FDA expands Roche hemophilia med approval
The drug, Hemlibra, won approval in the U.S. only for hemophilia A patients with factor VIII resistance, or inhibitors last year (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - October 8, 2018 Category: Pharmaceuticals Source Type: news

U.S. FDA Expands Indication for Roche's Bleeding Disorder Drug U.S. FDA Expands Indication for Roche's Bleeding Disorder Drug
Roche said on Thursday it received approval from U.S. regulators for its hemophilia A drug Hemlibra (emicizumab)for use in nearly all patients, as the Swiss drugmaker pushes deeper into diseases beyond cancer to replace revenue from older, patent-expired drugs.FDA Approvals (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - October 5, 2018 Category: Consumer Health News Tags: Hematology-Oncology News Alert Source Type: news

Bayer union chief on Berkeley job cuts: 'It's going to be a long road'
After roughly 100 workers at Bayer AG's Berkeley manufacturing site opted in July to take a severance package — on top of another 100 or so who had volunteered in January to leave the company — the rank-and-file believed they had done their part to help the company reorganize its hemophilia drug business. Late Tuesday afternoon, as Bayer officials met with leaders of the International Longshore and War ehouse Union Local 6, they discovered they were wrong: The company laid out a plan to cut 227… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - October 5, 2018 Category: Biotechnology Authors: Ron Leuty Source Type: news

Bayer union chief on Berkeley job cuts: 'It's going to be a long road'
After roughly 100 workers at Bayer AG's Berkeley manufacturing site opted in July to take a severance package — on top of another 100 or so who had volunteered in January to leave the company — the rank-and-file believed they had done their part to help the company reorganize its hemophilia drug business. Late Tuesday afternoon, as Bayer officials met with leaders of the International Longshore and War ehouse Union Local 6, they discovered they were wrong: The company laid out a plan to cut 227… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - October 5, 2018 Category: Pharmaceuticals Authors: Ron Leuty Source Type: news

FDA Approves Genentech ’s Hemlibra (emicizumab-kxwh) for Hemophilia A Without Factor VIII Inhibitors
South San Francisco, CA -- October 4, 2018 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Hemlibra ® (emicizumab-kxwh) for routine prophylaxis to... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 4, 2018 Category: Drugs & Pharmacology Source Type: news

U.S. FDA expands approval of Roche hemophilia drug
Roche on Thursday said U.S. regulators approved expanded use of its hemophilia A drug Hemlibra to include nearly all patients, as the Swiss drugmaker increases its focus on diseases beyond cancer to help replace revenue from older products that have lost patent protection. (Source: Reuters: Health)
Source: Reuters: Health - October 4, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

FDA expands approval of Roche's bleeding disorder drug
Roche said on Thursday U.S. regulators approved its hemophilia A drug Hemlibra, expanding its use in nearly all patients, as the Swiss drugmaker pushes deeper into diseases beyond cancer to replace revenue from older, patent-expired drugs. (Source: Reuters: Health)
Source: Reuters: Health - October 4, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

FDA approves Roche ’s Hemlibra for haemophilia A without factor VIII inhibitors
Roche announced today that the US Food and Drug Administration (FDA) has approved Hemlibra ® (emicizumab-kxwh) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children, ages newborn and older, with haemophilia A without factor VIII inhibitors. (Source: Roche Media News)
Source: Roche Media News - October 4, 2018 Category: Pharmaceuticals Source Type: news

FDA approves Roche ’s Hemlibra for haemophilia A without factor VIII inhibitors
Roche announced today that the US Food and Drug Administration (FDA) has approved Hemlibra ® (emicizumab-kxwh) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children, ages newborn and older, with haemophilia A without factor VIII inhibitors. (Source: Roche Investor Update)
Source: Roche Investor Update - October 4, 2018 Category: Pharmaceuticals Source Type: news

With Hemlibra, Roche seeks to break into tight hemophilia circle
Swiss drugmaker Roche is breaking into hemophilia A treatment, a $10 billion global market dominated by rivals who have cultivated close ties to sufferers of the genetic bleeding disorder. (Source: Reuters: Health)
Source: Reuters: Health - October 3, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

