BioTech 365

APRIL 26, 2021

Global Prenatal Screening Tests (In Vitro Diagnostics) Market Report 2020: Analysis and Forecast Model with COVID-19 Market Impact 2015-2030 – ResearchAndMarkets.com Global Prenatal Screening Tests (In Vitro Diagnostics) Market Report 2020: Analysis and Forecast Model with COVID-19 Market Impact 2015-2030 … Continue reading →

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BioTech 365

APRIL 26, 2021

Global Lyme Disease Tests (In Vitro Diagnostics) Market Report 2020: Analysis and Forecast Model with COVID-19 Market Impacts, 2015-2030 – ResearchAndMarkets.com Global Lyme Disease Tests (In Vitro Diagnostics) Market Report 2020: Analysis and Forecast Model with COVID-19 Market Impacts, 2015-2030 … Continue reading →

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BioTech 365

APRIL 26, 2021

Global Thyroid Function Tests (In Vitro Diagnostics) Market Report 2020: Analysis and Forecast Model with COVID-19 Market Impacts, 2015-2030 – ResearchAndMarkets.com Global Thyroid Function Tests (In Vitro Diagnostics) Market Report 2020: Analysis and Forecast Model with COVID-19 Market Impacts, 2015-2030 … Continue reading →

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BioTech 365

JUNE 1, 2021

North America In-Vitro Diagnostics Market Forecast to 2027 by Product and Services; Technology; Application; End User – ResearchAndMarkets.com North America In-Vitro Diagnostics Market Forecast to 2027 by Product and Services; Technology; Application; End User – ResearchAndMarkets.com DUBLIN–(BUSINESS WIRE)–The “North (..)

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BioTech 365

JULY 26, 2021

Latin America In-Vitro Diagnostic Tests Research Report 2021 – ResearchAndMarkets.com Latin America In-Vitro Diagnostic Tests Research Report 2021 – ResearchAndMarkets.com DUBLIN–(BUSINESS WIRE)–The “The Market for In Vitro Diagnostic Tests in Latin America” report has been added to ResearchAndMarkets.com’s (..)

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BioTech 365

SEPTEMBER 7, 2020

LONDON–(BUSINESS WIRE)–#healthcareindustry–Advancements in technology, customers’ changing expectations, and increasing investment in the healthcare industry have influenced significant growth in the in-vitro diagnostics market. To compete in … Continue reading →

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BioTech 365

JULY 27, 2021

In-Vitro Fertilization Market is Expected to Grow at a CAGR of 5.45% During the Period 2021-2026. In-Vitro Fertilization Market is Expected to Grow at a CAGR of 5.45% During the Period 2021-2026. – ResearchAndMarkets.com U.S.

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BioTech 365

MARCH 29, 2021

Insights on the In-vitro Diagnostics Global Market to 2027 – Development of Condition-Specific Markers and Tests Presents Opportunities – ResearchAndMarkets.com Insights on the In-vitro Diagnostics Global Market to 2027 – Development of Condition-Specific Markers and Tests Presents Opportunities – ResearchAndMarkets.com … (..)

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BioTech 365

MAY 27, 2021

Insights on the In Vitro Diagnostics (IVD) Quality Control Global Market to 2027 – Featuring Abbott Laboratories, Danaher and Merck Among Others – ResearchAndMarkets.com Insights on the In Vitro Diagnostics (IVD) Quality Control Global Market to 2027 – Featuring Abbott … Continue reading →

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BioTech 365

OCTOBER 8, 2020

DUBLIN–(BUSINESS WIRE)–The “2020 Three Scenarios of the Future In Vitro Diagnostics Market: Business-as-Usual, Economic Austerity, Technological Breakthroughs” report has been added to ResearchAndMarkets.com’s offering. … Continue reading →

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Pharmaceutical Technology

SEPTEMBER 19, 2022

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorisation for AstraZeneca ’s Evusheld (formerly AZD7442) for Covid-19 in the European Union (EU). The combination therapy was also found to retain in vitro neutralisation of SARS-CoV-2 virus’ Omicron BA.5

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Roots Analysis

AUGUST 7, 2023

On the other hand, cell free system / cell free expression system are ­in-vitro platforms that harness the transcription and translation machinery of living cells, in the form of cell lysates, to synthesize various types of biologics, particularly proteins. Interestingly, most of these kits are used for cell-free protein expression.

