Pharmaceutical Technology

AUGUST 16, 2022

antibody, ADX-914 re-regulates adaptive immune function by hindering IL-7 and TSLP-facilitated signalling. In July, the US Food and Drug Administration (FDA) approved Horizon’s supplemental Biologics License Application for Krystexxa (pegloticase) plus methotrexate, to aid uncontrolled gout patients attain a complete response to treatment.

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The Pharma Data

JANUARY 12, 2021

million additional doses of the casirivimab and imdevimab antibody cocktail, bringing total potential U.S. Under the new agreement, the government will purchase all finished doses of the casirivimab and imdevimab antibody cocktail delivered by June 30, 2021 , up to 1.25 TARRYTOWN, N.Y. , 12, 2021 /PRNewswire/ — . million doses.

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pharmaphorum

OCTOBER 5, 2022

Sanofi has added to its rare disease pipeline by licensing an antibody-RNA conjugate (ARC) for facioscapulohumeral muscular dystrophy (FSHD), a genetic muscle disorder, from US biotech miRecule.

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RNA Genetics Dermatology Antibody 105

The Pharma Data

DECEMBER 29, 2020

First antibody therapy to demonstrate anti-viral effect in patients hospitalized with COVID-19. NASDAQ: REGN) today announced encouraging initial data from an ongoing Phase 1/2/3 clinical trial of the Regeneron antibody cocktail, casirivimab and imdevimab, in hospitalized COVID-19 patients requiring low-flow oxygen. futility analysis).

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Drug Discovery World

FEBRUARY 28, 2024

In glioblastoma, as with many other highly recurrent cancers, tumour cells that escape treatment develop multiple genetic adaptations that allow them to proliferate. The Gladstone team realised that these mutated cells have a unique genetic signature that could be targeted. “We expressing cancers.

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The Pharma Data

MARCH 22, 2021

Investigational antibody cocktail of casirivimab and imdevimab also significantly shortened the duration of symptoms by four days. The combination of casirivimab and imdevimab is the only monoclonal antibody treatment to retain potency against key emerging variants, based on the recently updated EUA guidance from the U.S.

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pharmaphorum

DECEMBER 22, 2020

Since then Barron has been busy signing deals for therapies that are validated genetically, hoping that this will make them more likely to succeed in the clinic. The latest deals include a license agreement with San Diego-based Ligand Therapeutics , which has a subsidiary producing technology for neurological disorders.

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Drug Discovery World

NOVEMBER 9, 2023

DDW Editor Reece Armstrong speaks to Christian Leisner , Chief Executive Officer of antibody therapeutics’ developer CDR-Life about methods to increase access to antigens and improving immunotherapy treatments. RA: What kind of T-cell response can we expect from the MHC-targeting antibody fragment-based approach?

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pharmaphorum

MARCH 24, 2022

The examples remain few and far between, however, as in recent decades the pharma industry has turned its attention to synthetic molecules and biologics like antibodies. There’s a rich history of finding useful medicines from fungi, from the antibiotic penicillin to immune suppressant cyclosporine and cholesterol drug lovastatin.

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The Pharma Data

DECEMBER 17, 2020

NASDAQ: REGN ) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19. TARRYTOWN, N.Y. , 17, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc.

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XTalks

MAY 1, 2023

This makes Qalsody the first approved treatment to target a genetic cause of ALS. Tofersen was discovered by Ionis Pharmaceuticals, and Biogen licensed tofersen from Ionis under a collaborative development and license agreement. Developed by Eisai and Biogen, Leqembi is an amyloid beta-directed antibody.

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FDA Approval Gene Genetics Protein 89

pharmaphorum

NOVEMBER 19, 2021

Gilead Sciences has forged closer ties to its cancer drug partner Arcus Biosciences , although a licensing deal doesn’t go as far as the takeover that some market commentators have been predicting. Antibodies consists of two components – called Fab and Fc – with Fab handling targeting of the molecule and Fc responsible for function.

