covid-19 Archives - Page 41 of 113 - Medical Design Sourcing

Pfizer expands COVID-19 vaccine trial involving children under 12

Pfizer (NYSE:PFE) and its German partner BioNTech (NASDAQ: BNTX) will proceed with a COVID-19 vaccine trial involving as many as 4,500 children. The trial will significantly reduce the 30-mg dose that adults and adolescents receive. Investigators will administer a 10-µg dose to children aged 5 to 11 and give those aged six months to five years old a 3-µg dose.

The company anticipates data from 5- to 11-year-olds in September and plans on filing for emergency use authorization shortly after that.

The company anticipates that data for the 6-month to 2-year-old cohort will be available in October or November.

In related news, Pfizer and BioNTech must contend with concerns that their BNT162b2 could be linked to myocarditis in adolescents.

[Related: 50 of 2020’s best-selling pharmaceuticals]

A recently published preprint in the journal Pediatrics describes seven male adolescents who developed myocarditis after receiving the vaccine. All seven pa…

Biden administration wants to boost funding for new pharma manufacturing processes

President Joe Biden [Image courtesy of the White House]The Biden administration today released findings from 100-day supply chain assessments, determining the need to boost pharmaceutical manufacturing.

According to a fact sheet, the administration plans to take immediate action to “address vulnerabilities and strengthen resilience” with its effort to take on near-term supply chain disruptions for four products: semiconductor manufacturing and advanced packaging; large capacity batteries, like those for electric vehicles; critical minerals and materials; and pharmaceuticals and active pharmaceutical ingredients (APIs).

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

Biden administration wants to boost funding for new pharma manufacturing processes

President Joe Biden [Image courtesy of the White House]

The Biden administration today released findings from 100-day supply chain assessments, determining the need to boost pharmaceutical manufacturing.

According to a fact sheet, the administration plans to take immediate action to “address vulnerabilities and strengthen resilience” with its effort to take on near-term supply chain disruptions for four products: semiconductor manufacturing and advanced packaging; large capacity batteries, like those for electric vehicles; critical minerals and materials; and pharmaceuticals and active pharmaceutical ingredients (APIs).

President Biden and his team said they are crafting strategies for six industrial bases to be completed within a year as part of the President’s American Jobs Plan.

The administration intends to invest in the development of new pharmaceutical manufacturing proce…

Abbott, Walgreens partner on boosting COVID-19 testing in Philadelphia

Abbott (NYSE:ABT) and Wallgreens announced a pilot program designed to increase access to rapid COVID-19 testing in Philadelphia.

Under the newly formed partnership, Pennsylvania Electronic Benefit Transfer (EBT) cardholders in Philadelphia will be able to receive Abbott’s BinaxNOW COVID-19 antigen self tests weekly at no cost, according to a news release. Customers can visit any of 16 Walgreens’ 16 locations within Philadelphia’s city limits over the span of the program, which ranges all the way through the July 4 holiday.

Each cardholder can receive two test packs (two-count) per family member per week for up to five household members, totaling 10 packs (20 tests in total) per week for a cardholder, their spouse and their three dependents. Each family member would be able to test themselves twice over three days with at least 36 hours between tests.

Through the pilot program, Abbott and Walgreens aim to increase the understanding of h…

BD surpasses 2 billion orders for COVID-19 injection devices

[Image from BD]BD (NYSE:BDX) announced today that orders for its needles and syringes hit 2 billion amid global COVID-19 vaccination efforts.

Franklin Lakes, N.J.-based BD’s latest milestone comes less than six months after the company surpassed 1 million orders for vaccine delivery devices in December 2020.

The order total encompasses commitments to governments all over the globe, including the U.S., Australia, Brazil, Canada, France, Germany, India, the Philippines, Saudi Arabia, South Africa, Spain and the UK, among others.

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

FDA authorizes lower dose of REGEN-COV COVID-19 antibody cocktail

Regeneron (NSDQ:REGN) has announced that the FDA has signed off on a 1,200 mg subcutaneous or intravenous dose of its REGEN-COV antibody cocktail. The quantity is half of the initially authorized dose. The agency had previously authorized a 2,400 mg dose of the vaccine, including a combined dose of 1,200 mg of Casirivimab and 1,200 mg of Imdevimab.

The initial EUA for REGEN-COV did not include the option for a subcutaneous dose of the antibody cocktail. The option to make the product available via injection makes it easier for doctors or nurses to administer. The use of SARS-CoV-2 monoclonal antibodies has lagged behind vaccines, with only a fraction of eligible patients receiving such antibodies in the past year.

FDA came to its decision after reviewing data from a pivotal Phase 3 study that showed that the drug reduced the risk of hospitalization or death by 70%. The efficacy of the reduced dose is similar to the 2,400 mg dose.

REGEN-COV appears to be …

Drug prescription volume growth climbed to 21% in late May

Photo by Alexandros Chatzidimos from Pexels

As the U.S. economy continues to stabilize in the wake of the COVID-19 pandemic, prescription volumes continue to rebound as well. The overall market growth for prescription drugs from May 21–28 hit 21% year over year, according to IQVIA data. The growth rate in the prior two weeks was 13%.

New prescription growth from May 21 to 28 increased 34% year over year while retail growth hit 23%. In general, pharmacy chains have seen a rapid upward trend in sales since December 2020, with growth stabilizing in May 2021.

While mail-order prescriptions have expanded during the pandemic, total mail-order prescriptions accounted for only 5.2% of the total prescription drug market in late May.

All of the 42 therapeutic areas that Truist Securities tracks grew from May 21 to 28.

A recently released analyst report from UBS’s Kevin Caliendo, however, noted tha…

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 …