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Drug Discovery World

APRIL 25, 2023

Download our mitochondrial toxicity infographic and discover the benefits of novel in vitro strategies for consumer safety. Drug-induced mitochondrial dysfunction has been linked to compound attrition, organ toxicity, black-box warnings, and market withdrawals. Understand the importance of testing in early-phase drug discovery.

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Drug Discovery World

APRIL 25, 2023

Download this new mitochondrial toxicity infographic by Agilent and discover the benefits of novel in vitro strategies for consumer safety. Drug-induced mitochondrial dysfunction has been linked to compound attrition, organ toxicity, black-box warnings, and market withdrawals. Download now.

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Pharma Times

JANUARY 27, 2021

System will allow ‘in vitro diagnostics devices a faster and easier route to market’

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FDA Law Blog

MARCH 7, 2022

The pair of draft guidances laid out the transition for devices that are being marketed under an EUA and devices being marketed subject to enforcement discretion policies. Devices Marketed Under an Enforcement Policy. By Allyson B. Copies of the guidances can be found here and here. 510(k), de novo ) and have it accepted (i.e.,

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FDA Law Blog

FEBRUARY 19, 2024

Loloei tackled legal matters related to various aspects of the regulation of medical devices, in vitro diagnostics, and combination products including regulatory and compliance issues, dispute resolutions between the FDA and sponsors, and FDA enforcement actions. While at FDA, Ms. During her FDA tenure, Ms. Gibbs , HP&M Director.

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Pharmaceutical Technology

OCTOBER 5, 2022

Autologous CAR-T therapy does not easily lend itself to treating CLL, as it relies on extracting functional T-cells from the patient’s blood and genetically modifying them in vitro. Autologous CAR-T agents are now becoming the standard of care for patients in the third line and later settings, providing lucrative returns for these agents.

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Pharmaceutical Technology

SEPTEMBER 22, 2022

According to the partnership, Celltrion will oversee the development of ABP 102, after Abpro concludes in vitro studies, as well as hold the global marketing rights. According to preliminary data, the antibody has demonstrated enhanced efficacy and reduced toxicity versus other treatments for HER2+ cancer indication. .

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Pfizer

JANUARY 27, 2023

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. PAXLOVID is currently approved or authorized for conditional or emergency use in more than 70 countries to treat COVID-19.

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Pharmaceutical Technology

AUGUST 11, 2022

Further in vitro studies demonstrated that the most common variant that caused a loss in INHBE function was linked to a significant reduction in the secretion of the Activin E protein. Targeting gene expression that results in increased abdominal fat and leads to obesity is a key factor for the reduction of T2D and wider metabolic syndrome.

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pharmaphorum

DECEMBER 1, 2022

Exploring the implementation of complex in-vitro models for drug development. 3D Cell Culture has gained increasing momentum in the pharmaceutical industry over recent years, with the global 3D Cell Culture market predicted to reach a value of $3.48 Billion by 2028. Billion by 2028. Event Hashtag: #3DCellCulture2023. Who Should Attend?

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FDA Law Blog

MARCH 16, 2023

This announcement is the first traditional marketing authorization for a non-PCR based test to detect SARS-CoV-2. We are not aware of any other microbiological in vitro diagnostic test that contains the word “simple” in the regulation. symptomatic) when testing is started within 6 days of symptom onset.

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Drug Discovery World

AUGUST 3, 2023

The transaction expands Sygnature’s business operations into the North American market. NuChem Sciences employs over 300 staff in Montreal and Quebec City, Canada, where the company will continue to operate and drive further market expansion across North America.

