The Pharma Data

MAY 31, 2022

About Evrysdi® (risdiplam) Evrysdi is a survival motor neuron 2 (SMN2) splicing modifier designed to treat SMA caused by mutations in chromosome 5q that lead to SMN protein deficiency. Evrysdi is now approved in the US to treat SMA in children and adults of all ages. Jude Children’s Research Hospital.

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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

AUGUST 18, 2020

The companies will collaborate on developing and manufacturing REGN-COV2. We’re committing our manufacturing expertise and capacity, and our global distribution network to bring Regeneron’s potential antibody combination to as many people around the world as we possibly can.”. Regeneron will distribute REGN-COV2 in the U.S.

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Antibody Clinical Trials Clinical Trials Manufacturing 52

Roots Analysis

AUGUST 12, 2024

It is worth mentioning that molecular diagnostics is a subset of the broader in vitro diagnostics market. According to the World Health Organization, there are over 40,000 in vitro diagnostics products available in the market. This vast array of products highlights the critical role of diagnostics in healthcare.

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Genetics Gene Expression RNA DNA 40

XTalks

JUNE 12, 2023

Medtronic, the leading global medical device manufacturer, reported a revenue growth of 5 percent in the last fiscal year, affirming its position as the top global medical technology company by revenue. This article takes a comprehensive look at the top 10 medical device companies that are leading the charge in this rapidly evolving field.

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Druggist

FEBRUARY 17, 2021

For many customers, ointment or cream for insect bites is the first line of rescue in stings management. In this post, I will review the best ointment or cream for insect bites available over the counter and from pharmacies. I will also discuss alternative options for insect bites, mainly the use of antihistamines. 822 Reviews. £3.19.

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The Pharma Data

SEPTEMBER 1, 2020

Antigen test reliably and quickly triages people suspected of SARS-CoV-2, with results ready in 15 minutes, allowing informed treatment decisions. Antigen test accurately screens individuals with known exposure to infected SARS-CoV-2 patients, providing fast answers regarding their infection status. Food and Drug Administration (FDA).

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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

MAY 27, 2022

This dual targeting activates and redirects a patient’s existing T-cells to engage and eliminate target B-cells by releasing cytotoxic proteins into the B-cells. The pivotal phase II NP30179 expansion study included patients with heavily pre-treated and highly refractory DLBCL, with 58.3% After a median follow-up of 12.6 months, 39.4%

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Antibody In-Vitro Medicine Engineer 52

The Pharma Data

JANUARY 12, 2021

We are planning to manufacture doses for around two million patients in 2021 and hope to improve access to this treatment option for those that require.”. CT-P59 treatment groups also reported with significantly shortened time to clinical recovery ranging from 3.4 days quicker compared to placebo. days; 95% C.I, days compared to placebo [5.7

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The Pharma Data

MAY 17, 2023

BTK, also known as tyrosine-protein kinase BTK, is an enzyme that regulates B-cell development and activation and is also involved in the activation of innate immune system myeloid lineage cells, such as macrophages and microglia. Roche’s Chief Medical Officer and Head of Global Product Development.

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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%)

Trials 40

Trials In-Vitro Insulin Protein 40

Camargo

NOVEMBER 29, 2021

Recombinant therapeutic proteins. Fusion proteins. They may contain proteins that control the action of other proteins and cellular processes, genes that control production of vital proteins, modified human hormones, or cells that produce substances that suppress or activate components of the immune system.

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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. “We understand that diagnostic manufacturers often have diverse needs. Banczyk has expertise in medical and IVD filtration devices. Xu joined Sartorius in 2002.

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In-Vitro Manufacturing Production Antibody 52

The Pharma Data

SEPTEMBER 17, 2020

The test targets antibodies against the spike protein. 1 Specifically, the test targets antibodies which are directed against the particular region of the viral spike protein responsible for binding to the host cell receptor, which is required for the virus to enter the host cell. said Thomas Schinecker, CEO Roche Diagnostics.

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Roots Analysis

OCTOBER 22, 2023

Coding RNAs include messenger RNA (mRNA) and short interfering RNA (siRNA), which encode proteins and silence gene expression, respectively. ASOs are short single-stranded nucleotides that bind to specific messenger RNAs and prevent the production of a particular protein.

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RNA Protein Genetics Gene Expression 40

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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DNA Gene Protein In-Vitro 40

Roots Analysis

JANUARY 14, 2024

With the increased interest and gradual shift of investment from small molecule drugs to biologics and the establishment of several biologics manufacturing companies / biologics CMOs, more than 250 biologic therapies and vaccines have been developed, globally. They are different from small molecules in terms of their size and complexity.

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Contract Manufacturing Protein Manufacturing Production 40

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.

Protein 52

Protein Production Antibody In-Vitro 52

Roots Analysis

AUGUST 15, 2023

Overview of Cell Free Systems Cell-free systems are ­in-vitro platforms which allow occurrence of biochemical reactions in the absence of living cells. These expression systems utilize bio machinery harvested from the lysate of disrupted cells for the manufacturing of a wide array of macromolecular and small molecule products.

