Northwell.edu/CombatCOVID will be urged to consent and participated in future ongoing research projects at the Feinstein Institutes.

 

Boris Johnson improving and sitting up in bed, chancellor says

United Kingdom: Boris Johnson remains in intensive care in the hospital but has shown signs of improvement. The Prime Minister is reported to be sitting up in bed and “engaging positively” with the clinical team, the chancellor Rishi Sunak said in a daily media briefing yesterday evening.

 

Healx will use AI to seek combination therapies to treat COVID-19

Healx is working to accelerate the discovery and development of therapies for rare diseases that exist without treatment options. This includes cystic fibrosis, Alström syndrome, and other conditions relating to the heart and respiratory system that can put patients in the at-risk category if they develop COVID-19.

The start-up said that combination therapies can be particularly difficult to discover. To uncover potential combination treatments for COVID-19 requires a detailed analysis of the 8m possible pairs and 10.5bn drug triples stemming from the 4,000 approved drugs already on the market.

Healx’s platform, Healnet, aims to overcome this challenge by integrating and analyzing biomedical data from multiple sources to predict combination therapies that are most likely to succeed in the clinic.

The company said that the development of combination therapies is one of its “core strengths” and combination therapy candidates for treating COVID-19 will be available in May for preclinical testing.

 

Microneedle patches for potential COVID-19 vaccines or therapeutics   

These patches were recently put to use for testing out the PittCoVacc, and were initially developed by the University of Pittsburgh Medical Center as well as Carnegie Mellon University. Now, Ozdoganlar says he is looking for scientists to work with him on developing a therapy or a vaccine for the SARS-CoV-2 that is causing the current pandemic. Describing the nature of the collaboration, he says, “My lab can fabricate hundreds of microneedle arrays with your viable vaccine or antiviral drug very quickly for testing in your vaccine and drug development, and we can ramp up to thousands if needed.”                 

And the offer goes beyond the experimental stage. The investigator says his group can help with the manufacture of a proven vaccine once it is identified. Throwing the weight of his formidable expertise and experience with the microneedle arrays, as well as promising to use his connections to achieve the best possible output, he says, “We can provide the necessary expertise, experience, and connections to scale up the manufacturing of the vaccine patches using Good Manufacturing Practice (GMP) guidelines to the levels that will effectively address the COVID-19 vaccination needs.”                  

Vaccine Development for Covid-19

How is coronavirus vaccine development going in the U.S.?

Delivery of the vaccine involved a microneedle array to increase potency. The fingertip-sized patch uses dissolvable needles – made of sugar and protein pieces – to deliver the virus’s spike protein into the skin, eliciting an immune response.

Meanwhile, Janssen Pharmaceutical Co, a division of Johnson & Johnson, announced it will partner with Beth Israel Deaconess Medical Center (BIDMC) to support coronavirus vaccine development. Janssen has started preclinical testing of several projects in its work with Dr. Dan Barouch at BIDMC.

They expect to identify a COVID-19 vaccine candidate for clinical trials by the end of the year.

Both programs are benefiting from recent experiences in vaccine development. The Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center, for example, worked closely with Janssen on developing Zika and HIV vaccines.

“We had previous experience on SARS-CoV in 2003 and MERS-CoV in 2014. These two viruses, which are closely related to SARS-CoV-2, teach us that a particular protein, called a spike protein, is important for inducing immunity against the virus. We knew exactly where to fight this new virus,” said co-senior author Dr. Andrea Gambotto, associate professor of surgery at the Pitt School of Medicine. “That’s why it’s important to fund vaccine research. You never know where the next pandemic will come from.”

 

China’s CanSino Prepares to Advance COVID-19 Vaccine Candidate into Phase II

CanSino is assessing Adenovirus Type 5 Vector, Ad5-nCoV, as a potential vaccine candidate. Ad5-nCoV is a genetically engineered vaccine candidate with the replication-defective adenovirus type 5 as the vector to express SARS-CoV-2 spike protein, which intends to be used to prevent the disease caused by the novel coronavirus infection, the company said in its filing. Ad5-nCoV is built upon CanSino BIO’s adenovirus-based viral vector vaccine technology platform, which has also been successfully applied to develop the globally innovative vaccine against Ebola virus infection.

Citing a regulatory protocol publication, Fierce reported that the Phase II trial will include 500 healthy participants. The mid-stage trial will not include a high dose that was included in Phase I but will move forward with a mid-level and low-level dose. The dosing will be split evenly between the 500 participants. Following dosing, CanSino said it hopes to see the presence of COVID-19 antibodies in patients on day 28 following vaccination. The patients will be followed for six months following vaccination.

