Definition, Packaging and Pharmacy - Drug Discovery Digest

Analysis Life Sciences Thank You Ahead of a November deadline, FDA finalizes guidance on waivers, exemptions or exceptions from supply chain security requirements

Agency IQ

AUGUST 4, 2023

a wholesaler or pharmacy) would be able to see a valid chain of custody for a product. In March, the agency finalized a long-awaited guidance document that provides specific definitions for key terms and concepts under the DSCSA – including the terms counterfeit, diverted, fraudulent transaction and unfit for distribution.

FDA

FDA Science Production Packaging

CMS Final Medicaid Drug Rebate Rule Details New Misclassification Penalties and Numerous Other Changes

FDA Law Blog: Biosimilars

SEPTEMBER 30, 2024

Another rejected proposal was a definition of “vaccine” (vaccines are exempt from Medicaid rebates), which would have limited this term to a product that is administered prophylactically – i.e., to prevent rather than treat a disease. that is not supported by the statute and applicable regulations.” 1396r-8(k)(3).

Regulations

Regulations Drugs International Pharmacy

New England Journal of Medicine Publishes Positive Initial Regeneron Antibody Cocktail Results in Non-hospitalized Patients with COVID-19

The Pharma Data

DECEMBER 17, 2020

These follow-on data provided the first definitive prospective evidence demonstrating anti-viral activity for a treatment regimen now available for COVID-19, and also further documented the ability of this treatment to decrease the need for further medical attention,” said George D. Have chronic kidney disease. Have diabetes.

Hospitals

Hospitals Production Clinical Trials Virus

Regeneron’s COVID-19 Outpatient Trial Prospectively Demonstrates that REGN-COV2 Antibody Cocktail Significantly Reduced Virus Levels and Need for Further Medical Attention

The Pharma Data

OCTOBER 28, 2020

Today’s data, involving an additional 524 patients from the ongoing Phase 2/3 trial, provides definitive final virology results and meets the clinical endpoint of reducing medical visits. TARRYTOWN, N.Y. , 28, 2020 /PRNewswire/ — . Regeneron has shared these results with the U.S.

Virus

Virus Trials Clinical Trials Production

Regeneron Announces U.S. Government Agreement to Purchase Additional COVID-19 Antibody Cocktail Doses

The Pharma Data

JANUARY 12, 2021

Definition of High-Risk Patients. Monoclonal antibodies, such as casirivimab and imdevimab, may be associated with worse clinical outcomes when administered to hospitalized patients requiring high flow oxygen or mechanical ventilation with COVID-19. Have chronic kidney disease. Have diabetes.

Government

Government Hospitals Virus Production

Article EMA Thank You New EC report dives deep to better understand shortages of critical medicines

Agency IQ

JULY 12, 2024

A 2017 European Parliament resolution called on the European Commission and the European Council “to formulate a better definition of the concept – and analyse the causes – of shortages of medicines.” In October 2024, the European Commission published a communication putting forth a package of reforms to address medicines shortages.

Regulations

Regulations Packaging Production FDA

Regeneron Announces Encouraging Initial Data from COVID-19 Antibody Cocktail Trial in Hospitalized Patients on Low-flow Oxygen

The Pharma Data

DECEMBER 29, 2020

Definition of High-Risk Patients High-risk is defined as patients who meet at least one of the following criteria: — Have a body mass index (BMI) ?35 35 — Have chronic kidney disease — Have diabetes — Have immunosuppressive disease — Are currently receiving immunosuppressive treatment — Are ?

Hospitals

Hospitals Trials Clinical Trials Production

Which Arthritis Painkiller Works the Fastest?

The Pharma Data

MAY 13, 2021

I Have A Doctorate In Pharmacy, But Everything I Learned About Pain Relief In Pharmacy School Is Dead Wrong! Which is how I got into pharmacy — after all, what better way to spend your life than by removing illness from the world. . … And then got my Doctor of Pharmacy (Pharm.

Pharmacy

Pharmacy Doctors Production Therapies

Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

Agency IQ

JUNE 16, 2023

Based on the results of its evaluation of nominated categories of drug products to date, as well as consultation with the Pharmacy Compounding Advisory Committee (PCAC), FDA is also proposing to include certain categories of drug products on these lists. The rule, will also, if finalized, address communication with State boards of pharmacy.

