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Genome analyses track SARS-CoV-2's early introduction to the US and Europe

Fri, 09/11/2020 - 10:00
SARS-CoV-2 arrived in Washington State somewhere between late January and early February 2020, sparking rapid community transmission of the virus that went undetected for several weeks before this community spread became evident, prompting a change in testing criteria to emphasize individuals with no travel history. That's the scenario proposed by Trevor Bedford and colleagues after their analysis of the genetic sequences of 455 SARS-CoV-2 viruses from the Washington State outbreak collected between January 19 and March 15, 2020.

CureVac expected to receive up to 252 million euros from the German Federal Ministry of Research for further COVID-19 vaccine development and production capacity expansion

Thu, 09/10/2020 - 13:00
CureVac N.V. (Nasdaq: CVAC), a biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (mRNA) in clinical trials, has received notification from the German Federal Ministry of Education and Research (BMBF) that CureVac is expected receive up to 252 million euros to support the development of its COVID-19 vaccine candidate.

Sinovac reports preliminary Phase I/II results of COVID-19 vaccine in elderly volunteers

Thu, 09/10/2020 - 12:00
Sinovac Biotech Ltd. (NASDAQ: SVA) ("Sinovac" or the "Company"), a leading provider of biopharmaceutical products in China, announced that the inactivated COVID-19 vaccine candidate developed by Sinovac Life Sciences (Sinovac LS), or "CoronaVac," shows good safety and immunogenicity on healthy adults aged 60 and above from its phase I/II clinical studies conducted in China, which is comparable to the result in healthy adults aged from 18 to 59 in the earlier studies.

COVID-19 study links strict social distancing to much lower chance of infection

Thu, 09/10/2020 - 10:00
Using public transportation, visiting a place of worship, or otherwise traveling from the home is associated with a significantly higher likelihood of testing positive with the coronavirus SARS-CoV-2, while practicing strict social distancing is associated with a markedly lower likelihood, suggests a study from researchers at the Johns Hopkins Bloomberg School of Public Health.

Pfizer and BioNTech announce data from preclinical studies of mRNA-based vaccine candidate against COVID-19

Wed, 09/09/2020 - 12:00
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced preliminary preclinical data in mouse and non-human primate models from their BNT162b2 mRNA-based vaccine program against SARS-CoV-2, the virus that causes COVID-19 disease. In a non-human primate preclinical study, immunization with the BNT162b2, a nucleoside-modified messenger RNA (modRNA) candidate, protected rhesus macaques against SARS-CoV-2 infection.

Statement on AstraZeneca Oxford SARS-CoV-2 vaccine, AZD1222, COVID-19 vaccine trials temporary pause

Wed, 09/09/2020 - 10:00
As part of the ongoing randomised, controlled clinical trials of the AstraZeneca Oxford coronavirus vaccine, AZD1222, a standard review process has been triggered, leading to the voluntary pause of vaccination across all trials to allow an independent committee to review the safety data of a single event of an unexplained illness that occurred in the UK Phase III trial.

Small study shows convalescent plasma is safe to use in pediatric patients with COVID-19

Tue, 09/08/2020 - 12:00
Early findings from researchers at Children's Hospital of Philadelphia (CHOP) show that convalescent plasma appears to be a safe and possibly effective treatment for children with life-threatening cases of COVID-19. The results were published online Friday by the journal Pediatric Blood and Cancer.

Biopharma leaders unite to stand with science

Tue, 09/08/2020 - 10:00
The CEOs of AstraZeneca (LSE/STO/NYSE: AZN), BioNTech (NASDAQ: BNTX), GlaxoSmithKline plc (LSE/NYSE: GSK), Johnson & Johnson (NYSE: JNJ), Merck (NYSE: MRK), known as MSD outside the United States and Canada, Moderna, Inc. (Nasdaq: MRNA), Novavax, Inc. (Nasdaq: NVAX), Pfizer Inc. (NYSE: PFE), and Sanofi (NASDAQ: SNY), today announced a historic pledge, outlining a united commitment to uphold the integrity of the scientific process as they work towards potential global regulatory filings and approvals of the first COVID-19 vaccines.

Johnson & Johnson announces that Janssen's COVID-19 investigational vaccine candidate prevents severe clinical disease in pre-clinical studies

Mon, 09/07/2020 - 12:00
Janssen's lead SARS-CoV-2 investigational vaccine candidate, Ad26.COV2.S, prevented severe clinical disease in Syrian golden hamsters, upon challenge with SARS-CoV-2, the virus that causes COVID-19 in people. The data, published in Nature Medicine, demonstrated that the Company's investigational adenovirus serotype 26 (Ad26) vector-based vaccineJanssen's lead SARS-CoV-2 investigational vaccine candidate, Ad26.COV2.S, prevented severe

Don't fall for the 'next best action' trap

Mon, 09/07/2020 - 10:00
15 September, 2020. London, UK.
OKRA has announced a new, free webinar called 'Why Next Best Action is not enough', a panel will discuss the urgent need to move beyond the current trend of adding simplistic or 'dumb' AI tools to sales force dashboards.

