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: Gene splicing using nucleases. They are engineered to cut specific genomic targets in order to modify the expression of single genes and proteins.

Gene Splicing 130

Gene Splicing Gene DNA Recombinant DNA Technology 130

BioSpace

MARCH 21, 2024

Tegoprubart, Eledon Pharmaceuticals’ experimental anti-CD40L antibody, was part of the immunosuppressive treatment regimen used following the first-ever transplant of a kidney from a genetically modified pig to a human.

Gene Editing 98

Gene Editing Antibody Gene Genetics 98

Pharmaceutical Technology

APRIL 14, 2023

Both libraries feature up to 10,000 gene fragment combinations, and allow the high-throughput screening and characterisation of new and known sequence variants to develop therapeutic solutions. In July last year, Twist announced a partnership with Ildong to develop antibodies for use in immuno-oncology.

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Development Gene Therapy Gene Antibody 246

Pharmaceutical Technology

JANUARY 19, 2023

AOC 1020 has been designed for the treatment of the underlying cause of FSHD, which is caused by the abnormal expression of a gene known as double homeobox 4 or DUX4. This DUX4 protein abnormal expression leads to modifications in gene expression in muscle cells which are associated with progressive muscle function loss in FSHD patients.

Gene Expression 246

Gene Expression Gene Protein RNA 246

XTalks

SEPTEMBER 30, 2020

The research shows that the activity of the immune messenger type 1 interferon (IFN) protein is diminished, either by genetic mutations or an autoimmune attack by neutralizing antibodies against it, in a subset of COVID-19 patients. These rogue antibodies blocked interferon action and were not present in patients with mild COVID-19 cases.

Antibody 135

Antibody Genetics Research In-Vitro 135

Pharmaceutical Technology

JANUARY 17, 2023

The STAb therapy is based on a special type of bispecific antibody secretion. This antibody can detect targets on the tumour cell and the T cell. An artificial bridge created by these antibodies gets therapeutic T cells and tumour cells into contact. By Cytiva Thematic.

Development 276

Development Gene Therapy Antibody Gene 276

pharmaphorum

JUNE 27, 2022

The EMA’s human medicines advisory committee has recommended that BioMarin Pharmaceutical’s haemophilia A gene therapy Roctavian be approved in the EU, removing one of the last barriers to launch. The post BioMarin gene therapy for haemophilia on course for EU approval appeared first on.

Gene Therapy 97

Gene Therapy Gene Antibody Marketing 97

pharmaphorum

APRIL 22, 2022

Astellas has said it will book a $170 million impairment charge in its fourth quarter results as a result of a decision to halt the development of three gene therapy candidates for Duchenne muscular dystrophy in preclinical development. The post Astellas takes $170m charge as it drops DMD gene therapies appeared first on.

Gene Therapy 105

Gene Therapy Gene DNA Development 105

XTalks

JANUARY 4, 2024

Pfizer has kickstarted the new year with its first-ever gene therapy approval, awarded by Health Canada to the company’s Beqvez (fidanacogene elaparvovec) for the treatment of hemophilia B. There is a significant focus on developing gene therapies as longer-term solutions for the disease.

Gene Therapy 111

Gene Therapy Gene Gene Editing Sales 111

BioPharma Reporter

MAY 9, 2023

Hansa Biopharma and Genethon have entered a research and development collaboration to test imlifidase as a gene therapy treatment in patients with pre-existing neutralizing antibodies.

Gene Therapy 94

Gene Therapy Gene Antibody Development 94

pharmaphorum

OCTOBER 6, 2021

Voyager Therapeutics has just landed a new gene therapy alliance with Pfizer that could go some way towards easing the pain of losing three other partners in the space of a couple of years. Voyager meanwhile has had its own difficulties, albeit not related to safety. The Pfizer deal is a fillip for Voyager after a turbulent couple of years.

Gene Therapy 105

Gene Therapy Gene Antibody Manufacturing 105

pharmaphorum

JULY 20, 2022

Shares in VBL Therapeutics have lost around 78% of their value in pre-market trading after the company reported a phase 3 trial of its lead gene therapy VB-111 for ovarian cancer failed a pivotal trial. The post VBL craters as ovarian cancer gene therapy fails phase 3 test appeared first on.

Gene Therapy 98

Gene Therapy Gene Immune Response Antibody 98

Pharmaceutical Technology

JUNE 4, 2023

Adeno-associated virus vectors, alcohol dehydrogenase compositions, and antibody serum stabilisers are some of the accelerating innovation areas, where adoption has been steadily increasing. Among maturing innovation areas are anti-influenza antibody compositions and anti-interleukin-1, which are now well established in the industry.

