covid-19 Archives - Page 6 of 113 - Medical Design Sourcing

Pfizer to spend $120M to make COVID-19 oral treatment in U.S.

Pfizer (NYSE: PFE) announced today that it will invest $120 million into its Kalamazoo, Michigan facility to support U.S.-based production of its COVID-19 antiviral Paxlovid (nirmatrelvir/ritonavir).

The investment is expected to create more than 250 additional, high-skilled jobs at the Kalamazoo site.

The money will expand the production of active pharmaceutical ingredient (API) and registered starting materials (RSMs) used in the manufacture of nirmatrelvir. Pfizer noted in a news release that results from its EPIC-HR (Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients) study showed an 88% reduction in COVID-19-related hospitalization or death among adults treated with Paxlovid compared to placebo within five days of noticing symptoms.

“Pfizer Global Supply has made the impossible possible, making billions of vaccine doses and now millions of treatment courses to help battle the deadly COVID-19 pandemic,” said Prizer CEO Dr. Albert Bo…

Former SCWorx CEO indicted over alleged COVID-19 rapid tests scheme

The U.S. Dept. of Justice announced that Marc Schessel of SCWorx was indicted for charges related to an alleged COVID-19 test scheme.

Schessel, the former CEO of the New York-based company, was charged with two counts of securities fraud for his alleged participation in a scheme to mislead investors about SCWorx’s procurement of COVID-19 rapid test kits in the early stages of the COVID-19 pandemic.

Court documents alleged that Schessel caused SCWorx to issue multiple public statements claiming the company was buying and reselling at least 48 million COVID-19 test kits, despite knowing that such statements were false and misleading. In April 2020 — just a month after the COVID-19 pandemic took hold of the world — Schessel executed a supply agreement with an unnamed Australian company to obtain 2 million COVID-19 test kits per week for six months, starting on April 24, 2020.

The agreement was made based on an understanding that SCWorx had FDA’s…

Pfizer, BioNTech moving forward on seeking COVID-19 vaccine EUA for youngest children

[Photo by Eugene Chystiakov]Pfizer (NYSE:PFE) and BioNTech (Nasdaq:BNTX) announced today that data supports a third dose of their COVID-19 vaccine in young children.

Topline safety, immunogenicity and vaccine efficacy data from a Phase 2/3 trial evaluating a third 3-µg dose of the vaccine — marketed in the U.S. as Comirnaty — showed a strong immune response and a favorable safety profile similar to placebo in children aged six months to under five years old.

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

Expect more heart and lung failure years after COVID, Abbott’s heart failure CMO says

Dr. Philip Adamson is chief medical officer of Abbott’s heart failure business [Photo courtesy of Abbott]Two years into the COVID-19 pandemic, we know more than ever about the SARS-CoV-2 virus and how quickly it moves to ravage the human body.

What remains to be seen is how the virus — and perhaps more importantly, our immune system’s response to it — will affect the health of people long after infection, even in mild cases. This once-in-a-century pandemic that has already killed millions across the globe could leave hundreds of millions more with chronic conditions varying in acuity.

“Not only is the viral infection bad for some people, but the subsequent body’s reaction to the viral illness in many people is remarkable. I personally have never seen anything like it,” said Dr. Philip Adamson, chief medical officer of Abbott’s heart failure business. “I’ve lived through and trained through the AIDS epidemic and learned a lot abo…

Expect more heart and lung failure years after COVID, Abbott’s heart failure CMO says

Dr. Philip Adamson is chief medical officer of Abbott’s heart failure business [Photo courtesy of Abbott]

Two years into the COVID-19 pandemic, we know more than ever about the SARS-CoV-2 virus and how quickly it moves to ravage the human body.

What remains to be seen is how the virus — and perhaps more importantly, our immune system’s response to it — will affect the health of people long after infection, even in mild cases. This once-in-a-century pandemic that has already killed millions across the globe could leave hundreds of millions more with chronic conditions varying in acuity.

“Not only is the viral infection bad for some people, but the subsequent body’s reaction to the viral illness in many people is remarkable. I personally have never seen anything like it,” said Dr. Philip Adamson, chief medical officer of Abbott’s heart failure business. “I’ve lived throu…

FDA denies EUA for COVID-19 indication of SSRI fluvoxamine

[Fluvoxamine image from Wikipedia]

The infectious disease physician-scientist Dr. David R Boulware filed for emergency use authorization (EUA) of fluvoxamine, an established selective serotonin reuptake inhibitor (SSRI) whose brand name is Luvox.

The FDA has rejected the application, explaining the treatment benefit of the drug was “not persuasive” in the TOGETHER study that was the basis of the EUA application.

The randomized, double-blind study had a composite endpoint consisting of a reduction of emergency room visits due to worsening COVID-19 infection and hospitalization resulting from COVID-19 up to 28 days after randomization.

The study concluded that fluvoxamine reduced COVID-19 hospitalizations by as much as 30%.

Although the study met its primary endpoint, FDA noted that “the results were primarily driven by a reduction in the emergency department visits lasting greater than 6…

FDA allows booster dose Pfizer-BioNTech COVID-19 vaccine in children 5 to 11

The Pfizer-BioNTech vaccine booster had been previously limited in the U.S. to individuals at least 12 years old, but now children as young as 5 are eligible, thanks to an expanded emergency use authorization related to the vaccine.