EU Panel Backs Damoctocog Alfa Pegol for Hemophilia A EU Panel Backs Damoctocog Alfa Pegol for Hemophilia A
The EMA's CHMP recommended damoctocog alfa pegol (Jivi, Bayer AG) for the treatment and prophylaxis of bleeding in patients aged 12 years and older who have been previously treated for hemophilia A.International Approvals (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - September 24, 2018 Category: Consumer Health News Tags: Hematology-Oncology News Alert Source Type: news

21.09.18: Not intended for U.S. and UK Media
Bayer receives positive CHMP opinion for its hemophilia A treatment BAY94-9027The safety and efficacy profile of BAY94-9027 has been demonstrated in more than five years of clinical studies / Prophylaxis with BAY94-9027 enables sustained factor VIII concentrations in the blood over timemehr ... (Source: Bayer IR Newsfeed: Events)
Source: Bayer IR Newsfeed: Events - September 21, 2018 Category: Pharmaceuticals Source Type: news

Bayer receives positive CHMP opinion for its hemophilia A treatment BAY94-9027 (for specialized target groups only)
The safety and efficacy profile of BAY94-9027 has been demonstrated in more than five years of clinical studies / Prophylaxis with BAY94-9027 enables sustained factor VIII concentrations in the blood over time (Source: Bayer Company News)
Source: Bayer Company News - September 21, 2018 Category: Pharmaceuticals Source Type: news

Bayer hemophilia treatment wins thumbs-up from EU panel
Bayer AG's long-acting treatment for hemophilia A has won a recommendation from a European Medicines Agency (EMA) panel for the treatment of the rare genetic disorder in which blood does not clot easily. (Source: Reuters: Health)
Source: Reuters: Health - September 21, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

Bayer & #8217;s Jivi ® approved in Japan for hemophilia A (for specialized target groups only)
(Source: Bayer Company News)
Source: Bayer Company News - September 21, 2018 Category: Pharmaceuticals Source Type: news

21.09.18: Not intended for U.S. and UK Media
Bayer's Jivi® approved in Japan for hemophilia Amehr ... (Source: Bayer IR Newsfeed: Events)
Source: Bayer IR Newsfeed: Events - September 20, 2018 Category: Pharmaceuticals Source Type: news

Patent mining indicates promising routes for research
(Funda ç ã o de Amparo à Pesquisa do Estado de S ã o Paulo) Methodology developed by Brazilian scientists uses big data tools, has been validated in an analysis of studies on hemophilia, and can also be used to search for partnerships and technology transfer opportunities. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - August 31, 2018 Category: International Medicine & Public Health Source Type: news

Bayer wins FDA ok for hemophilia drug
Bayer AG has received U.S. FDA approval for a Factor VIII hemophilia drug, called Jivi. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - August 31, 2018 Category: Pharmaceuticals Source Type: news

FDA Clears New Hemophilia A Drug With Flexible Dosing FDA Clears New Hemophilia A Drug With Flexible Dosing
Jivi (antihemophilic factor [recombinant] PEGylated-aucl) is for routine prophylactic treatment, on-demand treatment, and perioperative management of bleeding in adults and in adolescents 12 and older.FDA Approvals (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - August 30, 2018 Category: Consumer Health News Tags: Hematology-Oncology News Alert Source Type: news

Bayer Receives FDA Approval for Jivi (antihemophilic factor (recombinant), PEGylated-aucl) for Prophylactic Treatment of Hemophilia A
WHIPPANY, N.J., Aug. 30, 2018 /PRNewswire/ -- Bayer announced today that the U.S. Food and Drug Administration (FDA) has approved Jivi ® (BAY94-9027, antihemophilic factor [recombinant] PEGylated-aucl) for the routine prophylactic treatment of... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 30, 2018 Category: Drugs & Pharmacology Source Type: news

