Date

Company name

Activity

Description

May 24, 2019

Novartis

Approval

AveXis, a Novartis company, announced that the US Food and Drug Administration (FDA) has approved Zolgensma® (onasemnogene abeparvovec-xioi) for the treatment of paediatric patients under the age of two with spinal muscular atrophy (SMA) and bi-allelic mutations in the survival motor neurone 1 (SMN1) gene.

October 29, 2020

Novartis

Acquisition

Novartis has announced the acquisition of Vedere Bio, which brings with it a strong new technology for AAV-based gene therapy delivery as well as a best-in-class optogenetics program to assist reinvent the treatment and prevention of vision loss. The acquisition expands Novartis' commitment to cell and gene therapy, allowing the company to go on with its efforts to provide transformative cures to a wide variety of patients suffering from blindness.

March 08, 2022

Novartis

Agreement

Voyager Therapeutics, Inc., a gene therapy company developing life-changing treatments and next-generation adeno-associated virus (AAV) capsids, announced an agreement through which Novartis may exercise options to license novel AAV capsids generated from Voyager's RNA-driven TRACERTM  capsid discovery platform for potential use with three undisclosed CNS targets and options to access capsids for two ad

April 26, 2024

Pfizer Inc.

Approval

Pfizer Inc. has approved BEQVEZ™ (fidanacogene elaparvovec-dzkt) for adults with moderate to severe haemophilia B who currently use factor IX (FIX) prophylaxis therapy, have current or historical life-threatening haemorrhage, or have repeated, serious spontaneous bleeding episodes, and do not have neutralising antibodies to adeno-associated virus serotype Rh74var (AAVRh74var) capsid as detected.

July 28, 2023

Pfizer Inc.

Agreement

Alexion, AstraZeneca Rare Disease, has announced that it has signed a formal purchase and licensing agreement with Pfizer Inc. (Pfizer) for a portfolio of preclinical gene therapy programs and related technology. The transaction strengthens Alexion and AstraZeneca's commitment to developing next-generation genomic therapeutics by adding complementary pipeline assets and breakthrough technology.

February 25, 2019

Roche Holding AG

Merger

Roche and Spark Therapeutics, Inc. announced the signing of a final merger agreement under which Roche will entirely acquire Spark Therapeutics for US$ 114.50 per share in an all-cash transaction.

March 27, 2024

Roche Holding AG

Investment

Roche (Basel, Switzerland) has obtained a €90 million investment to construct a gene therapy development centre. The investment was made as part of the German government's 'National Strategy for Gene and Cell Therapies', a collaboration between Bayer AG (Leverkusen, Germany) and the Berlin Institute of Health.

March 12, 2025

Roche Holding AG

Collaboration

Roche stated that it has signed an exclusive collaboration and licensing deal with Zealand Pharma. Under the terms of this agreement, the two firms will work together to co-develop and co-commercialize petrelintide, Zealand Pharma's amylin analogue, as a standalone therapy and in a fixed-dose combination with Roche's lead incretin asset CT-388.

April 22, 2025

Roche Holding AG

Investment

Roche said that it will invest USD 50 billion in the United States of America over the next 5 years. These investments will strengthen Roche's already significant US footprint, which includes 13 manufacturing and 15 R&D sites across the Pharmaceutical and Diagnostics Divisions. They are expected to create more than 12,000 new jobs, including nearly 6,500 construction jobs and 1,000 jobs at new and expanded facilities.

December 2, 2021

Astellas Pharma Inc.

Agreement

On November 23, Astellas Pharma Inc. and Dyno Therapeutics, Inc. inked an option and license agreement to develop next-generation adeno-associated virus (AAV) vectors for gene therapy directed to skeletal and cardiac muscle, using Dyno's CapsidMap™ platform.

Dyno's CapsidMap platform is a game-changing approach that uses in vivo experimental data and machine learning to create novel AAV capsids - the cell-targeting protein shells of viral vectors - that are optimised for tissue targeting and immune-evasion properties while also improving packaging capacity and manufacturability.

June 9, 2022

Astellas Pharma Inc.

Expansion

Astellas Pharma of Japan has finished construction of a $100 million gene therapy manufacturing plant in Sanford, North Carolina.