Last month, Moderna dosed the first patient with its COVID-19 vaccine candidate. Moderna’s mRNA-1273 is an mRNA vaccine that encodes for a perfusion stabilized form of the Spike (S) protein. It was chosen by Moderna researchers in collaboration with scientists at the NIAID Vaccine Research Center. As BioSpace previously reported, the mRNA vaccine candidate “codes for the genetic sequence for the spike protein, and when injected into the body, causes the patient’s cells to produce the protein (not the virus), which triggers an immune reaction that will prep itself to battle the virus.”

 

COVID-19: vaccine and drug development updates

An Australian study has highlighted ivermectin as of interest for further drug research efforts, with the drug inhibiting the growth of SARS-CoV-2 in cell culture within 48 hours. Ivermectin is an FDA-approved anti-parasitic drug that has previously shown efficacy in vitro against various viruses, including HIV, influenza, and Zika.

Takeda (Tokyo, Japan) and CSL Behring (PA, USA) has teamed up with four other companies to focus on developing a treatment using the blood plasma of recovered patients to improve speed over what would have usually been individual efforts – in the process, Takeda will forego its work on a Takeda-branded hyperimmune immunoglobin.

“The big challenge is driving enough plasma to make enough material that you can test in a pilot plan, and then finally in a much larger scale batch,” explained Bill Mezzanotte, head of research and development at CSL. “So by working together in both Europe and the US to start, we’ll be sending the material to one primary manufacturing site in each part of the world so that we can most quickly get batch material that can be both tested and then gotten out to the general public.”

Meanwhile, GlaxoSmithKline plc (Middlesex, UK) has purchased $250 million worth of shares in Vir Biotechnology, Inc (CA, USA) and will provide knowledge to help speed up the development of treatments, which include two neutralizing antibodies Vir is looking to advance into the clinic. This adds to Vir’s current partnerships with Wuxi Biologics (China) and Biogen (MA, USA).

A similar partnership has been announced by Amgen (CA, USA) and Adaptive Biotechnologies (WA, USA) – the partnership will leverage Amgen’s Icelandic subsidiary deCODE Genetics, which is testing the country’s population.

 

Coronavirus treatments: Hydroxychloroquine, vaccines, and drugs for COVID-19

Coronavirus was first discovered as the causative agent of COVID-19, scientists have been racing to get a better understanding of the virus’s genetic makeup and unravel how to effectively treat infections. There’s no cure and medical specialists can only treat the symptoms of the disease. Many different treatment options have been proposed and some older drugs seem to be associated with positive outcomes — but much more work is required. However, the long-term strategy to combat COVID-19, which has spread to every continent on Earth besides Antarctica, is to develop a vaccine.

Developing new vaccines takes time, and they must be rigorously tested and confirmed safe via clinical trials before they can be routinely used in humans. Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases in the US, has frequently stated that a vaccine is at least a year to 18 months away. Experts agree there’s a way to go yet.

Vaccines are incredibly important in the fight against the disease. We’ve been able to keep a handful of viral diseases at bay for decades because of vaccine development. Even so, there exists confusion and unease about their usefulness. This guide explains what vaccines are, why they are so important and how scientists will use them in the fight against the coronavirus. It also discusses the current treatment options being used and those that show promise in hospitals.

Hemp Companies Contribute to Fight against COVID-19 Crisis

COVID-19 Crisis Triggers Changes in Marijuana Consumer Behavior

It’s safe to say the world has never experienced something quite like the Coronavirus pandemic. Three months after appearing in Wuhan, China, the virus has infected more than 1.4 million individuals worldwide and claimed at least 87,000 lives. Countries have had to radically overhaul systems that have been in place for decades to help contain the virus. And many experts say things may not go back to ‘normal’ once the pandemic dies down.

One interesting development with the announcement of lockdowns in various U.S. states was the increased demand for marijuana. Both recreational and medical marijuana dispensaries were seeing increased sales as people stocked up. Soon after, most of the states with legal marijuana programs declared marijuana as essential, thus allowing the industry to keep running during the pandemic. Although marijuana businesses haven’t been granted access to disaster relief loans, most states have passed emergency measures to allow them to transact with their customers under safer and more hygienic conditions. This includes allowing curbside pickups and home deliveries.

 

Hemp Companies Contribute to Fight against COVID-19 Crisis

The COVID-19 pandemic has adversely affected lakhs of people worldwide with corporates, governments, and citizens of various countries having joined the arduous battle against the disease. When everyone is doing their part, hemp companies have also come forward to make their contributions and advance help during the crises. Most medical marijuana dispensaries have been allowed to remain open to take care of patients and many CBD brands have come forward to fight against the pandemic.