Gene 262

Gene Gene Therapy Genetics DNA 262

Pharmaceutical Technology

JULY 15, 2022

According to the positive interim findings from the Phase II/III KidCOVE clinical trial, a two-dose primary series of mRNA-1273 offered a strong neutralising antibody response in the young children with a favourable safety profile. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

Vaccination 264

Vaccination Vaccine Gene Therapy Antibody 264

pharmaphorum

JUNE 17, 2021

Biogen has four other Alzheimer’s candidates in its clinical pipeline behind recently-approved Aduhelm, but one of them – anti-tau antibody gosuranemab – has just been canned. The post Biogen abandons tau antibody for Alzheimer’s after phase 2 miss appeared first on.

Antibody 98

Antibody Protein Licensing Licensing 98

pharmaphorum

SEPTEMBER 13, 2021

AbbVie has expanded its ophthalmology pipeline via a licensing deal with Regenxbio, paying $370 million upfront to get its hands on a gene therapy for wet age-related macular degeneration (AMD) and other eye diseases. The post AbbVie spies potential in Regenxbio eye disease gene therapy appeared first on.

Gene Therapy 97

Gene Therapy Gene Sales Trials 97

Pharmaceutical Technology

NOVEMBER 14, 2022

In a field dominated by antibodies and small molecules, two cell-therapy based approaches have come under the spotlight for showing early signs of efficacy in treating lupus. Apart from the monoclonal antibodies and small molecules, researchers have long held an interest in exploring cell therapies for autoimmune conditions.

Antibody 362

Antibody Gene Therapy Manufacturing Trials 362

FDA Law Blog

DECEMBER 7, 2022

Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.

Gene Therapy 119

Gene Therapy Gene FDA Approval Production 119

Pharmaceutical Technology

APRIL 19, 2023

“Evidence is now available that most of the US population five years of age and older have antibodies to SARS-CoV-2, the virus that causes Covid-19, either from vaccination or infection, that can serve as a foundation for the protection provided by the bivalent vaccines.”

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Vaccination Vaccine Gene Therapy Gene 334

Pharmaceutical Technology

JULY 6, 2022

The researchers found evidence that antibodies are linked to an attack on the cells lining the blood vessels in the brain, causing inflammation and damage. The researchers also observed that antibodies produced in response to Covid-19 may wrongly act on cells vital to the blood-brain barrier.

Immune Response 162

Immune Response Antibody Gene DNA 162

Pharmaceutical Technology

JUNE 14, 2023

Inobrodib is an oral first-in-class cancer drug, indicated for patients who have previously received four or more lines of therapy, including an anti-CD38 monoclonal antibody, an immunomodulatory agent and a proteasome inhibitor. It inhibits p300 and CBP by binding into the conserved bromodomain of the twin proteins.

Protein 243

Protein Antibody Gene Trials 243

XTalks

DECEMBER 8, 2020

has announced that it has acquired the rights to an investigational gene therapy, HMR59, from Hemera Biosciences, LLC designed to help treat a severe form of age-related macular degeneration (AMD). The gene therapy was developed to treat both dry and wet macular degeneration. Janssen Pharmaceuticals Inc.

Gene Therapy 98

Gene Therapy Gene Protein Development 98

Pharmaceutical Technology

JULY 2, 2024

On 30 June 2024, at the tenth Congress of the European Academy of Neurology (EAN) 2024, during an e-presentation session on the topic of 'Headaches', Danilo Antonio Montisano, MD, presented real-world evidence findings from a retrospective, observational multicentre cohort study (RAMO) comparing the effectiveness of monoclonal antibodies against calcitonin (..)

Protein 130

Protein Antibody Gene 130

Pharmaceutical Technology

JUNE 29, 2022

These subjects received a minimum of two lines of systemic therapy previously, including the combination of an anti-CD20 monoclonal antibody and an alkylating agent. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. FL is a kind of indolent non-Hodgkin lymphoma (iNHL).

Gene Therapy 278

Gene Therapy Clinical Trials Clinical Trials Genetics 278

Pharmaceutical Technology

AUGUST 15, 2022

In baseline seronegative subjects, the updated vaccine offered a superior neutralising antibody response against Omicron (BA.1) Irrespective of previous infection or age, the vaccine-induced potent neutralising antibody responses against the BA.4 Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

Vaccination 214

Vaccination Vaccine Immune Response Clinical Trials 214

Pharmaceutical Technology

SEPTEMBER 8, 2022

The post Leading API biologics (cell, gene, vaccine and virus) companies in contract marketing appeared first on Pharmaceutical Technology. The increasing number of approvals of biologics over the years has increased the volume of contracts for innovator APIs and biologic-dose outsourcing.