These AI tools make sense for managers - they are very easy to apply, inexpensive, and give reps an enhanced view of the market - but in the medium-to-long term will likely cause more harm than good.

Preliminary results from Russian trials find that vaccine candidates led to no serious adverse events and elicit antibody response

Fri, 09/04/2020 - 10:00
Results from two early-phase Russian non-randomised vaccine trials (Sputnik V) in a total of 76 people are published today in The Lancet, finding that two formulations of a two-part vaccine have a good safety profile with no serious adverse events detected over 42 days, and induce antibody responses in all participants within 21 days.

Sanofi and GSK initiate Phase 1/2 clinical trial of COVID-19 adjuvanted recombinant protein-based vaccine candidate

Thu, 09/03/2020 - 12:00
Sanofi and GSK today started the Phase 1/2 clinical trial for their adjuvanted COVID-19 vaccine. The vaccine candidate, developed in partnership by Sanofi and GSK, uses the same recombinant protein-based technology as one of Sanofi's seasonal influenza vaccines with GSK's established pandemic adjuvant technology.

Vitamin D deficiency may raise risk of getting COVID-19

Thu, 09/03/2020 - 10:00
In a retrospective study of patients tested for COVID-19, researchers at the University of Chicago Medicine found an association between vitamin D deficiency and the likelihood of becoming infected with the coronavirus.

"Vitamin D is important to the function of the immune system and vitamin D supplements have previously been shown to lower the risk of viral respiratory tract infections," said David Meltzer, MD, PhD, Chief of Hospital Medicine at UChicago Medicine and lead author of the study.

New collaboration between Novartis and Africa Medical Supplies Platform to facilitate supply of COVID-19 related medicines

Wed, 09/02/2020 - 12:00
Novartis and the African Union (AU) through the Africa Medical Supplies Platform (AMSP) have announced a new collaboration to facilitate the supply of medicines from the Novartis Pandemic Response Portfolio to the AU member states and Caricom countries.

Steroid found to improve survival of critically ill COVID-19 patients

Wed, 09/02/2020 - 10:00
A new international study published today has shown that treating critically ill patients with COVID-19 with the steroid hydrocortisone improves their chances of recovery.

The study, led in the UK by Professor Anthony Gordon from Imperial College London with collaborators from the Intensive Care National Audit & Research Centre, found that patients receiving intensive care who were treated with a regular fixed dose of the steroid hydrocortisone for seven days had a better chance of recovery, compared with the patients who were not treated with the steroid.

Development of COVID-19 vaccine AZD1222 expands into US Phase III clinical trial across all adult age groups

Tue, 09/01/2020 - 12:00
AZD1222 development expanded into a Phase III clinical trial in the US to assess its safety, efficacy and immunogenicity.1)

The US trial, called D8110C00001, is funded by the Biomedical Advanced Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS) and the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health, and led by AstraZeneca.

Sanofi provides update on Kevzara® (sarilumab) Phase 3 trial in severe and critically ill COVID-19 patients outside the U.S.

Tue, 09/01/2020 - 10:00
Sanofi today announced that the global Phase 3 trial investigating intravenously administered Kevzara® (sarilumab) at a dose of 200 mg or 400 mg[1] in severely or critically ill[2] patients hospitalized with COVID-19 did not meet its primary endpoint and key secondary endpoint[3] when Kevzara was compared to placebo added to usual hospital care.

Improving FDA's COVID-19 vaccine authorization and approval process

Mon, 08/31/2020 - 12:00
On March 28, the Food and Drug Administration (FDA) exercised its Emergency Use Authorization (EUA) authority to allow the use of hydroxychloroquine for the treatment of COVID-19. On June 15, after a number of studies failed to find positive effects, the agency revoked this authorization. This chain of events raises questions about the speed, rigor and potential politicization of the authorization process. These actions also may have hurt the FDA's credibility and the public's trust in the agency, which could decrease the public's confidence in and adoption of eventual COVID-19 vaccines.

Vir Biotechnology and GSK start phase 2/3 study of COVID-19 antibody treatment

Mon, 08/31/2020 - 10:00
Vir Biotechnology, Inc. (Nasdaq: VIR) and GlaxoSmithKline plc (LSE/NYSE: GSK) announced that the first patient was dosed last week in a phase 2/3 study with VIR-7831 (also known as GSK4182136), a fully human anti-SARS-CoV-2 (Severe Acute Respiratory Syndrome coronavirus-2) monoclonal antibody, for the early treatment of COVID-19 in patients who are at high risk of hospitalisation.

Abbott's fast, $5, 15-minute, easy-to-use COVID-19 antigen test receives FDA Emergency Use Authorization

Fri, 08/28/2020 - 10:00
Abbott (NYSE: ABT) announced that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for its BinaxNOW™ COVID-19 Ag Card rapid test for detection of COVID-19 infection. Abbott will sell this test for $5. It is highly portable (about the size of a credit card), affordable and provides results in 15 minutes.