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 52

Antibody In-Vivo Medicine Vaccination 52

The Pharma Data

MARCH 29, 2022

AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination, has been granted 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. Christoph D.

Antibody 52

Antibody In-Vivo Vaccination Vaccine 52

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

The Pharma Data

JANUARY 31, 2021

They are well established drug targets, particularly in neurological and cardiovascular diseases, but many remain undrugged or poorly drugged, and may be tractable to structure-based approaches. Metrion will contribute intellectual property, know-how and use of screening models for the nominated ion channel target. ” About Sosei Heptares.

Drugs 52

Drugs Protein In-Vitro Development 52

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

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

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

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 52

Compliance Manufacturing Regulation Marketing 52

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 40

Licensing Licensing Drugs Manufacturing 40

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 246

Development Drugs Bioavailability In-Vivo 246

Pharmaceutical Technology

JANUARY 6, 2023

The preparation of a semi-solid dosage form – from formulation and development, to scale-up, commercial manufacturing, and packaging – should ideally take place under one roof in a contiguous, end-to-end workflow to avoid unnecessary equipment and process changes. In vitro release testing to demonstrate bioequivalence.

Production 130

Production Manufacturing Development Bioequivalency 130

XTalks

JANUARY 24, 2025

Key opportunities span the entire medical device product life cycle , from raw material sourcing and manufacturing to packaging, distribution and end-of-life management. For instance, in 2023, BD partnered with Casella to recycle 40,000 pounds of single-use medical devices, turning waste into pellets for manufacturing new products.

Packaging 59

Packaging Packaging Manufacturing Production 59

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 59

Gene Therapy Gene Production In-Vivo 59

XTalks

SEPTEMBER 14, 2020

Tension is mounting as nations big and small jockey around industry to ensure they are first in line to access a vaccine, should one prove to be successful against COVID-19. By the end of August, the World Health Organization (WHO) counted 33 vaccine candidates in some stage of clinical trial evaluation. The price of that prize is incalculable.

Vaccination 92

Vaccination Vaccine Antibody Life Science 92