FDA Approves First Gene Therapy for Hemophilia A FDA Approves First Gene Therapy for Hemophilia A
Most patients benefit from valoctocogene roxaparvovec for at least 2 years, but it ' s not known how long the effect lasts.Medscape Medical News (Source: Medscape Hematology-Oncology Headlines)
Source: Medscape Hematology-Oncology Headlines - June 30, 2023 Category: Cancer & Oncology Tags: Hematology-Oncology News Alert Source Type: news
FDA Gives Nod to Gene Therapy for Hemophilia A
(MedPage Today) -- The FDA approved valoctocogene roxaparvovec (Roctavian) as the first gene therapy for the treatment of adults with severe hemophilia A, drug developer Biomarin announced on Thursday.
Patients with severe disease are eligible... (Source: MedPage Today Hematology/Oncology)
Source: MedPage Today Hematology/Oncology - June 30, 2023 Category: Hematology Source Type: news
FDA Approves Roctavian (valoctocogene roxaparvovec-rvox) Gene Therapy for Adults with Severe Hemophilia A
SAN RAFAEL, Calif., June 29, 2023 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN), a global biotechnology company dedicated to transforming lives through genetic discovery, today announced that the United States Food and Drug... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 29, 2023 Category: Drugs & Pharmacology Source Type: news
$2.9 million gene therapy for severe hemophilia is approved by FDA
U.S. health regulators have approved a gene therapy for the most common form of hemophilia (Source: ABC News: Health)
Source: ABC News: Health - June 29, 2023 Category: Consumer Health News Tags: Health Source Type: news
Aiming for 'the year of Roctavian,' BioMarin awaits FDA decision on hemophilia gene therapy
The treatment, which could reduce or stop potentially deadly bleeds for years, could cost around $2 million or more. (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - June 28, 2023 Category: Pharmaceuticals Authors: Ron Leuty Source Type: news
FDA accepts Pfizer & #039;s application for hemophilia B gene therapy fidanacogene elaparvovec
Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has accepted the company's Biologics License Application (BLA) for fidanacogene elaparvovec for the treatment of adults with hemophilia B. In parallel, the European marketing authorization application (MAA) for fidanacogene elaparvovec has also been accepted and is under review by the European Medicines Agency (EMA). (Source: World Pharma News)
Source: World Pharma News - June 27, 2023 Category: Pharmaceuticals Tags: Featured Pfizer Business and Industry Source Type: news
FDA Accepts Pfizer ’s Application for Hemophilia B Gene Therapy Fidanacogene Elaparvovec
NEW YORK--(BUSINESS WIRE) June 27, 2023 -- Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) for fidanacogene elaparvovec for the treatment... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 27, 2023 Category: Drugs & Pharmacology Source Type: news
Inside the launch: CSL Behring's $3.5M-per-dose gene therapy Hemgenix given to first hemophilia B patient
Hemgenix received Food and Drug Administration approval as a treatment for hemophilia B in November, making it the first one-time gene therapy to receive marketing approval for the chronic bleeding disorder. (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - June 20, 2023 Category: Pharmaceuticals Authors: John George Source Type: news
Message from Dr Ahmed Al-Mandhari, WHO Regional Director, on the occasion of World Blood Donor ...
Every year on 14 June, countries around the world celebrate World Blood Donor Day. This year’s campaign focuses on patients requiring life-long support with blood transfusion or plasma proteins. The campaign highlights the role that every single person can play, by giving the valuable gift of blood or plasma regularly to ensure a safe and sustainable supply of blood and blood products for all those in need.
Access to a secure blood supply based on voluntary unpaid donation is vital for all patients, including many requiring life-long and regular transfusions for conditions such as sickle-cell anaemia and thalassaemia. I...
