Remote patient monitoring poised for further growth in clinical trials 

Remote patient monitoring technology from Biobeat can detect 14 cardio-pulmonary vital sign measurements. A number of pharma companies and contract research organizations are implementing the technology. Image courtesy of Biobeat.

Remote patient monitoring (RPM) is among the trends that will have the greatest impact on the pharma sector in 2021, according to the recent report, “The State of the Biopharmaceutical Industry, 2021 Edition,” from GlobalData. After a period of gradual uptake, RPM “witnessed a massive uptake in the life-sciences sector in 2020,” according to the GlobalData report.

The technology offers several advantages. It can help pharmaceutical companies continue making progress with clinical trials during a pandemic. The ability to gather data from patients remotely can also reduce the burden on medical staff while reducing gaps in clinical trial data. “One of the advantages when you have freq…

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AstraZeneca vaccine could curb COVID-19 transmission

Hopes for COVID-19 vaccines to beat back the pandemic assumed mass-vaccination would slow viral transmission, and not just prevent moderate-to-severe disease. 

Now, early data suggest that AstraZeneca’s (LON:AZN) COVID-19 vaccine, which it jointly developed with Oxford University, can curb viral transmission by up to 67%. 

There was more good news from the data. The ChAdOx1 vaccine offered 100% protection against severe disease in a Phase 3 trial. A single vaccine dose offered 76% efficacy between 22 and 90 days after vaccination. Delaying the second dose of vaccine by 12 weeks appeared to boost efficacy to 82%. Efficacy fell to 55% when the gap between doses dropped to less than six weeks. 

The study concluded that the U.K.’s strategy of aiming to vaccinate a large proportion of the population with the first dose before administering the second vaccine dose up to 12 weeks later is “an effective strategy.” 

Also heartening is the fact that a porti…

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Using technology to improve efficiency and safety in pharma manufacturing

Image courtesy of Nymi

The pandemic has amplified the pressure pharmaceutical companies face to improve operational performance while also forcing them to accelerate innovation, clinical trials and production. All of this requires employees to work as efficiently as possible.

Technology is available to meet these needs while also helping pharma companies respond to new worker safety challenges. Within pharma facilities, workers want to touch fewer surfaces and minimize their interactions. Accomplishing these goals requires deploying hands-free systems, conducting self-health attestations before shifts, and enforcing social distancing and contact tracing procedures.

Efficiency and safety are not mutually exclusive goals. Businesses that fall short in these areas risk their brand reputation, bottom line and employees’ lives. While many companies previously addressed individual challenges using point sol…

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Johnson & Johnson gearing up for COVID-19 vaccine data announcement

Johnson & Johnson (NYSE:JNJ) is poised to announce new data related to its Ad26 COVID-19 vaccine early next week. 

In an earnings call yesterday, management hinted that they expect results from the vaccine to be positive but stopped short at revealing details. 

“We think it’s very important to follow the data — to follow the science,” said JNJ CEO Alex Gorsky after declining to answer a question related to COVID-19 variants and vaccine efficacy until the official data announcement.

[Related: Johnson & Johnson pharma sales drive Street-beating Q4 results]

If the company’s adenovirus-based vaccine performs in the same league as those from Moderna (NSDQ:MRNA) and Pfizer (NYSE:PFE), Ad26 could play a vital role in stemming the COVID-19 crisis. Unlike competitors’ vaccines, Ad26 could be offered in a single dose, potentially simplifying mass-vaccination efforts. 

Former Operation Warp Speed chief Moncef Slaoui suggested that Ad26 vaccine…

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Tevogen Bio’s investigational t-cell therapy for COVID-19 wins funding

In July 2020, the clinical-stage biotech Tevogen Bio (Metuchen, N.J.) announced its plans to use its proprietary T-cell therapy to treat COVID-19.

Now, the company has announced that it has received funding from HMP Partners, a team of physician-investors, to advance what it terms an “investigational curative” therapy.

Tevogen will use the funding to support clinical trials for the therapy.

The company filed an investigational new drug application with the FDA in October 2020.

The company’s TVGN-489 therapy consists of allogenic lab-grown virus-specific T cells that it hopes will recognize and destroy COVID-19-infected calls.

HMP Partners believes the therapy could be effective against COVID-19 variants. “We believe it’s imperative to create a curative treatment that is not expected to be compromised by mutations,” said HMP CEO Dr. Manmohan Patel in a statement. “Unmodified virus-specific T-cells are well established as being effective and …

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Authorities investigating death of California recipient of COVID-19 vaccine

[Photo by Daniel Schludi on Unsplash]

Last week, Norwegian officials raised eyebrows when they announced that they were investigating the deaths of 23 elderly patients who had recently received COVID-19 vaccine doses. 

Now, California authorities are investigating the death of a Placer County-based patient who received a COVID-19 vaccine dose on Jan. 21. The patient died hours afterward. 

Placer County officials stressed they had not linked the death to the vaccine. 

They are planning on conducting an autopsy. 

Officials in Florida are also investigating the death of a 56-year-old physician who died 16 days after receiving the BNT162b2 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX).

Pfizer had stressed that it doesn’t “believe at this time that there is any direct connection to the vaccine” in the Florida physician’s death. 

Separately, the World Health Organi…

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Norway investigating deaths of 23 individuals who received COVID-19 vaccine

Image from Mark König on Unsplash

In Norway, authorities are investigating the deaths of nearly two dozen people who received the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX).

To date, it has analyzed data from 13 of those individuals.

The Norwegian Medicines Agency concluded that common adverse reactions to mRNA vaccines, including fever and nausea, could have contributed to deaths in elderly and frail patients.

The agency said in a statement that it had expected deaths close to the time of vaccination, given its plan to vaccinate elderly patients, many of whom have “serious underlying diseases.” Some 400 people in Norway die each week in nursing homes and long-term care facilities.

While it is clear that elderly individuals have a higher risk of mortality from all causes, it will take time to determine what role a vaccine might play, said Updesh Dosanjh, practice le…

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EU OKs Moderna COVID-19 vaccine

Moderna Logo (PRNewsFoto/Moderna Therapeutics)

The European Union has authorized the mRNA-1273 COVID-19 vaccine from Moderna (NSDQ:MRNA) ahead of schedule, responding to criticism that it had been too slow in its mass vaccination plans. The E.U. drug regulator had planned on meeting later in the month to discuss the vaccine. 

“This vaccine provides us with another tool to overcome the current emergency,” said Emer Cooke, Executive Director of European Medicines Agency (EMA), in a statement. “It is a testament to the efforts and commitment of all involved that we have this second positive vaccine recommendation just short of a year since the pandemic was declared by WHO.”

EMA has also authorized the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) on Dec. 21. It has not, however, given the greenlight to the vaccine from Oxford University and AstraZeneca, which is now available in the U.…

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