03/07/2024

Chiesi Global Rare Diseases Announces Publication of Long-Term Assessment of ELFABRIO^® (pegunigalsidase alfa-iwxj) in Fabry Disease

BOSTON, March 7, 2024 – Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people affected by rare diseases, today announced the publication of long-term data up to six years evaluating the safety and efficacy of treatment with ELFABRIO (pegunigalsidase alfa-iwxj) in adult patients with Fabry disease. The data are published in Genetics in Medicine, an official journal of the American College of Medical Genetics and Genomics.....

03/01/2024

Chiesi Global Rare Diseases Launches “Rethink Acromegaly” Campaign to Provide Important Disease Education and Support to the Acromegaly Community

BOSTON, March 1, 2024 – Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people affected by rare diseases, today announced the launch of Rethink Acromegaly, a disease education program. Intended to provide audiences with the latest information and resources, RethinkAcromegaly.com serves as a resource to empower people living with acromegaly, their caregivers, and healthcare professionals....

08/02/2024

Chiesi Global Rare Diseases Presents Long-Term Data on Treatment with Velmanase Alfa in Alpha-Mannosidosis and Announces Additional Presentations at the 20^th Annual WORLDSymposium™ Research Meeting

BOSTON, February 8, 2024 – Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people living with rare diseases, today announced the presentation of long-term data from up to 12 years of treatment with velmanase alfa in patients with alpha-mannosidosis (AM). The company also announced the presentation of immunogenicity and tolerability data from its pegunigalsidase alfa clinical trial program in Fabry disease, as well as analyses of the prevalence, diagnosis, and progression of...

Chiesi Global Rare Diseases Announces Health Canada Approval of MYALEPTA™ (metreleptin for injection) for the Treatment of Patients with Lipodystrophy

CANADA, February 5, 2024 – Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people affected by rare diseases, is pleased to announce the Health Canada approval of MYALEPTA™ (metreleptin for injection). As an adjunct to diet, MYALEPTA is indicated as a replacement therapy to treat the complications of leptin deficiency in lipodystrophy (LD) patients with confirmed congenital generalised LD (Berardinelli- Seip syndrome) or acquired generalised LD (Lawrence syndrome) in adults and children two..

04/02/2024

Chiesi Global Rare Diseases to Present at the 20^th Annual WORLDSymposium™ Research Meeting

BOSTON, February 4, 2024 – Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people living with rare diseases, today announced that nine abstracts have been accepted for presentation at the 20^th Annual WORLDSymposium™ Research Meeting to be held February 4-9, 2024, in San Diego, California. The company will also sponsor three satellite symposia, present a special film screening...

10/01/2024

Chiesi Global Rare Diseases Announces Publication of Results from Phase 3 BALANCE Study in Fabry Disease

BOSTON, January 10, 2024 – Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people affected by rare diseases, today announced the publication of data from the Phase 3 BALANCE study that evaluated the efficacy, safety and tolerability of pegunigalsidase alfa versus agalsidase beta in adult patients with previous agalsidase beta treatment and deteriorating renal function. The results are published in the peer-reviewed Journal of Medical Genetics (“Head-to-head trial of pegunigalsidase...

19/12/2023

Chiesi Global Rare Diseases Receives FDA Approval for FILSUVEZ® (birch triterpenes) topical gel for the Treatment of Epidermolysis Bullosa

BOSTON, December 19, 2023 - Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people affected by rare diseases, announced today that the U.S. Food and Drug Administration (FDA) approved FILSUVEZ® (birch triterpenes) topical gel for the treatment of partial thickness wounds in patients 6 months and older with Junctional Epidermolysis Bullosa (JEB) and Dystrophic Epidermolysis Bullosa (DEB). FILSUVEZ is the first approved treatment for wounds associated...

30/10/2023

Chiesi Global Rare Diseases Releases Report on the Burden of Care for Rare Diseases and Its Economic Impact on European Citizens

Note: This information is not intended for US audiences.
Parma (Italy), October 30, 2023 – Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people living with rare diseases, today published Rare Disease Burden of Care and the Economic Impact on Citizens, a comprehensive report that thoroughly examines the escalating care challenges and economic impact on European citizens living with rare ...

01/09/2023

Chiesi Global Rare Diseases Announces Multiple Presentations at SSIEM Annual Symposium 2023.

BOSTON, September 1, 2023 – Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people affected by rare diseases, today announced multiple presentations at the Society for the Study of Inborn Errors of Metabolism (SSIEM) Annual Symposium 2023 being held...

