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Global Heart Hub and Novartis partner to tackle ASCVD, a global health crisis and world’s #1 killer

Wed, 10/20/2021 - 10:00
Global Heart Hub and Novartis announced the launch of the Invisible Nation program. Invisible Nation will bring together a worldwide network of patient organizations and other stakeholders in the cardiovascular (CV) space committed to effecting systemic change in the management of atherosclerotic cardiovascular disease (ASCVD). The program aims to prevent many of the 15 million yearly ASCVD deaths(1) and reduce what could soon become $1 trillion in annual CV disease cost(2).

17 million doses of Johnson & Johnson COVID-19 vaccine to be donated to African Union countries

Tue, 10/19/2021 - 12:00
Johnson & Johnson welcomes the U.S. government's decision to donate 17 million doses of the Johnson & Johnson COVID-19 single-shot vaccine to countries in the African Union (AU). The United States is providing these doses through COVAX, committed to the AU, under an agreement signed recently by the U.S. government, Johnson & Johnson, and Gavi, the Vaccine Alliance.

Petrovax Pharm is taking part in the international pharmaceutical exhibition CPhI Worldwide-2021

Tue, 10/19/2021 - 10:00
Petrovax Pharm, the Russian biopharmaceutical company, will participate in CPhI Worldwide-2021 - the international specialized pharmaceutical industry exhibition. This year, it will be held from 9 to 11 November in Italy (Milan) on the territory of the largest exhibition complex Fiera Milano.

High effectiveness of mix-and-match COVID-19 vaccines

Mon, 10/18/2021 - 10:00
People who had received a first dose of the Oxford-AstraZeneca COVID-19 vaccine and received an mRNA vaccine for their second dose had a lower risk of infection compared to people who had received both doses of the Oxford-AstraZeneca vaccine. This is shown in a nationwide study performed by researchers at Umeå University, Sweden.

One coronavirus vaccine may protect against other coronaviruses

Fri, 10/15/2021 - 10:00
Northwestern Medicine scientists have shown for the first time that coronavirus vaccines and prior coronavirus infections can provide broad immunity against other, similar coronaviruses. The findings build a rationale for universal coronavirus vaccines that could prove useful in the face of future epidemics.

FDA awards 11 grants to clinical trials to develop new medical products for rare disease treatments

Thu, 10/14/2021 - 23:33
Today, the U.S. Food and Drug Administration announced it has awarded 11 new clinical trial research grants, equaling more than $25 million of funding over the next four years. The FDA's Congressionally-funded Orphan Products Grants Program awards these grants to clinical investigators to support the development of medical products for patients with rare diseases.

Roche's anti-amyloid beta antibody gantenerumab granted FDA Breakthrough Therapy Designation in Alzheimer's disease

Wed, 10/13/2021 - 10:00
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that gantenerumab, an anti-amyloid beta antibody developed for subcutaneous administration, has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of people living with Alzheimer's disease (AD).

Vaccines effective against most SARS-CoV-2 variants

Tue, 10/12/2021 - 12:00
Two of the commonly used coronavirus vaccines provide protection against multiple variants of the virus that causes COVID-19, including the highly infectious Delta variant, a new Yale study has found.

The findings, published Oct. 11 in the journal Nature, also show at those infected with the virus prior to vaccination exhibit a more robust immune response to all variants than those who were uninfected and fully vaccinated.

Vaccines effective against most SARS-CoV-2 variants

Tue, 10/12/2021 - 12:00
Two of the commonly used coronavirus vaccines provide protection against multiple variants of the virus that causes COVID-19, including the highly infectious Delta variant, a new Yale study has found.

The findings, published Oct. 11 in the journal Nature, also show at those infected with the virus prior to vaccination exhibit a more robust immune response to all variants than those who were uninfected and fully vaccinated.

Scientists discover a highly potent antibody against SARS-CoV-2

Tue, 10/12/2021 - 10:00
The newly identified antibody was isolated using lymphocytes from COVID-19 patients enrolled in the ImmunoCoV study being carried out by CHUV’s Service of Immunology and Allergy. This antibody is one of the most powerful identified so far against SARS-CoV-2. Structural characterization of the antibody indicates that it binds to an area that is not subjected to mutations of the spike protein.

