pharmaphorum

JUNE 28, 2022

billion partnership with US biotech Sutro Biopharma for a series of antibody-drug conjugates for cancer, focusing on applications in patients who don’t respond to current immunotherapies. Astellas has agreed a $1.36 The alliance includes an upfront payment of $90 million, backed by $422.5

Antibody 94

Antibody Immune Response Gene Therapy Drugs 94

Worldwide Clinical Trials

MAY 30, 2024

Differences in regulatory sentiments and industry sponsors’ subsequent clinical development strategies historically restricted access based on geography. An area of interest has been deciphering ALS’s genetic underpinnings and delivering functional copies of dysfunctional genes to the patient.

Gene 163

Gene Clinical Trials Clinical Trials Gene Therapy 163

pharmaphorum

JANUARY 13, 2022

Sanofi has joined a growing list of drugmakers going after alpha-synuclein targeting drugs for Parkinson’s disease, licensing a bispecific antibody from South Korea’s ABL Bio in a deal that could be worth more than $1 billion.

Antibody 85

Antibody Drugs Protein Licensing 85

Drug Discovery World

FEBRUARY 12, 2024

Leslie Orne, President and CEO, Trinity Life Sciences “AI and ML will play an increasingly important role in the clinical development and commercialisation of cell and gene therapies, which are typically targeted to small patient populations.

Genome 139

Genome Genomics Life Science Gene Therapy 139

XTalks

APRIL 12, 2021

Like other neurodegenerative disorders, such as Alzheimer’s disease and dementias, Parkinson’s disease research has been immensely challenging for biotechs, with a high rate of late-stage attrition in trials leading to a lack of disease-modifying therapies being approved. Axovant Gene Therapies. Prevail Therapeutics.

Gene Therapy 96

Gene Therapy Gene Trials Development 96

FDA Law Blog

NOVEMBER 2, 2023

While on the surface this may not seem like major advance for the field, this could be a game changer for the gene therapy space. These meetings have a question-and-answer format to provide clarity to sponsors about the particular topics at hand.

Medicine 59

Medicine Gene Therapy Gene Production 59

Drug Discovery World

APRIL 29, 2024

He holds a PhD in Chemistry for early work on antibody drug conjugates in 1987 and was awarded the Bioprocessing Lifetime Achievement Award in 2021. Carbone brings over 35 years of experience in operations, quality, and technology leadership in biotechnology, pharmaceuticals, and advanced therapies.

Drugs 52

Drugs Sales Gene Therapy Life Science 52

XTalks

JANUARY 17, 2024

Changes in what clinical performance data is used to inform the trial design and site selection, new approaches to patient recruitment and the rise of advanced treatments such as cell and gene therapy are rewriting the script.

Clinical Trials 124

Clinical Trials Clinical Trials Trials Gene Therapy 124

Drug Discovery World

NOVEMBER 13, 2023

Ahead of protein and antibody engineering conference PEGS Europe 2024 in Lisbon, DDW’s Megan Thomas looks at what to expect from each track of the annual biologics technology meeting. Hiroki Shirai, PhD, Coordinator, RIKEN Center for Computational Science, on: ‘Applying deep learning anomaly detection to antibody structures’.

Protein 59

Protein Antibody Engineer Scientist 59

Delveinsight

DECEMBER 8, 2020

Canadian antibody-drug discovery platform AbCellera Biologics is setting the groundwork for a massive Initial public offering worth USD 391 million. Not to lose sight of AbCellera’s AI-powered antibody discovery platform that speeds up the process of finding antibodies that can be developed into drugs.

Licensing 52

Licensing Licensing Gene Therapy Antibody 52

Drug Discovery World

OCTOBER 16, 2023

Alchemab, on the other hand, has developed a highly differentiated platform which enables the identification of novel drug targets and therapeutics by analysis of patient antibody repertoires, drawing from the expertise in Cambridge to progress the company’s mission to build a broad pipeline of protective therapeutics for hard-to-treat diseases.

Drugs 75

Drugs Life Science Gene Therapy Genome 75

Drug Discovery World

APRIL 5, 2023

In February this year, Akamis Bio announced an expansion of its ongoing partnership with the Parker Institute for Cancer Immunotherapy (PICI) to include a clinical collaboration with the Cancer Research Institute (CRI). DDW: You’re exploring NG-350A in the study.

