SARS-CoV-2

COVID-19 neutralising antibody tests – an integrated approach

Nina Garrett, R&D director at Abingdon Health discusses the key role antibody testing is playing in the pandemic and how an integrated approach with vaccines could help life resume. Millions of tests for COVID-19 are taken worldwide every day, as they become an increasingly important tool for our return to normality. Testing programmes have been …

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ViewPoints Interview: Maxwell Biosciences’ Dr. Gill Diamond and Joshua McClure Share Insights Novel Peptoids with Potent Antiviral Activity Against HSV-1 and SARS-CoV-2

In an interview with PharmaShots, Dr. Gill Diamond, Scientific Advisory Board Member and Joshua McClure, CEO and Co-founder of Maxwell Biosciences share their views on the news findings of the company published in MDI that demonstrated that several peptoids exhibit potent in vitro antiviral activity against both HSV-1 and SARS-CoV-2. Shots: The studies showed that …

ViewPoints Interview: Maxwell Biosciences’ Dr. Gill Diamond and Joshua McClure Share Insights Novel Peptoids with Potent Antiviral Activity Against HSV-1 and SARS-CoV-2 Read More »

BMS and Xencor Collaborate to Use Xtend XmAb Technology in SARS-CoV-2 Neutralizing mAb Combination for COVID-19

Shots: BMS to get non-exclusive access to Xencor’s Xtend Fc technology to extend the half-life of a novel Ab combination therapy that is intended to neutralize the SARS-CoV-2 virus to prevent COVID-19 BMS will solely lead research, development, regulatory and commercial activities for SARS-CoV-2 mAb Duo. Xencor is eligible to receive royalties from the sales …

BMS and Xencor Collaborate to Use Xtend XmAb Technology in SARS-CoV-2 Neutralizing mAb Combination for COVID-19 Read More »

Cell-Mediated Therapies for Infectious Disease Summit

In the fight against emerging coronavirus variants and spike mutations, the need for long-lasting immunity is greater than ever. This is why the time is now to look beyond antibodies and capitalize on the long-term immune response of T cell therapies. The Cell-Mediated Therapies for Infectious Disease Summit is the first and only meeting focused on novel …

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Qiagen’s PCR Tests Demonstrate Effectiveness in Detecting Mutations in SARS-CoV-2 Virus

Shots: Qiagen’s QIAstat-Dx and NeuMoDx tests remain accurate & effective in detecting SARS-CoV-2 infections The company started cross-checking variants in May’2020 & assessed the tests against genetic mutations of the virus uploaded to the GISAID and GenBank public databases. Qiagen will continue to conduct assessments on a biweekly basis Variants with potentially increased transmissibility include …

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Sorrento Presents Preliminary Results of STI-2020 Against COVID-19

Shots: The company presents the ongoing program of SARS-CoV-2 mutation surveillance for STI-2020 currently in pre/ clinical development for COVID-19 The data provides evidence of maintained binding potency in in vitro assays including the Spike amino acid changes found in SARS-CoV-2 viruses of the B.1.1.7 lineage, identified in the UK Additional neutralizing Abs were identified …

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Birinapant licensing; AvantGen, IGM pairs up for anti-SARS-CoV-2 antibodies; BeiGene, Novartis to co-dvelop Tislelizumab; Valo raises USD190 M; Bluebird Bio Spins-off

Medivir, IGM Biosciences enters into an exclusive licensing agreement for Birinapant Medivir AB has entered into an exclusive licensing agreement with IGM Biosciences to receive global, exclusive development rights for Birinapant. Birinapant is a clinical-stage SMAC mimetic that degrades Inhibitors of Apoptosis Proteins (IAPs) by binding to them, ultimately leading to cell death in tumor …

Birinapant licensing; AvantGen, IGM pairs up for anti-SARS-CoV-2 antibodies; BeiGene, Novartis to co-dvelop Tislelizumab; Valo raises USD190 M; Bluebird Bio Spins-off Read More »

ViewPoints Interview: Neoleukin’s Daniel-Adriano Silva Shares Insight on Novel Protein Designed to Treat or Block SARS-COV-2

In a recent interview with PharmaShots Daniel-Adriano Silva, PhD, Co-founder and Vice President Head of Research at Neoleukin shared the significance and promise of the findings published in Science and discuss the details of its De Novo Protein Design Shots: NL-CVX1 (CTC-445.2d) demonstrated the ability to prevent infection of multiple human cell lines in vitro and …

ViewPoints Interview: Neoleukin’s Daniel-Adriano Silva Shares Insight on Novel Protein Designed to Treat or Block SARS-COV-2 Read More »

Roche Launches Elecsys SARS-CoV-2 Antigen Test to Support High-Volume COVID-19 Testing

