Camargo

MAY 2, 2021

Advances in scientific knowledge and growth in the cell and gene therapy space have led to a new and exciting era of medicine for patients, as well as a new motivation for regulators to provide clear, efficient pathways for product developers. Note: Some medicines are in more than one category.

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Pharmaceutical Technology

SEPTEMBER 14, 2022

Emerging technologies such as 3D printing and bioprinting, electrospinning, electrospraying, microfluidics, nanofluidics, microelectromechanical, and bio-electromechanical systems are being utilised to prepare systems for the delivery of personalised medicine, meeting patient’s needs, and developing old drugs with new processes.

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Protein Marketing Manufacturing Reagent 100

Scienmag

MAY 18, 2021

(Boston)–Researchers from Boston University School of Medicine (BUSM) report the formation of human cells containing a green fluorescent protein or GFP (one of the most important proteins in biology and fluorescence imaging) genetically fused with two interferon stimulated genes (ISGs), namely Viperin and ISG15.

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The Pharma Data

MARCH 20, 2021

The Challenge: The demands of many labs simultaneously beginning COVID-19 screening programs are leading to a scarcity of resources like pipette tips and reagents. Medicine in Oxford, Biogazelle, a biotechnology company in Ghent, and the Centre For Proteome Research at the University of Liverpool. delays where reagents are in.

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FDA Law Blog

JANUARY 4, 2023

As you may know, there are challenges related to developing potency assay(s), and the Alliance for Regenerative Medicine and the American Society of Gene and Cell Therapy recently published a white paper on a workshop held to discuss these challenges. If I use GMP grade reagents, isn’t that sufficient to support their safety?

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Pharmaceutical Technology

FEBRUARY 15, 2023

RNA has the potential to underpin breakthrough treatments for a wide variety of diseases, including many cancers, and transform medicine as we know it. Outlook The era of mRNA-based genomic medicines is on the horizon. But the mRNA technology is not yet mature and there are no standardised manufacturing protocols yet.

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The Pharma Data

MAY 4, 2021

The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has banned the trade in unapproved COVID-19 vaccines for a year to prevent the use of vaccines that may not be safe or effective. . TGA warns of unlawful advertising of listed medicines. The public could also import personal supplies of vaccines. CDSCO Notice.

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Roots Analysis

FEBRUARY 21, 2022

Advancement in DNA sequencing technologies have resulted in noteworthy developments in various healthcare-related research fields, such as diagnostics and personalized medicine. Moreover, the manual protocols require extensive manipulation, costly reagents and long duration of skilled genomic library production.

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Marketing Gene Sequencing DNA Genome 52

The Pharma Data

MARCH 17, 2021

Standardisation enables labs to do more work on fewer instruments, through consolidation of workflows, systems and reagents. 8,9 Additionally, the plastic generated per test result has been reduced by up to 78% due to smaller reagent pack sizes with higher number of tests per pack.

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pharmaphorum

FEBRUARY 3, 2021

This can be partly attributed to the reagents and delivery modalities that were available at the time of the trial start in 2016, leading to low editing efficiency at the target loci. The rapid progress and promising outcomes to date make base editing a strong contender in this exciting and fast-paced era of precision medicine.

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pharmaphorum

OCTOBER 7, 2020

The company said the problems – which also include other items like reagents and screening kits – have resulted from a switch to a new warehouse, which ironically is intended to make production quicker and more efficient through the use of automated processes.

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The Pharma Data

JANUARY 24, 2021

As part of his work with Juno and Kite, Dr. Bond led R&D collaborations with genome editing companies including Editas Medicine and Sangamo Therapeutics. Bond led the development of allogeneic cell therapy platforms leveraging T cells from both donor-derived sources and induced pluripotent stem cells. FRSC at the University of Toronto.

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Engineer Gene Editing Genome Genomics 52

pharmaphorum

JANUARY 25, 2022

The Toronto-based company already counts many of the world’s largest pharma companies among its customers, using its platform for a range of tasks such as improving reagent and antibody selection to help scientists run more successful experiments, drawing on data from published studies and organisations’ internal databases.

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Pharmaceutical Technology

FEBRUARY 3, 2023

The field of genomic medicine has reached a true turning point. In June 2022, the European Medicines Agency approved an adeno-associated viral (AAV) vector-based therapy for adults with Hemophilia A, making the treatment available to an estimated 3,200 eligible patients. [1] CEVEC became part of Cytiva in October 2022.

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FDA Law Blog

AUGUST 3, 2022

In the LDT’s “toddler years,” when issuing its analyte specific reagent rule in 1997, FDA stated that it would generally exercise enforcement discretion over LDTS. Tests created by labs were important in 1992, but they play a far more vital role in medicine today.

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Roots Analysis

AUGUST 16, 2023

mRNA has completely revolutionized the field of medicine and significantly influenced the study and treatment of human diseases. The success of COVID-19 vaccines paved the path for mRNA-based drug products. Safety, efficacy and rapid production of mRNA drives the interest in this domain.

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FDA Law Blog

NOVEMBER 1, 2023

The PR first sets out to establish that it has authority to regulate in vitro diagnostic “test systems” as devices, and not just the system’s individual components, such as reagents, instruments, specimen collection devices, and software. The PR states that LDTs are not the “practice of medicine,” with which FDA generally may not interfere.

