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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XTalks

JULY 22, 2021

We’ve heard of cell-based meat — meat produced by in vitro cell cultures of animal cells — but its seafood equivalent could be on the horizon. Cell-based fish has been making a splash in recent years, with several alt-seafood companies making the semi-finals of a recent alternative protein competition.

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XTalks

APRIL 18, 2024

The Elecsys pTau217 assay is designed to detect amyloid pathology, a hallmark of Alzheimer’s disease, by measuring phosphorylated tau protein in human plasma. A positive result on the test indicates a high likelihood of amyloid presence, as confirmed by amyloid PET scans or cerebrospinal fluid (CSF) testing.

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Roots Analysis

JANUARY 14, 2024

Biologics activate certain proteins or cells in your immune system to create specific responses to targets, while many conventional systemic drugs activate the entire immune system in a more generalized manner. It is worth mentioning that in vitro gene expression requires a suitable host for the production of a specific gene product.

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The Pharma Data

DECEMBER 9, 2020

The company plans to do this by developing drugs that eliminate protein aggregation by either reducing the production of toxic proteins or removing them after the fact through autophagy. Atlas cofounded, seeded and incubated Vigil, with pre-clinical stage assets in-licensed from Amgen Inc., which will remain a key shareholder.

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XTalks

JUNE 30, 2023

Sartorius is a globally recognized player in the diagnostics industry, providing a variety of solutions for in vitro diagnostics kit (IVD) manufacturers. Sartorius understands the need for continuous innovation in the highly regulated and price-sensitive diagnostics market. Banczyk has expertise in medical and IVD filtration devices.

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The Pharma Data

APRIL 7, 2021

today announced the launch of the Elecsys Anti-p53 immunoassay for the in vitro quantitative determination of anti-p53 antibodies. The assay is now available for all markets accepting the CE Mark. The assay is now available for all markets accepting the CE Mark. said Thomas Schinecker, CEO Roche Diagnostics.

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The Pharma Data

JANUARY 16, 2021

Etta Biotech”), to set up a high titer transient protein expression platform for high quality protein production using JS Bio’s transient transfection media. JS Bio becomes the exclusive cell culture supplier for Etta Biotech’s transient transfection high titer protein expression platform. JS Bio’s parent company.

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XTalks

MARCH 6, 2024

Brain Awareness Week 2024 , taking place March 11 to 17 this year, is a global campaign that aims to demystify the complexities of the human brain and promote the significance of neuroscientific research. This relates to neurological conditions like dementia and Alzheimer’s disease, which account for up to 70 percent of dementia cases.

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Roots Analysis

NOVEMBER 30, 2021

Most of the facilities are providing in vitro bioassay services for cell and gene therapies. How Players are Complying with Developing Market? To get detailed information on the key players, strategic initiatives in this domain, likely partners for cell and gene therapy service providers, and the likely market evolution.

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Drug Discovery World

APRIL 3, 2023

DS: What motivated you and Dr David Bunka, CTO, to create Aptamer and did you imagine you would one day be operating on such a global scale?    I quickly recognised the commercial value of aptamers as being able to address the gap in the market where antibodies fail to perform, and together we established the business to begin aptamer development.

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pharmaphorum

MARCH 1, 2021

COVID-19 antigen tests diagnose active infection by detecting SARS-CoV-2 viral proteins in samples, as opposed to PCR tests which detect viral RNA and require lab processing, but can miss infections with low virus levels. The test – which can also be self-collected – showed a sensitivity of 93.8%

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The Pharma Data

JANUARY 12, 2021

The LumiraDx SARS-CoV-2 Antigen Test uses Fast Microfluidic Immunofluorescence (FMI) technology to detect antigen nucleocapsid protein from nasal or nasopharyngeal swabs with high sensitivity results in 12 minutes. LONDON , Jan. Test specificity was 99.5% in nasal swab specimens. in nasal samples and 97.8% in nasopharyngeal samples.

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Drug Discovery World

DECEMBER 29, 2023

Dr Sofia Ferreira, Director of Applications at Refeyn, discusses how various technologies can address the main challenges in membrane protein characterization, describing how novel technologies, such as mass photometry, can streamline and support analytical processes. Scientists use a multitude of membrane mimetics to overcome this issue.

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The Pharma Data

SEPTEMBER 17, 2020

The test targets antibodies against the spike protein. Basel, 18 September 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the launch of its Elecsys® Anti-SARS-CoV-2 S antibody test for markets accepting the CE Mark. This is the focus of vaccines in development and convalescent plasma therapy.

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The Pharma Data

MAY 18, 2021

About the VENTANA MMR RxDx Panel The VENTANA MMR RxDx Panel is a label expansion of Roche’s current on-market VENTANA MMR IHC Panel. Defects in the MMR machinery have been attributed to mutations in the MMR proteins. About 90,000 women globally die from endometrial cancer each year 1.

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Drug Discovery World

OCTOBER 4, 2022

There’s no question that cell and gene therapies have emerged as some of the most promising and innovative medicines on the market. . BV-101 is an adeno- associated virus (AAV) gene therapy vector that simultaneously addresses the metabolic dysfunction of diseased neurons and contributes to the clearance of the mutant huntingtin protein.

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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.

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Delveinsight

JANUARY 12, 2021

Birinapant is a clinical-stage SMAC mimetic that degrades Inhibitors of Apoptosis Proteins (IAPs) by binding to them, ultimately leading to cell death in tumor cells. The companies believe that their candidate in its original IgG format has shown potent neutralization activity in in vitro assays and in an in vivo animal model.