Positive results from the first study of high-dose influenza vaccine with a COVID-19 mRNA booster support co-administration recommendations

Mon, 10/11/2021 - 10:00
Interim results from the first co-administration descriptive study of Sanofi's Fluzone® High-Dose Quadrivalent vaccine with Moderna's COVID-19 mRNA investigational booster dose show that the administration of the vaccines at the same visit had similar immunogenicity responses and a similar safety and tolerability profile compared to each vaccine administered individually.

FDA approves innovative treatment for pediatric patients with congenital athymia

Fri, 10/08/2021 - 10:00
Today, the U.S. Food and Drug Administration approved Rethymic for the treatment of pediatric patients with congenital athymia, a rare immune disorder. Rethymic is the first thymus tissue product approved in the U.S.

"Today's action marks the first FDA approval of a therapy to treat this very rare and devastating disease in children," said Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research.

mRNA COVID vaccines highly effective at preventing symptomatic infection in health workers

Thu, 10/07/2021 - 10:00
COVID-19 vaccines are highly effective in preventing symptomatic illness among health care workers in real-world settings.

The study, published in the New England Journal of Medicine, found that health care personnel who received a two-dose regimen of Pfizer-BioNTech vaccine had an 89% lower risk for symptomatic illness than those who were unvaccinated.

GSK welcomes WHO recommendation for broad roll-out of its RTS,S/AS01e (RTS,S) malaria vaccine

Wed, 10/06/2021 - 10:00
GlaxoSmithKline (GSK) plc welcomes and applauds the WHO recommendation for the broader deployment of GSK's RTS,S malaria vaccine to reduce childhood illness and deaths from malaria in children living in sub-Saharan Africa and other regions with moderate to high transmission as defined by WHO.

AZD7442 request for Emergency Use Authorization for COVID-19 prophylaxis filed in US

Tue, 10/05/2021 - 10:00
AstraZeneca has submitted a request to the US Food and Drug Administration (FDA) for an Emergency Use Authorization (EUA) for AZD7442, its long-acting antibody (LAAB) combination, for prophylaxis of symptomatic COVID-19.

If granted, AZD7442 would be the first LAAB to receive an EUA for COVID-19 prevention. It is the first LAAB with Phase III data demonstrating a statistically significant reduction in the risk of developing symptomatic COVID-19 compared to placebo.

Pfizer and BioNTech receive CHMP positive opinion for COVID-19 vaccine booster in the European Union

Mon, 10/04/2021 - 10:00
Pfizer Inc. (NYSE: PFE, "Pfizer") and BioNTech SE (Nasdaq: BNTX, "BioNTech") today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion on the administration of the companies' COVID-19 vaccine as a booster dose at least six months after the second dose in individuals 18 years of age and older.

How to develop new drugs based on merged datasets

Fri, 10/01/2021 - 12:00
Polymorphs are molecules that have different molecular packing arrangements despite identical chemical compositions. In a recent paper, researchers at GlaxoSmithKline (GSK) and the Cambridge Crystallographic Data Centre (CCDC) combined their proprietary (GSK) and published (CCDC) datasets to better train machine learning (ML) models to predict stable polymorphs to use in new drug candidates.

New drug combination effective against SARS-CoV-2 infection

Fri, 10/01/2021 - 10:00
More countries with greater resources are opening up for a more normal life. But COVID-19 and the SARS-CoV-2 virus are still a significant threat in large parts of the world.

The lack of medicines that are effective, easy to distribute and easy to obtain are a significant part of the problem.

Phase II/III trial shows Ronapreve™ (casirivimab and imdevimab) significantly reduces viral load in patients hospitalised with COVID-19

Thu, 09/30/2021 - 10:00
Roche (SIX: RO, ROG; OTCQX: RHHBY) today confirmed positive data from the phase II/III 2066 study, investigating Ronapreve™ (casirivimab and imdevimab) in patients hospitalised with COVID-19. The trial met its primary endpoint, showing that Ronapreve significantly reduced viral load within seven days of treatment in patients who had not mounted a natural antibody response of their own (seronegative) and who required low-flow or no supplemental oxygen (p=0.0172).

Cleveland Clinic study suggests steroid nasal sprays may help improve outcomes in severe COVID-19 disease

Wed, 09/29/2021 - 12:00
A recent Cleveland Clinic study found that patients who regularly use steroid nasal sprays are less likely to develop severe COVID-19-related disease, including a 20 to 25% lower risk of hospitalization, ICU admission and mortality. The study was published in Journal of Allergy and Clinical Immunology: In Practice.