AuroBlog - Aurous Healthcare Clinical Trials blog

JUNE 8, 2023

The artificial sweetener sucralose (marketed as Splenda) is widely used and found in products like diet soda and chewing gum. As DNA holds the genetic code controlling how our bodies grow and are maintained, that’s a serious problem that […]

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DNA Scientist Genetics Production 245

Pharmaceutical Technology

FEBRUARY 15, 2023

In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Innovation in Pharmaceuticals: Genetically modified animal models. Regeneron Pharmaceuticals is one of the leading patent filers in the generation of genetically modified animal models.

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Genetics DNA Genome Genomics 130

Pharmaceutical Technology

NOVEMBER 8, 2022

Cyagen and Neurophth Therapeutics have entered a strategic partnership to jointly develop next-generation AAV gene therapy vectors for specific kinds of genetic ophthalmic ailments. Additionally, Neurophth will oversee the clinical trials and marketing of gene therapy products developed leveraging the new AAV capsids of Cyagen.

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Gene Therapy Gene Development Genetics 305

Pharma Marketing Network

NOVEMBER 23, 2024

Just as a chef relies on quality ingredients for the perfect dish, marketers depend on cutting-edge research to craft campaigns that resonate with their audience. The Connection Between Pharma Research and Marketing Effective marketing starts with understanding your audience.

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Marketing Research Big Data Medicine 52

Pharmaceutical Technology

MAY 25, 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) aims to launch a pilot genetic biobank that will gather patient data to associate drug-related adverse events to their genetic makeup. The first patients will have their genetic makeup sequenced in Spring 2024 and this data will be shared in 2025.

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Bio Pharma Dive

MARCH 20, 2024

million list price, the highest of any genetic medicine to come to market. Orchard is counting on the long-term data it’s accrued to convince insurers to cover Lenmeldy’s $4.25

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Gene Therapy Gene Genetics Medicine 202

pharmaphorum

AUGUST 10, 2021

Europe market has proved so hostile to gene therapies when it comes to pricing and reimbursement for gene therapies that bluebird bio has decided to quit the market altogether, according to Andrew Obenshain, president of its severe genetic diseases unit. market and will wind down in Europe.

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Gene Therapy Gene Marketing Genetic Disease 135

Pharmaceutical Technology

NOVEMBER 2, 2022

The European Medicines Agency (EMA) has granted full marketing authorisation (MA) for AstraZeneca ’s Covid-19 vaccine, Vaxzevria (ChAdOx1-S [Recombinant]). The vaccine initially received a conditional marketing authorisation (cMA) for use in the European Union (EU).

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Vaccine Vaccination Marketing Clinical Trials 147

XTalks

DECEMBER 4, 2024

Jupiter Neurosciences, a clinical-stage pharma company specializing in neuroinflammation, made its public market debut with an initial public offering (IPO) on the Nasdaq Capital Market under the symbol “JUNS.” ” The company priced 2,750,000 shares of common stock at $4.00

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Bioavailability Genetic Disease Marketing RNA 111

XTalks

NOVEMBER 26, 2024

A Marketing Authorization Application has been submitted to the European Medicines Agency (EMA), with a decision anticipated in 2025. BridgeBio has been highly active in the genetic diseases space. From a regulatory standpoint, BridgeBio has taken steps to ensure global access to Attruby.

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Genetic Disease Genetics Protein Clinical Development 105

Pharmaceutical Technology

OCTOBER 25, 2022

There are options in the future to possibly apply the worldwide research and development (R&D), manufacturing and marketing expertise of Astellas in gene therapy to AAV gene therapy development programmes of Taysha for genetic ailments of the central nervous system (CNS).

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Gene Therapy Gene Development Genetics 264

pharmaphorum

JANUARY 24, 2023

Ben Hargreaves finds that the vast amount of genetic data that exists today could help provide a faster, more targeted way of developing new drug candidates. The logical extension to this kind of approach is treating individual patients, with their individual genetic makeup.

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Genetics Drugs Genome Project Biobanking 98

XTalks

FEBRUARY 7, 2025

In the biotechnology sector, a biotech IPO occurs when a biotech firm lists its shares on a stock exchange, thereby attracting investment from public markets. Utilizing its proprietary Compass platform, Maze analyzes genetic data to create targeted therapies that address the root causes of disease.