10/05/2023

Chiesi Global Rare Diseases Announces FDA Approval of ELFABRIO® (pegunigalsidase alfa-iwxj) for the Treatment of Fabry Disease.

Updated August 17, 2023

BOSTON, May 10, 2023 – Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people affected by rare diseases, announced today that the U.S. Food and Drug Administration (FDA) has approved ELFABRIO (pegunigalsidase alfa-iwxj) in...

05/05/2023

Chiesi Global Rare Diseases Announces European Commission (EC) Authorization of PRX-102 (pegunigalsidase alfa) for the Treatment of Fabry Disease.

Updated August 17, 2023

PARMA, Italy and BOSTON, May 5, 2023 – Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people affected by rare diseases, today announced that the European Commission (EC) has granted marketing authorization to PRX 102 (pegunigalsidase alfa) in the European Union (EU) for the treatment of...

15/08/2023

Chiesi Global Rare Diseases Announces Co-Development Agreement with Aliada Therapeutics to Advance Blood-Brain Barrier-Crossing Platform Technology in Lysosomal Storage Disorders.

BOSTON, August 15, 2023 – Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people living with rare diseases, today announced a co-development agreement with...

31/07/2023

Santhera Completes Divestment of Raxone®/Idebenone Business to Chiesi Group.

Pratteln, Switzerland, July 31, 2023 – Santhera Pharmaceuticals (SIX: SANN) announced the full divestment of its Raxone®/idebenone business worldwide and for all indications to Chiesi Farmaceutici S.p.A., an international research focused healthcare group (Chiesi Group). The transaction replaces the...

18/04/2023

Chiesi Global Rare Diseases Announces U.S. Networkwide Sponsorship of BioInnovation Labs.

BOSTON, April 18, 2023 – Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people affected by rare diseases, today announced a U.S. Networkwide Sponsorship of BioInnovation Labs (BioLabs), the leading developer and operator of life science coworking spaces...

12/04/2023

Chiesi Farmaceutici S.p.A. Completes Acquisition of Amryt Pharma Plc.

Parma Italy, Dublin Ireland and Boston MA, April 12, 2023 – Chiesi Farmaceutici S.p.A. (“Chiesi”), an international, research-focused biopharmaceuticals and healthcare group, today announced the completion of the acquisition of Amryt Pharma Plc (“Amryt”) (Nasdaq: AMYT), a global, commercial-stage biopharmaceutical...

04/04/2023

Chiesi Global Rare Diseases Announces Collaboration with the National Alliance on Mental Illness to Offer Mental Health Resources for Fabry Disease.

BOSTON, April 4, 2023 – Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people affected by rare diseases, today announced a collaboration with the National Alliance on Mental Illness (NAMI), the nation’s largest ...

24/02/2023

Chiesi Global Rare Diseases Presents Long-Term Results from Phase 3 BALANCE and BRIGHT Studies in Fabry Disease at the 19^th Annual WORLDSymposium™ Research Meeting.

BOSTON, February 24, 2023 – Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people affected by rare diseases, today announced the oral presentation of long-term results from the Phase 3 BALANCE and BRIGHT studies...

24/02/2023

Chiesi Global Rare Diseases and Protalix BioTherapeutics Receive Positive CHMP Opinion for Pegunigalsidase Alfa for Treatment of Fabry Disease.

PARMA/BOSTON and CARMIEL, Israel, February 24, 2023 – Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people affected by rare diseases, and Protalix BioTherapeutics, Inc. (NYSE American:PLX) (TASE:PLX), a biopharmaceutical company, announced today that the European Medicines Agency’s (EMA) Committee for...

16/02/2023

Chiesi Global Rare Diseases Announces FDA Approval of Lamzede® (velmanase alfa-tycv) for Alpha-Mannosidosis.

BOSTON, February 16, 2023 – Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., an international research-focused healthcare Group (Chiesi Group), announced today that the U.S. Food and Drug Administration (FDA) has approved Lamzede® (velmanase alfa-tycv) for the treatment of non-neurological manifestations of alpha-mannosidosis (AM) in adult and pediatric patients.
See Boxed Warning - Hypersensitivity Reactions including Anaphylaxis and additional Important Safety Information....

15/02/2023

Chiesi Global Rare Diseases to Present at the 19^th Annual WORLDSymposium™ Research Meeting.

BOSTON, February 15, 2023 – Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people affected by rare diseases, today announced that eight abstracts have been accepted for presentation at the 19^th Annual WORLDSymposium™ Research Meeting to be held February 22–26, 2023 in Orlando....