PDR Pharmaceutical

Keeping tabs on Covid-19: New drug updates from the FDA, free tools to combat diabetes at home and knowing the right mask to combat spread
Keeping tabs on Covid-19: New drug updates from the FDA, free tools to combat diabetes at home and knowing the right mask to combat spread

Long before the World Health Organization declared Covid-19 a pandemic on March 11, 2020, pharma companies have been ramping up their operations, and utilizing knowledge gained from similar viruses in the past to aid in their research to find a vaccine. Some are looking at compounds formerly tested against viral pathogens such as Ebola and HIV, while others are offering new tech solutions that could combat the spread of coronavirus.
Each week, Pharma IQ will present a round-up of updates on research, treatment options and innovative solutions coming out of the industry as it plays a vital role in fighting the pandemic.
Sensyne Health boosts NHS impact and to help keep pregnant women with diabetes safe at home
AI tech company Sensyne Health has made GDm-Health™ digital, a remote monitoring system for the management of diabetes in pregnancy, available free-of-charge across NHS England in response to the coronavirus pandemic.
Lord Paul Drayson, CEO of Sensyne Health, said, “In light of the UK government’s guidelines around ‘social distancing’ to combat the ongoing Covid-19 pandemic, there is now a greater focus than ever before on the use of remote patient monitoring to reduce the burden on limited NHS resources and help high-risk people stay at home.”
According to the company, the device will give clinicians the opportunity to review changes in symptoms in real time and reduce the cost of what was traditionally a time-consuming method.
The wireless device connects to a smartphone application which monitors glucose levels in the blood of the patient. Using algorithms the device prioritizes patients in need and communicates this information directly to the hospital care teams. Sensyne Health said, this will help improve patient outcomes by keeping high-risk groups safe at home without putting them at unnecessary risk for regular check-ups.
FDA investigates effectiveness of malaria pills and other antiviral drugs to treat Covid-19
The US Food and Drug Administration (FDA) has been working closely with other government agencies to investigate the effectiveness of chloroquine and remdesivir to treat patients with mild-to-moderate Covid-19 symptoms and help prevent further spread of the disease.
Last month, Denis Hinton, Chief Scientist at the FDA, wrote a letter authorizing the emergency use of chloroquine, an approved drug to treat malaria, lupus and rheumatoid arthritis, to treat Covid-19, while the National Institutes of Health began a randomized controlled trial with remdesivir, an antiviral drug developed to treat Ebola, under the FDA’s investigational new drug requirements.
While there are no FDA-approved therapeutics or drugs to currently treat, cure or prevent Covid-19, FDA Commissioner Stephen Hahn, MD, said, “We must ensure these products are effective… [we must also] engage with domestic manufacturers to ramp-up production of products to mitigate any potential supply-chain pressures. If clinical data suggests products may be promising in treating Covid-19, we know there will be increased demand for it.”
The FDA has said it will continue working with innovators to expedite efforts, including leveraging scientific information about the virus and trials currently being conducted in countries including China, Japan, South Korea and Italy.
Cloud-based CTMS supports Covid-19 trials to bring treatments to market faster
Pharmaseal International, a UK-based provider of clinical trials management systems (CTMS), offered life science organizations the opportunity to use its Engility solution free-of-charge to help support moves to bring treatments for Covid-19 to market faster.
The cloud-based solution helps biopharmaceutical organizations and academic institutions manage and centralize their clinical trial lifecycles, regulatory documentation and remote workforce processes.
Daljit Cheema, CEO at Pharmaseal, said, “The team are committed to supporting global life science businesses to improve patients’ lives and would like to further extend this commitment and support during this pandemic to bring treatments to market faster.”
The company claimed, Engibility CTMS facilitates accelerated innovation by delivering new product updates through an intelligent software platform and can adapt to meet the needs of all organizations.
Clinova provides clarity on mask types to minimize risk of contracting Covid-19
In efforts to combat misinformation on mask types, Arsalan Karim, Director of Research and Development at Clinova, makers of the Covaflu Flu Respirator mask, stated, “There’s a lot of talk about different kinds of protective masks, and which one is best.
“While surgical masks protect against infectious agents transmitted by droplets, they do not protect against airborne infectious agents such as viruses, so they will not prevent the wearer from being potentially infected by Covid-19.
“However, the respirator face mask, which protects the wearer from aqueous and oily aerosols, smoke and fine dust, is also more effective at protecting against airborne infectious agents such as Covid-19 and SARS. Respirator masks prevent viruses from entering the body through the mucous membranes of the mouth and nostrils.”
While respiratory masks do not offer wearers 100 per cent protection, Clinova claims the masks will support the efforts of global national health services to combat the spread of the coronavirus.
To take a deeper dive into the effects of the Covid-19 crisis and understand the decisions the pharma industry are taking now to prepare for more resilient supply chains in the future, secure your place at our upcoming expert roundtable in April with Richard Ettl, CEO at SkyCell. Ettl will discuss how to transport pharma goods quickly and safely to patients and tackle the challenges presented by an unprecedented and ever-changing crisis. Sign up now to uncover solutions to shape the future of your supply chain.






