Showing: 1 - 10 of 11 RESULTS

Beyond Celiac Chosen by 9 Meters Biopharma as Exclusive Patient Organization to Recruit for First-Ever Phase 3 Clinical Trial

Premier Patient Recruiter for Celiac Disease Research, Beyond Celiac Taps Extensive Network to Advance Study

Go Beyond Celiac, an online patient database launched in 2017, allows its thousands of users to participate in research by sharing their celiac disease stories and experiences and learn how to become involved in research studies such as the Phase 3
Go Beyond Celiac, an online patient database launched in 2017, allows its thousands of users to participate in research by sharing their celiac disease stories and experiences and learn how to become involved in research studies such as the Phase 3
Go Beyond Celiac, an online patient database launched in 2017, allows its thousands of users to participate in research by sharing their celiac disease stories and experiences and learn how to become involved in research studies such as the Phase 3

Philadelphia, PA, Oct. 14, 2020 (GLOBE NEWSWIRE) — Beyond Celiac, the leading catalyst for a celiac disease cure in the United States, today announced it has been chosen by 9 Meters Biopharma, Inc. (Nasdaq: NMTR) as the exclusive patient organization to recruit for the first-ever Phase 3-stage clinical trial therapeutic for treatment of celiac disease. Beyond Celiac will use its unrivaled connection to the celiac disease community and its powerful online patient database to recruit participants for the study of larazotide acetate, which aims to address leaky gut in celiac disease.

“We really listen to our community’s wants and needs. Because of our extensive connection to the people and commitment to connecting researchers with our community, Beyond Celiac has become the partner of choice for leading biotechnology and pharmaceutical companies such as 9 Meters,” said Beyond Celiac CEO Alice Bast. “This is the furthest a celiac disease clinical trial has gone, and it’s an exciting opportunity for our organization to play a vital role in fulfilling its promise.”

9 Meters Biopharma is evaluating larazotide acetate for celiac disease patients who continue to experience gastrointestinal symptoms while following a gluten-free diet. Designed to tighten junctions between intestinal cells, larazotide acetate would act like shoelaces to help restore leaky junctions to a normal state and would be used in addition to the gluten-free diet. It is being tested at more than 100 clinical sites, with a goal of 525 study participants. Results are expected by the end of 2021.

By partnering with Beyond Celiac for recruitment, 9 Meters Biopharma now has access to the power of Go Beyond Celiac, a secure online patient database with thousands of users who share their celiac disease stories and experiences with researchers and seek to become involved in studies.

“Our conservative estimate is that our celiac disease program is at least two years ahead of everyone else’s,” said John Temperato, president and CEO of 9 Meters Biopharma. “Beyond Celiac is going to help us across the finish line in developing the effective treatments that celiac patients deserve.”

Celiac disease is a serious genetic autoimmune disorder that affects an estimated 1 in 133 Americans, more than half of whom are still undiagnosed. The disease causes damage to the small intestine, resulting in debilitating symptoms, and if left untreated, can lead to serious long-term health problems including infertility and some types of cancer.


About Beyond Celiac

Founded in 2003,

Johnson & Johnson pauses clinical trials for a Covid vaccine over patient illness

Johnson & Johnson has paused its clinical trials for a Covid-19 vaccine following a patient illness, just weeks after it announced it was in its final stage.

A pause is not entirely unexpected in vaccine trials. When another vaccine trial was temporarily stopped last month, experts hailed the move, pointing to it as an example of the scientific rigor that is being maintained despite the understandably intense public interest for a Covid-19 vaccine.

The Johnson & Johnson trial was paused after an “unexplained” illness in one of its participants and in compliance with regulatory standards, the company said in a news release Monday night. The pharmaceutical company said the patient’s condition was being reviewed and evaluated by the ENSEMBLE independent Data Safety Monitoring Board.

“We must respect this participant’s privacy,” the company’s statement said. “We’re also learning more about this participant’s illness, and it’s important to have all the facts before we share additional information.”

It’s unclear whether the patient received the experimental vaccine or were in the placebo-control group.

AstraZeneca also started its Phase 3 vaccine trial last month but was placed on pause in the U.S. after a participant in the United Kingdom was reported to have developed a spinal cord injury. The company resumed its trial with Oxford University in the U.K. but was awaiting Food and Drug Administration approval to continue in the U.S.

Dr. Francis Collins, director of the National Institutes of Health, told NBC News last month that the pause should reassure those with concerns about possible vaccine safety issues.