For instance, Cloudious9 has plans to donate a large number of infrared thermometers to the San Francisco Bay Area Emergency Services, where the supply is inadequate since January. These thermometers would help in ensuring the safety of the employees by minimizing the risk of exposure among them as well as the public. The company is also involved with local and state agencies to facilitate the process of procurement of critical medical supplies. Another company called Moxie is in the process of formulating hand sanitizers, which would be packaged and delivered to all customers along with other deliveries. These formulations would also be donated to hospitals, clinics, community members, etc. and given the high demand coupled with a low shortage this initiative would prove to be highly useful.

 

Massachusetts Sees More Applications for Medical Marijuana Cards during COVID-19 Pandemic

As the novel Coronavirus keeps the world in a perpetual state of fear and uncertainty, Massachusetts has registered an upsurge in the number of people seeking medical marijuana cards. This has been a consistent theme in most states that allow medical marijuana, with both medical and recreational marijuana stores experiencing increased demand.

In many states, this included marijuana businesses. States like Colorado have even taken extra steps like allowing curbside pickups and home deliveries to keep employees and patients safe. And most of these states registered increased demand for marijuana, which many uses to help with a variety of conditions including anxiety, insomnia, and chronic pain.

According to the Cannabis Control Commission (CCC), there were 1,300 new medical marijuana patients registered in Massachusetts between March 23 and April 1, compared to the 500 just 10 days prior. While some states designated both recreational and medical marijuana as essential, Massachusetts doesn’t allow recreational marijuana sales during the pandemic.

Before patients can apply for a medical marijuana card online, they must get a recommendation from a state-certified physician. And following social distancing directives, the CCC recently revised some of its rules temporarily to allow medical practitioners to certify new patients using telehealth. To be eligible, you must have a qualifying medical condition such as HIV or Parkinson’s disease.

 

Does CBD help with arthritis pain?

CBD, along with delta-9-tetrahydrocannabinol (THC) and other chemicals, is found in marijuana. But unlike THC, CBD is not “psychoactive” — that is, it does not cause the intoxication or high associated with marijuana use.  There’s a good chance you’ve tried it already: according to a Gallup poll in August of 2019, about 14% of Americans report using CBD products, and the number one reason is pain. The Arthritis Foundation conducted its poll and found that 29% reported current use of CBD (mostly in liquid or topical form), and nearly 80% of respondents were either using it, had used it in the past, or were considering it. Of those using it, most reported improvement in physical function, sleep, and well-being; of note, a minority reported improvement in pain or stiffness.

CBD might be a promising approach, and animal studies showing anti-inflammatory and pain-relieving effects, well-designed studies demonstrating compelling evidence that CBD is safe and effective for chronic arthritis pain in humans do not exist. A randomized trial of topical CBD for osteoarthritis of the knee has been published, but in abstract form only (meaning it’s a preliminary report that summarizes the trial and has not been thoroughly vetted yet); the trial lasted only 12 weeks, and results were mixed at best. One of the largest reviews examined the health effects of cannabis and CBD, and concluded that there is “substantial evidence that cannabis is an effective treatment for chronic pain in adults.” 

 

Cannabis May Ease Opioid Withdrawal Symptoms, Johns Hopkins Study Finds

Researchers are calling for formal clinical trials into the efficacy of marijuana for treating opioid use disorder after a newly published study found that cannabis may ease many common symptoms of opioid withdrawal. The study conducted by researchers at the Johns Hopkins University School of Medicine and published in the forthcoming issue of the Journal of Substance Abuse Treatment asked 200 people with past-month opioid and marijuana use whether their symptoms of opioid withdrawal improved or worsened when they consumed cannabis.

Of the 125 respondents who used marijuana to treat their withdrawal, nearly three-quarters (72 percent) said it eased their symptoms, while only 6.4 percent said it made them worse. Another 20 percent reported mixed results, and three people (2.4 percent) said cannabis didn’t seem to have an obvious effect either way. “These results show that cannabis may improve opioid withdrawal symptoms and that the size of the effect is clinically meaningful.”

The results of their new study, however, suggest that cannabis is doing far more to ease opioid withdrawal symptoms than to make them worse. Of 18 common symptoms the researchers examined, participants on average said that cannabis helped ease every single one.

As Coronavirus Cases Spike, Washington Marijuana Dispensaries Permitted to Remain Open

Washington Marijuana Dispensaries Permitted to Remain Open

As the cases of coronavirus continue to climb in the United States of America, the cannabis dispensaries in Washington have been permitted to remain operational. However, the state Governor Jay Inslee on Monday has ordered the closure of non-essential businesses. Jay Inslee has issued the directive of staying at home to check the further spread of deadly novel coronavirus (COVID-19). According to a report, the total number of cases in the USA has now mounted to 68,489; with 1032 people have already died due to the virus so far. 278 cases have already been reported, and five people have died due to the virus today only.