30.08.18: Not intended for U.S. and UK Media
Bayer receives US approval for modern hemophilia A treatment Jivi® with a step-wise prophylaxis dosing regimenJivi's extended half-life allows for twice-weekly initial dosing / May be adjusted to every five days and further individually adjusted to less or more frequent dosingmehr ... (Source: Bayer IR Newsfeed: Events)
Source: Bayer IR Newsfeed: Events - August 30, 2018 Category: Pharmaceuticals Source Type: news

Morning Break: Acne Vax; Jivi OK'd for Hemophilia; Gottlieb, Coffee, and Cancer
(MedPage Today) -- Health news and commentary from around the Web gathered by the MedPage Today staff (Source: MedPage Today OB/GYN)
Source: MedPage Today OB/GYN - August 30, 2018 Category: OBGYN Source Type: news

Bayer's hemophilia A treatment gets U.S. FDA approval
The U.S. Food and Drug Administration on Thursday approved Bayer AG's long-acting treatment for hemophilia A, a rare genetic disorder in which blood does not clot easily, the company said in a statement. (Source: Reuters: Health)
Source: Reuters: Health - August 30, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

Bayer's hemophilia A drug gets FDA approval
The U.S. Food and Drug Administration on Thursday approved Bayer AG's drug for the treatment of hemophilia A, a rare genetic disorder in which the blood does not clot normally, the company said in a statement. (Source: Reuters: Health)
Source: Reuters: Health - August 30, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

Bayer receives US approval for modern hemophilia A treatment Jivi ® with a step-wise prophylaxis dosing regimen (for specialized target groups only)
Jivi’s extended half-life allows for twice-weekly initial dosing / May be adjusted to every five days and further individually adjusted to less or more frequent dosing (Source: Bayer Company News)
Source: Bayer Company News - August 30, 2018 Category: Pharmaceuticals Source Type: news

Positive phase III results for Roche ’s Hemlibra for haemophilia A without factor VIII inhibitors published in New England Journal of Medicine
Roche today announced that pivotal data from the phase III HAVEN 3 study, which evaluated Hemlibra ® (emicizumab) prophylaxis administered every week or every two weeks in adults and adolescents aged 12 years or older with haemophilia A without factor VIII inhibitors, were published in the 30 August 2018 issue of the New England Journal of Medicine (NEJM). (Source: Roche Media News)
Source: Roche Media News - August 30, 2018 Category: Pharmaceuticals Source Type: news

Positive phase III results for Roche ’s Hemlibra for haemophilia A without factor VIII inhibitors published in New England Journal of Medicine
Roche today announced that pivotal data from the phase III HAVEN 3 study, which evaluated Hemlibra ® (emicizumab) prophylaxis administered every week or every two weeks in adults and adolescents aged 12 years or older with haemophilia A without factor VIII inhibitors, were published in the 30 August 2018 issue of the New England Journal of Medicine (NEJM). (Source: Roche Investor Update)
Source: Roche Investor Update - August 30, 2018 Category: Pharmaceuticals Source Type: news

Study by blood doctors a breakthrough for hemophiliacs
(University of the Witwatersrand) The HAVEN 3 study found that a new type of protein, emicizumab (trade name: Hemlibra), can be administered subcutaneously, rather than intravenously, and that it does not cause an immune response which prevents blood from clotting. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - August 30, 2018 Category: International Medicine & Public Health Source Type: news

Emicizumab Prophylaxis Cuts Bleeding in Hemophilia A
WEDNESDAY, Aug. 29, 2018 -- For patients with hemophilia A without factor VIII inhibitors, emicizumab prophylaxis leads to a significantly reduced bleeding rate, according to a study published in the Aug. 30 issue of the New England Journal of... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - August 29, 2018 Category: Pharmaceuticals Source Type: news

Morning Break: Monthly HIV Tx Effective; Curing Hemophilia; Elephants and Cancer
(MedPage Today) -- Health news and commentary from around the Web gathered by the MedPage Today staff (Source: MedPage Today Psychiatry)
Source: MedPage Today Psychiatry - August 15, 2018 Category: Psychiatry Source Type: news