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Drug Discovery World

MARCH 8, 2024

In vitro assays have shown superiority over the marketed monoclonal antibodies to respective target. Biopharmaceutical company Innovent Biologics has launched the first-in-human (FIH) Phase I clinical trial of IBI3002, a novel bispecific antibody targeting Interleukin 4 receptor α (IL-4Rα) and thymic stromal lymphopoietin (TSLP).

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BioSpace

JULY 3, 2022

Rather than selling, Novartis could spin Sandoz off into its own separate entity with its own listing on a stock exchange.

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Roots Analysis

AUGUST 18, 2023

In order to fasten the discovery of innovative drugs and personalized medication, improved in vitro simulation of human biology and pathologies is required. In order to fasten the discovery of innovative drugs and personalized medication, improved in vitro simulation of human biology and pathologies is required.

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BioTech 365

AUGUST 12, 2020

DUBLIN–(BUSINESS WIRE)–The “Diabetes Assays (In Vitro Diagnostics) – Global Market Analysis and Forecast Model (COVID-19 market impact)” report has been added to ResearchAndMarkets.com’s offering.

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Drug Discovery World

AUGUST 9, 2022

This work goes towards generating in vitro data showing how a candidate drug will be metabolised in the human body, data often included in new drug applications to regulatory agencies. . ?“We We are delighted that the Cypex team is joining BioIVT, bringing with them not only their market-leading products, but also their?

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FDA Law Blog

MARCH 31, 2024

Several witnesses also noted the lack of grandfathering provisions for tests already on the market in the proposed rule, something that was included in the VALID Act. This seems to have been the outcome that many lawmakers desired. Congress has on multiple times considered, and failed to enact, LDT legislation (see here and here ).

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XTalks

JUNE 26, 2023

Medical device and in vitro diagnostics technologies provider SurModic Inc. According to Surmodics, SurVeil DCB is approved to be marketed and sold in the US for percutaneous transluminal angioplasty of de novo or restenotic lesions in femoral and popliteal arteries having reference vessel diameters of 4 mm to 7 mm.

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Drug Discovery World

FEBRUARY 13, 2024

It has demonstrated efficacy in in vitro and in vivo models of fibrosis, as well as favourable safety and pharmacokinetic profiles in Phase I clinical studies. It has demonstrated efficacy in in vitro and in vivo models of fibrosis, as well as favourable safety and pharmacokinetic profiles in Phase I clinical studies.

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Pharmaceutical Technology

JUNE 6, 2023

Pharma Mar Overview Pharma Mar discovers, develops and markets marine-derived drugs to treat cancer. Pharma Mar offers in vitro diagnostic products used for detection of virus and bacteria in respiratory infections and human papilloma virus genotypes, among others. Buy the model here. The drug candidate is a marine-derived compound.

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Drug Discovery World

APRIL 4, 2023

The radiopharmaceuticals market is rapidly expanding with the development of a variety of targeting moieties. The platform will perform in vitro transcription translation from DNA-encoded libraries on beads. These moieties allow for specific binding to a tumour target of interest, thereby localising the treatment to diseased tissues.

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Drug Discovery World

OCTOBER 21, 2022

The test received marketing approval as an in vitro diagnostic medical device from the Ministry of Food and Drug Safety in January 2019. The subsidiary, called Bertis Bioscience, aims to establish a San Diego-based CLIA-certified lab facility in early Q4, 2022.

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BioTech 365

OCTOBER 26, 2020

NYSE: PKI) announced today that its PKamp™ Respiratory SARS-CoV-2 RT-PCR Panel has received clearance to be marketed as an in vitro diagnostic (IVD) device … Continue reading → Company’s latest test enables differential diagnosis between COVID-19, flu and RSV infection WALTHAM, Mass.–(BUSINESS

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FDA Law Blog

SEPTEMBER 27, 2022

Manufacturers can apply if they meet the following criteria: Demonstrated capacity for manufacturing and distributing high-quality in vitro diagnostics, AND at least one of the following: An existing technology adapted for POC or home detection of monkeypox virus, at design lock, with performance data.

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