XTalks

OCTOBER 20, 2023

Clinical-stage genome editing company Intellia Therapeutics has received clearance from the US Food and Drug Administration (FDA) for its Investigational New Drug (IND) application to start a pivotal phase III trial of NTLA-2001 for the treatment of transthyretin (ATTR) amyloidosis with cardiomyopathy.

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In-Vivo Gene Editing Trials Gene 52

The Pharma Data

DECEMBER 31, 2020

where he led global clinical development programs including clinical strategy, clinical development, and regulatory affairs. Prior to Taiho, he held the positions of senior vice president of Clinical Oncology and CMO at Geron Corporation. and CMO for Taiho Oncology, Inc.

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Gene Therapy Engineer Gene Research Analyst 52

The Pharma Data

DECEMBER 13, 2020

HMBD-001 is a uniquely differentiated anti-HER3 neutralizing antibody that was developed using Hummingbird’s proprietary Rational Antibody Discovery platform. HMBD-001 has been immune-engineered to bind with high affinity to the HER3 dimerization interface and block HER3 growth signals to the cancer. ” About NRG1 fusions.

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FDA Law Blog

JANUARY 4, 2023

Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and contr­­ols (CMC).

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Reagent Manufacturing Production Gene Therapy 59

pharmaphorum

OCTOBER 13, 2022

Bayer’s quest to revamp its drug discovery engine continues apace, with the company’s recently acquired Vividion subsidiary forging an alliance with Tavros Therapeutics, aimed at finding new drug targets and biomarkers in oncology. million in future payments tied to preclinical, clinical development, and commercial achievements.

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Gene Therapy Genomics Genome Drugs 64

The Pharma Data

OCTOBER 27, 2020

The Massachusetts-based biotech is investing in their proprietary “Gene Traffic Control” system, which tells the cells when to express which genes where and in what order within the chromatin regulatory system. Be Bio plans to use their $52 million Series A to precisely engineer B cells to treat a range of diseases. Sirnaomics.

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Gene Gene Therapy Medicine Development 52

Delveinsight

SEPTEMBER 14, 2021

Vor Biopharma has declared that the FDA has awarded their acute myeloid leukemia (AML) engineered hematopoietic stem cell therapy (eHSC), VOR33, a Fast Track Designation. VOR33 comprises CRISPR genome-edited hematopoietic stem and progenitor cells , which have been engineered to exclude CD33.

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RNA Clinical Trials Clinical Trials Drugs 67

FDA Law Blog

OCTOBER 6, 2022

Lewis, Senior Regulatory Device & Biologics Expert — On September 29, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to gene therapy chemistry, manufacturing, and controls. Release Criteria.

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Production Gene Therapy Gene Development 52

pharmaphorum

OCTOBER 21, 2022

Hookipa’s proprietary arenavirus platform is based on engineering arenaviruses to carry and deliver virus-specific or tumour-specific genes directly in patients in order to evoke an immune response by T cells, also known as CD8+ T cells.

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Licensing Licensing Immune Response Engineer 52

Scienmag

JUNE 22, 2021

Credit: Insilco June 22, 2021, New York / Hong Kong — Insilico Medicine, a global leader in end-to-end artificial intelligence for target discovery, small molecule chemistry, and clinical development, announced that it has closed a $255 million from biotechnology experts to progress Insilico Medicine’s current therapeutic programs into (..)

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Medicine Clinical Trials Clinical Trials Clinical Development 55

The Pharma Data

JANUARY 27, 2021

As a clinician, healthcare administrator, biotech entrepreneur and venture capital investor, Steve’s leadership and breadth of experience in the clinical development of cell and gene therapies will be invaluable to PlateletBio as we progress our cell therapy platform into the clinic later this year,” said Sam Rasty, Ph.D.,

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Genetic Engineering Gene Therapy Gene Engineer 40

The Pharma Data

DECEMBER 10, 2020

Spending several years with Sanofi in Paris, France as a Global safety officer, he then relocated to New Jersey, USA to work in Early and Late Stage Clinical Development in Immunology, when he became the Global Project Head of Dupixent, a medicine that has revolutionized the field of allergic and atopic diseases. Source link.

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Research Doctor Doctors Medicine 52

The Pharma Data

DECEMBER 13, 2020

Nasdaq: SYBX ), a clinical stage company bringing the transformative potential of synthetic biology to medicine, today announced SYNB1891 has advanced into the combination therapy stage of the ongoing Phase 1 trial. coli Nissle that produces cyclic di-AMP (CDA), a stimulator of the STING (STimulator of INterferon Genes) pathway.

