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Pardes Biosciences shares interim Phase 1 data on oral COVID-19 antiviral

Pardes Biosciences (NSDQ:PRDS) said its PBI-0451 twice-daily COVID-19 pill candidate had favorable tolerability and good oral bioavailability, based on interim data from an ongoing Phase 1 trial.

The company also said the drug candidate lacked clinically significant drug-drug interactions.

PRDS shares ticked down 8.70% to $10.29 today.

“We’re very encouraged by the safety profile and bioavailability profile we’re seeing to date,” said Brian Kearney, chief development officer at Pardes Bio, in an investor call.

Pardes Biosciences also noted that, in the interim results, PBI-0451 administered twice-daily maintained pharmacokinetics exposures anticipated to deliver strong antiviral activity against SARS-CoV-2.

The company plans on launching a Phase 2/3 study in the middle of 2022.

At present, two oral antivirals have won emergency use authorization (EUA) in the U.S.

FDA authorized Paxlovid from Pfizer (NYS…

PharmaJet partner touts interim safety results for needle-free COVID-19 vaccine

[Image from PharmaJet]

PharmaJet announced today that its partner, Technovalia, reported positive interim safety results from a needle-free COVID-19 vaccine trial.

Golden, Colorado-based PharmaJet’s needle-free injection systems are being studied with Covigen, a DNA-based vaccine developed by French-Thai pharmaceutical company BioNet-Asia in collaboration with Melbourne, Australia-based Technovalia. Enrollment for the trial began in June 2021.

Get the full story at our sister site, Drug Delivery Business News.

PharmaJet partner touts interim safety results for needle-free COVID-19 vaccine trial

[Image from PharmaJet]PharmaJet announced today that its partner, Technovalia, reported positive interim safety results from a needle-free COVID-19 vaccine trial.

Golden, Colorado-based PharmaJet’s needle-free injection systems are being studied with Covigen, a DNA-based vaccine developed by French-Thai pharmaceutical company BioNet-Asia in collaboration with Melbourne, Australia-based Technovalia. Enrollment for the trial began in June 2021.

Get the full story at our sister site, Drug Delivery Business News.

Omicron-specific mRNA vaccine elicited similar protection as original in early primate study

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

An NIH authored preprint concluded that an omicron-specific version of Moderna’s (NSDQ:MRNA) vaccine might not offer improved immunity or protection compared to the company’s current mRNA-1273 vaccine.

In a small study involving macaques, NIH researchers tested neutralizing antibody levels and B cell expansion in primates receiving mRNA-1273 and mRNA-1273.529, the updated vaccine.

The study involved a total of eight macaques who received two initial 100-μg doses of the mRNA-1273 vaccine. Nine months after the second dose, four primates received a dose of the existing vaccine, while the remaining four received the omicron-based version.

The study authors performed a challenge test, exposing the non-human primates to the omicron variant to gauge their immune response. The researchers ultimately concluded that both…

FDA resumes inspections in U.S. as omicron cases decline

The FDA announced last week that it is set to resume conducting domestic surveillance inspections after a brief postponement.

In December, the agency confirmed temporary changes to inspectional activities due to COVID-19 as the omicron variant of the virus led to surges across the world. The FDA implemented the changes in the U.S. on Dec. 29, 2021, to ensure the safety of its employees and the firms it regulates, highlighting plans to continue mission-critical work while postponing certain inspectional activities.

According to a news release, the FDA determined on Feb. 2 that it would resume the domestic surveillance inspections across all commodities following a decline in COVID-19 cases. The resumption went into effect today, Feb. 7.

The FDA said that, in addition to resuming the surveillance inspections, it continues to conduct both foreign and domestic mission-critical inspections and provide oversight of foods, drugs, medical products and tobacco in…

Thermo Fisher launches PCR testing platform that detects COVID-19 pathogens in the air

[Image from Thermo Fisher]Thermo Fisher Scientific (NYSE:TMO) announced today that it launched a new rapid environmental COVID-19 diagnostic platform.

Waltham, Massachusetts-based Thermo Fisher designed its Renvo rapid in-air pathogen PCR test for detecting the virus on air samples collected through the company’s Thermo Scientific AerosolSense Sampler.

