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Updated: 3 hours 10 min ago

FDA approves first oral blood thinning medication for children

Tue, 06/22/2021 - 12:00
The U.S. Food and Drug Administration approved Pradaxa (dabigatran etexilate) oral pellets to treat children 3 months to less than 12 years old with venous thromboembolism (a condition where blood clots form in the veins) directly after they have been treated with a blood thinner given by injection for at least five days.

BioNTech announces first patient dosed in Phase 2 clinical trial of mRNA-based BNT111 in patients with advanced melanoma

Tue, 06/22/2021 - 10:00
BioNTech SE (NASDAQ: BNTX, "BioNTech" or "the Company"), announced that the first patient has been treated in its BNT111 Phase 2 cancer vaccine trial (2020-002195-12; NCT04526899). The study is evaluating the Company's therapeutic cancer vaccine candidate BNT111 in combination with Libtayo® (cemiplimab) in patients with anti-PD1-refractory/relapsed unresectable Stage III or IV melanoma.

GSK and Vir Biotechnology announce continuing progress of the COMET clinical development programme for sotrovimab

Mon, 06/21/2021 - 12:00
GlaxoSmithKline plc and Vir Biotechnology, Inc. today announced final, confirmatory results from the Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early) trial demonstrating that sotrovimab, an investigational SARS-CoV-2 monoclonal antibody, significantly reduced the risk of hospitalisation or death among high-risk adult outpatients with mild-to-moderate COVID-19.

COVID-19 dual-antibody therapies effective against variants in animal study

Mon, 06/21/2021 - 10:00
COVID-19 therapies made from antibodies often are given to patients who are at high risk of severe illness and hospitalization. However, there have been nagging questions about whether such antibody therapies retain their effectiveness as worrisome new virus variants arise.

AstraZeneca welcomes Court ruling on supply of its COVID-19 vaccine to Europe

Fri, 06/18/2021 - 10:00
AstraZeneca today welcomed the ruling by the Court of First Instance in Brussels. The European Commission had requested 120 million vaccine doses cumulatively by the end of June 2021, and a total of 300 million doses by the end of September 2021. The judge ordered delivery of 80.2 million doses by 27 September 2021.

COVID-19 vaccines pre-prepared in syringes can be safely transported

Thu, 06/17/2021 - 12:00
One of the main reasons for the hold-ups in the mass vaccination campaigns against COVID-19 are the precautions that must be taken regarding the handling of the vaccines and their administration. They have to be transported under very specific conditions and the syringes used for their administration must be prepared at the same vaccination site.

CureVac provides update on Phase 2b/3 trial of first-generation COVID-19 vaccine candidate, CVnCoV

Thu, 06/17/2021 - 10:00
CureVac N.V. (Nasdaq: CVAC), a clinical-stage biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), today announced results of the second interim analysis of its international pivotal Phase 2b/3 study in approximatively 40,000 subjects (the HERALD study) of CureVac's first-generation COVID-19 vaccine candidate, CVnCoV.

U.S. government purchases additional 200 million doses of Moderna's COVID-19 vaccine

Wed, 06/16/2021 - 10:00
Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the U.S. government has purchased an additional 200 million doses of Moderna's COVID-19 vaccine, including the option to purchase other COVID-19 vaccine candidates from Moderna's pipeline.

Cancer cells fight for their footing by using an ageing gene

Tue, 06/15/2021 - 10:00
Researchers at the University of Helsinki and the Beatson Institute for Cancer Research in Glasgow have discovered how mutated cells promote their chances to form cancer. Typically, the accumulation of harmful cells is prevented by active competition between multiple stem cells in intestinal glands, called crypts.

Study identifies how COVID-19 linked to Alzheimer's disease-like cognitive impairment

Mon, 06/14/2021 - 12:00
A new Cleveland Clinic-led study has identified mechanisms by which COVID-19 can lead to Alzheimer's disease-like dementia. The findings, published in Alzheimer's Research & Therapy, indicate an overlap between COVID-19 and brain changes common in Alzheimer's, and may help inform risk management and therapeutic strategies for COVID-19-associated cognitive impairment.

