XTalks

JANUARY 29, 2024

Many companies have significantly pushed for sustainable packaging and efficient energy utilization, but medical device companies still need to catch up in sustainability approaches. Coloplast is focused on improving its products and packaging vis-à-vis reducing emissions.

Packaging 64

Packaging Packaging Production In-Vitro 64

Advarra

SEPTEMBER 23, 2022

Whether the drug’s proposed labeling (package insert) is appropriate, and what it should contain. . The Food and Drug Administration (FDA) is the federal entity in the U.S. charged with (among other things) “ensur[ing] that safe and effective drugs are available to improve the health of the people in the United States.” .

Clinical Trials 52

Clinical Trials Clinical Trials Trials Regulation 52

The Pharma Data

SEPTEMBER 1, 2020

Antigen test reliably and quickly triages people suspected of SARS-CoV-2, with results ready in 15 minutes, allowing informed treatment decisions. Antigen test accurately screens individuals with known exposure to infected SARS-CoV-2 patients, providing fast answers regarding their infection status. Food and Drug Administration (FDA).

In-Vitro 52

In-Vitro Antibody Medicine Clinical Trials 52

Pfizer

JANUARY 27, 2023

The European Commission (EC) will review the CHMP recommendation and is soon expected to make a final decision. This opinion from the CHMP confirms that the benefits of PAXLOVID in helping to reduce severe COVID-19-related outcomes, including hospitalization and death, in high risk patients continue to outweigh its potential risks.

Marketing 75

Marketing Production Drugs Licensing 75

Pfizer

AUGUST 15, 2022

Nirmatrelvir has shown consistent in vitro antiviral activity against the following variants: Alpha, Beta, Delta, Gamma, Lambda, Mu, and Omicron BA.1 One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course.

Drugs 99

Drugs Vaccination Vaccine In-Vitro 99

Pfizer

DECEMBER 13, 2022

Nirmatrelvir has shown consistent in vitro antiviral activity against the following variants: Alpha, Beta, Delta, Gamma, Lambda, Mu, and Omicron BA.1, One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course.

Drugs 110

Drugs Licensing Licensing Production 110

Pfizer

DECEMBER 20, 2022

FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™. Tuesday, December 20, 2022 - 04:30pm. Pfizer oral treatment remains available to eligible U.S. patients under Emergency Use Authorization as a critical tool in the fight against COVID-19. NEW YORK, December 20, 2022 -- Pfizer Inc. NYSE: PFE) announced today that the U.S. In the U.S.,

Drugs 69

Drugs Licensing Licensing Containment 69