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FDA OKs new therapy for some hemophilia patients
U.S. regulators have approved the first new treatment in nearly two decades to prevent internal bleeding in certain patients with hemophilia, an inherited blood-clotting disorder. (Source: ABC News: Health)
Source: ABC News: Health - November 16, 2017 Category: Consumer Health News Tags: Health Source Type: news

FDA Clears First-in-Class Emicizumab for Hemophilia A FDA Clears First-in-Class Emicizumab for Hemophilia A
Hemlibra is a first-in-class bispecific monoclonal antibody that bridges activated factor IX and X to replace the missing factor VIII.FDA Approvals (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - November 16, 2017 Category: Consumer Health News Tags: Hematology-Oncology News Alert Source Type: news

FDA Approves Hemlibra (emicizumab-kxwh) for Hemophilia A with Inhibitors
November 16, 2017 -- The U.S. Food and Drug Administration today approved Hemlibra (emicizumab-kxwh) to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A who have developed antibodies called... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 16, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Turns to Emerging Tech for Opioid Crisis
It will take more than medication alone to win the battle against opioid addiction, and now U.S. clinicians finally have a device-based therapy to help reduce the symptoms of opioid withdrawal. FDA granted a new indication to Innovative Health Solutions for its NSS-2 Bridge nerve stimulator. The new indication was reviewed under FDA's de novo pathway. “There are three approved drugs for helping treat opioid addiction. While we continue to pursue better medicines for the treatment of opioid use disorder, we also need to look to devices that can assist in this therapy,” said FDA Commissioner Scott Gottlieb, MD. G...
Source: MDDI - November 16, 2017 Category: Medical Devices Authors: Amanda Pedersen Tags: Regulatory and Compliance Source Type: news

Roche hemophilia drug wins FDA nod, with a warning
ZURICH (Reuters) - The U.S. Food and Drug Administration on Thursday approved Roche's Hemlibra, a new medicine for hemophilia A that the Swiss drugmaker is counting on to help to offset eroding sales of older medicines going off patent. (Source: Reuters: Health)
Source: Reuters: Health - November 16, 2017 Category: Consumer Health News Tags: healthNews Source Type: news

New Hemophilia Treatment Stems Bleeding Episodes
Source: HealthDay Related MedlinePlus Pages: Hemophilia (Source: MedlinePlus Health News)
Source: MedlinePlus Health News - November 16, 2017 Category: Consumer Health News Source Type: news

FDA approves new treatment to prevent bleeding in certain patients with hemophilia A
FDA approves new treatment to prevent or reduce frequency of bleeding episodes in patients with hemophilia A who have Factor VIII inhibitors. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 16, 2017 Category: American Health Source Type: news

FDA approves Roche hemophilia drug Hemlibra
ZURICH (Reuters) - The U.S. Food and Drug Administration on Thursday approved Roche's Hemlibra for hemophilia suffers, a new medicine the Swiss drugmaker is counting on to help it offset eroding sales of its older medicines that have begun going off patent. (Source: Reuters: Health)
Source: Reuters: Health - November 16, 2017 Category: Consumer Health News Tags: healthNews Source Type: news

FDA approves Roche ’s Hemlibra (emicizumab-kxwh) for haemophilia A with inhibitors
Roche today announced 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 with haemophilia A with factor VIII inhibitors. (Source: Roche Media News)
Source: Roche Media News - November 16, 2017 Category: Pharmaceuticals Source Type: news

FDA approves Roche ’s Hemlibra (emicizumab-kxwh) for haemophilia A with inhibitors
Roche today announced 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 with haemophilia A with factor VIII inhibitors. (Source: Roche Investor Update)
Source: Roche Investor Update - November 16, 2017 Category: Pharmaceuticals Source Type: news

FDA Approves New Treatment to Prevent Bleeding in Certain Patients with Hemophilia A
SILVER SPRING, Md., Nov. 16, 2017 -- (Healthcare Sales & Marketing Network) -- The U.S. Food and Drug Administration today approved Hemlibra (emicizumab-kxwh) to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hem... Biopharmaceuticals, FDA Genentech, Hemlibra, emicizumab, hemophilia (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - November 16, 2017 Category: Pharmaceuticals Source Type: news

New Hemophilia A Treatment, Hemlibra (Emicizumab-kxwh), Stems Bleeding Episodes
THURSDAY, Nov. 16, 2017 -- Hemlibra (emicizumab-kxwh) has been approved by the U.S. Food and Drug Administration to prevent or reduce the number of bleeding episodes among certain people with hemophilia A. The injected drug was approved for... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - November 16, 2017 Category: General Medicine Source Type: news

