coronavirus Archives - Page 32 of 99 - Medical Design Sourcing

Adamis Pharmaceuticals’ Tempol shows promise against SARS-CoV-2 in preclinical research

The investigational drug Tempol from Adamis Pharmaceuticals Corp. (NSDQ:ADMP) could be a potent oral antiviral treatment for COVID-19 based on cell culture research, according to scientists at the National Institutes of Health (NIH).

The positive research news caused Adamis Pharmaceuticals’ stock to jump 61% from $0.69 to $1.13 today. The quick jump in its stock valuation triggered a trading halt.

Tempol belongs to a growing class of anti-COVID-19 drugs that aim to stop viral replication.

Pfizer (NYSE:PFE) is also developing a similar potential COVID-19 treatment known as PF-07321332 that is a protease inhibitor. That investigational drug binds to a viral enzyme known as protease to stop viral replication.

Remdesivir, the subcutaneous injectable drug from Gilead Sciences (NSDQ:GILD) that won FDA approval on October 22, 2020, binds to the RNA polymerase and protease of SARS-CoV-2.

Tempol relies on a different mode of action. The drug in…

AstraZeneca could enlist Catalent to produce COVID-19 vaccines

After stopping the production of its COVID-19 vaccine at an Emergent Biosolutions facility in Baltimore, AstraZeneca (LON:AZN) is in negotiations with Catalent (NYSE:CTLT) to shift production to one of its plants in nearby Harmans, Md.

FDA has yet to authorize the AstraZeneca COVID-19 vaccine, although it has won full approval in Australia and Brazil and has received emergency use authorization (EUA) in 168 other countries.

As a majority of U.S. citizens have already received at least one COVID-19 vaccine dose, officials at AstraZeneca are reportedly mulling the option of pursuing full approval of its vaccine instead of EUA, according to The Wall Street Journal.

The U.S. government required Emergent Biosolutions to halt production of the AstraZeneca vaccine after a production error forced Emergent to discard 15 million COVID-19 vaccine doses. Emergent intended to produce AstraZeneca’s and Johnson & Johnson’s adenovirus-vectored vaccines in the same f…

Almost one-quarter of Americans remain vaccine-hesitant

[Photo by Maksim Goncharenok from Pexels]

A study from Informa Pharma Intelligence and YouGov concluded that vaccine hesitancy remains a significant hurdle in the U.S. A separate study published in JAMA indicates vaccine hesitancy is falling. Specifically, the number of people who were suspicious about COVID-19 vaccines fell from 46% in October 2020 to 35% in March 2021.

Conversely, the Informa-YouGov survey from April 21 and 22 concluded that 23% of Americans were vaccine-hesitant. The study had 1,327 adult participants.

While approximately half of the U.S. public has received at least one vaccine dose, vaccinating the remainder of the eligible population could be a hurdle.

But the recent data from the Informa-YouGov survey indicate that achieving President Biden’s goal of providing at least one vaccine dose to 70% of the American adults by July 4 is at least feasible.

Another factor tha…

Moderna seeks full FDA approval for its COVID-19 vaccine

Vials containing the Moderna COVID-19 vaccine sit on a table in preparation for vaccinations at Kadena Air Base, Japan, Jan. 4, 2021. As part of the DoD strategy for prioritizing, distributing and administering the COVID-19 vaccine, those providing direct medical care and emergency services will be prioritized to receive the vaccine at units based in Japan, including Kadena AB. (U.S. Air Force photo by Airman 1st Class Anna Nolte)

Moderna (NSDQ:MRNA) announced today that it submitted for full FDA approval of its mRNA COVID-19 vaccine for individuals 18 years of age and older.

Cambridge, Mass.-based Moderna initiated the rolling submission process with the FDA for a Biologics License Application (BLA) to license its mRNA COVID-19 vaccine, according to a news release. The move mirrors Pfizer and BioNTech, who last month initiated the process for a BLA for their COVID-19 vaccine.

Get the full story at our sister site, Drug Discovery &am…

Moderna seeks full FDA approval for its COVID-19 vaccine

Vials containing the Moderna COVID-19 vaccine. [Image from Wikipedia]

Moderna (Nasdaq:MRNA) announced today that it submitted for full FDA approval of its mRNA COVID-19 vaccine for individuals 18 years of age and older.

Cambridge, Mass.-based Moderna initiated the rolling submission process with the FDA for a Biologics License Application (BLA) to license its mRNA COVID-19 vaccine, according to a news release. The move mirrors Pfizer and BioNTech, who last month initiated the process for a BLA for their COVID-19 vaccine.

The company said it will continue to submit data to the FDA in support of the BLA on a rolling basis with a request for priority review. Once the submission is complete, the FDA will notify Moderna when it is formally accepted for review.

Moderna’s two-dose COVID-19 vaccine is currently available under the FDA’s emergency use authorization (EUA), which …

Abbott stock down on reduced 2021 earnings outlook

Abbott (NYSE:ABT) announced today that it is cutting its earnings outlook for the year amid reduced demand for COVID-19 diagnostics.

