BioTech 365

MAY 26, 2021

Biomedical Microelectromechanical Systems Markets: In Vivo Devices and Microcantilever Sensors – Global Forecast to 2025 – ResearchAndMarkets.com Biomedical Microelectromechanical Systems Markets: In Vivo Devices and Microcantilever Sensors – Global Forecast to 2025 – ResearchAndMarkets.com DUBLIN–(BUSINESS WIRE)–The (..)

In-Vivo 40

In-Vivo Marketing 40

XTalks

OCTOBER 20, 2023

Intellia said NTLA-2001 is the first investigational in vivo CRISPR-based gene editing therapy cleared to enter late-stage clinical development. As an in vivo therapy, it can edit genes inside the body rather than in cells extracted from patients. ATTR amyloidosis is a rare, progressive and fatal disease.

In-Vivo 52

In-Vivo Gene Editing Trials Gene 52

Pharmaceutical Technology

FEBRUARY 23, 2023

Moderna has entered a strategic research and development partnership with ElevateBio’s Life Edit Therapeutics to discover and develop new in-vivo mRNA gene editing therapies. Our novel editing systems have the potential to precisely modify gene targets for both in vivo and ex vivo therapeutic development.”

Gene Editing 147

Gene Editing Gene In-Vivo Gene Therapy 147

Pharmaceutical Technology

OCTOBER 5, 2022

In 2010, two patients with end-stage refractory chronic lymphocytic leukaemia (CLL) were administered Novartis’ autologous anti-CD19 chimeric antigen receptor T-cell (CAR-T) therapy, Kymriah (tisagenlecleucel), as part of a Phase I trial.

In-Vitro 279

In-Vitro In-Vivo Sales Clinical Trials 279

Pharmaceutical Technology

AUGUST 21, 2022

-D-N4-hydroxycytidine (NHC) in vivo. In March this year, the company filed applications seeking marketing authorisation for ritonavir in eight European countries, namely the Netherlands, Portugal, Spain, Denmark, Belgium, Poland, Sweden and Italy. A 240mg/kg twice a day dose of ASC10 led to a 4.0

In-Vivo 162

In-Vivo RNA Clinical Development Drugs 162

BioPharma Reporter

JULY 19, 2021

Celltrion Group has reported that data from an in vivo efficacy study shows that its monoclonal antibody treatment for COVID-19, regdanvimab (CT-P59), has a strong neutralizing effect against the rapidly spreading Delta variant.

Antibody 111

Antibody In-Vivo Regulation Marketing 111

pharmaphorum

JUNE 23, 2022

Novartis has shouldered its way into the in vivo gene editing category via a deal with US biotech Precision BioSciences, focused on a therapy for sickle cell disease (SCD). billion in potential milestones if the project advances through development and onto the market. billion agreement that started in 2020.

Gene Editing 97

Gene Editing In-Vivo Gene Sequencing Gene 97

Pharmaceutical Technology

JULY 20, 2022

Roche will use these new capsids to carry out preclinical, clinical and marketing activities for gene therapy programmes. Avista's computationally steered, in vivo scAAVengr platform uses a high-throughput method with the integrated quantitative validation of new cell-specific AAVs. Avista is entitled to receive $7.5m

Gene Therapy 147

Gene Therapy Gene Development In-Vivo 147

BioPharma Reporter

AUGUST 30, 2021

Seattle-based Umoja Biopharma, a company looking to reprogram immune cells in-vivo to create next-generation immunotherapies for the treatment of solid tumors and hematologic malignancies, has started work on its new development and manufacturing facility in Colorado.

Manufacturing 98

Manufacturing In-Vivo Development Regulation 98

Camargo

NOVEMBER 11, 2020

When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely. The “skinny label” has been used many times previously to enable ANDA applicants to reach the market in similar circumstances.

Development 242

Development Bioequivalency Generic Drugs Production 242

Pharmaceutical Technology

AUGUST 17, 2022

Merck (MSD outside North America) has entered a partnership agreement with Orna Therapeutics for discovering, developing and marketing various programmes based on next-generation RNA technology. These programmes will include therapies and vaccines in infectious disease and oncology areas.

RNA 147

RNA Vaccination Vaccine In-Vivo 147

Pharmaceutical Technology

SEPTEMBER 14, 2022

As an autologous cell therapy, manufacturing the infusion product is a highly specialised process involving tumour harvest and the extraction and large-scale ex vivo expansion of TILs. Tumour-infiltrating lymphocyte (TIL) therapy has been investigated as a treatment modality for melanoma for almost 20 years. versus 21.4% respectively.