“If anybody thinks we’re just glossing over these kinds of issues in the big rush to approve a vaccine, this ought to be reassuring,” Collins said during a “Doc to Doc” interview with NBC News medical correspondent Dr. John Torres, which was streamed on Facebook.

Pfizer and Moderna also have vaccine trials that went into Phase 3 in July, both of which require two doses about a month apart. The Johnson & Johnson vaccine is instead administered in one dose, avoiding the complicated coordination to require that people return in time for the second dose.

Johnson & Johnson announced last week that European Commission approved an advance purchase agreement from its parent company, Janssen Pharmaceutical Companies, for 200 million doses of the vaccine to E.U. member states following approval. The company also said it was looking to allocate up to 500 million vaccine doses toward international efforts for low-income nations.

Source Article

COVID-19 Antibodies Raise Unanswered Clinical Questions

While monoclonal antibody treatment may hold promise for COVID-19, its clinical benefit has yet to be proven, said experts from the Infectious Diseases Society of America (IDSA).

In a media briefing, IDSA experts discussed that while manufacturers of monoclonal antibody treatment, Regeneron and Eli Lilly, both applied for emergency use authorization (EUA) from the FDA to treat COVID-19, the data on both so far have yet to demonstrate any impact on patient care.

Reviewing the data, Adarsh Bhimraj, MD, co-chair of the IDSA COVID-19 Treatment and Management Guidelines Expert panel, noted how the endpoints of both trials examined decreases in viral load for patients. He characterized these as surrogate endpoints, or “disease-oriented endpoints,” which are only meaningful if they translate into patient-oriented outcomes, such as preventing death or disability.

“Curing the virus is not the same thing as curing the patient and making them better,” he said.

Bhimraj even compared these antibody therapies to the saga of hydroxychloroquine, which was also shown to have “a very fast reduction in viral load” in early studies, “but randomized controlled trials did not translate into patients getting better or not dying.”

Helen Boucher, MD, member of the IDSA Board of Directors, said she wanted to support the FDA in their efforts to make evidence-based decisions about EUAs, saying they wanted to keep “everyone assured when we make recommendations, they’re believable and everyone can feel good about them.”

Bhimraj pointed to the situation with convalescent plasma, which received an EUA outside the context of a randomized clinical trial.

“We don’t have clinical trial data and it’s been used in thousands and thousands of people,” he said. “An EUA is important, but … what are the consequences … of an EUA and what are the collateral effects, especially when other therapies exist?”

He emphasized how important it was to “let science and let objectivity … determine the decision-making rather than any kind of political pressure.”

Boucher noted that the difference between having enough data for an EUA application was different than having enough data for a decision to be made. She suggested if the FDA wanted more data, it could convene an advisory committee to help in the decision-making process, “but it’s not a requirement, as far as I know.”

She added that even if an EUA is issued, that’s only half the battle, given how much manufacturers would need to scale up to meet demand.

“Any kind of authorization or approval doesn’t necessarily mean the drug is available to anyone who needs it,” Boucher said.

Using the example of 50,000 people who may be infected with COVID-19 on any particular day, even 20% of those patients ending up in the hospital would require more product than the companies are prepared to produce right now. Boucher said it would take “months” to manufacture enough to treat everyone in this country who needs it.

Cost is potentially another issue, with the other existing COVID-19 treatments potentially being much less expensive. Boucher said the steroid, dexamethasone, costs

Rheumatoid arthritis drug cuts coronavirus deaths in clinical trial, Eli Lilly says

Eli Lilly and Company said on Thursday that there were fewer deaths among coronavirus patients who were given a combination therapy involving its rheumatoid arthritis drug and Gilead Sciences Inc’s GILD.O remdesivir drug compared to those who only received remdesivir.

The company has previously shared that the drug, baricitinib, which is marketed as Olumiant, in combination with remdesivir, was shown to cut hospitalization time for coronavirus patients. The findings come from a National Institute of Allergy and Infectious Diseases-sponsored trial dubbed the Adaptive COVID-19 Treatment Trial (ACTT-2).

The company previously shared that the drug, in combination with remdesivir, was shown to cut hospitalization time for coronavirus patients. 

The company previously shared that the drug, in combination with remdesivir, was shown to cut hospitalization time for coronavirus patients. 
(Photo courtesy of Eli Lilly)

In the data shared on Thursday, the company said that the largest benefits were observed in coronavirus patients requiring supplemental oxygen, and those who required high-flow oxygen/non-invasive ventilation.