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Gene Marketing Vaccination Vaccine 100

FDA Law Blog

MARCH 13, 2023

This meeting will host a panel of rare disease patients, caregivers, and advocates to have a focused discussion on the emerging field of gene therapy (regulated at the FDA by OTP). At least some (if not all) of the panelists will have had experience participating in gene therapy trials. One family’s daughter was the first U.S.

Gene Therapy 98

Gene Therapy Gene Trials Clinical Trials 98

pharmaphorum

NOVEMBER 30, 2020

Cure Rare Disease’s Rich Horgan discusses the importance of preclinical NAbs screening and helping rare disease patients better understand their eligibility for gene therapies. Neutralising antibodies (NAbs) present a unique challenge to researchers looking to treat patients with AAV treatment.

Gene Therapy 105

Gene Therapy Gene Antibody Clinical Trials 105

Pharmaceutical Technology

JUNE 4, 2023

Adeno-associated virus vectors, alcohol dehydrogenase compositions, and antibody serum stabilisers are some of the accelerating innovation areas, where adoption has been steadily increasing. Among maturing innovation areas are anti-influenza antibody compositions and anti-interleukin-1, which are now well established in the industry.

Gene Therapy 246

Gene Therapy DNA Gene Genetics 246

Medical Xpress

MARCH 8, 2023

A pilot trial by investigators from Brigham and Women's Hospital, a founding member of the Mass General Brigham health care system, tested the nasal administration of the drug Foralumab, an anti-CD3 monoclonal antibody.

Antibody 76

Antibody Gene Expression Gene Trials 76

BioPharma Reporter

DECEMBER 2, 2021

Several contract development and manufacturing organization (CDMO) supported biopharma projects have been flagged in the past month. We take a closer look.

Gene Therapy 93

Gene Therapy Antibody Gene Manufacturing 93

Pharmaceutical Technology

NOVEMBER 22, 2022

Despite China producing a significant proportion of the world’s API supply (mostly small molecule), it manufactures relatively few biosimilar and innovator drugs and no cell and gene therapies for the western markets of Europe and the US despite investments and an increasing number of startups to improve innovative manufacture.

Manufacturing 162

Manufacturing Gene Therapy Gene Contract Manufacturing 162

XTalks

JANUARY 21, 2025

The liquid portion of the blood (serum or plasma) containing antibodies is separated and tested using the Liason Biotrin parvovirus B19 IgG plus test on a Liason XL analyzer. If parvovirus B19 antibodies are present, they bind to the chemicals and particular particles in the test, producing a light signal.

FDA Approval 105

FDA Approval Manufacturing Development RNA 105

pharmaphorum

APRIL 16, 2021

The 2 nd Gene Therapy Immunogenicity Summit is the industry’s definitive forum enabling you to better modulate, measure and predict immune response to your gene therapy candidate. The impact of innate and anti-transgene immunogenicity on AAV vector-mediated gene transfer with Genethon.

Gene Therapy 52

Gene Therapy Gene Immune Response Antibody 52

pharmaphorum

OCTOBER 4, 2022

AstraZeneca’s rare disease firm Alexion is set to expand its genomic medicine portfolio with the acquisition of gene editing specialist LogicBio Therapeutics, in a deal worth approximately $68 million. The post AstraZeneca pays record 660% premium for gene editing company LogicBio appeared first on.

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Gene Editing Gene Genomics Genome 64

Pharmaceutical Technology

MAY 10, 2023

TYVYT is a PD-1 immunoglobulin G4 monoclonal antibody jointly developed by Innovent Biologics and Eli Lilly and Company. The approval was given to TYVYT (sintilimab injection) plus bevacizumab and chemotherapy (pemetrexed and cisplatin). This is the seventh indication of TYVYT (sintilimab injection) to be cleared by NMPA.

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Gene Antibody Production Trials 130

Medical Xpress

FEBRUARY 27, 2023

In a recently published editorial in the journal Genes & Cancer, researcher Tatsuro Jo from the Japanese Red Cross Nagasaki Genbaku Hospital's Department of Hematology discussed aggressive type adult T-cell leukemia/lymphoma (ATLL).

Antibody 98

Antibody Gene Research 98