Immune Response 246

Immune Response In-Vivo Production Manufacturing 246

Pharmaceutical Technology

MAY 31, 2023

It is expected to accelerate the development of CFT8919 in important international markets. In vivo and in vitro pre-clinical studies demonstrated that CFT8919 provides wider coverage of on-target resistant mutations and intracranial activity, indicating its potential to be effective against brain metastases.

In-Vivo 130

In-Vivo Bioavailability In-Vitro Licensing 130

Pharmaceutical Technology

FEBRUARY 1, 2023

Ellipses Pharma stated that the dual FLT3 inhibition and Aurora kinase demonstrated to overcome the acquired resistance to selectively inhibit FLT3 in vitro and in vivo. According to the company, approximately one-third of AML patients are diagnosed with FLT3 mutations related to a higher relapse risk and poor clinical outcomes.

FDA Approval 130

FDA Approval In-Vivo In-Vitro Trials 130

Camargo

DECEMBER 22, 2021

In addition, the size and complexity of a development program can vary significantly depending on product characteristics, market dynamics, and regulatory pathway. Gaining a thorough understanding of these factors can significantly impact development strategy and increase the likelihood of marketplace success. Clinical Pharmacology.

Bioequivalency 169

Bioequivalency Production Genotoxicity In-Vivo 169

Drug Patent Watch

JANUARY 14, 2025

Benefits of the Portfolio-Centric Approach Risk mitigation Increased profitability Broader market presence Therapeutic Area Dominance Some manufacturers are choosing to become the Gordon Ramsay of specific therapeutic areas. These allow manufacturers to skip certain in vivo studies, saving time and resources[3]. The results?

Generic Drugs 87

Generic Drugs Development Drugs Manufacturing 87

Pharmaceutical Technology

FEBRUARY 28, 2023

The bispecific antibody was found to conditionally activate the immune pathway in the tumour microenvironment in vitro and in vivo trials. It also activated tumour-infiltrating DCs and T cells in vivo pharmacodynamic studies. Biocytogen’s independently developed bispecific antibody, YH008, exerts antagonistic and agonistic activities.

In-Vivo 130

In-Vivo Antibody In-Vitro Licensing 130

pharmaphorum

JULY 13, 2022

Verve Therapeutics has started dosing patients in a phase 1b trial of its in vivo gene-editing drug for high cholesterol, designed to permanently switch off the PCSK9 gene with a one-shot treatment. dosing of *first patient* with VERVE-101, an in vivo CRISPR base editing medicine. Today: we are announcing.

Gene Editing 98

Gene Editing Trials Drugs In-Vivo 98

FDA Law Blog

MARCH 19, 2024

using phantoms, ex vivo animal tissue models, and/or in vivo animal testing), computationally, and/or clinically. When in vivo animal testing is needed, tests should follow good laboratory practices and the animal model should be representative of the intended clinical application.

In-Vivo 59

In-Vivo Marketing Regulation Development 59

pharmaphorum

OCTOBER 8, 2021

This year, we’ll be specifically focusing on next generation cell therapies and discussing: Novel in vivo delivery. This year, we’ll be specifically focusing on next generation cell therapies and discussing: Novel in vivo delivery. next generation innovations in cell therapies.

In-Vivo 52

In-Vivo Gene Manufacturing Marketing 52

Roots Analysis

FEBRUARY 27, 2024

The global genome editing market is anticipated to grow at a CAGR of 12.6% How is the genome editing market landscape evolving: Currently, there is an evident increase in demand for complex biological therapies (including regenerative medicine products), which has created an urgent need for robust genome editing techniques.

Genome 40

Genome Genomics Gene In-Vivo 40

Pharmaceutical Technology

FEBRUARY 23, 2023

The sooner challenging and unfixable compounds are identified and killed in development, the less R&D expenditure will be incurred, allowing you to focus on compounds that have the legs to make to it market. Quotient Sciences helps biotech and pharma customers in the development and optimization of drug products.

Development 246

Development Drugs Bioavailability In-Vivo 246

pharmaphorum

FEBRUARY 13, 2022

Quris’ BioAI safety prediction platform – which is based on human tissue samples on chips, nanosensors and machine learning – will be compared to traditional in vitro and in vivo laboratory techniques for spotting toxicity. The post Merck will assess Quris’ AI ‘patient-on-a-chip’ drug safety appeared first on.

Drugs 98

Drugs In-Vivo In-Vitro Pharma Companies 98

XTalks

DECEMBER 20, 2023

As we step into 2024, the life sciences continue to evolve at an unprecedented pace, driven by technological innovation, a deeper understanding of human biology and the application of new technologies in areas like drug development and health wearables. Regulatory bodies are also taking note of the applications of AI in drug development.

