FDA Approves Weekly Factor Therapy for Hemophilia A
(MedPage Today) -- The FDA has approved the recombinant antihemophilic factor Fc-VWF-XTEN fusion protein-ehtl (Altuviiio) for the treatment of adults and children with hemophilia A, Sanofi announced on Thursday.
The first-in-class factor VIII... (Source: MedPage Today Hematology/Oncology)
Source: MedPage Today Hematology/Oncology - February 24, 2023 Category: Hematology Source Type: news
Sanofi, poised to rival Roche in hemophilia, nabs FDA approval for Altuviiio
Sanofi and partner Sobi are coming back to the hemophilia A market with a vengeance after Roche’s Hemlibra ate up sales of their aging Eloctate. | Sanofi and partner Sobi are coming back to the hemophilia A market with a vengeance after Roche’s Hemlibra ate up sales of their aging Eloctate. The…#rocheshemlibra #eloctate #altuviiio (Source: Reuters: Health)
Source: Reuters: Health - February 24, 2023 Category: Consumer Health News Source Type: news
FDA Approves Altuviiio ([Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl]) Once-Weekly VIII Therapy for Hemophilia A
Paris and Stockholm– February 23, 2023– The U.S. Food and Drug Administration (FDA) has approved Altuviiio™ [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl], previously referred to as efanesoctocog alfa, a... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 23, 2023 Category: Drugs & Pharmacology Source Type: news
Gene Tx Shows Sustained Bleeding Control in Severe Hemophilia A at 2 Years
(MedPage Today) -- A single infusion of the gene therapy valoctocogene roxaparvovec led to significantly reduced bleeding rates that persisted in men with severe hemophilia A, 2-year results from the phase III GENEr8-1 trial showed.
Among 112... (Source: MedPage Today Hematology/Oncology)
Source: MedPage Today Hematology/Oncology - February 23, 2023 Category: Hematology Source Type: news
Hemophilia A Gene Therapy Durable at 2 Years; Under FDA Review Hemophilia A Gene Therapy Durable at 2 Years; Under FDA Review
Despite an anticipated price tag of $2.5 million, there ' s no way to predict who will have long-standing benefit from valoctocogene roxaparvovec and who will not.Medscape Medical News (Source: Medscape Hematology-Oncology Headlines)
Source: Medscape Hematology-Oncology Headlines - February 23, 2023 Category: Cancer & Oncology Tags: Hematology-Oncology News Source Type: news
Efanesoctocog Alfa Treatment'Victory' for Hemophilia A Patients Efanesoctocog Alfa Treatment'Victory' for Hemophilia A Patients
A once-weekly prophylactic treatment of this investigational agent led to normal or near-normal factor VIII activity levels in most patients with severe hemophilia A.Medscape Medical News (Source: Medscape Hematology-Oncology Headlines)
Source: Medscape Hematology-Oncology Headlines - February 22, 2023 Category: Cancer & Oncology Tags: Hematology-Oncology News Source Type: news
Europe Approves First Gene Therapy for Hemophilia B Europe Approves First Gene Therapy for Hemophilia B
The European Commission has approved etranacogene dezaparvovec (Hemgenix), the first gene therapy for severe and moderately severe hemophilia B (congenital factor X1 deficiency).International Approvals (Source: Medscape Hematology-Oncology Headlines)
Source: Medscape Hematology-Oncology Headlines - February 21, 2023 Category: Cancer & Oncology Tags: Hematology-Oncology News Alert Source Type: news
When Launched, Gene Therapy Roctavian Will Be Administered Mainly In 340B-Eligible Treatment Centers, Where It Will Be Substantially Discounted In Price
If approved, the gene therapy Roctavian will likely launch at a list price of ~$2.5 million. But experts anticipate considerable discounts in most instances of sales, as many hemophilia A patients will have the product administered in a 340B-eligible treatment center, at a 340B discounted price. (Source: Forbes.com Healthcare News)
Source: Forbes.com Healthcare News - February 16, 2023 Category: Pharmaceuticals Authors: Joshua Cohen, Contributor Tags: Healthcare /healthcare Innovation /innovation business pharma & Source Type: news
[Ad hoc announcement pursuant to Art. 53 LR] Roche reports good results for 2022 despite decline in demand for COVID-19 products
Basel, 2 February 2023Group sales grow by 2%1 at constant exchange rates (CER) and 1% in Swiss francs, despite lower COVID-19-related sales in both divisionsPharmaceuticals Division salesincrease by 2%; continued strong growth of newer medicines more than compensating for the impact of biosimilars and lower sales of Actemra/RoActemra (severe COVID-19)Diagnostics Division salesgrow by 3%; ongoing strong momentum in base business (+7%) more than compensating for the continuing decline in the demand for COVID-19 tests in the second half of the yearHighlightsin the fourth quarter of 2022 (incl. January 2023):US approvals ofLun...