They Thought Hemophilia Was a ‘ Lifelong Thing. ’ They May Be Wrong.
Experimental gene therapies have yielded promising results in early trials. But the drugs have left some patients wary, worried that success will not last. (Source: NYT Health)
Source: NYT Health - August 13, 2018 Category: Consumer Health News Authors: GINA KOLATA Tags: Hemophilia Genetics and Heredity Blood Proteins Drugs (Pharmaceuticals) Clinical Trials Biotechnology and Bioengineering Source Type: news

RCSI and Bayer enter research collaboration to improve hemophilia treatment
(RCSI) RCSI and Bayer have today announced a research collaboration that aims to improve treatments for people with severe hemophilia. The project will explore new treatments that can be tailored to the severity of each individual's condition in order to safely and effectively promote blood clotting in people with hemophilia. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - August 9, 2018 Category: International Medicine & Public Health Source Type: news

Why Spark's stock price is down 30 percent
Despite posting its first-ever profitable quarter, shares of Spark Therapeutics were trading down 30 percent Tuesday morning after the Philadelphia gene therapy company reported two patients had an adverse immune response to its experimental hemophilia A therapy. Spark said the immune response problem was addressed and it is moving forward with late-stage testing of the treatment, known as SPK-8011 that will begin by the end of the year. Hemophilia A is a genetic bleeding disorder caused by missing… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - August 7, 2018 Category: Biotechnology Authors: John George Source Type: news

Shire’s immunology unit shines in Q2 but haemophilia sales stall
(Source: FT.com - Drugs and Healthcare)
Source: FT.com - Drugs and Healthcare - July 31, 2018 Category: Pharmaceuticals Source Type: news

Balance, falls, and exercise: beliefs and experiences in people with hemophilia: a qualitative study - Flaherty LM, Schoeppe J, Kruse-Jarres R, Konkle BA.
BACKGROUND: Prior research has established that falls are commonplace in adults with hemophilia, and advises that physical therapy and exercise are successful in fall prevention. Recognizing obstacles and catalysts to physical therapy and exercise in peopl... (Source: SafetyLit)
Source: SafetyLit - July 28, 2018 Category: International Medicine & Public Health Tags: Ergonomics, Human Factors, Anthropometrics, Physiology Source Type: news

Pfizer begins late-stage testing of Spark's hemophilia B gene therapy
Pfizer Inc. said Monday it has started late-stage clinical testing of an experimental gene therapy treatment, originally developed by Spark Therapeutics in Philadelphia, for patients with hemophilia B. The transfer of the gene therapy program to Pfizer from Spark is now complete, the companies said. Under the terms of a product license agreement signed in December 2014, Pfizer has now assumed sole responsibility for all subsequent pivotal studies, all regulatory activities, manufacturing and gl obal… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - July 16, 2018 Category: American Health Authors: John George Source Type: news

Pfizer begins late-stage testing of Spark's hemophilia B gene therapy
Pfizer Inc. said Monday it has started late-stage clinical testing of an experimental gene therapy treatment, originally developed by Spark Therapeutics in Philadelphia, for patients with hemophilia B. The transfer of the gene therapy program to Pfizer from Spark is now complete, the companies said. Under the terms of a product license agreement signed in December 2014, Pfizer has now assumed sole responsibility for all subsequent pivotal studies, all regulatory activities, manufacturing and gl obal… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - July 16, 2018 Category: Biotechnology Authors: John George Source Type: news

Pfizer initiates pivotal Phase 3 program for investigational hemophilia B gene therapy
Pfizer Inc. (NYSE:PFE) and Spark Therapeutics (NASDAQ:ONCE) announced today that Pfizer initiated a Phase 3 open-label, multi-center, lead-in study (NCT03587116) to evaluate the efficacy and safety of current factor IX prophylaxis replacement therapy in the usual care setting. The factor IX prophylaxis efficacy data obtained in the lead-in study will serve as the within-subject control group for (Source: World Pharma News)
Source: World Pharma News - July 16, 2018 Category: Pharmaceuticals Tags: Featured Pfizer Business and Industry Source Type: news

