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Vertex Pharma Says FDA Lifts Clinical Hold On Phase 1/2 Trial Of VX-880 To Treat Type 1 Diabetes
(RTTNews) - Vertex Pharmaceuticals Inc. (VRTX) announced Tuesday that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold placed on the Phase 1/2 clinical trial of VX-880, an investigational stem cell-derived, fully differentiated pancreatic islet cell replacement therapy for people with type 1 diabetes (T1D) with impaired hypoglycemic awareness and severe hypoglycemia.
As a result, the Phase 1/2 trial will be reopened for screening, enrollment and dosing at multiple sites in the U.S.
To date, three patients have been dosed in the Phase 1/2 study with VX-880. Two patients received half the target dose of cells in Part A of the study. A third patient has received the full target dose in Part B of the study. Part B will evaluate safety and efficacy in five patients at the target dose before expanding to additional patients in Part C.
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Vertex Advances Inaxaplin Into Phase 2/3 Trial To Treat APOL1-Mediated Kidney Disease
Vertex Pharmaceuticals Inc. (VRTX) announced Monday that inaxaplin (VX-147) has advanced into the Phase 3 portion of the global Phase 2/3 pivotal clinical trial in APOL1-mediated kidney disease (AMKD), where a 45 mg once daily oral dose will be compared to placebo, on top of standard of care.
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514 ngày trước
Vertex Receives CHMP Positive Opinion For The First CRISPR/Cas9 Gene-Edited Therapy CASGEVY
Vertex Pharmaceuticals Inc. (VRTX) announced Friday that the European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the conditional approval of CASGEVY (exagamglogene autotemcel [exa-cel]), a CRISPR/Cas9 gene-edited therapy, for the treatment of severe sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT).
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622 ngày trước
Vertex Pharma Inks Licensing Agreement To Use CRISPR Therapeutics' Gene Editing Technology
Biotechnology company Vertex Pharmaceuticals, Inc. (VRTX) and gene editing company CRISPR Therapeutics, Inc. (CRSP) announced Monday that they have entered into a new non-exclusive licensing agreement for the use of CRISPR Therapeutics' gene editing technology, known as CRISPR/Cas9, to accelerate the development of Vertex's hypoimmune cell therapies for type 1 diabetes (T1D).
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885 ngày trước
Vertex Pharma To Acquire ViaCyte For $320 Mln In Cash
Vertex Pharmaceuticals Inc. (VRTX) announced Monday that the company has entered into a definitive agreement under which Vertex will acquire privately-held biotechnology company ViaCyte for $320 million in cash.
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1144 ngày trước
U.S. Pending Home Sales Fall More Than Expected In July
A report released by the National Association of Realtors on Thursday showed pending home sales in the U.S. fell by more than expected in the month of July. NAR said its pending home sales index decreased by 0.4 percent to 71.7 in July after sliding by 0.8 percent to 72.0 in June. Economists had expected pending home sales to edge down by 0.1 percent.
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1h 3phút trước
Eurozone Economic Confidence Weakens In August
Eurozone economic sentiment softened unexpectedly in August as only industry and retail trade showed improvements, survey results from the European Commission showed Thursday. The economic sentiment indicator slid to 95.2 in August from a revised 95.7 in the previous month. The score was forecast rise to 96.0.
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1h 14phút trước
Walgreen Co. Now Operating As Private Standalone Company Under Sycamore Partners
Independent retail pharmacy Walgreen Co. announced Thursday it is now operating as a private standalone company following the closure of the acquisition of Walgreens Boots Alliance, Inc. (WBA) by New York-based private equity firm Sycamore Partners.
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1h 25phút trước
U.S. Economy Surges More Than Previously Estimated In Q2
The U.S. economy grew by more than previously estimated in the second quarter of 2025, according to revised data released by the Commerce Department on Thursday. The report said real gross domestic product shot up by 3.3 percent in the second quarter compared to the previously reported 3.0 percent surge. Economists had expected the jump in GDP to be upwardly revised to 3.1 percent.
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1h 36phút trước
