[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

Pfizer announces positive top-line results from Phase 3 study of hemophilia B gene therapy candidate
Pfizer Inc. (NYSE: PFE) today announced positive top-line results from the Phase 3 BENEGENE-2 study (NCT03861273) evaluating fidanacogene elaparvovec, an investigational gene therapy, for the treatment of adult males with moderately severe to severe hemophilia B. (Source: World Pharma News)
Source: World Pharma News - December 29, 2022 Category: Pharmaceuticals Tags: Featured Pfizer Business and Industry Source Type: news

Drug Prices Reach New High —in the Millions
The most recent gene therapy approved in the U.S. set a price record: $3.5 million for CSL’s Hemgenix, a treatment for hemophilia B. A new era of expensive drugs has arrived: medicines priced in the millions of dollars a patient. Since August, U.S. or European health regulators have approved four…#bluebirdbioinc #cslshemgenix (Source: Reuters: Health)
Source: Reuters: Health - December 26, 2022 Category: Consumer Health News Source Type: news

Recombinant adeno-associated virus (rAAV) technology pioneered by AskBio's Dr. Jude Samulski is key component of all FDA approved AAV gene therapeutics
Asklepios BioPharmaceutical, Inc. (AskBio), a wholly-owned and independently-operated subsidiary of Bayer AG, today announced that the FDA's approval of a new adeno-associated virus (AAV) gene therapy to treat adults with hemophilia B marks another milestone for the advancement of AAV therapeutics and highlights the important research contributions made by AskBio Co-Founder, President and Chief Scientific Officer, R. Jude Samulski, PhD. (Source: World Pharma News)
Source: World Pharma News - December 20, 2022 Category: Pharmaceuticals Tags: Featured Bayer Business and Industry Source Type: news

CHMP recommends expansion of EU label for Hemlibra to include people with moderate haemophilia A
Thepositive CHMP opinion is based on the results of the HAVEN 6 study, which demonstrated effective bleed control and afavourable safety profile ofHemlibra in people with moderatehaemophilia A without inhibitors1Given that many people with moderatehaemophilia A may not receive prophylaxis, they may endure a worsened clinical burden with only 15% living a bleed-free life2If approved,Hemlibra, already approved for severehaemophilia A in the EU, will offer an effective and convenient prophylactic treatment option with afavourable safety profile for people with moderatehaemophilia ABasel, 16 December 2022 - Roche (SIX: RO, ROG...
Source: Roche Media News - December 16, 2022 Category: Pharmaceuticals Source Type: news

CHMP recommends expansion of EU label for Hemlibra to include people with moderate haemophilia A
Thepositive CHMP opinion is based on the results of the HAVEN 6 study, which demonstrated effective bleed control and afavourable safety profile ofHemlibra in people with moderatehaemophilia A without inhibitors1Given that many people with moderatehaemophilia A may not receive prophylaxis, they may endure a worsened clinical burden with only 15% living a bleed-free life2If approved,Hemlibra, already approved for severehaemophilia A in the EU, will offer an effective and convenient prophylactic treatment option with afavourable safety profile for people with moderatehaemophilia ABasel, 16 December 2022 - Roche (SIX: RO, ROG...
Source: Roche Investor Update - December 16, 2022 Category: Pharmaceuticals Source Type: news

Gene therapies may cure disease but can we afford them?
CSL’s $3.5mn single-dose treatment for haemophilia sparks debate over how to pay for revolutionary drugs (Source: FT.com - Drugs and Healthcare)
Source: FT.com - Drugs and Healthcare - December 15, 2022 Category: Pharmaceuticals Source Type: news

The basics of blood and associated disorders
This article provides an overview of some of the blood ' s key components, blood cells and their formation and functions, blood groups and some of the problems that can arise from malfunctions. A case study on haemophilia A as a blood disorder is presented to consolidate knowledge (Source: Current Awareness Service for Health (CASH))
Source: Current Awareness Service for Health (CASH) - December 14, 2022 Category: Consumer Health News Source Type: news

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 Media News - December 11, 2022 Category: Pharmaceuticals Source Type: news