Audentes Therapeutics began construction on the 135,000-square-foot facility in late 2019, which will support Astellas' development and commercial production of adeno-associated virus (AAV) vectors for gene treatments.

July 10, 2023

Astellas Pharma Inc.

Agreement

Astellas Pharma Inc. and 4D Molecular Therapeutics, Inc. have announced a license agreement in which Astellas gains rights to use 4DMT's intravitreal retinotropic R100* vector for one genetic target implicated in rare monogenic ophthalmic disease(s), with the option to add up to two additional targets implicated in rare monogenic ophthalmic diseases after paying additional option exercise fees.

February 25, 2021

Sanofi S.A.

Collaboration

Sanofi has signed an exclusive licensing and collaboration agreement with SIRION Biotech to develop tissue-selective adeno-associated virus (AAV) vectors for next-generation gene therapies across multiple therapeutic categories, according to a statement from SIRION, a German gene delivery technology company.

Date

Company name

Activity

Description

March 7, 2022

WuXi AppTec

Expansion

WuXi Advanced Therapies (WuXi ATU), a wholly owned subsidiary of WuXi AppTec, has launched Tetracycline-Enabled Self-Silencing Adenovirus. This method is a cutting-edge innovative process for transfection-free, scalable production of adeno-associated virus (AAV) to Good Manufacturing Practice (GMP) standards. TESSA™, developed by OXGENE in the United Kingdom, a WuXi Advanced Therapies company, will expedite AAV manufacturing and significantly reduce the cost for manufacturing cell and gene therapies. This will enable global customers to deliver ground-breaking therapeutics to patients as soon as possible.

January 13, 2020

WuXi AppTec

Expansion

WuXi Advanced Therapies, a leading global Contract Development and Manufacturing Organisation (CDMO) that provides end-to-end contract services to the advanced therapies industry, has announced the addition of a fully integrated adeno-associated virus (AAV) Vector Suspension Platform to help accelerate cell and gene therapy development, manufacturing, and release while providing greater predictability.

January 15, 2021

Thermo Fisher Scientific Inc.

Acquisition

Thermo Fisher Scientific Inc., the world leader in science services, and Groupe Novasep SAS (Novasep), a leading provider of services and technologies for the life sciences industry, announced that Thermo Fisher has completed the acquisition of Henogen S.A., Novasep's viral vector manufacturing business in Belgium, for approximately €725 million in cash.

March 24, 2019

Thermo Fisher Scientific Inc.

Acquisition

Thermo Fisher Scientific Inc., the world leader in science services, and Brammer Bio, a leader in viral vector manufacturing for gene and cell therapies, announced today that they have reached a definitive agreement in which Thermo Fisher will acquire Brammer Bio for approximately $1.7 billion in cash. Brammer Bio is a leading viral vector contract development and manufacturing organisation (CDMO), helping biopharma customers deliver breakthrough medicines to patients by unlocking the potential of gene therapies and gene-modified cell treatments.

June 1, 2023

Lonza Group

Acquisition

Lonza, a global manufacturing partner in the pharmaceutical, biotech, and nutraceutical markets, announced the acquisition of Synaffix B.V. (Synaffix), a biotechnology firm focussing on commercialising its clinical-stage technology platform for ADC development. Synaffix revenues and margins will be recognised inside the Lonza business beginning with the date of purchase.

November 26, 2019

Lonza Group

Agreement

Lonza and DiNAQOR AG, a global gene therapy platform firm, have established a strategic agreement to advance DiNAQOR's preclinical initiatives for the treatment of cardiac myosin-binding protein-C (MYBPC3) cardiomyopathies, a hereditary disorder that can lead to heart failure.

October 13, 2021

FUJIFILM Diosynth Biotechnologies

Collaboration

LEXEO Therapeutics, a fully integrated clinical-stage gene therapy company that is developing adeno-associated virus (AAV)-mediated treatments for genetic conditions, and FUJIFILM Diosynth Biotechnologies, a world-leading contract development and manufacturing organisation (CDMO) for biologics, viral vaccines, and viral vectors, today announced a strategic collaboration to support the development and manufacturing of LEXEO's AAV-based gene therapies.