The agency agreed to expand the vaccine’s use in children to “provide continued protection against COVID-19,” said FDA Commissioner Robert M. Califf in a news release.

While “COVID-19 tends to be less severe in children than adults,” Califf noted that the omicron wave has resulted in more children getting infected and hospitalized with COVID-19 infections. “Children may also experience longer-term effects, even following initially mild disease,” he added.

The FDA has determined that vaccine effectiveness in all authorized populations wanes in the weeks and months following administration of a second dose.

“The FDA has determined that the known and potential benefits of a single booster dose of the Pfizer-BioNTech COVID…

FDA authorizes Labcorp’s non-prescription COVID-19 test that also detects flu, RSV

The FDA authorized Labcorp’s seasonal respiratory virus RT-PCR DTC test for use without a prescription.

Individuals with symptoms of respiratory viral infection consistent with COVID-19 can use the seasonal respiratory virus test that can identify and differentiate multiple respiratory viruses at the same time, which marks the first direct-to-consumer, multi-analyte COVID-19 test authorized by FDA.

Users can self-collect a nasal swab sample at home and send it to Labcorp for testing. It can identify and differentiate influenza A and B (the flu), respiratory syncytial virus (RSV) and SARS-CoV-2, the virus causing COVID-19. Results are delivered through an online portal, with healthcare provider follow-up for positive or invalid test results.

Samples can be self-collected by individuals 18 years and older on their own, by those 14 and older with adult supervision, or with adult assistance for individuals aged two years and older.

“While the FD…

AstraZeneca paying up to $157M for broad-spectrum monoclonal antibodies against COVID

RQ Biotechnology (London) emerged from stealth mode today, saying that AstraZeneca will pay it up to $157 million plus royalties for its existing mAbs against SARS-CoV-2.

“Our vision is to build on our successful debut with neutralizing antibody therapy for SARS-CoV-2 and develop innovative medicines to address current and evolving unmet needs in other viral infectious diseases,” said Hugo Fry, a former Sanofi executive who is CEO of RQ Bio.

“By combining our expertise and innovative excellence in core areas, we have created a smarter approach to antibody generation, making us uniquely positioned to deliver fast patient impact,” Fry said in a news release.

The agreement gives AstraZeneca an exclusive worldwide license to develop, manufacture and commercialize mAbs against SARS-CoV-2.

“The COVID-19 pandemic has changed the landscape for immune therapies, including the use of monoclonal antibodies to protect vulnerable patien…

NIH licenses COVID-19 research technologies to WHO initiative

The Biden-Harris administration has announced that the NIH has licensed COVID-19 research technologies and vaccine candidates to the Medicines Patent Pool (MPP).

Working with the WHO’s COVID-19 Technology Access Pool (C-TAP), the NIH will provide licenses to enable manufacturers to use the technologies to develop COVID-19 vaccines, treatments and diagnostics.

In total, NIH is providing 11 COVID-19 technologies under two licenses, bringing the number of technologies licenses to MPP to the following 14 items:

A VSV-EBOV-based vaccine candidate. This SARS-CoV-2 vaccine candidate is based on a modified approved Ebola vaccine known as Ervebo from Merck & Co. ACE2 Dimer construct (Research tool for drug development). This technology is a plasmid encoding human ACE2 dimers, which refers to two conjoined copies of ACE2. ACE2 is a protein involved in COVID-19 infections. NIH notes that the research tool can help isolate antibodies generated against SARS-CoV-2. …

Lucira Health asks FDA for EUA on molecular at-home COVID/flu test

Lucura Health’s COVID-19 & Flu test [Photo courtesy of Lucira]Lucira Health (Nasdaq: LHDX) today said it has asked the FDA for an emergency use authorization (EUA) for its combination COVID-19 and flu test.

Emeryville, California-based Lucira said the at-home test would be available with a prescription to test for SARS-CoV-2, Influenza A and Influenza B. The Nucleic Acid Amplification Test (NAAT) platform has a sensitivity and specificity comparable to lab-based PCR assays, the company said, and runs on a palm-sized device for results from a single nasal swab within 30 minutes.

PCR tests pick up infectiousness faster than the rapid antigen tests commonly used at home, which are more likely to deliver false negatives and often don’t detect infections in the first few days when someone is contagious.

Lucira’s at-home COVID-19 test was the first to secure an EUA from the FDA in November 2020. The company said it hopes for its latest EUA ahead o…

Lucira Health asks FDA for EUA on molecular at-home COVID/flu test

Lucura Health’s COVID-19 & Flu test [Photo courtesy of Lucira]

Lucira Health (Nasdaq: LHDX) today said it has asked the FDA for an emergency use authorization (EUA) for its combination COVID-19 and flu test.

Emeryville, California-based Lucira said the at-home test would be available with a prescription to test for SARS-CoV-2, Influenza A and Influenza B. The Nucleic Acid Amplification Test (NAAT) platform has a sensitivity and specificity comparable to lab-based PCR assays, the company said, and runs on a palm-sized device for results from a single nasal swab within 30 minutes.

PCR tests pick up infectiousness faster than the rapid antigen tests commonly used at home, which are more likely to deliver false negatives and often don’t detect infections in the first few days when someone is contagious.

Lucira’s at-home COVID-19 test was the first to secure an EUA from the FDA in Novem…