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Immune Response Engineer Medicine Clinical Trials 40

The Pharma Data

DECEMBER 17, 2020

Kurtz brings more than 26 years of experience in global manufacturing, engineering, supply chain, CMC development and program management for drugs and devices at various stages of development. Cadavid will be responsible for the strategy, direction and execution of the company’s clinical development programs.

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Development Gene Therapy Engineer Life Science 52

The Pharma Data

MAY 31, 2022

Senior Vice President, Clinical Development, BlueRock Therapeutics. “We We are excited that our Phase 1 clinical trial has completed enrollment and believe it is a critical next step toward the development of a novel cell therapy that has the potential to transform the treatment landscape for this devastating disease.”.

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Trials Engineer Clinical Trials Clinical Trials 52

The Pharma Data

JANUARY 19, 2021

Fulcrum Therapeutics is a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases in areas of high unmet medical need. Fulcrum’s proprietary product engine identifies drug targets which can modulate gene expression to treat the known root cause of gene mis-expression.

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Gene Expression Containment Genetics Clinical Development 40

The Pharma Data

NOVEMBER 2, 2020

Past research has suggested that people who carry certain variants in the FGF21 gene tend to have a sweet tooth and a preference for carbohydrates. So, Arora and his colleagues there developed a lab-engineered antibody that essentially mimics the hormone. More information. SOURCES: Puneet Arora, M.D., 2, 2020, online.

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Antibody Drugs Hormones Insulin 52

The Pharma Data

OCTOBER 19, 2020

Caris Precision Oncology Alliance members also have access to the Caris Pharmatech oncology trial network, which can help reduce the time it takes to identify and connect appropriate patients with novel targeted cancer therapies in clinical development.

Life Science 52

Life Science Clinical Trials Clinical Trials RNA 52

pharmaphorum

OCTOBER 26, 2022

We design our clinical development strategy and the trials with this aim in mind.”. In 2021, he was awarded the Champion of Hope award from Global Genes. Previously he was with Accenture where he led large teams in outsourcing projects across Europe and US for clients in the transportation and retail businesses.

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Development Trials Marketing Life Science 96

Roots Analysis

OCTOBER 30, 2023

These RNA based therapeutics play a crucial role in protein production and regulation of gene functions. The support from venture capitalists and big pharmaceutical companies will continue to drive the development of circular RNA therapeutics and RNA therapeutics market growth over the forecast period.

RNA 40

RNA Vaccine Vaccination Development 40

The Pharma Data

NOVEMBER 4, 2020

Ltd (“Juyou”), a biotechnology company that develops and sells medical and cosmetic skincare products, for the commercialization and development of Pliaglis ® in mainland China (the “License Agreement”). For additional information, please visit [link].

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Licensing Licensing Dermatology Production 40

XTalks

MAY 9, 2024

What factors do you attribute to the company’s success in the discovery and development of differentiated antibody therapeutics? With hundreds of antibodies undergoing pre-clinical and clinical development, it is anticipated that the number of antibody medications in clinical trials and approved by regulatory agencies will rise.

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Antibody Clinical Trials Clinical Trials Medicine 52

The Pharma Data

JUNE 26, 2021

The safety profile of PDS in the clinical trial setting is well understood and will continue to be closely monitored. Roche has a robust phase III clinical development programme underway for PDS, including the Portal, Pagoda and Pavilion studies. 9 Both the Pagoda and Pavilion trials are actively recruiting participants.

Drug Delivery 52

Drug Delivery Clinical Trials Clinical Trials Medicine 52

The Pharma Data

OCTOBER 14, 2020

Live replicating orthopoxviruses, like vaccinia or horsepox, can be engineered to express foreign genes and have been explored as platforms for vaccine development because they possess; (1) large packaging capacity for exogenous DNA inserts, (2) precise virus-specific control of exogenous gene insert expression, (3) lack of persistence or genomic integration (..)

Vaccine 40

Vaccine Vaccination Development Medicine 40

The Pharma Data

MAY 15, 2023

8,19 About the Vabysmo® (faricimab) clinical development programme Roche has a robust phase III clinical development programme for Vabysmo. Our pipeline includes gene therapies and treatments for geographic atrophy and other vision-threatening diseases, including rare and inherited conditions.

