The Pharma Data

DECEMBER 29, 2020

As in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes. The primary clinical objective of this initial analysis was to determine if there was sufficient efficacy in these patients to warrant continuing the trial (i.e., futility analysis).

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The Pharma Data

NOVEMBER 16, 2020

16, 2020 — Scientists are reporting early success with an experimental herpes vaccine that uses a genetically modified version of the virus. The gene edit prevents the virus from performing its normal evasive maneuver: hiding out in nervous system cells in order to elude the immune system. MONDAY, Nov.

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The Pharma Data

JANUARY 24, 2021

With a presidential inauguration and a federal holiday, it wasn’t an enormously busy week for clinical trial news, but there was a fair amount, nonetheless. It inked a deal with the National Institute of Allergy and Infectious Diseases (NIAID) to launch a Phase I trial. Read on to see. COVID-19-Related. Non-COVID-19-Related.

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The Pharma Data

NOVEMBER 24, 2020

She represents the National Association of Pediatric Nurse Practitioners, and said providers must be ready to explain this to people who line up to get any COVID-19 vaccine. Already, some volunteers in trials of candidate vaccines from drug companies Moderna, Pfizer and AstraZeneca have reported flu-like symptoms after immunization.

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The Pharma Data

DECEMBER 14, 2020

Food and Drug Administration issued the EUA for use of the vaccine in individuals ages 16 years and older late Friday evening, allowing a national vaccine campaign against the virus to begin this week. Centers for Disease Control and Prevention Director Robert R. Redfield, M.D., The vaccine is administered in two doses three weeks apart.

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The Pharma Data

JANUARY 11, 2021

million, will boost its vaccine rollout to now include health care workers, nursing home residents and staff, as well as those living in congregate settings such as assisted living or shelters. Herd immunity will be reached when the virus encounters enough people with immunity that it dies out. The clock is ticking.” But the U.S.

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The Pharma Data

DECEMBER 4, 2020

And I think we’ll see a significant reduction” in the virus, Biden told CNN. In the United States, an advisory panel on Tuesday approved a vaccine distribution plan that recommends health care workers and nursing home residents and staff be the first to receive any approved coronavirus vaccine. A global scourge.

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The Pharma Data

DECEMBER 3, 2020

Though coronavirus cases have exploded recently, with new infections topping 1 million a week, a far smaller proportion of people who get the virus now are dying from it. Around the world, researchers are testing 57 vaccines in clinical trials, and nearly 100 others are being tested in animals or cell, the Times reported.

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The Pharma Data

NOVEMBER 20, 2020

The clinical evidence from Regeneron’s outpatient trial suggests that monoclonal antibodies such as casirivimab and imdevimab have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load. “The Yancopoulos, M.D.,

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The Pharma Data

DECEMBER 14, 2020

ICU nurse Sandra Lindsay, with Long Island Jewish Medical Center in Queens, New York, received the Pfizer-BioNTech COVID-19 vaccine. Both vaccines have demonstrated about 94-95% efficacy in clinical trials. Most biotechs when they launch an IPO have no products in the clinic, or perhaps have one or two in early-stage trials.

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The Pharma Data

JANUARY 12, 2021

“Patients in our antibody cocktail outpatient clinical trial experienced significant reductions in virus levels and required fewer medical visits for COVID-19, suggesting the therapy can help reduce the current burden on hospitals and healthcare systems,” said George D. .

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The Pharma Data

DECEMBER 3, 2020

The TAK-620-303 (SOLSTICE) trial (NCT02931539) is a multicenter, randomized, open-label, active-controlled trial comparing eight weeks of treatment with either maribavir or investigator assigned treatment (IAT) in transplant recipients with CMV infection refractory or resistant to existing antiviral treatments (i.e.,

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The Pharma Data

DECEMBER 17, 2020

NASDAQ: REGN ) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19. TARRYTOWN, N.Y. , 17, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc.

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PLOS: DNA Science

JUNE 1, 2023

Two clinical trials were conducted and results published in December. “Until now, doctors and nurses had no way to stop blisters and wounds from developing on dystrophic EB patient skin and all we could do was to give them bandages and helplessly watch as new blisters formed. Primary investigator M.