Gene Therapy 52

Gene Therapy Gene Immune Response Development 52

Delveinsight

AUGUST 20, 2020

FDA rejects BioMarin’s gene therapy and Gilead’s filgotinib over concerns. The FDA refused to approve BioMarin’s hemophilia A gene therapy valoctocogene roxaparvovec. a share in cash to get its hands on the anti-FcRn antibody, nipocalimab. The removal of an AdComm was seen as a positive.

Gene Therapy 52

Gene Therapy Research Gene Antibody 52

The Pharma Data

OCTOBER 14, 2020

15, 2020 (GLOBE NEWSWIRE) — VBL Therapeutics (Nasdaq: VBLT), today announced that the European Patent Office (EPO) has granted Patent # 3328401 , which covers VBL’s proprietary investigational anti-MOSPD2 monoclonal antibodies to treat oncology conditions. TEL AVIV, Israel, Oct. About VBL Vascular Biogenics Ltd.,

Antibody 52

Antibody Gene Therapy Containment Clinical Trials 52

The Pharma Data

APRIL 27, 2022

We plan to discuss these data with health authorities, and we will continue to expand our tislelizumab clinical development program in pursuit of novel, synergistic combinations with the ultimate goal of extending survival for more patients.”.

Medicine 52

Medicine Clinical Development Gene Therapy Development 52

Delveinsight

AUGUST 5, 2021

Marinus will pursue clinical development of the therapy and move it via the regulatory process in Europe. A year-old Mestag has the funds to build a pipeline of antibodies and bring its single-cell approach toward the clinic. A filing in the region is foreseen by the end of the third quarter.

Vaccination 98

Vaccination Vaccine Gene Therapy Development 98

XTalks

DECEMBER 24, 2020

From rare disease drug approvals to treatments involving immunotherapies and gene therapies and awarding of a Nobel Prize to the inventors of the gene-editing tool CRISPR, 2020 was a year of great activity and productivity despite the backdrop of the pandemic. Antibody drugs were also developed as targeted COVID-19 treatments.

Life Science 111

Life Science Vaccination Vaccine Gene 111

XTalks

OCTOBER 22, 2020

In this sense, pharmaceutical companies have developed different strategies to produce a wide variety of advanced therapy medicinal products (ATMP) and biological products, such as monoclonal antibodies, recombinant proteins, gene therapy viral vectors, CAR-T cells and oncolytic viruses, in order to deliver new medical needs in our society.

Manufacturing 98

Manufacturing Development Production Gene Therapy 98

The Pharma Data

AUGUST 7, 2020

As the pharma industry stands firm in its commitment to advance the sector to fight Covid-19, news has emerged from the European Commission who intend to streamline the development of therapies using genetically modified organisms to treat Covid-19. Regenerative medicine and advanced therapies thriving despite Covid-19 disruption.

Clinical Trials 52

Clinical Trials Clinical Trials Gene Trials 52

The Pharma Data

MAY 15, 2023

Roche’s Chief Medical Officer and Head of Global Product Development. “If If approved, this would be the third indication for Vabysmo, the first bispecific antibody available for the treatment of retinal conditions that can cause blindness.” 7 About Vabysmo® (faricimab) Vabysmo is the first bispecific antibody approved for the eye.

Antibody 40

Antibody In-Vitro Clinical Development Medicine 40

The Pharma Data

DECEMBER 17, 2020

Cadavid will be responsible for the strategy, direction and execution of the company’s clinical development programs. Prior to Fulcrum, Cadavid held several leadership positions at Biogen, including Senior Medical Director of the multiple sclerosis clinical development group. based Rinri Therapeutics.

Development 52

Development Gene Therapy Engineer Life Science 52

The Pharma Data

APRIL 12, 2023

4-7 Additionally, phase I data for an investigational anti-interleukin-6 (IL-6) treatment in uveitic macular edema (UME), to be presented for the first time, suggest the monoclonal antibody may improve visual acuity in patients with UME. Chief Medical Officer and Head of Global Product Development.

Antibody 40

Antibody In-Vitro Development Trials 40

The Pharma Data

NOVEMBER 3, 2020

According to the FDA, the purpose of Fast Track designation is to get important new drugs to patients earlier by facilitating the development, and expediting the review, of drugs to treat serious conditions and fill an unmet medical need. LogicBio is also developing a Next Generation Capsid platform for use in gene editing and gene therapies.

