Interim data from phase III study presented at ASH 2022 show Hemlibra achieved meaningful bleed control in infants from birth
The HAVEN 7 studywas designed to further confirm the benefit of preventative treatment (prophylaxis) withHemlibra from birth in previously untreated or minimally treated infants with severehaemophilia A without inhibitorsIn the study, 77.8% of participants had no bleeding episodes that required treatment1In addition, real-world efficacy and safety data from the EUHASS database and ATHN 7 study were also presented2,3Basel, 11 December 2022 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced interim results from the phase III HAVEN 7 study. The study shows Hemlibra® (emicizumab) achieved meaningful bleed control with a ...
Source: Roche Investor Update - December 11, 2022 Category: Pharmaceuticals Source Type: news
Getting ready for primetime in cell & gene therapy
Cell and gene therapies (CGTs) have a lot going for them from an industry perspective – with a market predicted to reach US$50 billion annually by 2027, an opportunity to expand the frontier of medical science and the potential to save or improve countless lives. But with logistical, supply chain and manufacturing complexities interwoven into development, bringing CGTs to large patient populations may prove uniquely challenging.With over 3,633 therapies in development as of mid-2022, CGTs are two of the fastest-growing areas of healthcare. To date, less than two dozen therapies have made it to market, but this numbe...
Source: EyeForPharma - December 8, 2022 Category: Pharmaceuticals Authors: Clare Jackson Source Type: news
Despite Eye-Popping $3.5 Million Price Tag For Gene Therapy Hemgenix, Budget Impact For Most Payers Will Be Relatively Small
On November 22nd, the Food and Drug Administration (FDA) approved the world’s first gene therapy for hemophilia B; Hemgenix (etranacogene dezaparvovec). Hemgenix will have a list price of $3.5 million per use. This sets a new record for the most expensive single-use gene therapy in the U.S. In…#icer #phase3 #fda #factorix #instituteforclinicalandeconomicrevi #cslbehring #hemgenixs #foodanddrugadministration #dutch #etranacogenedezaparvovec (Source: Reuters: Health)
Source: Reuters: Health - December 2, 2022 Category: Consumer Health News Source Type: news
Despite Eye-Popping $3.5 Million Price Tag For Gene Therapy Hemgenix, Budget Impact For Most Payers Will Be Relatively Small
The first gene therapy for hemophilia B, Hemgenix, will have a list price of $3.5 million per use. This sets a new record for the most expensive single-use gene therapy in the U.S. In spite of the very high price tag, the budgetary impact of the product for most payers will be comparatively small. (Source: Forbes.com Healthcare News)
Source: Forbes.com Healthcare News - December 2, 2022 Category: Pharmaceuticals Authors: Joshua Cohen, Contributor Tags: Healthcare /healthcare Innovation /innovation business pharma & Source Type: news
Monthly News Roundup - November 2022
FDA Approves Hemgenix, a Historic, One-Time Gene Therapy for Hemophilia B
In November, the U.S. Food and Drug Administration (FDA) approved CSL Behring’s Hemgenix (etranacogene dezaparvovec-drlb), an adeno-associated virus vector-based gene... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - November 30, 2022 Category: Pharmaceuticals Source Type: news
FDA Approves First Gene Therapy for Adults With Hemophilia B
MONDAY, Nov. 28, 2022 -- The U.S. Food and Drug Administration has approved Hemgenix (etranacogene dezaparvovec) for the treatment of hemophilia B in adults.
Hemgenix, an adeno-associated virus vector-based gene therapy, is administered via... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - November 28, 2022 Category: General Medicine Source Type: news
FDA Approves First Gene Therapy, Hemgenix, for Adults With Hemophilia B
MONDAY, Nov. 28, 2022 -- The U.S. Food and Drug Administration has approved Hemgenix (etranacogene dezaparvovec) for the treatment of hemophilia B in adults.
