XTalks

JULY 25, 2022

Byondis announced that the US Food and Drug Administration (FDA) accepted their Biologics License Application (BLA) for [vic-]trastuzumab duocarmazine (SYD985), an investigational therapy being studied to treat HER2-positive unresectable locally advanced or metastatic breast cancer. Vic-]Trastuzumab Duocarmazine Mechanism of Action.

Antibody 59

Antibody Drugs Clinical Trials Clinical Trials 59

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.

RNA 105

RNA Genetics Dermatology Antibody 105

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.

Medicine 105

Medicine Genomics Genome Engineer 105

Delveinsight

DECEMBER 8, 2020

KaliVir, Astellas Pharma forms a licensing deal for VET2-L2 oncolytic virus. KaliVir Immunotherapeutics and Astellas Pharma entered into a worldwide exclusive licensing agreement for the development, research, and commercialization of VET2-L2 to widen the horizon of therapeutic approaches available in the Immuno-Oncology market.

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Licensing Licensing Gene Therapy Antibody 52

pharmaphorum

JUNE 8, 2022

Roche has secured its first regulatory approval for mosunetuzumab, a first-in-class CD20xCD3 bispecific antibody, as a treatment for patients with follicular lymphoma (FL) in the EU. Patients also have to undergo lymphodepleting chemotherapy to help prepare the body for the CAR-T cells.

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Sales Antibody Licensing Licensing 105

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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Antibody Production Manufacturing Clinical Trials 52

XTalks

JANUARY 4, 2024

The adeno-associated viral (AAV) vector-based gene therapy received approval in Canada for the treatment of adults aged 18 years or older with moderately-severe to severe hemophilia B who are negative for neutralizing antibodies to variant AAV serotype Rh74, Pfizer Canada revealed in its announcement of the approval. Priced at $3.5

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Gene Therapy Gene Gene Editing Sales 111

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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Antibody Trials Production Clinical Trials 52

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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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.

Trials 111

Trials Clinical Trials Clinical Trials Licensing 111

The Pharma Data

NOVEMBER 20, 2020

NASDAQ: REGN) today announced that the antibody cocktail casirivimab and imdevimab administered together (formerly known as REGN-COV2 or REGEN-COV2), a therapy currently being investigated for use in COVID-19 , has received Emergency Use Authorization (EUA) from the U.S. TARRYTOWN, N.Y., November 21, 2020 – Regeneron Pharmaceuticals, Inc.

Antibody 52

Antibody Production Clinical Trials Clinical Trials 52

The Pharma Data

APRIL 12, 2023

Program uses Denali’s Antibody Transport Vehicle (ATV) technology to cross the blood-brain barrier (BBB) and aims to increase target engagement Biogen Inc. Nasdaq: DNLI) today announced that Biogen has exercised the option to license Denali’s Antibody Transport Vehicle (ATV): Amyloid beta program (ATV:Aβ).

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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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Licensing Licensing Genetics Sales 52

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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Antibody Trials Clinical Trials Clinical Trials 52

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.

Antibody 52

Antibody Medicine Production Trials 52

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

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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Licensing Licensing Gene Therapy Genetics 80

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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Vaccine Vaccination Doctor Doctors 111

pharmaphorum

NOVEMBER 30, 2020

The drug is an antibody-drug conjugate where a monoclonal antibody is linked to monomethyl auristatin, a cancer-killing “payload” It is targeted against AXL, a signalling molecule that is overexpressed in several haematologic and solid malignancies.

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Development Drugs Antibody Immune Response 52

Velocity Clinical Research

AUGUST 8, 2024

It’s been just over a year since the monoclonal antibody Lecanemab received traditional approval from the FDA as a treatment for Alzheimer’s disease. We understand the tau protein, that some people have inflammation in the brain or a genetic predisposition. And the more we learn, the more possibilities that creates for treatment.”

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Clinical Trials Clinical Trials Genetics Clinical Research 105

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.

Antibody 59

Antibody Sales Drugs Trials 59

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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Drugs Antibody Sales Branding 66

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.

Drugs 52

Drugs Antibody Development Engineer 52

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.

Antibody 52

Antibody DNA Clinical Trials Clinical Trials 52

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.

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Gene Therapy Gene Antibody Research 52

pharmaphorum

SEPTEMBER 22, 2022

Like other CAR-Ts, Calibr’s therapy is manufactured from a patient’s own T-cells, which are harvested and genetically modified to fight cancer before being reintroduced into the body. In the absence of the antibody, the CAR-T cells are dormant.

Antibody 52

Antibody Licensing Licensing Engineer 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.

Bacteria 69

Bacteria Marketing Licensing Licensing 69

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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Antibody Trials Production Clinical Trials 40

The Pharma Data

NOVEMBER 21, 2020

NASDAQ: REGN) today announced that the antibody cocktail casirivimab and imdevimab administered together (also known as REGN-COV2 or REGEN-COV2), a therapy currently being investigated for use in COVID-19, has received Emergency Use Authorization (EUA) from the U.S. government allocation program. Regeneron Pharmaceuticals, Inc.

Antibody 40

Antibody Production Clinical Trials Clinical Trials 40

pharmaphorum

JANUARY 10, 2022

There are still licensing deals to be done in the COVID-19 category it seems, after Novartis paid around $163 million to license rights to an antiviral drug developed by Molecular Partners. Ensovibep has the potential to become the first multi-specific antiviral molecule for the treatment of COVID-19, according to Novartis.

Trials 52

Trials Drugs Antibody Genetic Engineering 52

Delveinsight

AUGUST 17, 2021

The vaccine induces neutralizing antibodies as a response against the natural TBE virus, as the sequence and structure of the virus subtype match those found in nature. “We Food and Drug Administration, which could have entered the ultra-rare genetic disease market. Global President, Vaccines, Pfizer. The rarity of disease – 1.36

FDA Approval 98

FDA Approval Medicine Vaccine Vaccination 98

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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Gene Therapy Gene Trials Clinical Trials 98

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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Antibody Production Trials Medicine 40

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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Genetics DNA Life Science Clinical Trials 52

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.

Drugs 52

Drugs Licensing Licensing Sales 52

FDA Law Blog

DECEMBER 7, 2022

This product was developed by uniQure prior to being licensed to CSL Behring. We know, for example, the use of viral vectors results in antibody production that could inhibit future administration of gene therapies using the same or similar viruses, which will inform treatment decisions by patients with their doctors.

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Gene Therapy Gene FDA Approval Production 119

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.

Drugs 52

Drugs In-Vivo Licensing Licensing 52