Protein 52

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The Pharma Data

DECEMBER 20, 2020

In the rejection, the agency indicated they need to conduct pre-approval inspections at two of scPharmaceuticals’ third-party manufacturing facilities that they couldn’t do because of travel restrictions related to the COVID-19 pandemic. The drug is a once-daily, beta-3 adrenergic agonist. and Europe, including Russia.

In-Vitro 52

In-Vitro FDA Approval Drugs Manufacturing 52

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] ).

Antibody 52

Antibody Licensing Licensing Development 52

Pharmaceutical Technology

NOVEMBER 22, 2022

Messenger RNA vaccines contain nucleic acids that code for a specific protein, or target antigen, related to a virus or disease. When an mRNA vaccine is administered, a patient’s body produces that protein to prompt a desired immune response. Before COVID-19, Merck held the record for the fastest modern vaccine ever developed.

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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.

In-Vitro 52

In-Vitro Genotype Reagent Protein 52

The Pharma Data

MARCH 17, 2021

The PRO analysis included patients in both arms of the study and measured their experiences with side effects, symptoms, and health-related quality of life, in those receiving Verzenio plus ET versus ET alone. The detailed data were presented at the virtual 17th St. Gallen International Breast Cancer Conference.

HR 52

HR Trials In-Vitro Manufacturing 52

pharmaphorum

JANUARY 17, 2023

In addition, the construction of a specialised manufacturing facility for mRNA vaccines was agreed. In addition, the construction of a specialised manufacturing facility for mRNA vaccines was agreed. As it stands, mRNA vaccines and therapeutics can only provide benefits if they can reach the living cells and be processed into protein.

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Pfizer

JANUARY 27, 2023

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. The European Commission (EC) will review the CHMP recommendation and is soon expected to make a final decision.

Marketing 75

Marketing Production Drugs Licensing 75

Pharmaceutical Technology

AUGUST 26, 2008

As understanding of biological systems has forged ahead, pharmaceutical companies have made increasing use of biotechnology in discovering and manufacturing new medicines. It was once derided as the stuff of science fiction, but in recent years, biotechnology has emerged as an important growth area in pharmaceuticals.

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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.

Licensing 52

Licensing Licensing Antibody Gene Therapy 52

Pfizer

DECEMBER 20, 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. 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. In the U.S., approximately 7.6

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Drugs Licensing Licensing Containment 69

Pfizer

DECEMBER 13, 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. Nirmatrelvir has shown consistent in vitro antiviral activity against the following variants: Alpha, Beta, Delta, Gamma, Lambda, Mu, and Omicron BA.1, The additional 3.7

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Drugs Licensing Licensing Production 110

The Pharma Data

JULY 23, 2021

The antibody combination was granted a Special Approval Pathway under article 14-3 of the Pharmaceuticals and Medical Devices Act. “Ronapreve has been shown to improve survival in high-risk, non-hospitalised COVID-19 patients by reducing the risk of hospitalisation and death.

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Antibody Medicine Production In-Vitro 52

The Pharma Data

MARCH 22, 2022

Pfizer continues to invest to support the manufacturing and distribution of PAXLOVID, including exploring potential contract manufacturing options. Financial details of the agreement were not disclosed. High and upper-middle income countries will pay more than lower income countries.

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In-Vitro Contract Manufacturing Manufacturing Development 52

The Pharma Data

FEBRUARY 8, 2021

Janssen Presents Results from Phase 3 ACIS Study in Patients with Metastatic Castration-Resistant Prostate Cancer Treated with ERLEADA ® (apalutamide) and ZYTIGA ® (abiraterone acetate) CombinationS. months; hazard ratio [HR] 0.69 [95% CI, 0.58-0.83]; 0.83]; p<0.0001). months; hazard ratio [HR] 0.69 [95% CI, 0.58-0.83]; 0.83]; p<0.0001).

HR 52

HR In-Vitro Development Clinical Trials 52

Pfizer

NOVEMBER 23, 2022

Europe plays a critical role in the delivery of PAXLOVID to patients across the globe, as the site of four of Pfizer’s key PAXLOVID manufacturing facilities. 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.

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Licensing Licensing Drugs Manufacturing 40

Pfizer

JANUARY 27, 2023

Working with collaborators, we have conducted research where the original SARS-CoV-2 virus has been used to express the spike protein from new variants of concern. and global regulatory requirements for our oral treatment, PAXLOVID™, Pfizer undertakes in vitro work (e.g., It is important to note that these studies are required by U.S.

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The Pharma Data

MARCH 16, 2021

Among them, mutations E484K, N501Y and del 69-70 are located in the spike protein, the region that enables the virus to attach to and enter the human cell. The cobas SARS-CoV-2 Variant Set 1 Test is designed to detect key spike mutations in virus variants associated with increased human-to-human transmission. 1.1.7), South Africa (B.1.351),

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