Shots: Roche has launched Elecsys SARS-CoV-2 Ag test as an aid in the diagnosis of SARS-CoV-2 infections, in the markets accepting the CE Mark. Additionally, Roche has also filed a EUA to the US FDA The test showed 94.5% sensitivity across 200 PCR confirmed symptomatic individuals & 99.9% specificity across 2747 PCR negative symptomatic & …

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UK groups get £12m funding for COVID-19 monitoring software

Researchers at the Wellcome Sanger Institute in the UK are working on software to monitor the genome of SARS-CoV-2 coronavirus in the hope of spotting changes that could affect the fight against COVID-19. Backed by £12.2 million in UK government funding, Wellcome Sanger and the COVID-19 Genomics UK (COG-UK) Consortium intend to develop a real-time …

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Qiagen Launches Portable Digital SARS-CoV-2 Antigen Test in the US

Shots: Qiagen has initiated the commercialization of the portable digital QIAreach SARS-CoV-2 antigen test in the US that can be used by laboratories to detect active infections in 2-15mins. The test provides a higher throughput testing for SARS-CoV-2 antigen by processing up to 8 tests/ hub. The digital results do not need subjective interpretation and …

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Lilly seeks emergency clearance for Covid-19 monoclonal antibodies on Phase II data

The company announced data on the combination of two antibodies against the SARS-CoV-2 virus, showing significant reductions in viral load compared with placebo. The company has applied for an EUA for LY-CoV555 and will seek an authorization for the combination of that drug with LY-CoV016 next month.

FDA issues Covid-19 vaccine guidance as White House reportedly relents

The guidance calls for a median two months’ worth of follow-up safety data from well-designed Phase III studies as a precondition for a vaccine receiving an EUA. The Wall Street Journal reported that the White House had backed down in its opposition to the guidance, which pushes the date of an EUA past Election Day.

BioNTech and Pfizer Initiates Rolling Submission to EMA for SARS-CoV-2 Vaccine Candidate, BNT162b2

Shots: The Rolling Submission is based on the preliminary results from pre-clinical and early clinical studies in adults, which shows that BNT162b2 triggers the production of neutralizing antibodies and TH-1 dominant CD4+ and CD8+ T cells that target SARS-CoV-2. BioNTech and Pfizer plan to work with the EMA’s CHMP to complete the rolling review process …

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Amid mixed messages about his Covid-19 diagnosis, Trump looks like a one-man clinical trial

While the White House and doctors at Walter Reed have sought to reassure the public that Trump’s condition is improving, he has received numerous drugs for Covid-19, including the steroid dexamethasone, which is typically administered only to those who are critically ill.

Report: FDA takes closer look at adverse event that occurred in AstraZeneca Covid-19 vaccine study

Reuters reported Wednesday that U.S. regulators would look at data from previous clinical trials that came from the same scientists who created the vaccine, AZD1222, which originated at the University of Oxford and is also known as ChAdOx1 nCoV-19.

Moderna’s Covid-19 vaccine shows antibody, T-cell responses a month after second dose in interim Phase I data

The company published interim data from the Phase I study of mRNA-1273 in 40 older and elderly adults, showing responses comparable to those seen in younger adults. The vaccine is being tested in a 30,000-participant Phase III trial.

AstraZeneca starts Phase I study of long-acting double-antibody cocktail for Covid-19

The drug, AZD7442, is designed to potentially provide at least six months of protection from Covid-19. The trial, which is funded by federal defense and health authorities in the U.S., is enrolling up to 48 healthy volunteers in the U.K. AstraZeneca’s double-antibody approach is similar to that of Regeneron and Roche with their drug, REGN-COV2.

Study uses genomic data to trace Covid-19 ‘superspreader’ event linked to February Biogen exec meeting

The study, by researchers at Harvard, MIT, The Broad and other institutions, used genomic analysis of cases linked to the Biogen meeting, linking much of the community transmission in the Boston area to a European genetic variant of SARS-CoV-2 that first appeared at the meeting.

Qiagen to Launch Digital Test for Detecting SARS-CoV-2 Antibodies in the US

Shots: Qiagen reports the launch of the Access Anti-SARS-CoV-2 Total test that runs on a portable device and provides accurate results on Total Ig Abs (IgA, IgM, IgG) in 10mins. The device can process up to 8 samples simultaneously or up to 32 tests/hour The test was developed in collaboration with Ellume, following the US …

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Stephen Hahn and the terrible, horrible, no good, very bad FDA weekend

The FDA commissioner took to Twitter Monday night to defend his performance at the agency, which came under sharp criticism amid accusations that the authorization of a plasma treatment for Covid-19 was politically motivated and that he stood by while President Trump unfairly maligned FDA staffers, prompting calls for his resignation.

