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 (..)

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pharmaphorum

AUGUST 26, 2022

BioMarin Pharma has its landmark first approval for Roctavian – the first for a haemophilia gene therapy – and will now have to see if that can convert that into a viable business in Europe. If approved will price the gene therapy at $2 to $3 million after discounts, saying the price there will reflect the higher price of current treatments.

Gene Therapy 111

Gene Therapy Gene Antibody Marketing 111

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. In Alzheimer’s, the protein runs amok, forming tangles that have been linked to cell damage and neuronal death.

Antibody 98

Antibody Protein Licensing Licensing 98

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. Treatment involves replacing the missing FIX clotting protein, traditionally through regular infusions.

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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.

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Immune Response Antibody Gene DNA 162

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.

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Gene Therapy Gene Protein Development 98

XTalks

JUNE 28, 2023

Gene therapies for Duchenne muscular dystrophy (DMD) have been an area of intense research and Sarepta’s Elevidys is now the first one to be approved by the US Food and Drug Administration (FDA). DMD is caused by the absence of dystrophin, a protein that helps maintain the integrity of muscle cells.

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Gene Therapy Gene Protein FDA Approval 98

XTalks

AUGUST 30, 2022

The hemophilia A gene therapy Roctavian delivers a functional gene to enable the body to make an essential blood clotting protein on its own. A lack of sufficient functioning factor VIII and factor IX blood clotting proteins would result in the development of hemophilia A and hemophilia B, respectively.

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Gene Therapy Gene Clinical Trials Clinical Trials 98

XTalks

JUNE 30, 2023

It’s been a big week for cell and gene therapy approvals in the US, including a much-awaited approval for one to treat hemophilia A, the most common form of hemophilia. Hemophilia A is a rare genetic bleeding disorder that is caused by a mutation in the gene that encodes the key blood clotting protein factor VIII (FVIII).

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Gene Therapy Gene FDA Approval Antibody 98

Camargo

NOVEMBER 29, 2021

Gene and cellular therapies. Recombinant therapeutic proteins. Fusion proteins. Monoclonal antibodies (mAbs). Gene-based and cellular biologics, for example, often are at the forefront of biomedical research, and may be used to treat a variety of medical conditions for which no other treatments are available.

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Development Protein Production Hormones 180

Roots Analysis

SEPTEMBER 9, 2024

Over the years, pharmaceutical companies have shifted their priorities from traditional interventions towards more advanced pharmacological strategies, such as protein therapeutics. Further, $400 billion is the anticipated sales of protein-based therapeutics in 2023. The mRNA is then translated into to form functional proteins.

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Protein Gene Production DNA 40

Worldwide Clinical Trials

MAY 30, 2024

Tofersen (Intrathecal injection) This is an antisense oligonucleotide (ASO) that targets SOD1 mRNA to reduce the synthesis of SOD1 protein. An area of interest has been deciphering ALS’s genetic underpinnings and delivering functional copies of dysfunctional genes to the patient.

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Gene Clinical Trials Clinical Trials Gene Therapy 204

Pharmaceutical Technology

MAY 9, 2023

FibroGen has signed an exclusive licence agreement with Fortis Therapeutics for the FOR46 antibody-drug conjugate (ADC) that targets a new epitope on CD46, a protein-coding gene. FOR46 is currently being investigated in a Phase I trial as a potential treatment for metastatic castration-resistant prostate cancer (mCRPC).

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Drugs Clinical Development Antibody Protein 130

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. An AbbVie antibody called ABBV-0805 successfully cleared a phase 1 trial but seems to have been shelved.

Antibody 98

Antibody Drugs Protein Licensing 98

Pharmaceutical Technology

APRIL 18, 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.

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Protein Vaccine Vaccination Production 147

Pharmaceutical Technology

FEBRUARY 1, 2023

Since the FDA approved AstraZeneca’s monoclonal antibody therapy Synagis (palivizumab) 25 years ago, drug development successes for RSV have been few and far between. In 2013, this changed when an NIH lab reported the structure of the RSV protein, leading to the exploration of the RSV structure in ways that were not previously possible.

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Vaccine Vaccination Antibody Development 162

pharmaphorum

DECEMBER 2, 2021

The drug – called UCB0599 – targets a protein called alpha synuclein that tends to get misfolded and accumulates into clumps in the brains of Parkinson’s patients, and is thought to damage neurons – somewhat analogous to amyloid and tau proteins in Alzheimer’s disease.

Antibody 111

Antibody Licensing Licensing Gene Therapy 111

Pharmaceutical Technology

FEBRUARY 15, 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.

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In-Vivo Genomics Genome Gene Editing 162

XTalks

APRIL 1, 2025

In hemophilia patients, inhibitors are antibodies that interfere with the effectiveness of clotting factor replacement therapies. Through RNA silencing, it targets the expression of antithrombin, a protein that inhibits blood clotting. The ATLAS-INH trial enrolled 77 patients with inhibitory antibodies to FVIII or FIX.

FDA Approval 59

FDA Approval RNA Clinical Trials Clinical Trials 59

Pharmaceutical Technology

AUGUST 23, 2022

It comprises messenger ribonucleic acid (mRNA) that encodes for the initial spike protein of SARS-CoV-2 along with mRNA that encodes for Omicron BA.4/BA.5 5 variant spike protein. According to pre-clinical findings, a booster dose of this vaccine elicited a robust neutralising antibody response against the variants Omicron BA.1,

Vaccine 130

Vaccine Vaccination Gene Therapy Protein 130

pharmaphorum

APRIL 21, 2022

The pharma company has decided to end its collaboration with Swedish biotech BioArctic on alpha-synuclein-targeting antibody ABBV-0805, which was in early-stage clinical testing, as well as a portfolio of follow-up antibodies. AZ/Takeda are meanwhile running phase 2 trials of their MEDI 1342 antibody candidate.