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The Pharma Data

MARCH 16, 2022

TIB Molbiol offers a broad range of VirSNiP variant test kits for the detection of key spike protein mutations. The company launched eight RUO VirSNiP test kits for use on LightCycler® and cobas z 480 analyzers, for the detection of key spike protein mutations present in the novel B.1.1.529 3 and Delta.

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Delveinsight

FEBRUARY 23, 2021

The company plans to use the capital to expand its pipeline of protein-based vaccines and biologic cancer therapies utilizing its innovative and proprietary Trimer-Tag technology platform. The company, however, is optimistic and gearing up to find more opportunities to advance in the ALS market. LightDeck Diagnostics Gets USD 5.65

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The Pharma Data

JANUARY 20, 2021

The LumiraDx SARS-CoV-2 Antigen Test is authorized for use by FDA under an Emergency Use Authorization (EUA) only for the detection of SARS-CoV-2 nucleocapsid protein. The LumiraDx SARS-CoV-2 Antigen Test is authorized for use by FDA under an Emergency Use Authorization (EUA) only for the detection of SARS-CoV-2 nucleocapsid protein.

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The Pharma Data

NOVEMBER 11, 2020

ADDS IN VITRO PHARMACOLOGY AND EXPANDS PROTEIN SCIENCES. CREATES UNIQUE CO-LOCATED, FULLY-INTEGRATED, HIGH-CAPACITY R&D CENTRE. CREATES CENTRE OF EXCELLENCE FOR STRUCTURE-BASED DRUG DESIGN. ” About Dorothy Crowfoot Hodgkin Dorothy Hodgkin (née Crowfoot) was born in Cairo in 1910.

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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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The Pharma Data

DECEMBER 14, 2020

The global GBM treatment market is projected to reach $3.3 representing the largest market. The effectiveness of standard therapy with TMZ is limited because the response of GBM to TMZ is dependent upon the expression of the DNA repair enzymatic protein, O 6 -alkylguanine DNA alkyltransferase (MGMT). Lantern’s A.I.

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The Pharma Data

JANUARY 11, 2021

Using its novel yeast display system and large diverse human antibody libraries, AvantGen has identified a panel of high affinity human monoclonal antibody clones that bind to two distinct epitopes on the receptor binding domain of the SARS-CoV-2 spike protein. These findings have been published in Frontiers in Immunology ( [link] ).

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The Pharma Data

SEPTEMBER 1, 2020

Basel, 1 September 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it will launch a SARS-CoV-2 Rapid Antigen Test, in late September, for markets accepting the CE Mark. Antigen test reliably and quickly triages people suspected of SARS-CoV-2, with results ready in 15 minutes, allowing informed treatment decisions.

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The Pharma Data

MARCH 22, 2022

Current variants of concern can be resistant to treatments that work by binding to the spike protein found on the surface of the SARS-CoV-2 virus. Financial details of the agreement were not disclosed. Nirmatrelvir is designed to inhibit viral replication at a stage known as proteolysis, which occurs before viral RNA replication.

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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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The Pharma Data

JANUARY 12, 2021

Head of Medical and Marketing Division at Celltrion Healthcare. “We INCHEON, South Korea–( BUSINESS WIRE )– Celltrion Group today announced top-line results from its randomised, double-blind, and placebo controlled global Phase II/III clinical trial of CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate. days; 95% C.I,

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Delveinsight

JANUARY 18, 2021

The present Angelman syndrome treatment market revolves around the management of symptoms rather than curing the condition. . Several pharmaceutical and biotech companies in the Angelman syndrome market are exploring the novel curative approaches. As a consequence, Ovid halted everything related to OV101 and Angelman syndrome.

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Roots Analysis

MARCH 16, 2023

It is important in the process of protein synthesis because mRNA is responsible for transferring genetic information from DNA to ribosomes, which then decodes the genetic information into a protein. In the last few years, researchers have become interested in using in vitro transcribed (IVT) mRNA as a drug delivery agent.

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Roots Analysis

OCTOBER 16, 2023

Once isolated, molecular clones can be used to generate multiple copies of DNA for the analysis of gene sequences and / or to express proteins obtained for the study or utilization of protein function. These clones can be manipulated and mutated in vitro to alter the expression and function of a protein.

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The Pharma Data

DECEMBER 13, 2020

PXL770 is a first-in-class, oral direct adenosine monophosphate-activated protein kinase (AMPK) activator. The STAMP-NAFLD trial was a 12-week, randomized, parallel group study in 120 presumed NASH patients with or without type 2 diabetes (T2DM). In the T2DM patients, baseline fasting glucose (121-144 mg/dL) and HbA1c (6.6-7.1%)

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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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Drug Discovery World

JULY 22, 2022

Patient-derived xenografts (PDX) of melanoma were grafted into hIL2 mice, and TILs derived from the same melanoma patient were reactivated and expanded in vitro with IL2 and used to treat the PDX engrafted in the mice. However, adverse effects such as cytokine release syndrome (CRS) and neurotoxicity still occur. Jespersen et al.

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Drug Discovery World

NOVEMBER 8, 2023

Ahead of protein and antibody engineering conference PEGS Europe 2024 in Lisbon, DDW’s Megan Thomas looks at what to expect from each track of the annual biologics technology meeting.

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