FDA’s emergency authorization for convalescent plasma in Covid-19 sparks controversy

While the emergency use authorization granted Sunday was not seen as scientifically unwarranted, it drew concerns from some experts that it could hinder enrollment in clinical trials, while the timing and circumstances of the FDA’s move fueled suspicions that political pressure – rather than science and data alone – may have played a role.

Trump launches baseless attack on FDA; agency controversially authorizes plasma treatment for Covid-19

Over the weekend, Trump called the agency, without evidence, part of a “deep state” that was slow-walking vaccines and drugs for Covid-19. The next day, the agency authorized convalescent plasma despite having turned it down shortly before due to insufficient evidence.

UK doctors call for tighter rules on coronavirus antibody tests

Doctors have called for rules to be tightened on coronavirus antibody tests in the UK amid fears that false readings could put the public at risk. It’s not even known for sure that having antibodies against the SARS-CoV-2 coronavirus confers immunity. But with many other diseases the presence of specific antibodies indicates that the body …

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ViewPoints: COVID-19 Vaccine Distribution the Next Supply Chain Frontier

An overview of various aspects of the supply chain that would be crucial in the production and distribution of COVID-19 Vaccine. Write to us at connect@pharmashots.com if you want a PDF copy of this report. Over the past seven months, the global pandemic caused by the spread of SARS-CoV-2, the virus that leads to coronavirus …

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Report: FDA halted move to authorize convalescent plasma for Covid-19 over evidence concerns

The New York Times reported that the FDA was prepared to issue an emergency use authorization for the treatment last week, but NIH Director Francis Collins and NIAID Director Anthony Fauci intervened, arguing that data were too weak.

Could AI avert a future coronavirus pandemic?

Could AI prevent future pandemics by developing an armoury of drugs that work against all coronaviruses? This is a question that a consortium of European pharma companies hopes to answer as it aims to rapidly develop new therapies to combat the pandemic. The Corona Accelerated R&D in Europe (CARE) has been hastily set up by …

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Trials of Gilead’s remdesivir in Covid-19 not diverse enough, experts write

In a commentary, physicians and pharmacists wrote that percentages of Black, Latino and Native American patients in two Phase III studies of the drug that the company is using for FDA approval were disproportionate to Covid-19’s incidence in those communities.

Moderna secures more than $1.5B federal government deal to provide Covid-19 vaccine

The agreement, which includes 100 million doses of mRNA-1273 and an option to acquire 400 million more, brings the total amount of money the biotech company has received from the federal government for its vaccine efforts to nearly $2.5 billion.

Report: Russia says its Covid-19 vaccine ready for market despite no Phase III data

Russian President Vladimir Putin said a vaccine developed at a Moscow research institute that appears to still be in Phase I development among fewer than 100 participants had undergone all necessary tests.

Big Pharma plays CMO as Pfizer signs on to produce Covid-19 drug remdesivir for Gilead

Gilead Sciences had said in its second-quarter earnings that it would partner with companies in North America, Europe and Asia to manufacture the antiviral drug, which received an emergency use authorization from the FDA in May.

Vela Diagnostics’ ViroKey SARS-CoV-2 RT-PCR Test Receives the US FDA’s Emergency Use Authorization

Shots: The US FDA has granted EUA to the Vela’s PCR test that detects SARS-CoV-2 in nasopharyngeal and oropharyngeal swabs The manual version of the ViroKey enables flexible sample processing and quick adoption of the test by laboratories with existing ABI 7500 Fast Dx instruments but for high throughput testing, an automated version of the …

Vela Diagnostics’ ViroKey SARS-CoV-2 RT-PCR Test Receives the US FDA’s Emergency Use Authorization Read More »

Platform study designed to rapidly screen potential Covid-19 drugs enrolls first patients

Three of the companies making drugs used in the Phase II I-SPY COVID-19 study – Amgen, AbbVie and Takeda – announced the patient enrollments Monday. The study, which will enroll up to 1,500 critically ill patients, could test around 10 drugs.

Pfizer, BioNTech score deal to supply 120M Covid-19 vaccine doses to Japan

Financial terms of the deal were not disclosed, but it follows a $1.95 billion contract between the two companies and the U.S. government. Assuming clinical trial success and regulatory approval, they would supply the vaccines in early 2021, ahead of the rescheduled Tokyo Olympics.

Sanofi, GSK nab $2.1B deal from federal government to provide Covid-19 vaccine

The companies will provide 100 million doses of their jointly developed vaccine. But with a Phase I/II study planned in September, it is behind in development compared with those of Moderna and Pfizer and BioNTech, which have already started late-stage clinical testing.