According to a news release, the company designed the test for environmental surveillance only, rather than diagnostic purposes, in communal locations like schools, businesses, healthcare facilities, government buildings nad other public areas. It offers fast, accurate detection of SARS-CoV-2 (the virus causing COVID-19) pathogens through indoor air sampling without the need for specialized training or sending samples to a lab for analysis.

Thermo Fisher’s system uses proprietary Oscar PCR technology to shorten thermocycling times and produce results in just 30 minutes, improving on the four to 24…

Labcorp launches on-demand platform for purchasing diagnostics

Labcorp (NYSE:LH) announced today that it launched Labcorp OnDemand to ease the experience of using the company’s diagnostics.

Burlington, North Carolina-based Labcorp’s Labcorp OnDemand provides a platform on which individuals can purchase tests online, collect samples in their own home or schedule test appointments at one of Labcorp’s 2,000 patient service centers.

The OnDemand platform includes a suite of the company’s most commonly used tests, including wellness, allergy, COVID-19, women’s health and fertility tests, according to a news release. Through Labcorp OnDemand, the company’s Pixel by Labcorp COVID-19 PCR and combined COVID-19 + flu at-home collection kits are available and will continue to be available at zero upfront out-of-pocket costs for those who meet clinical guidelines.

Labcorp expects to make additional Labcorp OnDemand test kit options available through physicians, health plans and employers thro…

Could nasal vaccines be the next big weapon against COVID-19?

Mucosa and relevant structures. [Image from Wikipedia]Because of the way they provide protection, nasal vaccines are being considered as the best long-term way to prevent COVID-19 infection.

The New York Times reported that India-based Bharat Biotech, which has the Covaxin COVID-19 vaccine authorized in India and elsewhere, may offer even stronger protection against the virus with its experimental nasal vaccine.

Get the full story at our sister site, Drug Delivery Business News.

Could nasal vaccines be the next big weapon against COVID-19?

Mucosa and relevant structures. Image from Wikipedia.

Because of the way they provide protection, nasal vaccines are being considered as the best long-term way to prevent COVID-19 infection.

The New York Times reported that India-based Bharat Biotech, which has the Covaxin COVID-19 vaccine authorized in India and elsewhere, may offer even stronger protection against the virus with its experimental nasal vaccine.

Get the full story at our sister site, Drug Delivery Business News.

FDA could authorize Pfizer-BioNTech vaccine for young children in late February

The FDA has requested that Pfizer apply for emergency authorization for the BNT162b2 vaccine for children 6 months of age to 5 years old, according to media reports.

The agency is awaiting data from a third dose of the vaccine in the age group, which could be available in March.

Pfizer could apply for emergency use authorization as soon as tomorrow and win authorization by the end of February, according to The Washington Post.

In December, Pfizer and its partner BioNTech (NSDQ:BNTX) announced that an independent data monitoring committee concluded the study met non-inferiority requirements for the 6- to 24-month-old group but not for the 2- to under 5-year-old group.

The vaccine was well tolerated in the young age group.

Recipients in the trial are receiving 3 µg doses of mRNA, which is one-tenth the amount used in adults.

For 5- to 12-year-olds, the authorized dose is 10 µg.

The first two doses are administered 21 days…

Study bolsters case that vaccines protect against long-COVID

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

It may be too soon to know how often the omicron variant is associated with so-called long-COVID, but research from the Leavitt Partners’ COVID-19 Patient Recovery Alliance confirms that vaccination protects against the condition.

Those who received at least one authorized COVID-19 vaccine dose before diagnosis were between seven and 10 times less likely to report two or more long-COVID-19 symptoms, according to the preprint study conducted before the surge of the delta variant.

Those who received a vaccine four weeks after diagnosis were four to six times less likely to develop the condition.

Get the full story from our sister site, Drug Discovery & Development.

Study bolsters case that vaccines protect against long-COVID

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

It may be too soon to know how often the omicron variant is associated with so-called long-COVID, but research from the Leavitt Partners’ COVID-19 Patient Recovery Alliance confirms that vaccination protects against the condition.

Those who received at least one authorized COVID-19 vaccine dose before diagnosis were between seven and 10 times less likely to report two or more long-COVID-19 symptoms, according to the preprint study conducted before the surge of the delta variant.

Those who received a vaccine four weeks after diagnosis were four to six times less likely to develop the condition.

There are limits to how well researchers understand the condition given the fuzziness of the definition of long-COVID and the continual emergence of SARS-CoV-2 variants, said Michael A. Simon, principal data scientis…