Jay Inslee’s order has become effective for citizens right from Monday afternoon and will become effective for business organizations on Wednesday. The Governor’s order “Stay Home, Stay Healthy” is scheduled to continue for two weeks. As per the order, all the businesses considered to be non-essential will stop operations that may not be completed by workers from home. Washington citizens have been asked to pay heed to state public health advisories of staying home as reports are surfacing that now America may emerge as the new epicenter of the highly contagious pandemic. Residents in Washington can step out of their homes only to purse important activities.

Meanwhile, the Washington State Liquor and Cannabis Board or WSLCB has permitted dispensaries to permit customers to collect their orders outside the business at curbside. Earlier, the practice was followed only for medical cannabis patients.

 

FBI reviewing CBD use policy for agents

The Federal Bureau of Investigation said its policy on CBD use by agents is currently “under review.”

Marijuana Moment took a look at how Charlotte Figi—the 13-year-old CBD pioneer who passed away this week from a likely coronavirus infection—inspired state lawmakers to enact new Cannabidiol-focused laws which in turn essentially forced Congress to pass a budget rider protecting all state medical cannabis programs from federal interference. Meanwhile, messages of condolence for her family are pouring in from state and federal senators and representatives from across the country.

A coalition of marijuana industry groups is asking states for access to coronavirus-related loans and assistance that the federal government won’t provide. “Like all essential businesses, cannabis businesses are facing significant uncertainty and costs to provide for our employees and to maintain the medical supply chain during this pandemic. Yet, unlike every other essential business, there is an underlying federal-state tension that puts our businesses in a uniquely vulnerable and dire operational and financial position. This is particularly true of our small and minority-owned businesses.”

 

The study suggests the frequency and severity of negative reactions to cannabis

The study notes that in the United States, medicinal cannabis use is now legal in 33 states, as well as the District of Columbia (D.C.). Meanwhile, 11 states, D.C., and Canada have legalized recreational cannabis use. Consequently, more people who have not used cannabis before may try the drug in the future. As the authors note, these users “may have limited knowledge of the possible adverse effects of cannabis.” The authors, therefore, wanted to find out more about what types of adverse reactions happen when someone uses cannabis, how likely they are to occur, and what factors might make a person more likely to experience them.

The team was specifically interested in acute adverse reactions, in which negative side effects happen for a short duration. The authors note that previous research has explored different chronic adverse reactions to cannabis use, whereas there is less research on acute adverse effects. Dr. Carrie Cuttler, an assistant professor of psychology at Washington State University, Pullman, and one of the paper’s authors, notes, “There have been surprisingly little research on the prevalence or frequency of various adverse reactions to cannabis and almost no research trying to predict who is more likely to experience these types of adverse reactions.”

“With the legalization of cannabis in Washington and 10 other states, we thought it would be important to document some of this information so that more novice users would have a better sense of what types of adverse reactions they may experience if they use cannabis.”

 

What to know about vaping CBD

With its legalization in many countries around the world, many people have started to use Cannabidiol (CBD) products for its potential medical benefits. CBD users ingest the compound in various ways, including vaping.

Some studies suggest that CBD may help treat some chronic conditions, such as anxiety and pain. However, most studies have evaluated the effects of taking CBD orally and not through inhalation. The Centers for Disease Control and Prevention (CDC) recommend against vaping, as the long-term effects are still unknown. Studies on vaping CBD oil are lacking. Most clinical trials around CBD have focused on oral capsules, sublingual sprays, or oral solutions.

People living with asthma and chronic obstructive pulmonary disease often use aerosolized therapies. This delivery system supplies the medication directly into the lungs, which results in a rapid clinical effect. Generally, people also need smaller doses compared with oral or subcutaneous injections. The features of condensation aerosols can make vaping seem like a more effective method of taking CBD. However, since vaping is still a relatively new practice, researchers are unclear about its benefits and risks and need to conduct further investigations.

 

COVID-19 Could Add Impetus to Campaigns for Marijuana Home Cultivation

Patients and industry players alike have applauded the decision by numerous states to classify marijuana as an essential commodity, allowing medical and recreational marijuana stores to remain open. As the Coronavirus pandemic ravages the U.S., several state governments have implemented statewide lockdowns to curb its spread.

People are to practice self-isolation and only head outside for essentials like food and medicine, and all but the most essential businesses have been ordered to close. They are also encouraged to wash their hands with soap and water or hand sanitizer regularly.

The open businesses include supermarkets, pharmacies, and daycare centers, and they have permission to operate during the lockdown as they provide essential goods and services. Fortunately for the many people who rely on marijuana to deal with a variety of health issues, numerous states have stated that marijuana is just as essential. They have taken additional steps such as allowing curbside pickups and home deliveries to ensure both the sellers and patients stay safe as they transact. According to some, allowing people to grow their marijuana at home might make the self-isolation and social distancing measures even more effective.

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