“Using the ordinal scale that ranged from recovered to death, the odds of improvement in clinical status at Day 15 were 30% greater in patients being treated with baricitinib in combination with remdesivir compared with remdesivir,” the company said in a news release. “A numerical decrease in death (35%) through Day 29 was observed in patients treated with baricitinib plus remdesivir compared to remdesivir in the overall population.”

In coronavirus patients receiving oxygen, the difference was more pronounced. Mortality at Day 29 was 60% lower in patients requiring supplemental oxygen, and 43% lower for patients requiring high-flow oxygen/non-invasive ventilation.


Baricitinib is not currently approved by the FDA to treat COVID-19, although the company is gearing up to seek Emergency Use Authorization (EUA), according to the news release.

“We are excited that these results add to the potential role for baricitinib to treat hospitalized COVID-19 patients,” Ilya Yuffa, Lilly senior vice president and president of Lilly Bio-Medicines, said in a statement. “Lilly is committed to identifying impactful preventions and treatments, and we are engaged in discussions with the FDA regarding the potential to make baricitinib available to hospitalized patients as quickly as possible.”


The company said it is working to have the full trial analysis completed and a peer-reviewed manuscript “available soon.”

Source Article

ASH Releases Clinical Practice Guidelines on the Use of Preventive Anticoagulation in Patients with COVID-19

ASH Releases Clinical Practice Guidelines on the Use of Preventive Anticoagulation in Patients with COVID-19

PR Newswire

WASHINGTON, Oct. 8, 2020

Evidence-based recommendations will inform prevention of COVID-related blood clotting

WASHINGTON, Oct. 8, 2020 /PRNewswire/ — Today, ASH released new guidelines to help clinicians prevent serious blood clotting complications affecting COVID-19 patients. The recommendations suggest that clinicians should use a standard prophylactic anticoagulant dose over higher doses to prevent clotting in patients who have been hospitalized with COVID-19, including those in intensive care.

American Society of Hematology logo.
American Society of Hematology logo.

Abnormal blood clotting has been reported as a complication associated with increased risk of death in patients with COVID-19, particularly hospitalized patients. The guidelines address both critically ill hospitalized patients – people who are ill enough to require intensive care – and acutely ill hospitalized patients – people who require monitoring and treatment in the hospital but not intensive care. It is common for clinicians to administer anticoagulants to these patients upon admission to try to prevent formation of blood clots; however, there is uncertainty regarding the right dose to give. For both acutely and critically ill patients, the guidelines suggest the use of a standard prophylactic dose of anticoagulation upon admission to the hospital. The use of higher doses of anticoagulants is not recommended, as it may pose greater risk for serious bleeding that outweighs potential benefits. However, the guideline panel highlighted the importance of individualized decision-making and acknowledged that a higher dose of anticoagulants may be appropriate in patients judged to be at especially high clotting risk and low bleeding risk.

“COVID-19 is the most important public health problem of our lifetime, with more than one million deaths worldwide. Data suggest that abnormal blood clotting plays an important role in why patients die or get very sick from this disease. Thus, it is important that these patients be given anticoagulants to try to prevent clots, and data available right now suggest that standard dosing provides the best balance of benefits and risks,” said ASH President Stephanie Lee, MD, of Fred Hutchinson Cancer Research Center. “Equipping clinicians with evidence-based guidelines that focus on the prevention of clotting has the potential to save lives.”

In June 2020, ASH formed a multidisciplinary, internationally representative panel to develop the guidelines. The panel was chaired by Drs. Adam Cuker, of the University of Pennsylvania; Holger Schunemann, of McMaster University; and Reem Mustafa, of University of Kansas Medical Center. The panel urgently examined all available evidence, including early reports from observational studies. Development of these guidelines, including systematic evidence review, was supported by the McMaster University GRADE Centre, a world leader in guideline development. At this time, the best available evidence is very low quality, and the recommendations are framed with conditions, explanations, and a call for more research. The systematic reviews and recommendations will continue to be maintained and updated, especially as better evidence from randomized clinical trials becomes available.

“The development of these guidelines

Clinical Challenges: Managing Hyperkalemia Through Diet

It’s one of the biggest conundrums nephrologists face – how to prevent or treat chronic hyperkalemia by managing diet in patients with chronic kidney disease.

