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.

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Pharmaceutical Technology

FEBRUARY 3, 2023

With scientists fervently developing mRNA vaccines, nucleic acid therapeutics, and viral vector-based gene therapies, clinicians are set to have a growing number of tools available to treat a wide range of conditions, from infectious diseases to genetic disorders and more.

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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.

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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. Biogen said it would now focus its efforts on its other tau candidates, headed by BIIB076, which is in phase 1 testing and was in-licensed from Neurimmune.

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STAT News

DECEMBER 22, 2022

For those not familiar with the term, “biobucks,” they refer to future payments promised in licensing deals in the pharmaceutical industry.

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Pharmaceutical Technology

JUNE 2, 2023

Switzerland-based company Lonza has boosted its antibody-drug conjugates (ADCs) offering with the acquisition of Dutch biotechnology company Synaffix for a total consideration of $172m (€160m). The deal includes $107.17m (€100m) of initial financial consideration in cash and an additional $64.3m (€60m) in performance-based consideration.

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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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Delveinsight

JANUARY 12, 2021

Medivir, IGM Biosciences enters into an exclusive licensing agreement for Birinapant. Medivir AB has entered into an exclusive licensing agreement with IGM Biosciences to receive global, exclusive development rights for Birinapant. AvantGen Enters into a Licensing Agreement for its Anti-SARS-CoV-2 Antibodies with IGM Biosciences.

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Licensing Licensing Antibody Gene Therapy 52

pharmaphorum

DECEMBER 2, 2021

Novartis has licensed a potential drug for Parkinson’s from Belgium’s UCB that it thinks could be the first oral, disease-modifying drug for the disease – if it can avoid the fate of earlier drugs in the class. The track record of drugs targeting alpha-synuclein isn’t that good however.

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Antibody Licensing Licensing Gene Therapy 111

pharmaphorum

OCTOBER 31, 2022

The New York biotech said today that the SIERRA trial of Iomab-B – an antibody armed with a radioisotope designed to deliver targeted treatment to tumours and spare healthy tissues – met its primary objective. However, current regimens based on intensive chemo- and radiotherapy are very aggressive so are not suitable for frail patients.

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Trials Gene Therapy Drugs Antibody 124

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.

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Antibody Drugs Protein Licensing 98

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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Camargo

DECEMBER 13, 2021

A biologics license application (BLA) is required for biological products subject to licensure under the PHS Act, and FDA approval to market a biologic is granted by issuance of a biologics license. Bispecific antibodies, antibody-drug conjugates, and gene therapies all have their own specific features that must be taken into account.

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Pharmaceutical Technology

AUGUST 23, 2022

According to pre-clinical findings, a booster dose of this vaccine elicited a robust neutralising antibody response against the variants Omicron BA.1, In July, the US FDA approved the companies’ supplemental Biologics License Application (sBLA) for their Covid-19 vaccine, Comirnaty, for use in adolescents aged 12 to 15 years.

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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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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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The Pharma Data

JANUARY 13, 2021

Germany-based Cevec Pharmaceuticals GmbH signed a licensing agreement with Biogen for the use of its proprietary ELEVECTA Technology for the manufacturing of adeno-associated virus (AAV) vectors for gene therapy applications. Few details of the deal were disclosed in the announcement. Oxgene – U.K.-based

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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. .”

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pharmaphorum

MARCH 31, 2021

Novartis has added to its pipeline of radiopharmaceuticals pipeline once again, licensing a series of agents from iTheranostics that can be used to show where tumours are located in the body. . billion to buy targeted radioligand therapy Lu-PSMA-617 from Endocyte , shortly after encouraging results in a phase 2 prostate cancer trial.

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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

AUGUST 5, 2021

Janssen has the option for an exclusive license to develop and commercialize therapies directed against up to two targets through the deal. A year-old Mestag has the funds to build a pipeline of antibodies and bring its single-cell approach toward the clinic. No financial terms were revealed.

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The Pharma Data

FEBRUARY 1, 2021

The FDA issued straight-to-final guidance that provides sponsors of monoclonal antibody and other therapeutic protein COVID-19 treatments with recommendations for potency assays to ensure consistent product quality. The guidance does not cover vaccines, hyperimmune globulins, gene therapies, cell therapies or convalescent plasma.