Moderna snags another $472M from BARDA, launches Phase III Covid-19 vaccine trial

The company had received $483 million from BARDA in April to fund the development of the vaccine, mRNA-1273, through Phase III, but that amount was based on a smaller anticipated number of participants than the 30,000 it now plans to enroll into the trial, named COVE.

Moderna gets further $472m as expanded phase 3 COVID-19 trial begins

A US government agency is to give a further $472 million to biotech Moderna, after it announced plans to expand a phase 3 trial for its potential COVID-19 jab. The latest funding from the Biomedical Advanced Research and Development Authority follows a tranche worth $483 million, awarded to kick-start development of Moderna’s mRNA-based vaccine codenamed …

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Pfizer, BioNTech get $1.95B from HHS to supply Covid-19 vaccine

The companies will supply 100 million doses of the vaccine by the end of the year, and the government will have the option to acquire 500 million more. However, the FDA must grant an authorization based on its safety and efficacy, for which there are only preliminary data so far.

Synairgen says inhaled biologic lowered risk of Covid-19 worsening in hospitalized patients

The company said that patients receiving the drug, SNG001, had a 79% lower risk of requiring ventilation or dying compared with those on placebo, sending the company’s stock soaring more than 400%, but it did not clarify what that meant in terms of patient numbers.

FDA guidance eases some Covid-19 vaccine concerns, but others remain

Amid fears of a premature emergency use authorization for a Covid-19 vaccine granted for political reasons, the guidance that the FDA released at the beginning of the month sets much tougher standards. But trial enrollment, anti-vaccine sentiment and other potential problems persist.

Sinopharm launches Phase III trial of inactivated-virus vaccine in Abu Dhabi

The Beijing company said it selected the United Arab Emirates because of its ethnic diversity, which will enable it to determine the feasibility of taking its program global. It claims that its study is the first Phase III inactivated vaccine trial, but another Chinese firm has also launched one in Brazil.

Russian hackers suspected in Covid-19 vaccine intellectual property theft, report says

A joint report by cybersecurity agencies in the U.K. and Canada, endorsed by their U.S. counterparts, states that the hacker group Cozy Bear had been targeting organizations involved with Covid-19 vaccine development efforts.

Moderna publishes Phase 1 Covid-19 vaccine data showing robust immune responses

Evaluation of durability is still under evaluation, but the responses to mRNA-1273 show neutralizing antibody titers multiple times higher than those of recovered patients. Additionally, T-cell responses suggest potentially lower risk of enhanced respiratory disease.

Gilead Covid-19 drug remdesivir benefited from $6.5B in NIH-funded basic research, study finds

Research on the drug’s molecular target dates back to the 1950s. A spokesperson for Gilead noted that the company anticipates potentially investing more than $1 billion on the drug this year alone.

NIAID launches clinical trial network for preventive drugs, vaccines against Covid-19

The NIAID create the Covid-19 Prevention Trials Network by combining four existing ones, primarily focused on HIV and AIDS, which will continue that work in addition to their new focus on Covid-19.

BARDA, DoD give Regeneron $450M contract for Covid-19 antiviral drug

The contract covers manufacture and supply of the two-antibody drug cocktail REGN-COV2. The company had announced Monday that it entered the drug into three late-stage clinical studies, both as a treatment for existing SARS-CoV-2 infections and a preventive treatment for healthy exposed people.

Regeneron starts late-stage trials of antiviral antibody cocktail in Covid-19

The company also said that the Phase III study of the autoimmune disease drug Kevzara that it was running with Sanofi failed to meet either its primary or key secondary endpoints among critically ill Covid-19 patients.

The FAIR Toolkit Helps Researchers with Data Challenges

Since the spread of COVID-19 was first reported, researchers of all types have mobilized to meet the challenges its causative agent, SARS-CoV-2, presents to the world. Data scientists in particular have been quick to apply their expertise to the problems of identifying, tracking and predicting outbreaks; diagnosing COVID-19; identifying infected individuals and detecting non-compliance with …

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Drug Repurposing for SARS-CoV-2 Using Network Polypharmacological Approach

Drug development is a multidisciplinary field that requires a drug to successfully pass through different stages — from chemical design to biological experimentation on cells and animals, and finally three phases of human clinical trials — before being approved by the FDA for clinical administration. However, following such a path would not be feasible under …

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Coronavirus: 5 Ways You Can Use Social Media and Digital Marketing to Help the Public During the COVID-19 Pandemic

Today I am going to share some important ways that doctors, hospitals and healthcare marketers can use social media to inform the public during the COVID-19 crisis. Priority One: Use social media to convince people to comply with social distancing, and consequently help us all, “flatten the curve!” The US Surgeon General, Dr. Jerome Adams, …

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