March 25, 2024

FUJIFILM Diosynth Biotechnologies

Agreement

FUJIFILM Diosynth Biotechnologies, a world-leading contract development and manufacturing organisation for biologics, vaccines, advanced therapies, and oncolytic viruses, announced an extension of its manufacturing agreement with argenx to provide drug product and finished goods services for efgartigimod, a monoclonal antibody (mAb) fragment that targets the neonatal Fc receptor (FcRn) in patients with severe autoimmune disease.

April 22, 2025

FUJIFILM Diosynth Biotechnologies

Agreement

FUJIFILM Diosynth Biotechnologies, a global contract development and manufacturing organisation (CDMO) for biologics, vaccines, and advanced therapies, has announced a 10-year manufacturing supply agreement worth more than $3 billion with Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) to produce its industry-leading biologic medicines in the United States, where they treat millions of patients worldwide.

November 5, 2024

Charles River Laboratories International, Inc.

Partnership

NJ Bio, Inc. announced a new strategic relationship with Charles River Laboratories (CRL) to improve ADC production capabilities and accelerate the transition of ADC initiatives from the laboratory to the clinic. This collaboration brings together CRL's competence in antibody engineering with NJ Bio's expertise in the creation and production of innovative linker-payloads, resulting in a formidable collaborative platform for ADC development.

May 2, 2024

Charles River Laboratories International, Inc.

New Product Launch

Charles River Laboratories International, Inc. has announced the launch of its portfolio of reference materials for adeno associated virus (AAV) and lentiviral vector (LVV), which are intended to streamline Cell and Gene Therapy (CGT) research and development as it scales to Good Manufacturing Practice (GMP) quality.

January 16, 2024

Charles River Laboratories International, Inc.

Expansion

Charles River Laboratories International, Inc. has announced the availability of their off-the-shelf Rep/Cap plasmid product, which is intended to expedite AAV-based gene therapy operations. Following the previously announced launch of its lentiviral packaging and AAV Helper plasmid products, the addition of AAV Rep/Cap (RC2, 5, 6, 8, 9) rounds out a comprehensive range of contract development and manufacturing organisation (CDMO).

Date

Company name

Activity

Description

November 13, 2023

Forge Biologics (Forge)

Acquisition

Ajinomoto Co., Inc. and Forge Biologics (Forge) announced the signing of a definitive agreement under which Ajinomoto Co. will acquire Forge, a leading manufacturer of genetic medicines, in an all-cash transaction worth $620 million.

November 13, 2024

Forge Biologics (Forge)

Agreement

Affinia Therapeutics, an innovative gene therapy company with a pipeline of rationally designed adeno-associated virus (AAV) gene therapies for devastating cardiovascular and neurological diseases, and Forge Biologics ("Forge"), a leading manufacturer of genetic medicines and member of the Ajinomoto Bio-Pharma Services group, announced an agreement to transfer technology and manufacture clinical trial material under Current Good Manufacturing Practice (cGMP) standards to help.

September 14, 2022

Coave Therapeutics

Collaboration

Coave Therapeutics is working with the Institute of Neurodegenerative Diseases (IMN) in Bordeaux to produce gene therapy proteins that target protein degradation in neurodegenerative illnesses.

September 16, 2021

Coave Therapeutics

Agreement

Coave Therapeutics ('Coave'), a clinical-stage biotechnology company focused on developing life-changing gene therapies for rare ocular and CNS (Central Nervous System) diseases, has signed an exclusive licensing, co-development, and commercialisation agreement with Théa, a leading European speciality pharmaceutical company focused on ophthalmology.

Date

Company name

Activity

Description

December 3, 2020

Nationwide Children's Hospital

Partnership

Nationwide Children's Hospital and Mercy Health — Children's Hospital formed a formal affiliation on January 1, 2020. Since then, they have worked closely together to promote subspeciality paediatric physician recruitment, continuing medical education, and care coordination for families in northwest Ohio and southeast Michigan.

May 14, 2025

Nationwide Children's Hospital

Expansion

Nationwide Children's Hospital has begun building of a new patient tower on its Columbus, Ohio, site. The hospital's emergency department, newborn and paediatric intensive care units (NICU; PICU), as well as the haematology, oncology and blood and marrow transplant departments, will all be expanded in the new facility.