FDA Law Blog: Biosimilars

MAY 16, 2024

Houck — Employee diversion of controlled substances from hospitals has been an issue since at least 1986 when I became a diversion investigator with the Drug Enforcement Administration (“DEA”). A registered nurse also admitted she replaced fentanyl and hydromorphone with saline solution for administration to patients.

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The Pharma Data

DECEMBER 1, 2020

1, 2020 — Health care workers and people in nursing homes should be at the front of the line for upcoming COVID-19 vaccines, a U.S. TUESDAY, Dec. Centers for Disease Control and Prevention advisory panel recommended Tuesday.

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The Pharma Data

NOVEMBER 18, 2020

18, 2020 /PRNewswire/ — Tampa General Hospital provided the first monoclonal antibody treatment to a COVID-19 positive patient today. It is one of the nation’s busiest adult solid organ transplant centers and is the primary teaching hospital for the USF Health Morsani College of Medicine. TAMPA, Fla.,

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The Pharma Data

DECEMBER 29, 2020

29, 2020 /PRNewswire/ — Phase 3 program in hospitalized patients to continue based on passing futility analysis on ability to reduce incidence of death or mechanical ventilation. First antibody therapy to demonstrate anti-viral effect in patients hospitalized with COVID-19. TARRYTOWN, N.Y. , Regeneron Pharmaceuticals, Inc.

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The Pharma Data

JANUARY 12, 2021

Doses are being supplied for use pursuant to the FDA Emergency Use Authorization for high-risk patients with mild to moderate COVID-19 in order to reduce the risk of progression to severe COVID-19 and/or hospitalization. Regeneron Pharmaceuticals, Inc. NASDAQ: REGN ) today announced that the U.S. Yancopoulos , M.D., In the U.S.

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The Pharma Data

JANUARY 16, 2021

” He pledged to ramp up vaccination availability in pharmacies, build mobile clinics to get vaccines to underserved rural and urban communities and encourage states to expand vaccine eligibility to people 65 and older, The New York Times reported. The American Hospital Association (AHA) also weighed in on Biden’s proposal.

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The Pharma Data

NOVEMBER 20, 2020

Casirivimab and imdevimab are not authorized for use in patients who are hospitalized or require oxygen therapy due to COVID-19, or for people currently using chronic oxygen therapy because of an underlying comorbidity who require an increase in baseline oxygen flow rate due to COVID-19. . “The Yancopoulos, M.D.,

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The Pharma Data

NOVEMBER 21, 2020

Casirivimab and imdevimab are not authorized for use in patients who are hospitalized or require oxygen therapy due to COVID-19, or for people currently using chronic oxygen therapy because of an underlying comorbidity who require an increase in baseline oxygen flow rate due to COVID-19. . Yancopoulos , M.D., Limitations of Authorized Use.

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The Pharma Data

JANUARY 27, 2021

27, 2021 — Retired doctors and nurses are being called to the front lines of the U.S. The rules, drafted under the Public Readiness and Emergency Preparedness Act, will also be adapted to allow licensed doctors, nurses and health practitioners to administer shots across state lines, Zients said. WEDNESDAY, Jan. More than 23.5

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The Pharma Data

AUGUST 27, 2020

What is clear is a big flu season combined with coronavirus could overwhelm hospitals. The vaccine will also be available privately in pharmacies and some supermarkets to adults ineligible for an NHS jab. Doctors and nurses are being asked to put new measures in place to allow the vaccine to be given safely during the pandemic.

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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.

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The Pharma Data

JANUARY 13, 2021

“Every vaccine dose that is sitting in a warehouse rather than going into an arm could mean one more life lost or one more hospital bed occupied.” 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.

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Drug & Device Law

MAY 15, 2023

The relevant facts were quite concisely stated: In the fall of 2021, [plaintiff’s] 15-year-old [daughter] visited [defendant’s] pharmacy seeking to be vaccinated for COVID-19 without parental consent. includ[es] retail pharmacies. UPMC Pinnacle Hospitals , 283 A.3d Presence Center & Suburban Hospitals Network , 191 N.E.3d.

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