Source: WHO EMRO News - June 13, 2023 Category: Middle East Health Source Type: news
Hemophilia Therapy Reduces Bleeding in Late-Stage Study Hemophilia Therapy Reduces Bleeding in Late-Stage Study
Pfizer Inc said on Tuesday late-stage study data for its experimental hemophilia therapy showed superiority to the current standard of care treatment in reducing bleeding rates in patients.Reuters Health Information (Source: Medscape General Surgery Headlines)
Source: Medscape General Surgery Headlines - June 1, 2023 Category: Surgery Tags: Hematology-Oncology News Source Type: news
Pfizer's Approach To Hemophilia Is'Certainty Differentiated '
said Tuesday its experimental hemophilia treatment cut down on bleeding episodes in a pivotal study. But Pfizer stock dipped. X The drug is a under-the-skin injection administered once a week. It targets TFPI, an inhibitor in the body that prevents blood clots from forming. Pfizer hopes its drug,…#hemophilia #pfizer #bpfizer #marketsmithcom #pfizerstock #chrisboshoff #umerraffat #novonordisk #nvo #bayer (Source: Reuters: Health)
Source: Reuters: Health - May 31, 2023 Category: Consumer Health News Source Type: news
Clotting factor activity levels and bleeding risk in people with haemophilia playing sports - Versloot O, Kemler E, Blokzijl J, Timmer M, Schuuring M, van Galen KPM, Kremer Hovinga ICL, van der Valk PR, van Vulpen LFD, Schutgens REG, van Koppenhagen CF, van der Net J, Fischer K.
BACKGROUND: Improved treatment options for people with haemophilia (PWH) have increased the possibilities for sports participation, but the risk of sports-induced bleeding (SIB) is still considered considerable by many. AIM: To assess sports associ... (Source: SafetyLit)
Source: SafetyLit - May 26, 2023 Category: International Medicine & Public Health Tags: Age: Adolescents Source Type: news
[Ad hoc announcement pursuant to Art. 53 LR] Roche reports strong sales growth in base business of both divisions in the first quarter; Group sales decline due to expected drop in demand for COVID-19 tests
As expected, significantly lower demand for COVID-19 tests leads to a decrease inGroup sales (-3%1 at constant exchange rates [CER] and -7% in Swiss francs); excluding this effect, Group sales grow 8%Pharmaceuticals Divisionsales up 9%; strong demand for newer medicines; Vabysmo for severe eye diseases is already the strongest growth driverDiagnostics Division base business grows 4%, whiledivisional salesare 28% lower due to exceptionally high demand for COVID-19 tests in the first quarter of 2022Highlights in the first quarter:US approval of Polivy (first-line treatment for an aggressive form of blood cancer)EU approva...
Source: Roche Investor Update - April 26, 2023 Category: Pharmaceuticals Source Type: news
[Ad hoc announcement pursuant to Art. 53 LR] Roche reports strong sales growth in base business of both divisions in the first quarter; Group sales decline due to expected drop in demand for COVID-19 tests
Basel, 26 April 2023As expected, significantly lower demand for COVID-19 tests leads to a decrease inGroup sales (-3%1 at constant exchange rates [CER] and -7% in Swiss francs); excluding this effect, Group sales grow 8%Pharmaceuticals Divisionsales up 9%; strong demand for newer medicines; Vabysmo for severe eye diseases is already the strongest growth driverDiagnostics Division base business grows 4%, whiledivisional salesare 28% lower due to exceptionally high demand for COVID-19 tests in the first quarter of 2022Highlights in the first quarter:US approval of Polivy (first-line treatment for an aggressive form of blo...
Source: Roche Media News - April 26, 2023 Category: Pharmaceuticals Source Type: news
Mauritius: World Hemophilia Day 2023 Observed to Spread Awareness On Blood Disorder
[Government of Mauritius] In the context of the World Hemophilia Day observed annually on 17 April, a ceremony was organised by the Ministry of Health and Wellness in collaboration with the Hemophilia Association of Mauritius, yesterday, at the Gold Crest Hotel in Quatre Bornes to mark the day. (Source: AllAfrica News: Health and Medicine)
Source: AllAfrica News: Health and Medicine - April 18, 2023 Category: African Health Source Type: news