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The Pharma Data

JANUARY 26, 2021

“Notably, the 70 percent decrease in risk of hospitalizations or death seen in this Phase 3 trial of bamlanivimab and etesevimab together is consistent with the reduction in risk of hospitalization or ER visits seen with bamlanivimab alone in the Phase 2 trial. INDIANAPOLIS, Jan. Across 1,035 patients, there were 11 events (2.1

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The Pharma Data

NOVEMBER 18, 2020

. “Tampa General Hospital and USF Health were already actively conducting clinical trials on COVID-19 and had the team, location and infrastructure in place to identify and care for the patients who can benefit most from this treatment.”

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The Pharma Data

DECEMBER 11, 2020

Health care workers and nursing home residents and staff should get the first shots, according to guidelines issued recently by the U.S. Instead, a modified version of the vaccine will be tested in a smaller trial set to begin in February, the newspaper said. Who is first in line? Centers for Disease Control and Prevention.

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The Pharma Data

DECEMBER 2, 2020

Still, the temperature requirement could dictate who will be vaccinated first in Britain: While nursing home residents were supposed to be the top priority under an advisory committee’s plans, efforts to limit transportation of the vaccine may mean that National Health Service staff will receive the shots first, the Times reported.

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The Pharma Data

NOVEMBER 21, 2020

The clinical evidence from Regeneron’s outpatient trial suggests that monoclonal antibodies such as REGEN-COV2 have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load. .” Yancopoulos , M.D.,

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The Pharma Data

DECEMBER 12, 2020

Health care workers and nursing home residents and staff should get the initial shots, according to guidelines issued recently by a U.S. The nursing home industry applauded the approval. The association represents 14,000 nursing homes and assisted living facilities. ” Who is first in line to be vaccinated?

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The Pharma Data

DECEMBER 14, 2020

Residents of nursing homes, who have suffered a disproportionate share of COVID-19 deaths, will begin to get shots next week, the Times reported. ” The nursing home industry applauded the approval. The association represents 14,000 nursing homes and assisted living facilities.

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The Pharma Data

AUGUST 3, 2021

Bristol Myers Squibb conducted a subsequent confirmatory Phase 3 study evaluating romidepsin plus CHOP (Ro-CHOP) versus CHOP in first-line PTCL patients, but the trial did not meet the primary efficacy endpoint of progression free survival. Reactivation of hepatitis B virus infection was reported in 1% of patients in clinical trials.

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The Pharma Data

DECEMBER 18, 2020

“To go from having a [genetic] sequence of a virus in January, to having two vaccines available in December, is a remarkable achievement.” Moderna’s vaccine was shown to be 94 percent effective in its large clinical trial, while Pfizer’s vaccine was 95 percent effective. ” Earlier this week, Gen.

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The Pharma Data

DECEMBER 21, 2020

This latest strain of coronavirus is concerning because it has so many mutations — nearly two dozen — and some are on the spiky protein that the virus uses to attach to and infect cells, the AP reported. The new COVID-19 vaccines target that spiky protein. billion, the Post reported.

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The Pharma Data

DECEMBER 22, 2020

Instead, it may have been identified there first because the British government has a strong monitoring system that has tracked tens of thousands of genomic sequences of virus samples. The United States does not have nearly the same level of virus surveillance, the newspaper said. “It may very well be here.

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The Pharma Data

JANUARY 13, 2021

Right now, the vaccines are largely being distributed to people in the highest-risk categories, including frontline health care workers and older people and staff in nursing homes. More community centers and pharmacies will also be added to the list of places where people can be vaccinated, the Times reported. The clock is ticking.”

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The Pharma Data

DECEMBER 31, 2020

Right now, most shots are being given at hospitals, clinics and nursing homes, but Perna and Slaoui agreed that the pace of vaccination should pick up considerably once doses are given out by the major pharmacy chains. But a faster-spreading virus could swamp hospitals with seriously ill patients. A global scourge.

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The Pharma Data

DECEMBER 23, 2020

That includes two companies — Sanofi and Novavax — that have yet to begin large clinical trials in the United States. Instead, it may have been identified there first because the British government has a strong monitoring system that has tracked tens of thousands of genomic sequences of virus samples.

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Drug & Device Law

JANUARY 17, 2024

O’Lear is a criminal case, in which the defendant was convicted by a jury of healthcare fraud (billing Medicare and Medicaid for fictitious mobile X-rays at nursing homes) and aggravated identity theft. The unvaccinated could disrupt the potentially lengthy trial if they became ill and exposed others to the virus.

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