In a first, scientists edit genes inside a man ’ s body to try to cure a disease. What ’ s next?
Scientists have attempted to cure a patient with a rare genetic disorder by rewriting the DNA inside his body, in a first-of-its-kind therapy they hope could one day be applied to numerous other conditions including hemophilia and sickle cell disease. The procedure, which took place on Monday at the University of California at San Francisco's Benioff Children's Hospital in Oakland, Calif., involved sending what the […]Related:American Heart Association president has heart attackFDA warns of ‘deadly risks’ of the herb kratom, citing 36 deathsHow we got the...
Source: Washington Post: To Your Health - November 16, 2017 Category: Consumer Health News Source Type: news

Scientists Have Made Their First Attempt at Gene Editing Inside a Human Patient
(OAKLAND, Calif.) — Scientists for the first time have tried editing a gene inside the body in a bold attempt to permanently change a person’s DNA to try to cure a disease. The experiment was done Monday in California on 44-year-old Brian Madeux. Through an IV, he received billions of copies of a corrective gene and a genetic tool to cut his DNA in a precise spot. “It’s kind of humbling” to be the first to test this, said Madeux, who has a metabolic disease called Hunter syndrome. “I’m willing to take that risk. Hopefully it will help me and other people.” Signs of whether i...
Source: TIME.com: Top Science and Health Stories - November 15, 2017 Category: Consumer Health News Authors: Marilynn Marchione / AP Tags: Uncategorized gene editing Genetics health Innovation onetime overnight Research Source Type: news

CHMP Backs Rurioctocog alfa pegol (Adynovi) for Hemophilia A CHMP Backs Rurioctocog alfa pegol (Adynovi) for Hemophilia A
The European Medicines Agency committee recommended approval of rurioctocog alfa pegol for the treatment and prophylaxis of bleeding in patients aged 12 years and older with hemophilia A.International Approvals (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - November 10, 2017 Category: Consumer Health News Tags: Hematology-Oncology News Alert Source Type: news

Pfizer, hemophilia society launch disease-awareness app game for boys in Qatar
Pfizer  and the Friends of Haemophilia Society have launched an app game specifically designed to help boys aged four years and older learn about and manage their hemophilia.  (Source: mobihealthnews)
Source: mobihealthnews - November 9, 2017 Category: Information Technology Source Type: news

Spark Therapeutics and Pfizer amend license agreement for investigational SPK-9001 in hemophilia B
Spark Therapeutics (NASDAQ:ONCE) and Pfizer Inc. (NYSE:PFE) have entered into an amendment to their license agreement for SPK-9001, an investigational gene therapy for hemophilia B. Spark Therapeutics will enroll up to five additional participants in the current Phase 1/2 clinical trial who will receive SPK-9001 manufactured using an enhanced process to test its comparability to the SPK-9001 received by the first 10 participants enrolled in the ongoing trial. (Source: World Pharma News)
Source: World Pharma News - November 8, 2017 Category: Pharmaceuticals Tags: Featured Pfizer Business and Industry Source Type: news

Spark, Pfizer amend agreement for experimental hemophilia gene therapy
Spark Therapeutics and Pfizer Inc. have amended their license agreement for an experimental gene therapy for hemophilia B — which could result in additional payments of up to $25 million for Spark. Under the amended agreement, Spark Therapeutics, a Philadelphia gene therapy company spun out of Children’s Hospital of Philadelphia, will enroll up to five additional participants in the current phase-I/II clinical tri al testing the treatment known as SPK-9001. The new participants will receive… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - November 7, 2017 Category: American Health Authors: John George Source Type: news

Parenting And Living With Hemophilia Education Event From TwelveStone...
Post-Acute Care Provider Launches Chronic Disease Educational Series(PRWeb October 31, 2017)Read the full story at http://www.prweb.com/releases/2017/11/prweb14859060.htm (Source: PRWeb: Medical Pharmaceuticals)
Source: PRWeb: Medical Pharmaceuticals - October 31, 2017 Category: Pharmaceuticals Source Type: news

FDA Grants Breakthrough Therapy Designation for BioMarin's Valoctocogene Roxaparvovec (formerly BMN 270), an Investigational Gene Therapy for Hemophilia A
SAN RAFAEL, Calif., Oct. 26, 2017 -- (Healthcare Sales & Marketing Network) -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) announced today that the U.S. Food and Drug Administration (FDA) granted valoctocogene roxaparvovec (formerly BMN 270) Breakthrough ... Biopharmaceuticals, FDA BioMarin Pharmaceutical, Valoctocogene, Roxaparvovec, Hemophilia (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - October 26, 2017 Category: Pharmaceuticals Source Type: news

Sobi: Alprolix(R) Approved in the Kingdom of Saudi Arabia for the Treatment of Haemophilia B
STOCKHOLM, Oct. 25, 2017 -- (Healthcare Sales & Marketing Network) -- Swedish Orphan Biovitrum AB (publ) (Sobi™) today announces that the Saudi Food & Drug Authority (SFDA) in the Kingdom of Saudi Arabia has approved Alprolix® (eftrenonacog alfa), for... Biopharmaceuticals, Regulatory Swedish Orphan Biovitrum, Sobi , Alprolix, eftrenonacog alfa, haemophilia B (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - October 25, 2017 Category: Pharmaceuticals Source Type: news