Life Science 119

Life Science Gene Editing Development Clinical Trials 119

Pharma Marketing Network

DECEMBER 21, 2020

those that modify the expression of an individual’s genes or repair abnormal genes) has entered clinical practice, including 11 RNA therapeutics, 2 in vivo gene therapies, and 2 gene-modified cell therapies. Almost two decades after the human genome was sequenced, a trickle of new genetic medicines (i.e.,

Genetics 52

Genetics Medicine Gene Therapy Marketing 52

The Pharma Data

NOVEMBER 10, 2020

This model has the benefit of giving companies direct oversight of their in vivo studies, allowing them to move faster while operationalizing every dollar of their seed financing. Photo courtesy of Mispro. There’s an emerging business model in biotech town, and it’s called the Contract Vivarium (CV).

Marketing 52

Marketing In-Vivo Scientist Research 52

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.

Marketing 52

Marketing Gene Drugs Protein 52

pharmaphorum

SEPTEMBER 28, 2022

Vertex Pharma and partner CRISPR Therapeutics will start a rolling marketing application in the US for their gene-editing drug for sickle cell disease (SCD) and beta thalassaemia later this year. The time places exa-cel in pole position to become the first drug developed based on CRISPR/Cas9 gene-editing technology to reach the market.

Gene Editing 59

Gene Editing Gene In-Vivo Clinical Trials 59

pharmaphorum

MAY 27, 2021

Life sciences tools company Esco Lifesciences Group has scored $200m in a series A and crossover round co-led by Novo Holdings and Vivo Capital. He added that the Asian market had shifted and was no longer purely price reliant. The post Novo Holdings leads $200m financing into Esco Lifesciences Group appeared first on.

Life Science 59

Life Science In-Vivo Manufacturing Gene Therapy 59

Roots Analysis

DECEMBER 22, 2021

In recent years, Treg based therapies have become a research hotspot in the field of immunotherapy due to their ability to prevent / delay graft rejection and control autoimmune responses generated post adoptive transfer in vivo. Regulatory T-Cell Therapies (Tregs) Market by Target Indications. Mechanism of Tregs. Web: [link].

Immune Response 52

Immune Response Research In-Vivo Marketing 52

pharmaphorum

APRIL 12, 2021

C4XD said it has developed a molecule small enough to be formulated into a pill, which has also been able to block IL-17 in vivo. We believe that our small molecule programme has the potential to create high value, efficacious and convenient oral IL-17 therapeutics for this large market.

Drugs 52

Drugs In-Vivo Licensing Licensing 52

Roots Analysis

JANUARY 27, 2025

The American Society of Gene and Cell Therapy (ASGCT) defines cell therapy as a therapeutic modality that involves the administration of either normal or modified cells to patients for the treatment of various diseases. In order to manufacture GMP regulated cell therapies, it is necessary to assess each manufacturing step at regular intervals.

Manufacturing 40

Manufacturing Contamination Production Gene Therapy 40

pharmaphorum

JANUARY 25, 2022

As the area of bringing a digital therapeutic to market means passing the same level of regulatory scrutiny as a traditional, pharmaceutical therapy, this means “prescription digital therapeutics must undergo extensive clinical trials to demonstrate their safety and effectiveness before they ever reach patients,” said McCann.

Medicine 111

Medicine In-Vivo In-Vitro Development 111

The Pharma Data

MARCH 8, 2021

This program included assays such as Big Blue and PIG-a designed to provide a robust measure of a drug or chemical’s ability to induce mutations in vivo. The totality of the data from these studies indicates that molnupiravir is not mutagenic or genotoxic in in vivo mammalian systems. “We

Trials 69

Trials In-Vivo Genotoxicity RNA 69

XTalks

AUGUST 19, 2022

The cells are prepared outside of the body ( ex vivo ) and then infused into the patient. After billions of dollars of investment, the company’s market valuation nosediving from nearly $10 billion in 2018 to just above $250 million currently and FDA delays, Zynteglo’s approval is the much-needed vote of confidence for bluebird.

Gene Therapy 95

Gene Therapy FDA Approval Gene Clinical Trials 95

Roots Analysis

FEBRUARY 15, 2023

Recent activity in Bioavailability Enhancement Market At present, the bioavailability enhancement technology and service providers are actively trying to consolidate their presence in this field by entering into strategic alliances, to meet the indubitably rising demand for effective therapeutics.

Bioavailability 52

Bioavailability In-Vivo Marketing Drugs 52

pharmaphorum

JUNE 12, 2022

CTX001 is an ‘ex vivo’ application of gene-editing, in which the technology is used to modify a patient’s own cells outside the body to make foetal haemoglobin (HbF), which can serve as a substitute to regular haemoglobin in both diseases. billion product if it gets approved for both indications.

Gene Editing 59

Gene Editing Gene Gene Therapy Drugs 59