Hyperkalemia is the medical term that describes potassium levels in a patient’s blood that are higher than normal. Hence, the traditional recommendation for managing these with patients is to keep them off foods high in potassium.

The problem, as pointed out by Kamyar Kalantar-Zadeh, MD, MPH, PhD, chief of nephrology, hypertension, and kidney transplantation at the University of California Irvine School of Medicine, is that potassium is critical to the normal functioning of cells, and ensures the proper functioning of nerves and muscles, including the heart. “So potassium is extremely important,” he told MedPage Today, “And it has been shown to lower blood pressure, lower the risk of stroke and heart disease, and increase longevity.”

According to the National Kidney Foundation, a normal amount of potassium in the typical healthy American’s diet is 3,500 to 4,500 mg per day, while a potassium-restricted diet will usually be 2,000 mg per day. Foods that are high in potassium and likely to be targeted for restriction include many fruits and vegetables including such mainstays as bananas, avocados, and oranges.

“Everything that is healthy has potassium in it,” said Kalantar-Zadeh. “It is the quintessential component of fresh fruit and vegetables.”

Heart-healthy diets are therefore loaded with potassium, he continued. “So it is heartbreaking to have to tell a patient, or hear my dietitian tell patients, that they have to eliminate or limit foods like bananas, or avocados, or fruits and nuts – all of those things that are heart healthy.”

So, restricting diet can present patients and caregivers with therapeutic tradeoffs and associated challenges.

For example, a recent article in Kidney Medicine noted that low-potassium diets can adversely affect patients’ acid-base balance and intestinal microbiota, and result in nutritional deficiencies that reduce health-related quality of life.

The authors also wrote that patient adherence to these dietary restrictions can be problematic since it requires individualized dietary regimens and access to skilled dietitians and regular counseling – something that may not be too common in regular clinical practice. Furthermore, the article stated, there are a number of patient-reported barriers to adherence that are associated with diet restriction, including “a lack of appetite, craving salty foods, being too tired to cook, finding the diet bland and tasteless, difficulty tracking nutrient intake, feeling deprived, and lack of motivation to eat the right foods.”

Kalantar-Zadeh emphasized that while kidney disease has a close relationship with hyperkalemia, in many cases a patient’s condition can be managed before he or she develops chronic hyperkalemia. That does entail a close look at diet, but restriction does not have to mean elimination, he said.

In an article in Nutrients that Kalantar-Zadeh co-authored, he and his colleagues emphasized that careful control of the dietary potassium load is an important aspect of the management of chronic kidney disease and heart failure patients with, or at risk of hyperkalemia.


AIM ImmunoTech Announces IRB Approval to Enroll COVID-19 ‘Long Haulers’ in the AMP-511 ME/CFS Clinical Trial of Ampligen

COVID-19 Patients May Continue to Experience Chronic Fatigue-Like Symptoms

Charles Lapp, MD

Charles Lapp, MD, at a recent AIM ImmunoTech Inc. planning meeting on COVID-19-induced chronic fatigue in ‘Long Haulers,’ at the Hunter-Hopkins Center, Charlotte, N.C.
Charles Lapp, MD, at a recent AIM ImmunoTech Inc. planning meeting on COVID-19-induced chronic fatigue in ‘Long Haulers,’ at the Hunter-Hopkins Center, Charlotte, N.C.
Charles Lapp, MD, at a recent AIM ImmunoTech Inc. planning meeting on COVID-19-induced chronic fatigue in ‘Long Haulers,’ at the Hunter-Hopkins Center, Charlotte, N.C.

OCALA, Fla., Oct. 06, 2020 (GLOBE NEWSWIRE) — AIM ImmunoTech Inc. (NYSE American: AIM) is pleased to announce that it has received Institutional Review Board (IRB) approval for the expansion of the AMP-511 Expanded Access Program (EAP) clinical trial for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) to include patients previously diagnosed with SARS-CoV-2, but who still demonstrate chronic fatigue-like symptoms. Patients in the trial are treated with AIM’s flagship pipeline drug Ampligen.

These patients — commonly referred to as Post-COVID-19 Chronic Fatigue (PCCF) / “Long Haulers” because of the persistence of their symptoms — will be able to receive Ampligen treatments alongside the ME/CFS patients in the EAP. Up to 20 of the 100 active participants can be Long Haulers, according to the new trial protocol amendment. AIM is currently preparing the IRB-approved protocol for submission to the U.S. Food and Drug Administration (“FDA”).