Source: Roche Media News - February 2, 2023 Category: Pharmaceuticals Source Type: news
[Ad hoc announcement pursuant to Art. 53 LR] Roche reports good results for 2022 despite decline in demand for COVID-19 products
Group sales grow by 2%1 at constant exchange rates (CER) and 1% in Swiss francs, despite lower COVID-19-related sales in both divisionsPharmaceuticals Division salesincrease by 2%; continued strong growth of newer medicines more than compensating for the impact of biosimilars and lower sales of Actemra/RoActemra (severe COVID-19)Diagnostics Division salesgrow by 3%; ongoing strong momentum in base business (+7%) more than compensating for the continuing decline in the demand for COVID-19 tests in the second half of the yearHighlightsin the fourth quarter of 2022 (incl. January 2023):US approvals ofLunsumio (follicular lymp...
Source: Roche Investor Update - February 2, 2023 Category: Pharmaceuticals Source Type: news
European Commission approves label expansion of Roche ’s Hemlibra to include people with moderate haemophilia A in the EU
Hemlibra, already approved for severe haemophilia A in the EU, will now also provide an effective and convenient prophylactic treatment option for people with moderate haemophilia AModerate haemophilia A can have a significant impact on the lives of people affected, with only 15% living a bleed-free life1The approval is based on the HAVEN 6 results, whereHemlibra demonstrated effective bleed control and a favourable safety profile in people with moderate haemophilia A without inhibitors2Basel, 01 February 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission approved the expansion of the He...
Source: Roche Investor Update - February 1, 2023 Category: Pharmaceuticals Source Type: news
European Commission approves label expansion of Roche ’s Hemlibra to include people with moderate haemophilia A in the EU
Hemlibra, already approved for severe haemophilia A in the EU, will now also provide an effective and convenient prophylactic treatment option for people with moderate haemophilia AModerate haemophilia A can have a significant impact on the lives of people affected, with only 15% living a bleed-free life1The approval is based on the HAVEN 6 results, whereHemlibra demonstrated effective bleed control and a favourable safety profile in people with moderate haemophilia A without inhibitors2Basel, 01 February 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission approved the expansion of the He...
Source: Roche Media News - February 1, 2023 Category: Pharmaceuticals Source Type: news
Once-Weekly Efanesoctocog Alfa Beneficial in Severe Hemophilia A
THURSDAY, Jan. 26, 2023 -- Once weekly efanesoctocog alfa provides superior bleeding prevention to prestudy prophylaxis for patients with severe hemophilia A, according to a study published in the Jan. 26 issue of the New England Journal of... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - January 26, 2023 Category: Pharmaceuticals Source Type: news
New Class of Factor VIII Replacement Therapy Prevents Bleeds in Severe Hemophilia A
(MedPage Today) -- Treatment with investigational efanesoctocog alfa (formerly BIVV001) -- a new class of factor VIII replacement therapy -- prevented bleeding episodes in patients with severe hemophilia A, according to results from the phase... (Source: MedPage Today Hematology/Oncology)
Source: MedPage Today Hematology/Oncology - January 26, 2023 Category: Hematology Source Type: news
Risk of fractures, repeated fractures and osteoporotic fractures among patients with hemophilia in Taiwan: a 14-year population-based cohort study - Pai YY, Wang JD, Ho HE, Chou YJ, Ho WC, Chan WC, Chu WM, Tsan YT.
The world is aging, and hemophilia patients are as well. The association between patients with hemophilia (PWH) and low bone mineral density is clear. However, the incidence of fractures in patients with hemophilia is inconclusive, and no research has yet ... (Source: SafetyLit)
Source: SafetyLit - January 10, 2023 Category: International Medicine & Public Health Tags: Economics of Injury and Safety, PTSD, Injury Outcomes Source Type: news