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Keeping tabs on Covid-19: New drug updates from the FDA, free tools to combat diabetes at home and knowing the right mask to combat spread | PDR Pharmaceutical Keeping tabs on Covid-19: New drug updates from the FDA, free tools to combat diabetes at home and knowing the right mask to combat spread Long before the World Health […]

Keeping tabs on Covid-19: Vaccine results show encouraging signs in UK and China, as Israeli study offers hope to severe sufferers
Keeping tabs on Covid-19: Vaccine results show encouraging signs in UK and China, as Israeli study offers hope to severe sufferers

Following last week’s news that MIT and 3M were collaborating on a paper-based coronavirus diagnostic solution and Pfizer and BioNTech were told they could fast-track two investigational vaccine candidates by the FDA, the global race to develop a vaccine really heated up this week.
Much headway has been over the past seven days by scientists from across the world of pharma, with positive results coming out of studies in the UK and China. Below we present our pick of pharma industry developments in the battle to halt the spread of Covid-19 from over the past week.
Vaccine shows robust immune responses
Interim results from the ongoing Phase I/II COV001 trial led by the University of Oxford has found that a potential vaccine, AZD1222, can be tolerated and generated robust immune responses against the SARS-CoV-2 virus.
The vaccine, which showed the result in all evaluated participants, was co-invented by the University of Oxford and its spin-out company Vaccitech. Phase I/II interim data demonstrated that AZD1222 could generate a rapid antibody and T-cell response against SARS-CoV-2.
The results, which were published in The Lancet, confirmed a single dose of AZD1222 resulted in a four-fold increase in antibodies to the SARS-CoV-2 virus spike protein in 95 per cent of participants one month after injection.
Professor Andrew Pollard, chief investigator of the Oxford Vaccine Trial at the University of Oxford and co-author of the trial, remarked: “The interim Phase I/II data for our coronavirus vaccine shows that the vaccine did not lead to any unexpected reactions and had a similar safety profile to previous vaccines of this type.
“The immune responses observed following vaccination are in line with what we expect will be associated with protection against the SARS-CoV-2 virus, although we must continue with our rigorous clinical trial program to confirm this.”
Pollard added that the team saw the strongest immune response in participants who had received two doses of the vaccine.
Late-stage Phase II/III trials are now underway in the UK, Brazil and South Africa, and are set to begin in the US.
Regulators will cooperate on Covid-19 vaccine claims WHO scientist
World Health Organization (WHO) chief scientist Soumya Swaminathan has said that country and regional regulators will cooperate and combine efforts to speed through approvals on Covid-19 vaccines when they become available.
With more than 200 Covid-19 vaccines in development, there has been concern about the speed with which the vaccines will be approved and made available to the general public.
Swaminathan warned: “While speed is important, it cannot be at the cost of compromising on the safety or the efficacy standards.”
The scientist’s comments came as animal tests of a potential Covid-19 vaccine being developed by Chinese researchers showed signs that it triggers an immune response against the novel coronavirus.
ARCoV, a messenger RNA vaccine, is the second potential Covid-19 vaccine China’s military-backed research unit has moved to clinical trials.
Prospective study focuses on personalizing treatment of severe Covid-19 patients
Researchers at Israel’s Rabin Medical Center have published prospective data, in collaboration with MeMed, on a host immune biomarker used in managing the care and treatment of patients with severe Covid-19 infection.
The study is the first of its kind to investigate how real-time measurements of IP-10, a host-immune protein biomarker, can be used to monitor and regulate inflammation in severe Covid-19 patients. The researchers used MeMed’s technology platform MeMed Key to conduct the study which revealed that the IP-10 biomarker could be a valuable resource for predicting disease severity and progression.
Dr. Boaz Tadmor, head of Rabin Medical Center’s Central Research Authority explained: “In the majority of Covid-19-positive patients, the host mounts a localized immune response sufficient to clear the virus from the upper airways and possibly the lungs, following which the immune response recedes and the patient recovers. But in some patients, less than 15 per cent, hyperinflammation or a ‘cytokine storm’ is triggered, which has been implicated in acute lung injury, multiple organ failure and mortality.
“A key challenge for clinicians in managing care for these patients is the lack of sufficient data on predictive biomarkers, as well as preventive measures and continuous ways to measure Covid-19-induced hyperinflammation,” Dr. Tadmor added.
Download 4G Clinical’s white paper to understand the challenges associated with basket and umbrella trial design within oncology studies and learn how to innovate your study design strategy to increase trial flexibility and agility during Covid-19.






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Keeping tabs on Covid-19: Vaccine results show encouraging signs in UK and China, as Israeli study offers hope to severe sufferers | PDR Pharmaceutical Keeping tabs on Covid-19: Vaccine results show encouraging signs in UK and China, as Israeli study offers hope to severe sufferers Following last week’s news that MIT and 3M were […]