Category: Industry News

Sigilon Therapeutics Announces Strategic Reprioritization

CAMBRIDGE, Mass., Dec. 13, 2021 (GLOBE NEWSWIRE) — Sigilon Therapeutics, Inc. (NASDAQ: SGTX), a biotechnology company that seeks to develop functional cures for chronic diseases through its Shielded Living TherapeuticsTM platform, today announced a strategic reprioritization to enable the Company to focus on MPS-1 and diabetes.“There have been key learnings in our Phase 1/2 trial […]

uniQure and CSL Behring Achieve Primary Endpoint in HOPE-B Pivotal Trial of Etranacogene Dezaparvovec Gene Therapy for Hemophilia B

Press release source: uniQure and CSL Behring via Globe Newswire CSL Behring, a global biotherapeutics leader, and uniQure N.V., a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced that etranacogene dezaparvovec, an investigational adeno-associated virus five (AAV5)-based gene therapy for the treatment of patients with severe to moderately […]

Sigilon Therapeutics Announces Update on SIG-001 Phase 1/2 Study in Hemophilia

Source: Sigilon press release Sigilon Therapeutics, Inc., a biotechnology company that seeks to develop functional cures for chronic diseases through its Shielded Living Therapeutics™ platform, reported that fibrosed spheres were observed during a retrieval procedure in a patient in its Phase 1/2 study of SIG-001 in severe or moderately severe hemophilia A.The SIG-001 trial had been […]

Pfizer Giroctocogene Fitelparvovec (Hemophilia A Gene Therapy) AFFINE Phase 3 Study Update

The following is a news release from Pfizer. Read the full statement here (view PDF):We would like to share a recent update to our gene therapy clinical program for Hemophilia A (C3731003; AFFINE study) evaluating giroctocogene fitelparvovec, that we are developing with Sangamo.Following the observation of factor VIII (FVIII) levels greater than 150% in some […]

Recall: Monoject Flush Prefilled Saline Syringes by Aligned Medical Solutions Recalled Due to Potential for Plunger to Draw Back After Air Has Been Expelled and Reintroduce Air Back into Syringe

Monoject Flush Prefilled Saline Syringes by Aligned Medical Solutions: Recall – Due to Potential for Plunger to Draw Back After Air Has Been Expelled and Reintroduce Air Back into Syringe Read the full press release from the FDA Issue: Aligned Medical Solutions is recalling Cardinal Health’s Monoject Flush Prefilled Saline Syringes placed into 9,378 kits. […]

Astellas Reports Fourth Death In Orphan Disease Gene Therapy Clinical Trial

The following is a news release from Astellas Pharma Inc. Read the release. Astellas Pharma Inc. reports that the ASPIRO clinical trial participant, who developed a serious adverse event as described on September 1, passed away on September 9. The cause of death is still pending. Astellas is gathering the relevant clinical information and incorporating […]

Important Update Regarding Availability of Stimate

Important Update Regarding Availability of Stimate Source: CSL Press releaseRecently, CSL Behring announced that the company has chosen to end their distribution agreement with Ferring Pharmaceuticals for STIMATE® nasal spray, effectively thereby removing this medication as a valuable treatment option for patients with von Willebrand Disease (VWD) and mild hemophilia A. Background For over a […]

Cardinal Health Issues Nationwide Recall of Select Monoject™ Flush Prefilled Saline Syringes

Read the U.S. Food & Drug Administration’s announcement here.On August 4, 2021, Cardinal Health initiated a nationwide recall of approximately 267 million MonojectTM Flush Prefilled Saline Syringes (0.9% Sodium Chloride). The products have been found to reintroduce air into the syringe after the air has been expelled. This could result in injection of air into […]

Gilead Warns of Counterfeit HIV Medication Being Distributed in the United States

The following is sourced from Gilead. Read the update in its entirety “Gilead Warns of Counterfeit HIV Medication Being Distributed in the United States”. Click to view the original press release. Foster City, Calif., August 5, 2021 – Gilead Sciences has become aware of tampered and counterfeit versions of its once-daily single tablet HIV treatment regimen […]

Sigilon Therapeutics Announces Clinical Hold on SIG-001 Phase 1/2 Study in Hemophilia A

The following is sourced from a press release from Sigilon Therapeutics. Read the update in its entirety here. The U.S. Food and Drug Administration (FDA) has placed a clinical hold on Sigilon Therapeutics’ phase 1/2 study of SIG-001 in patients with severe or moderately severe hemophilia A.SIG-001 is a cell-based therapy, designed to carry significant amounts […]