Hemgenix, an adeno-associated virus vector-based gene therapy, is administered via... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - November 28, 2022 Category: Pharmaceuticals Source Type: news
FDA approves most expensive drug yet at $3.5 million per dose
CHICOPEE, Mass. (WWLP)- The FDA has just approved the most expensive drug on the market to date. The drug, known as Hemgenix, costs $3.5 million per dose and is administered to patients with the rare disorder Hemophilia B. Hemophilia B is the rarer form of the blood clotting disorder resulting…#hemophilia #chicopee #mass #bleeding #disorder #fda #drug #disorderhemophilia #protein #gene (Source: Reuters: Health)
Source: Reuters: Health - November 28, 2022 Category: Consumer Health News Source Type: news
FDA approves most expensive drug yet at $3.5 million per dose
CHICOPEE, Mass. (WWLP) — The FDA has just approved the most expensive drug on the market to date. The drug, known as Hemgenix, costs $3.5 million per dose and is administered to patients with the rare disorder Hemophilia B. Hemophilia B is the rarer form of the blood clotting disorder resulting…#hemophilia #chicopee #mass #bleeding #disorder #fda #drug #disorderhemophilia #protein #gene (Source: Reuters: Health)
Source: Reuters: Health - November 27, 2022 Category: Consumer Health News Source Type: news
FDA approves most expensive drug yet at $3.5 million per dose
CHICOPEE, Mass. (WWLP)- The FDA has just approved the most expensive drug on the market to date. The drug known as Hemgenix costs $3.5 million per dose and is administered to patients with the rare disorder Hemophilia B. Hemophilia B is a blood clotting disorder resulting from insufficient amounts…#hemophilia #chicopee #mass #disorder #genetherapy #disorderhemophilia #drug #fda #protein #hemgenix (Source: Reuters: Health)
Source: Reuters: Health - November 27, 2022 Category: Consumer Health News Source Type: news
FDA Approves World's Most Expensive Drug At $3.5 Million Per Dose To Treat Hemophilia
FDA Approves World's Most Expensive Drug At $3.5 Million Per Dose To Treat Hemophilia Authored by Naveen Anthrapully via The Epoch Times, The U.S. Food and Drug Administration (FDA) has approved CSL Behring’s hemophilia B gene therapy, a one-off infusion treatment with a list price of $3.5…#naveenanthrapully #fdaapproves #cslbehring #hemophilia #hemophiliaauthored #fda #hemgenix #factor #behring #csl (Source: Reuters: Health)
Source: Reuters: Health - November 26, 2022 Category: Consumer Health News Source Type: news
Regulators have approved the world's most expensive medicine that costs $3.5 million per patient
The FDA approved a treatment costing $3.5 million, making it the world's most expensive medicine. - Hemgenix effectively treated several patients with the blood condition Hemophilia B in trials. - An independent study said a fair price for the drug would be about $2.9 million. US regulators have…#hemophilia #expensivemedicine #fda #hemgenix #drug #fdaapproved #hemophiliadrug #approvedhemgenix #treatmentcosting #factor (Source: Reuters: Health)
Source: Reuters: Health - November 25, 2022 Category: Consumer Health News Source Type: news
Regulators have approved the world's most expensive medicine that costs $3.5 million per patient
The FDA approved a treatment costing $3.5 million, making it the world's most expensive medicine. Hemgenix effectively treated several patients with the blood condition Hemophilia B in trials. An independent study said a fair price for the drug would be about $2.9 million. US regulators have…#hemophilia #expensivemedicine #fda #hemgenix #drug #fdaapproved #hemophiliadrug #treatmentcosting #factor #expensive (Source: Reuters: Health)
Source: Reuters: Health - November 25, 2022 Category: Consumer Health News Source Type: news
FDA approves $3.5M Hemgenix gene therapy drug
The FDA approved a $3.5 million gene therapy treatment, Hemgenix, which treats people with Hemophilia B. (Source: Health News - UPI.com)
Source: Health News - UPI.com - November 24, 2022 Category: Consumer Health News Source Type: news
FDA approves $3.5 million treatment for hemophilia, now the most expensive drug in the world
The US Food and Drug Administration on Tuesday approved Hemgenix, a new drug to treat hemophilia. Manufacturer CSL Behring set the price at $3.5 million per treatment, making it the most expensive drug in the world. (Source: CNN.com - Health)
Source: CNN.com - Health - November 24, 2022 Category: Consumer Health News Source Type: news