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The Pharma Data

SEPTEMBER 8, 2021

TIB Molbiol is a biotech company that has supplied the global market with reagents for research and medical diagnostics for over 30 years. We are looking forward to contributing to the strong network of Roche Diagnostics.”. About TIB Molbiol. The majority of assays are used to test for infectious diseases.

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The Pharma Data

MAY 17, 2021

So asserted Lutz Uharek, a professor of internal medicine and founder and CEO of Xencura, at RAPS Euro Convergence 2021 on 12 May in discussing some of the challenges and opportunities for academic centers in developing cell and gene therapies.

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The Pharma Data

DECEMBER 2, 2020

ERS Genomics – Ireland’s ERS Genomics Limited, and Germany’s Vivlion GmbH, announced a non-exclusive license agreement granting Vivlion access to ERS Genomics’ CRISPR/Cas9 patent portfolio, to enhance Vivlion’s gene editing reagents and screening services.

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The Pharma Data

MARCH 16, 2022

3, and Delta ([link] About TIB Molbiol TIB Molbiol is a subsidiary of Roche Diagnostics that has supplied the global market with reagents for research and medical diagnostics for over 30 years. These kits can detect and differentiate between Omicron subvariants BA.1, The majority of assays are used to test for infectious diseases.

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Advarra

NOVEMBER 29, 2022

However, despite the promise of these therapies, the regulations governing them lag the science, which in turn hinders the clinical translation of these novel medicines. The FDA recently announced a new initiative as part of its NIH Accelerating Medicines Partnership Program. But review issues are not the only problems.

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The Pharma Data

MARCH 13, 2021

Hereditary Angioedema (HAE), like so many other rare diseases, is highly complex, and patients, their families and caregivers often undergo years of strain trying to understand their disease, get a definitive diagnosis and gain access to the medicines they need. At Takeda we are a committed champion for the patients we serve. Interactions.

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The Pharma Data

OCTOBER 19, 2020

DB ( Becton, Dickinson and Company ) received a CE mark for its BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes for assessing immune function in COVID-19 patients. It allows the test to be used for people without any symptoms or suspicion of COVID-19, supporting widespread population testing. Please read more here. .

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The Pharma Data

JULY 11, 2021

Hereditary Angioedema (HAE), like so many other rare diseases, is highly complex, and patients, their families and caregivers often undergo years of strain trying to understand their disease, get a definitive diagnosis and gain access to the medicines they need. At Takeda we are a committed champion for the patients we serve. Interactions.

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The Pharma Data

MAY 15, 2023

She is also a board member at BBI Solutions, a UK based diagnostic reagents and a Novo Holdings company. Shamiram holds an AB from Smith College and Doctor of Medicine as well as a Master of Public Health, both from Emory University, U.S.A. About Novartis Novartis is reimagining medicine to improve and extend people’s lives.

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XTalks

OCTOBER 19, 2023

This could involve tweaking experimental conditions, changing reagents or redesigning the assay. There is also an increasing focus on personalized and precision medicine, where treatments are tailored to individual patients based on genetic or molecular data, which requires assays to detect and quantify these unique markers.

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XTalks

OCTOBER 1, 2020

Prior to starting Fountain Therapeutics in 2018, with co-founders Tom Rando, MD, PhD and Tom Cheung, PhD, Dr. Rodgers was an assistant professor at The Eli and Edythe Broad Center for Regenerative Medicine and Stem Cell Research at the Keck School of Medicine of The University of Southern California (USC).

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The Pharma Data

OCTOBER 14, 2020

Prestige BioPharma – Singapore-based Prestige received a positive opinion from the European Medicines Agency Orphan Drug Commission (COMP) for its first-in-class anti-PAUF monoclonal antibody, PBP1510, for the treatment of pancreatic cancer. Talking Medicines – Scotland’s Talking Medicines will join Tech Nation’s Applied AI 2.0

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The Pharma Data

SEPTEMBER 7, 2020

The test offers an alternative to lab-developed tests (LDTs) or Analyte Specific Reagent (ASR) combinations, potentially minimising variability and complexity in testing, reducing workload and alleviating risk for laboratories. The cobas BKV Test has robust coverage with a limit of detection of 21.5 IU/mL to 1E+08 IU/mL in EDTA plasma.

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The Pharma Data

AUGUST 4, 2020

The test offers an alternative to lab-developed tests (LDTs) or Assay Specific Reagents (ASR) combinations, potentially minimising variability and complexity in testing, reducing workload and alleviating risk for laboratories. The cobas EBV test has robust coverage with a limit of detection of 18.8

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DNA In-Vitro Medicine Reagent 52

XTalks

JANUARY 6, 2025

Whether its the integration of nanotechnology in medicine, the evolution of point-of-care (POC) diagnostics or the transformative impact of CRISPR and regenerative medicine, these biotech trends are pushing scientific boundaries and creating new opportunities for businesses and researchers alike. billion by 2031.

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The Pharma Data

DECEMBER 23, 2020

The agreement includes a £500,000 upfront payment to Avacta which gives Astrea the rights to generate and develop Affimer reagents in-house for affinity separation. BioNTech – Germany’s BioNTech and partner Pfizer secured authorization from the European Medicines Agency for its COVID-19 vaccine. It is a division of Gamma Biosciences.

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