Clinical Trials 52

Clinical Trials Clinical Trials Gene Editing Genome 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.

In-Vivo 52

In-Vivo In-Vitro Antibody Development 52

Drug Discovery World

MAY 30, 2023

From antibody-drug conjugates and RNA, to CRISPR and CAR-T therapy, DDW asked the drug discovery industry what the most important development in oncology over the last five years has been. We expect this field to grow significantly in the coming years as these and other earlier stage assets are developed.

Research 52

Research Drugs Protein RNA 52

pharmaphorum

APRIL 28, 2022

The new hub will focus on centralising things like clinical development strategy, clinical operations, and regulatory approval strategy – not necessarily drug development itself. How big pharma tackles rare diseases.

Pharma Companies 57

Pharma Companies Branding Development Marketing 57

The Pharma Data

SEPTEMBER 15, 2020

In addition to the COVID-19 vaccine program, Pfizer aims to deliver five innovative vaccines by 2025, subject to clinical success and regulatory approval. Clinical Phase 1/2 study results demonstrated never before observed fold rises of RSV neutralizing antibodies; a fold rise of 15.2 for RSV A and 18.0

Gene Therapy 52

Gene Therapy Vaccination Vaccine Trials 52

Pharmaceutical Technology

AUGUST 26, 2008

. “The inherent advantages of biopharma are that it allows you to pursue therapies against targets that are not small molecule therapies, for example by targeting protein-protein interactions and targeting GPCRs (G-protein coupled receptors),” he says. “Biotechnology has exploded across the industry.

Antibody 130

Antibody Licensing Licensing Production 130

XTalks

AUGUST 2, 2023

2) Darzalex (daratumumab) Darzalex is a targeted monoclonal antibody that slows or stops the progression of multiple myeloma (a blood cancer) by binding to the CD38 protein on multiple myeloma cells. Meanwhile, BioMarin’s gene therapy Roctavian is approved by the FDA for the treatment of hemophilia A. billion in 2022, a 32.44

Sales 98

Sales Manufacturing FDA Approval Life Science 98

Drug Discovery World

OCTOBER 17, 2023

This is an invaluable approach for precision medicine because it promises a detailed view of desired and undesired effects of treatments with cell and gene therapy agents or antibodies. Spatial omics technologies are ideally suited for characterising cells and their interactions within a tissue.

Gene Expression 52

Gene Expression Drugs Protein Gene 52

The Pharma Data

NOVEMBER 5, 2020

Velders is presently chairman of HollandBIO, the association of Dutch biotech companies, and provides years of experience, specifically in the cell and gene therapy areas. Taveras will lead all research and non-clinical development functions supporting the company’s pipeline of investigational therapies.

Genome 40

Genome Genomics Medicine Life Science 40

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. If approved, PDS would be the first and only nAMD therapy indicated to allow six months between treatments. Faricimab is the first investigational bispecific antibody designed for the eye.

Drug Delivery 52

Drug Delivery Clinical Trials Clinical Trials Medicine 52

Pfizer

SEPTEMBER 28, 2022

Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bispecific immune checkpoint modulators, targeted cancer antibodies and small molecules. Statement from Pfizer Chairman and CEO Albert Bourla on Testing Positive for COVID-19.

Vaccination 101

Vaccination Vaccine Medicine Clinical Trials 101

Pfizer

OCTOBER 19, 2022

Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bispecific immune checkpoint modulators, targeted cancer antibodies and small molecules. and a submission pending with the EMA for an Omicron BA.4/BA.5-adapted Leadership.

Vaccination 40

Vaccination Vaccine Clinical Trials Clinical Trials 40

The Pharma Data

AUGUST 11, 2020

In the field of immune cell therapy, this includes registrational CAR T cell agents for numerous diseases, and a growing early-stage pipeline that expands cell and gene therapy targets, and technologies. To date, the Opdivo clinical development program has treated more than 35,000 patients. Embryo-Fetal Toxicity.

Trials 52

Trials Hormones Clinical Trials Clinical Trials 52

The Pharma Data

AUGUST 11, 2020

In the field of immune cell therapy, this includes registrational CAR T cell agents for numerous diseases, and a growing early-stage pipeline that expands cell and gene therapy targets, and technologies. To date, the Opdivo clinical development program has treated more than 35,000 patients. Embryo-Fetal Toxicity.

Trials 52

Trials Hormones Clinical Trials Clinical Trials 52