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Delveinsight

JANUARY 19, 2021

Enhertu is an antibody-drug conjugate (ADC) that comprises a humanized anti-HER2 IgG1 monoclonal antibody. Fujifilm Increases Legroom In Cell And Gene Therapy, Plans For New Manufacturing Facility. Fujifilm is trying everything to build its position in the cell and gene therapy domain even stronger.

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The Pharma Data

JANUARY 10, 2021

Depending on the development of the escalating COVID-19 pandemic in the United States and on the resulting impact on enrollment, the Company expects to complete enrollment of this study in 2022 enabling a potential Biologics License Application (BLA) submission by 2023 under the accelerated approval pathway.

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The Pharma Data

DECEMBER 20, 2020

Pfizer and BioNTech announced additional data on neutralizing antibody and T-cell responses from their Phase I/II trial of their COVID-19 vaccine conducted in Germany. The trial will evaluate one or two drugs on COVID-19, currently Eli Lilly’s LY3819253 (also LY-COV555, an antibody from their collaboration with AbCellera).

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The Pharma Data

APRIL 27, 2022

About Tislelizumab Novartis is evaluating tislelizumab, a uniquely designed anti-PD-1 monoclonal antibody, in a global clinical development program consisting of 14 pivotal clinical trials across a broad array of solid tumors, with more than 8,800 patients enrolled to date in 35 countries.

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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

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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.

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The Pharma Data

SEPTEMBER 15, 2020

The results demonstrated that Penta immune responses were robust and noninferior to licensed meningococcal vaccines (MenB and MenACWY) in individuals 10-25 years of age, regardless of prior MenACWY exposure. Clinical Phase 1/2 study results demonstrated never before observed fold rises of RSV neutralizing antibodies; a fold rise of 15.2

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The Pharma Data

NOVEMBER 3, 2020

It may also allow for priority or rolling review of a company’s Biologics License Application (BLA). LogicBio is also developing a Next Generation Capsid platform for use in gene editing and gene therapies. About LogicBio Therapeutics.

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Pfizer

SEPTEMBER 28, 2022

Emergency uses of the original and bivalent vaccines have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID 19) in: . • individuals 6 months of age and older (original vaccine). • individuals 12 years of age and older (bivalent vaccine)

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The Pharma Data

MAY 15, 2023

Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Vabysmo® (faricimab) for the treatment of macular edema following retinal vein occlusion (RVO). 7 About Vabysmo® (faricimab) Vabysmo is the first bispecific antibody approved for the eye.

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The Pharma Data

JUNE 26, 2021

Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA), under Priority Review, for Port Delivery System with ranibizumab (PDS) for the treatment of neovascular or “wet” age-related macular degeneration (nAMD). Faricimab is the first investigational bispecific antibody designed for the eye.

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Drug Delivery Clinical Trials Clinical Trials Medicine 52

XTalks

MAY 29, 2024

In its acquisitions, J&J also acquired antibody-drug conjugate (ADC) developer Ambryx and cardiac med tech Laminar along with more than 50 smaller, early-stage licensing deals and partnerships. billion to acquire Telavant for an anti-TL1A antibody, an inflammatory bowel disease candidate ready for Phase III trials.

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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. Most recently, Holland served as Global Head of licensing at Lonza AG. Venugopal most recently served as executive director at Intercept Pharmaceuticals.

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Genomics Genome Medicine Life Science 40

Pfizer

OCTOBER 19, 2022

Emergency uses of the vaccines have not been approved or licensed by FDA but have been authorized by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals aged 6 months and older for the Pfizer-BioNTech COVID-19 Vaccine and 5 years and older for the Pfizer-BioNTech COVID-19 Vaccine, Bivalent.

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The Pharma Data

APRIL 27, 2021

CARMEN-LC05, a trial investigating tusamitamab ravtansine , an anti-CEACAM5 antibody-drug conjugate (ADC), in combination with pembrolizumab versus pembrolizumab alone in patients with first-line non-squamous NSCLC started. SAR440234 , T cell engaging multi specific antibody, has been discontinued in leukemia. Collaborations.

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