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Antibody Protein Gene Therapy Pharma Companies 97

Pharmaceutical Technology

FEBRUARY 14, 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.

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In-Vivo DNA Antibody Gene 130

XTalks

MAY 9, 2024

Genmab, a trailblazer in the field of antibody therapeutics, celebrates this milestone by reflecting on its impressive journey from a small-scale startup to a global leader in cancer treatment and beyond. Since then, innovative science has been at Genmab’s core, as we harness the power of human antibodies to improve the lives of patients.

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Antibody Clinical Trials Clinical Trials Medicine 52

Pharmaceutical Technology

NOVEMBER 7, 2022

5 Omicron variants’ spike protein and 25µg encoding for the virus’ initial strain. Additionally, 28 days following inoculation, this vaccine showed enhanced neutralising antibody responses against Omicron BA.4/BA.5 Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. 1 subvariant.

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Vaccine Vaccination Gene Therapy Clinical Trials 130

XTalks

OCTOBER 12, 2021

14-3-3 zeta) protein, which the UToledo researchers had been studying for its role in immune-related pathologies, such as aortic aneurysms and in signaling pathways involving the pro-inflammatory cytokine interleukin-17. However, they found the opposite to be true, where the protein was actually protective against development of the disease.

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Vaccine Vaccination Research Immune Response 105

Delveinsight

DECEMBER 3, 2020

Roche receives FDA authorization for the quantitative COVID-19 antibody test. Roche has got an authorization from the FDA for a more accurate COVID-19 blood test capable of measuring the levels of specific antibodies, which target the cell-unlocking spike protein of coronavirus. Janssen buys a gene therapy asset.

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Gene Therapy Gene Antibody Research 52

Roots Analysis

NOVEMBER 30, 2021

Bioassay – A Prerequisite for the Cell and Gene Therapy Development. Over the past few years, investigational new drug (IND) filings for cell and gene therapy product have significantly increased. Companies Offering Bioassay Services for Cell and Gene Therapies. How Players are Complying with Developing Market?

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Bioassay Gene Therapy Gene Development 52

XTalks

OCTOBER 22, 2024

Vyloy is a first-in-class monoclonal antibody that targets the CLDN18.2 transmembrane tight junction protein, which is commonly found in some gastric and GEJ cancers. gene, and an estimated 60 percent of all gastric cancers harbor the protein. targeting antibody-drug conjugate. On the other hand, Merck & Co.

FDA Approval 105

FDA Approval Drugs Licensing Licensing 105

pharmaphorum

NOVEMBER 12, 2020

UCB has made a new foray into the gene therapy space, buying fellow Belgium-based company Handl to get control of its adeno-associated virus (AAV) capsid delivery platform and two research programmes in neurodegenerative diseases. The post UCB revs up its gene therapy drive with Handl acquisition appeared first on.

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Gene Therapy Gene Manufacturing Contract Manufacturing 52

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 52

Gene Therapy Gene Protein Development 52

pharmaphorum

FEBRUARY 3, 2022

Al Sandrock’s shock departure from Biogen in November sparked speculation about where he would show up next, and the answer came in today – gene therapy specialist Voyager Therapeutics. Dr. Al Sandrock has joined our Board of Directors & Executive Committee to help Voyager shape the future landscape of AAV #gene therapy.

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Gene Therapy Gene Clinical Trials Clinical Trials 97

pharmaphorum

NOVEMBER 2, 2021

Dr Laura Moriarty, senior marketing manager at Bio-Rad, looks at the impressive immuno-therapeutic potential of bispecific antibodies (bsAbs). Though their bispecific nature complicates large-scale production and purification workflows, with challenges such as antibody chain mispairing, bsAbs have come a long way since first developed.

Antibody 52

Antibody Immune Response Production Engineer 52

Delveinsight

AUGUST 26, 2021

Shape Therapeutics inks gene therapy deal with Roche worth up to USD 3 Billion. Seattle biotech firm Shape Therapeutics has signed a deal potentially exceeding USD 3 billion with pharma giant Roche to bolster the development of gene therapies for Alzheimer’s and Parkinson’s disease. was swooped up by Real Chemistry in January.

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Vaccine Vaccination Gene Therapy RNA 98

Pharmaceutical Technology

MARCH 27, 2023

National Resilience will use the funding to establish a significant domestic biomanufacturing capacity and capabilities for vaccines, nucleic acids including mRNA, and biologics including antibodies, proteins and multi-specifics. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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Gene Therapy Manufacturing Vaccine Vaccination 130

pharmaphorum

JANUARY 5, 2022

The FDA thinks an antibody-drug conjugate (ADC) developed by AbbVie could set new standards in treatment for certain patients with lung cancer, awarding the drug breakthrough status.

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Pharmaceutical Technology

DECEMBER 9, 2022

The move is particularly timely given the significant growth expected in global sales of cell and gene therapies. Beyond our expertise in small molecules, we have built a solid reputation with biopharmaceutical companies for the characterisation and analysis of monoclonal antibodies, therapeutic proteins and biosimilars.

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Development Production Manufacturing Vaccine 130

Delveinsight

JANUARY 12, 2021

Birinapant is a clinical-stage SMAC mimetic that degrades Inhibitors of Apoptosis Proteins (IAPs) by binding to them, ultimately leading to cell death in tumor cells. It is an IgM antibody targeting Death Receptor 5 (DR5), and IGM is hoping to test Birinapant with IGM-8444 for the treatment of solid cancers later this year.

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Licensing Licensing Antibody Gene Therapy 52