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Marketing Genetics Vaccine Vaccination 66

Pharma Mirror

MAY 7, 2021

The leading Australian CRO for biotechs and Frost & Sullivan Asia-Pacific CRO Market Leadership Award winner, Avance Clinical, has expanded its gene technology clinical trial services to meet the increasing global demand predicted to reach $17.4 billion Market Demand appeared first on Pharma Mirror Magazine. billion by 2023.

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Clinical Trials Clinical Trials Gene Marketing 130

Pharmaceutical Technology

AUGUST 18, 2022

The US Food and Drug Administration (FDA) has granted approval for bluebird bio ’s Zynteglo (betibeglogene autotemcel, beti-cel) for the treatment of the underlying genetic cause of beta?thalassemia thalassemia in adult and paediatric patients.

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World of DTC Marketing

DECEMBER 29, 2020

These vaccines were developed using different “platform technologies” that involve slotting genetic material from the virus into a tried and tested delivery package. It’s estimated that the COVID 19 vaccine market could be worth almost $100 billion. However, this is time-consuming. That’s a hell of an incentive.

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Pharmaceutical Technology

JUNE 10, 2023

CIGB-128 is under clinical development by Center for Genetic Engineering and Biotechnology and currently in Phase I for Brain Tumor. According to GlobalData, Phase I drugs for Brain Tumor does not have sufficient historical data to build an indication benchmark PTSR for Phase I.

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Genetic Engineering Engineer Genetics Clinical Trials 100

Pharmaceutical Technology

JUNE 10, 2023

CIGB-128 is under clinical development by Center for Genetic Engineering and Biotechnology and currently in Phase I for Brain Tumor. According to GlobalData, Phase I drugs for Brain Tumor does not have sufficient historical data to build an indication benchmark PTSR for Phase I.

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Genetic Engineering Engineer Genetics Clinical Trials 100

World of DTC Marketing

JANUARY 1, 2022

4our: TV will still be the first choice for DTC marketers – TV is excellent a creating awareness, but the reach and frequency models need adjustment. Medications, mental health, social deprivation, self-esteem, and genetics all play a role in our ability to control our weight, and judgment is never a constructive approach.

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XTalks

MARCH 19, 2025

Elevidys is the first FDA-approved gene therapy for DMD a rare genetic disorder characterized by progressive muscle degeneration. This drop likely reflects market concerns over the therapys safety profile. Sarepta is reviewing all available data. Late in 2024, Elevidys was recognized among Times Best Innovations.

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Gene Therapy Gene Genetics Clinical Trials 80

Bio Pharma Dive

SEPTEMBER 18, 2024

The FDA’s clearance could double Kisqali’s breast cancer market. Elsewhere, Novo is exploring new ways to deliver genetic therapies and Bain is funding a growing CDMO.

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Genetics Marketing 143

XTalks

MARCH 28, 2024

Duvyzat, a histone deacetylase (HDAC) inhibitor that works to reduce inflammation and muscle loss, is the first nonsteroidal drug approved to treat patients with all genetic variants of DMD. Progressive muscle weakness in the disease is caused by genetic mutations in the dystrophin gene that lead to a lack of functional dystrophin protein.

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Pharmaceutical Technology

SEPTEMBER 30, 2022

These approvals represent crucial milestones for bluebird bio, the gene therapy field, and patients with rare genetic diseases. Prior to bluebird's approvals, there were only two FDA-approved gene therapies for inherited conditions on the market.

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Gene Therapy FDA Approval Gene Genetic Disease 289

STAT News

APRIL 3, 2023

On Monday, Vertex Pharmaceuticals and its partner CRISPR Therapeutics said they had met their previously announced goal of filing by the end of March a marketing application for their therapy known as exa-cel.

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Worldwide Clinical Trials

JANUARY 6, 2025

Similarly, the EMAs PRIority MEdicine (PRIME) designation and conditional marketing authorization enable accelerated approval for drugs addressing critical and underserved medical needs, provided they meet stringent evidence requirements.