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Drugs Antibody Engineer Development 52

The Pharma Data

OCTOBER 28, 2020

NASDAQ: REGN) today announced positive, prospective results from an ongoing Phase 2/3 seamless trial in the COVID-19 outpatient setting showing its investigational antibody cocktail, REGN-COV2, met the primary and key secondary endpoints. Regeneron Pharmaceuticals, Inc. Yancopoulos , M.D., President and Chief Scientific Officer of Regeneron.

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The Pharma Data

DECEMBER 5, 2020

NASDAQ: REGN) today announced updated data for REGN5458, a BCMAxCD3 bispecific antibody, from the Phase 1 portion of a Phase 1/2 trial in patients with relapsed or refractory (R/R) multiple myeloma. These allow for the creation of bispecific antibodies that closely resemble natural human antibodies with no linkers or artificial sequences.

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pharmaphorum

JUNE 7, 2022

million licensing agreement with Alectos Therapeutic, as it continues to rebuild a pipeline behind its side-lined Alzheimer’s therapy Aduhelm. It’s not the first time that Biogen has licensed rights to a drug targeting lysosomal function in Parkinson’s disease.

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Delveinsight

DECEMBER 1, 2020

BASE10 Collaborates with DNA Link for COVID-19 Antibody Test Research. US-based BASE10 Genetics and Korean firm DNA Link announced a collaboration on a research project to appraise the usability of the DNA Link’s antibody test, AccuFind COVID-19 IgG, in a healthcare setting. CABOMETYX is already approved in the U.S.

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pharmaphorum

JUNE 16, 2022

It also probably marks the end of the road for crenezumab, which Roche’s Genentech subsidiary licensed from AC Immune in 2006 in a deal initially valued at $300 million. Before the end of the year, Roche should report results from two phase 3 studies in early-stage patients.

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Trials Clinical Trials Clinical Trials Licensing 111

pharmaphorum

JUNE 16, 2021

California biotech Ambrx Biopharma is hoping to raise $126 million from a listing on the New York Stock Exchange (NYSE) that will be used in part to fund clinical development of ARX-788, its HER2-targeting antibody drug conjugate (ADC). billion upfront, when it licensed the ADC from Daiichi Sankyo in 2019.

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pharmaphorum

JUNE 2, 2021

The deal gives Amgen rights to the KHK4083 antibody in all countries except Kyowa’s home market of Japan, and is back-loaded with potential milestone payments worth another $850 million plus royalties on sales. Kyowa will co-promote the drug in the US if approved, with opt-in rights in some other countries as well.

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Drugs Licensing Licensing Sales 52

pharmaphorum

FEBRUARY 5, 2021

23andMe is best known for its saliva-based health and ancestry DNA testing targeted at consumers, but the company also uses its genetic database to look for new targets for drug development. That’s been achieved thanks to a group of 10 million people worldwide who have agreed to allow their genetic data to be used for research.

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pharmaphorum

APRIL 12, 2021

Sanofi has licensed a potential inflammatory diseases drug from Manchester University spin-off C4X Discovery Holdings in a deal worth up to €414 million ($492 million). This follows a tie-up between C4XD, Sano Genetics and BenevolentAI to accelerate research into inflammatory bowel disease, which was signed in February.

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The Pharma Data

MAY 31, 2022

Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) to treat adults with prurigo nodularis, a chronic inflammatory skin disease that causes extreme itch and skin lesions. The target action date for the FDA decision is September 30, 2022.

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pharmaphorum

NOVEMBER 6, 2020

Novartis noted that the results from this trial do not affect Ilaris’ licensed indications or other trials and the safety profile was comparable to placebo plus standard of care. Novartis is also working with Molecular Partners to develop therapies based on genetically engineered proteins known as DARPins.

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Trials Genetic Engineering Licensing Licensing 40

pharmaphorum

JUNE 7, 2021

The Scottish agency has allowed restricted use of the drug by NHS Scotland, limiting it to patients who are clinically ineligible for or refractory to treatment with Takeda’s Adcetris (brentuximab vedotin), an antibody-drug conjugate (ADC) also used for relapsed CTCL. Other decisions.