Novavax COVID-19 vaccine demonstrates 90% overall efficacy and 100% protection against moderate and severe disease in PREVENT-19 Phase 3 trial

Mon, 06/14/2021 - 10:00
Novavax, Inc. (Nasdaq: NVAX), today announced that NVX-CoV2373, its recombinant nanoparticle protein-based COVID-19 vaccine, demonstrated 100% protection against moderate and severe disease, 90.4% efficacy overall, and met the primary endpoint in its PREVENT-19 pivotal Phase 3 trial.

An omega-3 that's poison for tumors

Fri, 06/11/2021 - 10:00
So-called "good fatty acids" are essential for human health and much sought after by those who try to eat healthily. Among the Omega-3 fatty acids, DHA or docosahexaenoic acid is crucial to brain function, vision and the regulation of inflammatory phenomena.

In addition to these virtues, DHA is also associated with a reduction in the incidence of cancer.

Common diabetes drug shows promise as treatment for COVID-19 lung inflammation

Thu, 06/10/2021 - 12:00
Metformin is a widely prescribed blood sugar-lowering drug. It is often used as an early therapy (in combination with diet and lifestyle changes) for type 2 diabetes, which afflicts more than 34 million Americans.

Metformin works by lowering glucose production in the liver, reducing blood sugar levels that, in turn, improve the body's response to insulin.

Pfizer and BioNTech to provide 500 million doses of COVID-19 vaccine to U.S. government for donation to poorest nations

Thu, 06/10/2021 - 10:00
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced plans to provide the U.S. government at a not-for-profit price 500 million doses of the companies' COVID-19 vaccine, 200 million doses in 2021 and 300 million doses in the first half of 2022, to further support the multilateral efforts to address the surge of infection in many parts of the world and to help end the pandemic.

FDA grants accelerated approval for Alzheimer's drug

Wed, 06/09/2021 - 12:00
The U.S. Food and Drug Administration approved Aduhelm (aducanumab) for the treatment of Alzheimer's, a debilitating disease affecting 6.2 million Americans. Aduhelm was approved using the accelerated approval pathway, which can be used for a drug for a serious or life-threatening illness that provides a meaningful therapeutic advantage over existing treatments.

Valneva completes Phase 3 trial recruitment for its inactivated COVID-19 vaccine candidate

Wed, 06/09/2021 - 10:00
Valneva SE, a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, today announced that it has completed recruitment for the pivotal Phase 3 trial of its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001.

CDC COVID-19 study shows mRNA vaccines reduce risk of infection by 91 percent for fully vaccinated people

Tue, 06/08/2021 - 18:51
A new CDC study finds the mRNA COVID-19 vaccines authorized by the Food and Drug Administration (Pfizer-BioNTech and Moderna) reduce the risk of infection by 91 percent for fully vaccinated people. This adds to the growing body of real-world evidence of their effectiveness. Importantly, this study also is among the first to show that mRNA vaccination benefits people who get COVID-19 despite being fully vaccinated

Bayer to advance two first-of-its-kind cell and gene therapies for Parkinson's disease

Tue, 06/08/2021 - 10:00
Bayer AG announced today that BlueRock Therapeutics (BlueRock), a clinical stage biopharmaceutical company and wholly-owned subsidiary of Bayer AG, successfully administered the first dose of its pluripotent stem cell-derived dopaminergic neurons, named DA01, to a Parkinson's disease patient in their open-label Phase 1 clinical study.

Protein identified as new therapeutic anti-viral target for COVID-19

Mon, 06/07/2021 - 12:00
New research identified a novel interaction between the SARS-CoV-2 spike protein and the galectin-3-binding protein (LGALS3BP) which could be a new therapeutic anti-viral target. The research also found the presence of detectable viral RNA in blood in COVID-19 patients is a strong predictor of mortality.

Monoclonal antibody prevents HIV infection in monkeys, study finds

Mon, 06/07/2021 - 10:00
An experimental, lab-made antibody can completely prevent nonhuman primates from being infected with the monkey form of HIV, new research published in Nature Communications shows.

The results will inform a future human clinical trial evaluating leronlimab as a potential pre-exposure prophylaxis, or PrEP, therapy to prevent human infection from the virus that causes AIDS.