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Clinical Trials Clinical Trials Trials Genetics 130

Pharmaceutical Technology

SEPTEMBER 20, 2022

The production of commercial dose non-sterile products such as tablets, capsules, ointments, creams, and powders is rising due to their growing global demand, attributed to increasing demand for anti-ageing products, hereditary factors, genetic mutations, exposure to harmful radiation, and rising geriatric population.

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Pharmaceutical Technology

FEBRUARY 7, 2023

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Takeda ’s dengue virus vaccine candidate, Qdenga (Dengue Tetravalent Vaccine [Live, Attenuated]). The vaccine candidate has been approved for active immunisation against the infection in people from four years of age.

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Vaccine Vaccination Genetics Trials 264

Pharmaceutical Technology

FEBRUARY 2, 2023

The European Medicines Agency is currently reviewing a marketing authorisation application for daprodustat and a regulatory decision is expected in the first half of this year. Last December, GSK and Wave Life Sciences entered a strategic partnership to drive the discovery and development of oligonucleotide therapies for new genetic targets.

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Worldwide Clinical Trials

NOVEMBER 12, 2024

CGTs address rare and complex diseases at the root cause with increasing use in cancer, genetic disorders, and autoimmune diseases. While many market-approved cell therapies available today are autologous products, allogeneic interventions are growing more common.

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Gene Therapy Clinical Supply Trials Gene 182

pharmaphorum

AUGUST 8, 2022

As we reported this morning, the deal gives Pfizer already-approved SCD therapy Oxbryta (voxelator) – which industry watchers reckon could see a dramatic uptick in sales with Pfizer’s marketing muscle – plus a phase 3 antibody candidate, a phase 1 follow-up to Oxbryta that could offer improved dosing.

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Pharmaceutical Technology

JULY 29, 2022

However, in patients with urea cycle disorders, genetic defects result in inadequate amounts of the enzymes needed to convert nitrogen into urea. The most common marketed drugs in this space aim to address the hyperammonaemia caused by the defective genes in this disorder. GlobalData is the parent company of Pharmaceutical Technology.

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BioSpace

APRIL 11, 2024

and Canadian markets, Amylyx is now charting a path in Wolfram syndrome with promising interim Phase II data for its lead asset AMX0035. On the heels of withdrawing Relyvrio from the U.S.

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Genetic Disease Genetics Marketing 92

Pharmaceutical Technology

MARCH 2, 2023

The European Medicines Agency (EMA) is also reviewing Reata’s marketing authorisation application (MAA) for SKYCLARYS in Europe. There are three more drug candidates with major trial readouts that are expected in 2023. The FDA granted Orphan Drug, Fast Track, and Rare Pediatric Disease Designations for the medication.

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FDA Approval Trials Genetics Drugs 264

XTalks

SEPTEMBER 27, 2024

In a news release published yesterday, Pfizer announced it will voluntarily withdraw its sickle cell disease (SCD) therapy Oxbryta (voxelotor) from all markets worldwide. Pfizer said it has notified regulatory authorities of the market withdrawal. This is a significant turn of events as Pfizer acquired the drug in the $5.4

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Marketing Gene Therapy Sales Drugs 105

Pharmaceutical Technology

JULY 6, 2022

The European Commission (EC) has granted approval for the expanded conditional marketing authorization (CMA) of Novavax’s Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), in the European Union (EU) for adolescents of the age 12 to 17 years. A protein-based vaccine, NVX-CoV2373 is made from the genetic sequence of the SARS-CoV-2 virus’ first strain.

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Vaccine Vaccination Protein Clinical Trials 264

Pharmaceutical Technology

JUNE 15, 2023

The market responded warmly to the reanalysis. Shares in Eloxx were up 19% at market open compared to previous day’s (14 June) close. Eloxx is conducting a Phase II trial (NCT05448755) investigating ELX-02 in the treatment of Alport syndrome – a genetic disorder characterised by kidney disease.

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Trials Genetics Protein Marketing 246

Pharmaceutical Technology

JUNE 29, 2022

The European Commission (EC) has granted marketing authorisation for Gilead Sciences’ subsidiary Kite’s CAR T-cell therapy, Yescarta (axicabtagene ciloleucel), to treat adults with relapsed or refractory follicular lymphoma (FL). .

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