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Drugs Licensing Licensing Antibody 52

pharmaphorum

SEPTEMBER 17, 2020

There are two antibodies already on the market that target PCSK9 – Amgen’s Repatha (evolocumab) and Sanofi/Regeneron’s Repatha (alirocumab) – but these require subcutaneous injection every two to four weeks.

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pharmaphorum

AUGUST 16, 2020

ChAdOx1 – which is in large-scale phase 2/3 trials – was licensed by AZ in April and renamed AZD1222, and should be ready for first deliveries before the end of the year. It will be provided on a no-profit basis while the pandemic is ongoing.

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The Pharma Data

NOVEMBER 29, 2020

Y-mAbs Therapeutics has a target action date of November 30 for its Biologics License Application (BLA) for Danyelza (naxitamab) for patients with relapsed/refractory high-risk neuroblastoma. The drug was developed by researchers at Memorial Sloan Kettering Cancer Center and exclusively licensed to Y-mAbs.

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Genetic Disease Antibody Licensing Licensing 52

pharmaphorum

AUGUST 7, 2020

Inhibition of LRRK2 activity may slow the progression of Parkinson’s disease in patients with and without known genetic risks based on restoration of lysosomal function.

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The Pharma Data

JANUARY 17, 2021

These models are engrafted with mouse tumors derived from the same strain background; this genetic similarity between tumor and host prevents the host from rejecting the tumor. Standard mice may develop anti-drug antibodies (ADA), which can neutralize the therapeutic or even trigger anaphylaxis.

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FDA Law Blog

MARCH 13, 2023

We were able to phase out the antibody infusions he was getting, and, best of all, we were allowed to start interacting with the world! The treatment consists of inserting healthy genes into an affected individual’s affected cells and tissues to try and stop or treat the disease. His eczema cleared up completely.

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The Pharma Data

MARCH 4, 2021

Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for Dupixent ® (dupilumab) as an add-on treatment for children aged 6 to 11 years with uncontrolled moderate-to-severe asthma. Detailed results from this Phase 3 trial will be published later this year. Source link:[link].

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pharmaphorum

DECEMBER 21, 2020

As it’s just a messenger molecule, it does not affect the body’s own genetic code when it is injected as a vaccine – but what it does do is instruct cells to code for copies of a certain protein. The body produces antibodies against the protein, which neutralise the virus in the event of an infection.

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pharmaphorum

DECEMBER 21, 2020

billion acquisition of VelosBio and its anti-ROR1 antibody-drug conjugate (ADC) VLS-101, as well as a partnership with Dragonfly Therapeutics for a cancer programme based on the biotech’s TriNKET natural killer (NK) cell engager platform. billion alliance with Taiho and Astex for cancer antibodies, including a KRAS drug, and a $4.2

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The Pharma Data

OCTOBER 30, 2020

NASDAQ: REGN) received today a recommendation from the independent data monitoring committee (IDMC) for the REGN-COV2 antibody cocktail treatment trials for COVID-19 that the current hospitalized patient trial be modified. TARRYTOWN, N.Y. , Regeneron Pharmaceuticals, Inc.

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pharmaphorum

JANUARY 31, 2022

Regeneron’s rival antibody product was approved by the FDA to treat a genetic form of elevated cholesterol – homozygous familial hypercholesterolemia (HoFH) – and is also testing it in other, more common forms of dyslipidaemia and in acute pancreatitis prevention.

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XTalks

AUGUST 15, 2023

struck a worldwide collaboration (excluding Japan) and license agreement with niraparib developer Tesaro (acquired by GSK in 2019) for exclusive rights to the drug in prostate cancer. Niraparib is also sold by GSK under the name Zejula in other indications. In April 2016, Janssen Biotech, Inc.

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The Pharma Data

FEBRUARY 13, 2022

About Dupixent Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. If approved, Dupixent will be the first biologic medicine available in the U.S.

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