“It is anticipated that COVID-19 will trigger a large number of CFS cases, providing an opportunity for the medical community to learn more about the onset and pathogenesis of CFS,” according to Charles Lapp, MD, a global expert in ME/CFS. “The investigational immune-modulating antiviral drug Ampligen might have a role to play in this scenario.”

Many survivors of the first SARS-CoV-1 epidemic in 2003 continued to report classic chronic fatigue-like symptoms after recovering from the acute illness. In fact, approximately 27% of survivors met the CDC criteria for chronic fatigue syndrome (See: There is now increasing evidence that patients with COVID-19 — the disease caused by SARS-CoV-2 — can develop a similar, ME/CFS-like illness (See: AIM CEO Thomas K. Equels states, “With millions of U.S. cases of COVID-19 already on record we can expect a tidal wave of new U.S. cases of COVID-19 sufferers who will exhibit serious chronic fatigue-like symptoms. In addition, unpublished data from AIM indicates that ME/CFS patients respond better to Ampligen the earlier they receive the drug, so enrolling ‘Long Haulers’ earlier in their diagnosis could potentially benefit these patients while also providing valuable information for all ME/CFS patients.”

In June, AIM filed a provisional utility patent application for Ampligen as a potential therapy for COVID-19-induced ME/CFS-like illness (See:

About AIM ImmunoTech Inc.
AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus.

Cautionary Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act (PSLRA) of 1995. Words such as “may,” “will,” “expect,” “plan,” “anticipate” and similar expressions (as well as other words or expressions referencing

Eyenovia to Present Clinical Study Updates at the American Academy of Optometry Annual Meeting

Optometry and ophthalmology doctors to present latest analyses and updates from studies of its MAP therapeutics for mydriasis, pediatric myopia and presbyopia

Eyenovia, Inc. (NASDAQ: EYEN), a clinical stage ophthalmic biopharmaceutical company developing a pipeline of microdose array print (MAP™) therapeutics, today announced that Drs. Siddarth Rathi and April Jasper will present the latest analyses and updates from the company’s clinical studies at the American Academy of Optometry Academy 2020 At Home Con.

This press release features multimedia. View the full release here:

On Wednesday, October 7, April Jasper, OD, medical monitor for the company’s CHAPERONE study and member of the Eyenovia Scientific Advisory Board, will provide pre-recorded updates on the CHAPERONE (evaluation of low-dose atropine for the reduction of pediatric myopia progression) and the VISION (evaluation of low-dose pilocarpine for improvement in near vision) clinical trials. Dr. Jasper will also provide an update on the company’s upcoming Mydcombi (low-dose tropicamide and phenylephrine fixed combination for pupil dilation) NDA filing with the U.S. Food and Drug Administration (FDA).

On Thursday, October 8 at 6 p.m. EDT, Siddarth Rathi, MD, of The Eye Institute of West Florida and medical monitor for the MIST 1 and MIST 2 studies, will present additional analyses of data from the MIST 1 and MIST 2 studies of Eyenovia’s proprietary first-in-class fixed combination microdose formulation of phenylephrine and tropicamide for mydriasis (pupil dilation). Clinical results will cover Pupil Dilation Speed with MAP™ Fixed Combination (FC) Tropicamide 1% Phenylephrine 2.5% (TR-PH)-Ophthalmic Solution.

About Eyenovia

Eyenovia, Inc. (NASDAQ: EYEN) is a clinical stage ophthalmic biopharmaceutical company developing a pipeline of microdose array print (MAP™) therapeutics. Eyenovia’s pipeline is currently focused on the late-stage development of microdosed medications for presbyopia, myopia progression and mydriasis. For more Information, please visit

About MicroPine for Progressive Myopia

MicroPine (atropine ophthalmic solution) is being evaluated in the CHAPERONE Phase 3 clinical study for reduction in pediatric myopia progression. Progressive myopia is estimated to affect close to 5 million children in the United States who suffer from uncontrolled axial elongation of the sclera leading to increasing levels of myopia and in some cases major pathologic changes such as retinal atrophy, myopic maculopathy, retinal detachment, posterior subcapsular cataract, glaucoma and visual impairment. MicroPine has been developed for comfort, hygiene and ease-of-use in children. Microdose administration of MicroPine is anticipated to result in low systemic and ocular drug exposure. A recent therapeutic evidence assessment and review by the American Academy of Ophthalmology indicates Level 1 (highest) evidence of efficacy for the role of low dose atropine for progressive myopia (Ophthalmology 2017;124:1857-1866; Ophthalmology 2016; 123(2) 391:399).

