In-Vitro, Packaging and Trials - Clinical Research Informer

How the IND 30-day Hold Impacts Clinical Trial Activities

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

Clinical Trials Clinical Trials Trials Regulation

Roche announces donation of essential medicines to Ukraine

The Pharma Data

MARCH 3, 2022

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.

Medicine

Medicine In-Vitro Packaging Packaging

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

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

In-Vitro Antibody Medicine Clinical Trials

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

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

Drugs Licensing Licensing Production

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

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

Drugs Vaccine Vaccination In-Vitro

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

Pfizer

DECEMBER 20, 2022

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

Drugs Licensing Licensing Containment

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

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

Marketing Production Drugs Licensing

Pfizer Signs Agreement to Provide the European Union with PAXLOVID™

Pfizer

NOVEMBER 23, 2022

(NYSE: PFE) today announced an agreement with the European Commission (EC) to supply its COVID-19 oral therapy, PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) to countries participating in the Joint Procurement Agreement across Europe. This agreement will supply participating countries up to 3.4

Licensing

Licensing Licensing Drugs Manufacturing

Comprehensive Guide to Medical Device Safety, Systems, and Regulatory Compliance: FAQ

Cloudbyz

AUGUST 19, 2024

European Medicines Agency (EMA): Regulates medical devices within the European Union through the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Introduction to Medical Device Safety, Systems, and Regulations The medical device industry is a rapidly evolving field that plays a critical role in modern healthcare.

Compliance

Compliance Manufacturing Regulation Marketing

Evusheld long-acting antibody combination recommended for approval in the EU for the pre-exposure prophylaxis (prevention) of COVID-19

The Pharma Data

MARCH 25, 2022

AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination, has been recommended for marketing authorisation in the European Union (EU) for the pre-exposure prophylaxis (prevention) of COVID-19 in a broad population of adults and adolescents aged 12 years and older weighing at least 40 kg.

Antibody

Antibody In-Vivo Medicine Vaccine

Evusheld long-acting antibody combination approved in the EU for pre-exposure prophylaxis (prevention) of COVID-19 in a broad population

The Pharma Data

MARCH 29, 2022

Evusheld significantly reduced the risk of developing symptomatic COVID-19 in PROVENT Phase III trial, with protection lasting at least six months Evusheld retains neutralising activity against the Omicron BA.2 1-3 Evusheld was generally well-tolerated in the trial. 1-3 Evusheld was generally well-tolerated in the trial.

Antibody

Antibody In-Vivo Vaccine Vaccination

The Important Role that Biopharmaceutics Plays in Accelerating Early-Phase Drug Development

Pharmaceutical Technology

FEBRUARY 23, 2023

Many compounds present sub-optimal pharmacokinetic (PK) data (either predicted from in-vitro and pre-clinical data or measured in the clinic), such as poor exposure (leading to high doses), large variability, short half-life requiring more than once-a-day dosing, or C max -related adverse events (AEs).

Development

Development Drugs Bioavailability In-Vivo

FDA Issues “Cliffs Notes”-style Guidance on Cell and Gene Therapy; What Questions Did They Answer? (Part 1)

FDA Law Blog

DECEMBER 6, 2024

The draft guidance recommends that no more than 15 questions are included in the briefing package. CBER will not commit to reviewing packages greater than 250 pages. Section #1: FDA Interactions Given the wide range of sponsors (i.e.,

Gene Therapy

Gene Therapy Gene Production In-Vivo

COVID-19 Pandemic Coverage

XTalks

SEPTEMBER 14, 2020

By the end of August, the World Health Organization (WHO) counted 33 vaccine candidates in some stage of clinical trial evaluation. As of July, the company and its federal partner stated that it is on track to supply between 500 million to 1 billion doses a year at a dose of 100 µg now selected for their Phase III trial.

Vaccine

Vaccine Vaccination Antibody Life Science

Clinical Research Informer

How the IND 30-day Hold Impacts Clinical Trial Activities

Roche announces donation of essential medicines to Ukraine

Trending Sources

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

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

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

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

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

Pfizer Signs Agreement to Provide the European Union with PAXLOVID™

Comprehensive Guide to Medical Device Safety, Systems, and Regulatory Compliance: FAQ

Evusheld long-acting antibody combination recommended for approval in the EU for the pre-exposure prophylaxis (prevention) of COVID-19

Evusheld long-acting antibody combination approved in the EU for pre-exposure prophylaxis (prevention) of COVID-19 in a broad population

The Important Role that Biopharmaceutics Plays in Accelerating Early-Phase Drug Development

FDA Issues “Cliffs Notes”-style Guidance on Cell and Gene Therapy; What Questions Did They Answer? (Part 1)

COVID-19 Pandemic Coverage

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