The Pharma Data

JANUARY 27, 2021

Bruker is one of the world’s leading analytical instrumentation companies providing high-performance scientific instruments and high-value analytical and diagnostic solutions to scientists globally. I look forward to updating the market when we have definitive clinical performance data.”.

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The Pharma Data

JANUARY 12, 2021

The LumiraDx SARS-CoV-2 Antigen test is authorized in the United States for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. LONDON , Jan. Test specificity was 99.5%

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The Pharma Data

JANUARY 20, 2021

The LumiraDx SARS-CoV-2 Antigen Test is authorized in the United States for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. LONDON , Jan. Inverness Medical Technology Inc.

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The Pharma Data

MAY 3, 2021

Included were articles on the mid-career transition from research scientist to regulatory professional, continuous professional development and the value of graduate-level qualifications, and findings from two surveys on different aspects of the profession. Continuous professional development. Who is the average regulatory professional?

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The Pharma Data

NOVEMBER 1, 2020

For Product Enquiries and How to Order: All BD SARS-CoV-2 diagnostic products have regulatory authorizations in the markets where they are sold. The first shipment of 1.2 million SARS-CoV-2 Assays for use on the BD Veritor Plus System to be delivered in The Netherlands by mid-November. THE HAGUE, NETHERLANDS and FRANKLIN LAKES, N.J. ,

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XTalks

SEPTEMBER 20, 2024

As of 2024, the global CAR T-cell therapy market is valued at $4.6 billion and is projected to reach $15.2 billion by 2035. Despite this, CAR T-cell therapies are currently limited to treating B-cell malignancies, and most patients do not achieve progression-free survival.

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The Pharma Data

AUGUST 18, 2020

REGN-COV2 is Regeneron’s two-antibody combination currently in late-stage clinical trials for the treatment and prevention of COVID-19 infection. The companies will collaborate on developing and manufacturing REGN-COV2. Regeneron will distribute REGN-COV2 in the U.S. and Roche will be responsible for distribution outside the U.S. Schleifer, M.D.,

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Antibody Clinical Trials Clinical Trials Manufacturing 52

Roots Analysis

OCTOBER 19, 2023

Bacteria plays a crucial role in maintaining the ecosystem balance. However, there are few species of bacteria that can cause several infectious diseases ( such as strep throat, salmonellosis, tuberculosis, whooping cough ). These are mainly transmitted through air, water, living organisms, and food.

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Pharmaceutical Technology

FEBRUARY 20, 2023

DDL was founded in 1994, also originally started by a group of scientists operating in a university, also specialising in infectious diseases, but with more of a focus on HPV and Hepatitis. This may sound obvious, but it is still a major hurdle in drug development. of the clinical trial population globally. participation of white subjects.

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pharmaphorum

NOVEMBER 4, 2020

However, in vitro or binding-based efficacy insight needs to be confirmed by reliable clinical evidence, as shown by the outcomes of COVID-19 trials with remdesivir and hydroxychloroquine. million worldwide and continues to increase despite the global public health measures that have been put in place.

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FDA Law Blog

NOVEMBER 8, 2022

In one of the conference’s well-attended sessions, Dr. William Maisel, Chief Medical Officer and Director at CDRH’s Office of Product Evaluation and Quality, shared FDA’s experience with EUAs over the last two and a half years as well as more detail on transition planning for those devices marketed under an EUA or enforcement policy (EP).

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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.

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