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.,

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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 I am grateful to have received four doses of the Pfizer-BioNTech vaccine and I am feeling well while experiencing very mild symptoms. FDA Emergency Use Authorization Statement. AUTHORIZED USE.

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FDA Law Blog

AUGUST 3, 2022

Thirty years ago today, FDA announced that it had the authority to regulate you. Not yet understanding how important you’d become, you entered the regulatory world without a name – the Agency simply referred to you as “home brew” products. Mullen — Happy Birthday Laboratory Developed Tests (LDTs). 92P-0405 (Aug.

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The Pharma Data

JULY 23, 2021

Roche’s Chief Medical Officer and Head of Global Product Development. Roche’s Chief Medical Officer and Head of Global Product Development. The antibody combination was granted a Special Approval Pathway under article 14-3 of the Pharmaceuticals and Medical Devices Act. About Ronapreve (casirivimab and imdevimab).

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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

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FDA Law Blog

DECEMBER 11, 2023

1] Yet FDA’s conclusions about the Agency’s ability to regulate the entire laboratory industry are based on fundamentally flawed assumptions about the number of entities and tests that will be subject to FDA regulation. 5] This stratification, though, assumes that LDTs will follow the same pattern as IVDs currently regulated by FDA.

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FDA Law Blog

NOVEMBER 1, 2023

Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.

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The Pharma Data

DECEMBER 9, 2020

OHMX.bio – Belgium-based OHMX.bio and Fujirebio Europe were awarded a €720,000 research grant from Flanders Innovation & Entrepreneurship (VLAIO) to develop a clinical in vitro diagnostics (IVD) platform incorporating third generation sequencing (TGS) technologies. A solution could be at hand with Overland Pharmaceuticals.

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The Pharma Data

JANUARY 27, 2021

Eurofins Discovery will be conducting the IND-enabling in-vitro preclinical primary pharmacology and safety pharmacology studies on TD-0148A at its state-of-the-art facilities at Eurofins Cerep, DiscoverX and Panlabs. This approach makes Eurofins Discovery uniquely qualified to fulfill the needed studies for this innovative product.

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pharmaphorum

OCTOBER 4, 2022

Criteria for regulation. The FDA regulates software that meets the definition of a medical device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). peer-reviewed clinical studies or clinical practice guidelines) meet Criterion 2 and are not medical devices subject to FDA regulation and oversight.

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The Pharma Data

JANUARY 13, 2021

To date, Brilacidin has received Fast Track designation for three different clinical indications: COVID-19, Oral Mucositis, and Acute Bacterial Skin and Skin Structure Infection (qualifying for Fast Track under Qualified Infectious Disease Product designation).

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The Pharma Data

MAY 4, 2021

Multiple innovative and biosimilar products across our portfolio delivered growth, demonstrating the strength of our business and the depth and breadth of our growth drivers. Raises Full-Year 2021 Guidance (3) for Revenues to a Range of $70.5 Billion and Adjusted Diluted EPS (2) to a Range of $3.55 per share amounts). Adjusted Income (2).

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