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How the IND 30-day Hold Impacts Clinical Trial Activities

Advarra

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.” .

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Roche announces donation of essential medicines to Ukraine

The Pharma Data

We are also actively working on solutions to ensure continued access to treatment for Ukrainian patients in ongoing clinical trials, including for those who have left Ukraine and moved to other countries. Roche vehemently condemns the violent invasion of the country.

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Roche to launch SARS-CoV-2 Rapid Antigen Test in countries accepting CE mark, allowing fast triage decisions at point of care

The Pharma Data

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).

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Pfizer to Provide U.S. Government with an Additional 3.7 Million Treatment Courses of PAXLOVID™ to Help Combat COVID-19

Pfizer

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
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Statement from Pfizer Chairman and CEO Albert Bourla on Testing Positive for COVID-19

Pfizer

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
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U.S. FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™

Pfizer

Results from these analyses are consistent with previously disclosed efficacy and safety data for the trials. 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. NEW YORK, December 20, 2022 -- Pfizer Inc. In the U.S., approximately 7.6

Drugs 69
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Pfizer Receives Positive CHMP Opinion for Conversion of PAXLOVID™ Conditional Marketing Authorization to Full Marketing Authorization in the European Union

Pfizer

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.