Feasibility Dose-finding Atropine Studies: ATOM 1; ATOM 2; LAMP (Independent Collaborative Group Trials)

About MicroLine for Presbyopia

MicroLine (pilocarpine ophthalmic solution) is a pharmacologic treatment for presbyopia which will be evaluated in the VISION 1 and VISION 2 Phase 3 clinical studies. Presbyopia is the non-preventable, age-related hardening of the natural lens, which causes a gradual loss of the eye’s ability to accommodate or focus on nearby

Insilico Medicine launches new system for COVID-19 basic and clinical research

Today Insilico Medicine, a global leader in artificial intelligence for drug discovery and development, announced the launch of a new system for COVID-19 basic and clinical research. COVIDomic is a foundational technology that enables scientists to use anonymized patient data to integrate with a variety of existing data sets.

Bioinformatics and Artificial Intelligence (AI) tools can then be applied in many ways, starting with better stratifying COVID-19 patients, understanding the disease trajectory and identifying relevant disease pathways and targets.

COVIDomic is built using massive multi-omics data sets, sophisticated dimensionality reduction algorithms and deep learning systems. This amount of computing will rely on Intel Xeon processors.

The development team is inviting scientists globally to contribute to the development of the system and engage in active research collaborations.

COVIDomic is a cloud-based platform that uses AI approaches to identify risk factors associated with severe disease progression.

A researcher can upload wide combinations of patient data, including viral and human genomes, rich metadata (describing patient’s lifestyle, co-morbid disorders and biological age), results of blood tests and even transcriptomic sequencing of lung fluid or nasal swabs (to identify changes in microbial communities).

As a result, the platform identifies the minimum number of relevant features that could be used to define severe disease progression for a given population.

COVIDomic is an open access tool to stratify risk and severity from multimodal data sets, including multi-omics data. Insilico Medicine’s AI-driven generative biology approach is a unique offering in the marketplace. We are part of many COVID-19 consortiums and collaborations but COVIDomic is a system that will help scientists and researchers alike to predict the severity of the disease.”

Alex Zhavoronkov, PhD, Founder and CEO, Insilico Medicine

“By predicting outcomes, clinicians can establish protocols and treatments we hope will reduce the severity and mortality of infection.”

“Analyzing massive amounts of data – quickly – across geographies and data sets is essential for gaining insights into how the novel coronavirus affects people across the world,” noted Rick Echevarria, Intel Vice President, Sales, Marketing, and Communications Group.

“Intel computing power enables AI that can help researchers in the fight against COVID-19. We hope that by sharing our expertise, resources and technology we can help accelerate research across diverse geographies and with companies such as Insilico Medicine.”

Source Article

Clinical Trials Hit by Ransomware Attack on Health Tech Firm

The incidents also follow more than a thousand ransomware attacks on American cities, counties and hospitals over the past 18 months. The attacks, once treated as a nuisance, have taken on greater urgency in recent weeks as American officials worry they may interfere, directly or indirectly, with the November election.

A ransomware attack in Germany resulted in the first known death from a cyberattack in recent weeks, after Russian hackers seized 30 servers at University Hospital Düsseldorf, crashing systems and forcing the hospital to turn away emergency patients. As a result, the German authorities said, a woman in a life-threatening condition was sent to a hospital 20 miles away in Wuppertal and died from treatment delays.

ERT’s clients at IQVIA and Bristol Myers Squibb said they had been able to limit problems because they had backed up their data, but the attack forced many clinical trial investigators to move to pen and paper.

In a statement, IQVIA said that the attack had “had limited impact on our clinical trials operations,” and added, “We are not aware of any confidential data or patient information, related to our clinical trial activities, that have been removed, compromised or stolen.”

Pfizer and Johnson & Johnson, two companies working on a coronavirus vaccine, said their coronavirus vaccine trials had not been affected.

“ERT is not a technology provider for or otherwise involved in Pfizer’s Phase 1/2/3 Covid-19 vaccine clinical trials,” Amy Rose, a spokeswoman for Pfizer, said.

Companies and research labs on the front lines of the pandemic have been repeat targets for foreign hackers over the past seven months, as countries around the world try to gauge one another’s responses and progress in addressing the virus. In May, the F.B.I. and the Department of Homeland Security warned that Chinese government spies were actively trying to steal American clinical research through cybertheft.

Source Article