The news sent ABT shares down more than 6% to $109.25 apiece in morning trading. MassDevice‘s MedTech 100 Index, which includes stocks of the world’s largest medical device companies, was down slightly.

Abbott had previously projected adjusted EPS of at least $5 this year. Now, it’s predicting EPS in the $4.30 to $4.50 range. EPS under GAAP will be $2.75 to $2.95, according to the company.

It appears that progress against the pandemic in the U.S. and many other developed countries was bad news for Abbott’s earnings. The company says positive trends have suddenly and fundamentally impacted market demand for COVID-19 tests.

The accelerated rollout of COVID-19 vaccines has significantly reduced cased numbers in the U.S. and other wealthy countries. In addition, the CDC has updated its recommendat…

CureVac’s COVID-19 vaccine candidate inches forward to Phase 2b/3 efficacy readout

CureVac (NSDQ:CVAC) has announced that its first-generation COVID-19 vaccine has passed its first interim analysis but has chosen not to share efficacy data until a statistically significant efficacy analysis is ready.

The Tübingen, Germany–headquartered company is developing two mRNA-based vaccines. The mRNA vaccines from Moderna (NSDQ:MRNA) and Pfizer (NYSE:PFE) are currently two of the most popular COVID-19 vaccines in the world.

The data and safety monitoring board also concluded that there were no safety concerns linked to the CVnCoV in the HERALD study.

The company’s second-generation vaccine is known as CV2CoV, which it is developing in collaboration with GSK.

Sinopharm publishes COVID-19 vaccine trial data

An article recently published in JAMA concluded that two inactivated COVID-19 vaccines from Sinopharm (OTCMKTS: SHTDY) were 72.8% and 78.1% effective, respectively, based on interim Phase 3 study results.

The lower figure refers to the protection from a COVID-19 vaccine based on two 5-µg doses based on the SARS-CoV-2 isolate WIV04 complete genome. The second vaccine in the study was based on two 4-µg vaccine doses developed with the HB02 strain of SARS-CoV-2. Some 13,459 received the WIV04-based vaccine, while 13,465 received the HBO2 version.

A placebo group including 13,465 participants received aluminum hydroxide, a common adjuvant.

In all, the study involved 40,380 participants. Most participants in the study were relatively young men.

Sinopharm recruited study participants in the United Arab Emirates, Egypt, Jordan and Bahrain. The study population consisted of adults at least 18 years of age who believed they had not contracted COVID-19 o…

COVID-19 vaccine booster questions remain

Image from Nataliya Vaitkevich via Pexels

While the question of when the vaccinated public will require a COVID-19 booster remains unclear, some long-term care advocates are pushing for guidance to avoid a potential resurgence in infections in the fall and winter.

Nursing home residents were among the first to receive COVID-19 vaccines. Providing boosters to the demographic is vital to prevent the spread of COVID-19 infections, which was a significant driver of overall mortality from the novel coronavirus at the beginning of the pandemic. “Hence, if and when the residents’ immunity wanes, we must be on high alert, lest we relive the horrors of the past year,” said Dr. Mike Wasserman, a member of California’s Vaccine Advisory Committee in an interview with ABC News.

Complicating matters is the fact that many older adults have a diminished ability to produce antibodies, increas…

U.K. authorizes J&J COVID-19 vaccine

The United Kingdom announced that it approved the single-dose COVID-19 vaccine developed by Johnson & Johnson’s Janssen Pharmaceutical business.

The Medicines and Healthcare products Regulatory Agency (MHRA) granted the regulatory approval, making Janssen’s the fourth COVID-19 vaccine authorized by the independent regulator and the first to be approved as a single-dose option, according to a news release.

Get the full story at our sister site, Pharmaceutical Processing World.

U.K. authorizes J&J COVID-19 vaccine

The United Kingdom announced that it approved the single-dose COVID-19 vaccine developed by Johnson & Johnson’s Janssen Pharmaceutical business.

The Medicines and Healthcare products Regulatory Agency (MHRA) granted the regulatory approval, making Janssen’s the fourth COVID-19 vaccine authorized by the independent regulator and the first to be approved as a single-dose option, according to a news release.

Read: 9 things to know as AstraZeneca and J&J COVID-19 vaccines face safety scrutiny

Approval gives authorization to the use of the vaccine in people aged 18 years old and above in the UK, the MHRA said, while the decision on use of the vaccine in pregnant or breastfeeding women should be made in consultation with a healthcare professional after considering the benefits and risks, the regulatory body said.

“We have undertaken a thorough review of the conditional marketing authorization applica…

FDA shifts gears as mask shortages ease

KN95 mask (Image from the Oklahoma State Department of Health)

The FDA wants healthcare providers to move away from using certain imported disposable masks, such as KN95s.

The recommendation to ease off using non-NIOSH-approved masks comes less than two months after the agency said providers could transition away from reusing decontaminated masks.

Get the full story on our sister site, Medical Design & Outsourcing.