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Antibody In-Vitro Clinical Development Medicine 40

Pharmaceutical Technology

MAY 12, 2023

The team then engineered the phages through gene editing to improve their targeting ability. The US Food and Drug Administration has granted fast-track designation to SNIPR001, which is currently in clinical development. SNIPR001 also reduced the number of E coli more than naturally occurring phages.

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The Pharma Data

APRIL 12, 2023

1 9 , 20 It develops when new and abnormal blood vessels grow uncontrolled under the macula, causing swelling, bleeding and/or fibrosis. 2 6 About the Vabysmo ® ( faricimab ) clinical development programme Roche has a robust phase III clinical development programme for Vabysmo.

Antibody 40

Antibody In-Vitro Development Trials 40

Pharmaceutical Technology

AUGUST 17, 2022

Biopharmaceutical contract development and manufacturing organisation (CDMO) AGC Biologics has entered a strategic collaboration with RoosterBio to expedite the manufacturing of cell and exosome therapies. These capabilities comprise cell and exosome genetic engineering for expressing therapeutic targets.

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Manufacturing Gene Therapy Genetic Engineering Gene 130

Delveinsight

DECEMBER 8, 2020

The company made a mark when it struck a deal with the pharmaceutical engine, Eli Lilly, to work on its COVID 19 therapy – human antibody bamlanivimab – which managed to secure EUA with the USFDA. Germany-based life sciences titan, Bayer, has set out on a collaborating spree to explore CAR-T cell gene therapy and oncology.

Licensing 52

Licensing Licensing Gene Therapy Antibody 52

pharmaphorum

JANUARY 4, 2023

The cell and gene therapy (CGT) industry is poised to achieved a significant milestone at the end of 2022: the first approval of an allogeneic T-cell therapy in the world. . Most of the cell therapies in clinical development today are of autologous origin. Unique logistics considerations.

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Gene Therapy Manufacturing Gene Production 98

Advarra

AUGUST 10, 2023

Rapid growth in gene therapy is expected to receive additional support as the Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) prepares to launch Operation Warp Speed for Rare Diseases. Peter Marks, head of FDA’s CBER – the organization responsible for regulating gene therapies.

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Gene Therapy Development Gene Drugs 52

The Pharma Data

NOVEMBER 22, 2020

It was engineered with the intention of improving deep-lung delivery of Treprostinil in PAH patients by means of a dry powder inhaler. LEPR deficiency obesity is caused by variants in the LEPR gene that often lead to severe obesity starting early in life with insatiable hunger and endocrine abnormalities. with LEPR deficiency obesity.

Licensing 52

Licensing Licensing Drugs Gene 52

Delveinsight

FEBRUARY 12, 2021

Furthermore, GlaxoSmithKline is developing GSK3377794 (NY-ESO-1 T-cells; GSK ‘794), a NY-ESO-1-directed genetically modified autologous T-cell immunotherapy and is an engineered T-cell therapy. What can be expected from ongoing clinical trials in the Synovial sarcoma landscape? million in 2017. How is it typically treated?

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Marketing Clinical Trials Clinical Trials Development 52

The Pharma Data

DECEMBER 9, 2020

The Chinese biopharmaceutical industry is growing in leaps and bounds, but there is still a huge unmet need when it comes to getting patients access to the breakthrough therapeutic modalities and platforms like RNAi, cell and gene therapy and others. A solution could be at hand with Overland Pharmaceuticals.

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In-Vivo In-Vitro Antibody Development 52

The Pharma Data

OCTOBER 15, 2020

Mukul Agarwal, former vice president of Corporate Development, at Forty Seven, Inc., Axovant – Kristin Vuori was named to the board of directors at Axovant Gene Therapies Ltd. Before joining MaxCyte, Meeks served as vice president of Business Development at Synpromics, which is now part of AskBio. Additionally, Parag V.

In-Vivo 52

In-Vivo Business Development Manufacturing Development 52

The Pharma Data

AUGUST 9, 2021

We believe this highly sophisticated and specifically engineered ADC is fulfilling its promise to reshape the treatment of HER2-positive metastatic breast cancer, with the goal to move into earlier lines of treatment for HER2-positive breast cancer and many other HER2-expressing tumour types across our broad clinical trial programme.”.

Trials 52

Trials Medicine Development Clinical Trials 52

The Pharma Data

OCTOBER 26, 2020

The treatment induced HPV-specific T-cell responses and was associated with increased levels of immune cell infiltration in the tumors and expression of genes associated with activation of the immune system. . – . . – . About TG4001.

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Vaccine Vaccination Trials Containment 40