Haemophilia A/sialorrhoea: Comparator therapies not implemented, added benefit not proven
(Institute for Quality and Efficiency in Health Care) In two early benefit assessments, IQWiG was unable to derive an added benefit from the data presented because current standards of care were not implemented in the studies. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - July 9, 2018 Category: International Medicine & Public Health Source Type: news

Takeda chief seeks to allay £46bn Shire bid concerns
Christophe Weber ‘very comfortable’ with durability of lucrative haemophilia franchise (Source: FT.com - Drugs and Healthcare)
Source: FT.com - Drugs and Healthcare - June 27, 2018 Category: Pharmaceuticals Source Type: news

ASH to collaborate on clinical practice guidelines on von Willebrand Disease
(American Society of Hematology) The American Society of Hematology (ASH) will collaborate with the International Society on Thrombosis and Haemostasis (ISTH), National Hemophilia Foundation (NHF), World Federation of Hemophilia (WFH), and the University of Kansas Medical Center to develop clinical practice guidelines on the diagnosis and management of von Willebrand Disease (VWD).   (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - June 21, 2018 Category: International Medicine & Public Health Source Type: news

FDA grants Priority Review to Roche ’s Hemlibra for people with haemophilia A without factor VIII inhibitors
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the US Food and Drug Administration (FDA) has accepted the company's supplemental Biologics License Application (sBLA) and granted Priority Review for Hemlibra® (emicizumab-kxwh) for adults and children with haemophilia A without factor VIII inhibitors. The sBLA is based on data from the phase III HAVEN 3 study. (Source: World Pharma News)
Source: World Pharma News - June 7, 2018 Category: Pharmaceuticals Tags: Featured Roche Business and Industry Source Type: news

FDA grants Roche priority review for haemophilia treatment
The company's Hemlibra has nabbed a fast-track review for people with a certain form of haemophilia from by the U.S. Food and Drug Administration. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - June 5, 2018 Category: Pharmaceuticals Source Type: news

Roche gets priority review from FDA for Hemlibra
ZURICH (Reuters) - Roche has been given fast-track review by the U.S. Food and Drug Administration (FDA) for its Hemlibra treatment for people with a form of haemophilia, the Swiss drugmaker said on Tuesday. (Source: Reuters: Health)
Source: Reuters: Health - June 5, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

FDA grants Priority Review to Roche ’s Hemlibra for people with haemophilia A without factor VIII inhibitors
Roche today announced that the US Food and Drug Administration (FDA) has accepted the company ’s supplemental Biologics License Application (sBLA) and granted Priority Review for Hemlibra® (emicizumab-kxwh) for adults and children with haemophilia A without factor VIII inhibitors. (Source: Roche Media News)
Source: Roche Media News - June 5, 2018 Category: Pharmaceuticals Source Type: news

FDA grants Priority Review to Roche ’s Hemlibra for people with haemophilia A without factor VIII inhibitors
Roche today announced that the US Food and Drug Administration (FDA) has accepted the company ’s supplemental Biologics License Application (sBLA) and granted Priority Review for Hemlibra® (emicizumab-kxwh) for adults and children with haemophilia A without factor VIII inhibitors. (Source: Roche Investor Update)
Source: Roche Investor Update - June 5, 2018 Category: Pharmaceuticals Source Type: news

Spark, Pfizer report progress on gene therapy for hemophilia
Spark Therapeutcis and Pfizer have cleared a key hurdle in their effort to develop a gene therapy treatment for patient with hemophilia B. On Tuesday, the companies said all 15 hemophilia B patients in Philadelphia-based Spark’s ongoing phase-I/II clinical trial of its investigational gene therapy SPK-9001 had discontinued routine infusions of factor IX concentrates – and none of the 15 participants experienced serious adverse ev ents. Hemophilia B is a rare, genetic bleeding disorder found… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - May 22, 2018 Category: Biotechnology Authors: John George Source Type: news