Regulations

Regulations FDA Science Production

Regeneron’s Casirivimab and Imdevimab Antibody Cocktail for COVID-19 is First Combination Therapy to Receive FDA Emergency Use Authorization

The Pharma Data

NOVEMBER 20, 2020

Definition of High-Risk Patients. Monoclonal antibodies, such as casirivimab and imdevimab, may be associated with worse clinical outcomes when administered to hospitalized patients requiring high flow oxygen or mechanical ventilation with COVID-19. Have chronic kidney disease. Have diabetes. Are ?

Therapies

Therapies FDA Clinical Trials Hospitals

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

Agency IQ

DECEMBER 1, 2023

Based on the results of its evaluation of nominated categories of drug products to date, as well as consultation with the Pharmacy Compounding Advisory Committee (PCAC), FDA is also proposing to include certain categories of drug products on these lists. fit in this definition.

FDA

FDA Science Regulations Production

Regeneron’s REGEN-COV2 is First Antibody Cocktail for COVID-19 to Receive FDA Emergency Use Authorization

The Pharma Data

NOVEMBER 21, 2020

Definition of High-Risk Patients. Monoclonal antibodies, such as casirivimab and imdevimab, may be associated with worse clinical outcomes when administered to hospitalized patients requiring high flow oxygen or mechanical ventilation with COVID-19. Have chronic kidney disease. Have diabetes.

FDA

FDA Clinical Trials Hospitals Government

Analysis Life Sciences Thank You Cannabis groups to Congress: FDA should regulate CBD as a dietary supplement

Agency IQ

AUGUST 25, 2023

However, the Farm Bill created a new definition for hemp and marijuana , allowing hemp to be removed from the CSA and facilitating an explosion in commercialization of CBD products. This meant that prior to the passage of the 2018 Farm Bill, hemp and its derivatives were considered Schedule I substances under the CSA. Earl Blumenauer (D-OR).

Regulations

Regulations FDA Science Production

A Texas Mess

Drug & Device Law

JANUARY 4, 2024

Alabama State Board of Pharmacy , 61 F.4th Okuley’s Pharmacy & Home Medical , N.E.3d For “covered persons” and “covered countermeasures” the Act provides extensive preemption: (8) Preemption of State law During the effective period of a declaration. . ., 247d-6d(b)(8). “To 4th 902, 905 (11th Cir. Leonard , 61 F.4th

Vaccine

Vaccine FDA FDA Approval Pharmacy

Two New Appellate COVID-Related Developments

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. A court acting without “a rational and explainable basis” by definition abuses its discretion.

Vaccine

Vaccine Pharmacy Hospitals Licensing

Drug Discovery Digest

Analysis Life Sciences Thank You Ahead of a November deadline, FDA finalizes guidance on waivers, exemptions or exceptions from supply chain security requirements

CMS Final Medicaid Drug Rebate Rule Details New Misclassification Penalties and Numerous Other Changes

Trending Sources

New England Journal of Medicine Publishes Positive Initial Regeneron Antibody Cocktail Results in Non-hospitalized Patients with COVID-19

Regeneron’s COVID-19 Outpatient Trial Prospectively Demonstrates that REGN-COV2 Antibody Cocktail Significantly Reduced Virus Levels and Need for Further Medical Attention

Regeneron Announces U.S. Government Agreement to Purchase Additional COVID-19 Antibody Cocktail Doses

Article EMA Thank You New EC report dives deep to better understand shortages of critical medicines

Regeneron Announces Encouraging Initial Data from COVID-19 Antibody Cocktail Trial in Hospitalized Patients on Low-flow Oxygen

Which Arthritis Painkiller Works the Fastest?

Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

Regeneron’s Casirivimab and Imdevimab Antibody Cocktail for COVID-19 is First Combination Therapy to Receive FDA Emergency Use Authorization

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

Regeneron’s REGEN-COV2 is First Antibody Cocktail for COVID-19 to Receive FDA Emergency Use Authorization

Analysis Life Sciences Thank You Cannabis groups to Congress: FDA should regulate CBD as a dietary supplement

A Texas Mess

Two New Appellate COVID-Related Developments

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