Gilead notches remdesivir indication to treat young children

FDA has announced that it has signed off on the use of COVID-19 therapy Veklury (remdesivir) from Gilead Sciences (Nasdaq:GILD) to include children at least 28 days old who weigh at least 3 kg (roughly 7 lb) and test positive results for COVID-19.

The indication is limited to children who are either hospitalized or have a high risk of developing severe COVID-19, including hospitalization or death.

In October 2020, remdesivir became the first FDA-approved COVID-19 treatment and is now the first drug to win approval for children under 12 years of age.

Remdesivir was formerly authorized for use in young children under emergency use authorization but was FDA-approved for COVID-19-infected individuals at least 12 years old who weigh at least 40 kg (roughly 88 lb).

“As COVID-19 can cause severe illness in children, some of whom do not currently have a vaccination option, there continues to be a need for safe and effective COVID-19 treatment options for …

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FDA extends approval of remdesivir to encompass non-hospitalized high-risk

Gilead Sciences’ (NSDQ:GILD) Veklury (remdesivir) became the first FDA-approved COVID-19 drug when it was approved in October 2020.

Now, the company has announced that the FDA has granted expedited approval of a supplemental new drug application (sNDA) for the drug to treat non-hospitalized adult and adolescent patients with a high risk of progression to severe COVID-19, including hospitalization or death.

The drug was formerly approved for hospitalized adults and children in a hospital or healthcare setting capable of offering similar care. Now, it can be administered in some outpatient settings.

FDA also expanded the emergency use authorization of the drug for non-hospitalized children younger than 12 with a high risk of disease progression.

Demand has surged for COVID-19 therapies, including remdesivir that retain efficacy against the omicron variant of SARS-CoV-2.

Gilead first discovered and developed remdesivir in 2009 as a investigati…

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COVID drugs come in 3 flavors; it’s time for more diversity

A scanning electron microscope image shows SARS-CoV-2 (yellow). Credit: NIAID-RML

Our industry’s response to COVID-19 defied the conventional wisdom that it takes years to deliver new drugs.

Makers of monoclonal antibodies led the pack, most notably Regeneron (NSDQ:REGN), which manufactured the 8-g, two-antibody cocktail administered to then-President Donald Trump last fall. Eli Lilly (NYSE:LLY) and Vir Biotechnology (NSDQ:VIR) pulled off similar feats. Prior speed records were measured in years, not months.

Vaccine developers moved even larger mountains. The colossal trials required to assess efficacy and safety — 30,000 to 60,000 volunteers each — were planned, executed and submitted to the FDA in under a year. Most thought it couldn’t be done in under a decade.

And small-molecule drug makers made important contributions too. Despite all the controversy surrounding the red herrings hydroxychl…

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WHO to test three anti-inflammatory therapies in COVID-19 patients

The World Health Organization (WHO) is adding three anti-inflammatory therapies to its global Solidarity COVID-19 trial. WHO is referring to the expanded trial as “Solidarity PLUS.”

WHO will investigate the following drugs as potential treatments for hospitalized COVID-19 patients:

Ipca Laboratories’ artesunate is an FDA-indicated treatment for severe malaria in adult and pediatric patients. Last year, the drug became the only drug with that indication. In vivo and in vitro SARS-CoV-2 studies involving artesunate have been promising. A study published in ACS Chemical Neuroscience concluded that the drug could potentially treat neurological symptoms related to COVID-19. Novartis’s Gleevec (imatinib mesylate) is a kinase inhibitor. FDA indications for the drug include a range of cancers, including leukemia and gastrointestinal stromal tumors. A separate group of researchers is also evaluating the safety and efficacy of the drug in hospitalized adults with COVID-19.…
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34 of the most innovative pharmaceutical products

Photo by Myriam Zilles on Unsplash

The Galien Foundation has revealed its latest nominees for the 2021 Prix Galien USA Award highlighting innovations in biotechnology, pharmaceutical agents, medical technology and digital health products. Entrants to the competition must have received FDA approval within the past five years and demonstrate exceptional therapeutic potential. The Galien Foundation does not use financial data to make its selections.

The organization will announce final winers in the competition at ceremony in New York City on October 28, 2021. 

In terms of pharmaceutical agents, the organization selected the following 34 nominees:

Company Drug name

AbbVie Inc.

Rinvoq (upadacitinib)

Adlon Therapeutics L.P., a subsidiary of Purdue Pharma 

Adhansia XR (methylp…

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Roche retools COVID-19 strategy 

The Swiss pharma giant Roche (OTCMKTS:RHHBY) has canceled two Phase 2 COVID-19 studies while looking to identify a new site to conduct a clinical study for the oral antiviral AT-527, which it is developing with Atea Pharmaceuticals (NSDQ:AVIR.O). The two companies were looking to launch a trial in the U.K., but falling COVID-19 cases there have complicated recruitment. 

“There’s just simply not enough patients to enroll with the speed we were hoping for,” said Bill Anderson, head of Roche’s pharmaceutical division, in a conference call. 

Roche and Atea hoped AT-527 would offer a more convenient alternative to intravenous treatments such as antibody cocktails or Gilead Science’s (NSDQ:GILD) remdesivir.

One of the two canceled Phase 2 studies was for the monoclonal antibody astegolimab (RG6149), which the company had licensed from Amgen (NSDQ:AMGN). 

The other Phase 2 trial Roche halted related to RG7880 (efmarodocokin alfa), which the company hoped…

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Study: Remdesivir supports clinical improvement in hospitalized COVID-19 patients

Remdesivir diagram

A multicenter study involving a substantial number of minorities indicated that remdesivir supported clinical improvement in the majority of patients.

The hospitalized remdesivir group had an average time to clinical improvement of five days versus seven days for those not receiving the drug. Remdesivir recipients had a 28-day mortality rate of 7.7% compared with a 14% rate for matched controls. The study authors note, however, that this finding was not statistically significant in the time-to-death analysis

Combining remdesivir with corticosteroids did not appear to provide additional benefit.

The study, which was recently published in JAMA, involved 2,483 patients in a five-hospital system in Baltimore, and Washington, D.C.

From that patient pool, 342 participants received remdesivir, with 184 of those individuals also receiving corticosteroids. More than 80.0% of th…

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3 notable types of innovative drugs from 2020

Chemical structure of the COVID-19 therapy remdesivir. Image is from Wikipedia.

Last year, FDA approved 53 drugs, leading the industry to describe 2020 as “a strong year for new drug therapy.”

There are several drugs that stand out, according to Todd Wills, the co-author of a study that analyzes how innovative drugs are based on their structure.

The drugs that follow are examples of notable innovative therapies.

[Related: Here’s what molecular shape can tell you about pharma innovation]

1. COVID-19 therapies

One of the prominent drugs that stands out as structurally novel is remdesivir from Gilead Sciences (NSDQ:GILD). The first COVID-19 treatment to win FDA approval, remdesivir (Veklury), was first developed as an Ebola treatment. But the broad-spectrum antiviral also showed promise against the SARS-CoV-2 virus.

Gilead recently announced that sales of remdesivir beat …

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