Bayer submits its extended half-life hemophilia A compound for marketing authorization in Japan (for specialized target groups only)
Pivotal studies with BAY94-9027 showed that bleed protection was achieved with extended dosing intervals (Source: Bayer Company News)
Source: Bayer Company News - October 17, 2017 Category: Pharmaceuticals Source Type: news

Bioverativ and Bicycle Therapeutics to develop new haemophilia and sickle cell disease treatments
US biotechnology company Bioverativ has entered a new research collaboration with UK-based Bicycle Therapeutics to discover, develop and commercialise new therapies for haemophilia and sickle cell disease. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - September 7, 2017 Category: Pharmaceuticals Source Type: news

​Alnylam halts hemophilia drug trial due to patient death, renewing worries over safety
Alnylam Pharmaceuticals, one of the state ’s largest and most valuable biotechs, has temporarily halted a mid-stage trial of one of its experimental drugs for hemophilia after one patient died, shaving $1 billion from its market cap. Cambridge-based Alnylam (Nasdaq: ALNY) said Thursday that it had suspended the Phase 2 trial of fitusiran after a patient died of brain swelling triggered by a blood clot. The company said the death was “possibly related” to the treatment, and that it hopes to… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - September 7, 2017 Category: American Health Authors: Max Stendahl Source Type: news

Bayer submits marketing authorization application for BAY94-9027 for the treatment of Hemophilia A in the EU (for specialized target groups only)
Pivotal studies with BAY94-9027 showed that bleed protection was achieved with extended dosing intervals (Source: Bayer Company News)
Source: Bayer Company News - September 7, 2017 Category: Pharmaceuticals Source Type: news

Blood Disorders
Centers for Disease Control and Prevention. 07/19/2017 This Web page provides links to information, tips, sources, and treatment centers for several blood disorders: Thalassemia, Hemophilia, Sickle Cell Disease, and Thrombosis and Hemostasis. (Text) (Source: Disaster Lit: Resource Guide for Disaster Medicine and Public Health)
Source: Disaster Lit: Resource Guide for Disaster Medicine and Public Health - September 5, 2017 Category: International Medicine & Public Health Authors: The U.S. National Library of Medicine Source Type: news

PRAC Confirms No Difference in Risk Between Hemophilia A Drugs PRAC Confirms No Difference in Risk Between Hemophilia A Drugs
The EMA's Pharmacovigilance Risk Assessment Committee has confirmed its earlier conclusion that factor VIII medications do not differ in their risk for inhibition.News Alerts (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - September 1, 2017 Category: Consumer Health News Tags: Hematology-Oncology News Alert Source Type: news

Prophylaxis Linked to Improved Function, HRQoL in Hemophilia
Improved function, QoL, activity, pain but not joint structure in adults with hemophilia with joint disease (Source: The Doctors Lounge - Oncology)
Source: The Doctors Lounge - Oncology - August 31, 2017 Category: Cancer & Oncology Tags: Internal Medicine, Oncology, Orthopedics, Pediatrics, Pharmacy, Journal, Source Type: news

Bayer submits Biologics License Application in the U.S. for BAY94-9027 – a long-acting factor VIII for the treatment of Hemophilia A (for specialized target groups only)
Pivotal studies with BAY94-9027 showed that bleed protection was achieved with extended dosing intervals (Source: Bayer Company News)
Source: Bayer Company News - August 31, 2017 Category: Pharmaceuticals Source Type: news

Sangamo and Pfizer begin dosing in Phase I/II trial for haemophilia A
Sangamo Therapeutics and Pfizer have begun dosing patients in a Phase I/II clinical trial (Alta) of investigational gene therapy SB-525 to treat patients with a rare genetic blood disease known as haemophilia A. (Source: Drug Development Technology)
Source: Drug Development Technology - August 28, 2017 Category: Pharmaceuticals Source Type: news

Minecraft-based Pfizer app uses gamification to help kids with hemophilia
Pfizer this week launched a modification of the popular sandbox game Minecraft, offering children with hemophilia a new way to learn about staying safe and prepared and maintaining their treatment plans.   (Source: mobihealthnews)
Source: mobihealthnews - August 25, 2017 Category: Information Technology Source Type: news

FDA accepts Roche ’s BLA for emicizumab to treat Haemophilia A
The US Food and Drug Administration (FDA) has accepted Roche ’s biologics licence application (BLA) and granted a priority review for emicizumab prophylaxis (preventative) to treat patients with Haemophilia A with factor VIII inhibitors. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - August 24, 2017 Category: Pharmaceuticals Source Type: news

To End HIV Stigma, We Must Fight a Long History
August 24, 2017Health workers can play a key role in ending discrimination against people who live with HIV.“Because of the lack of education on AIDS, discrimination, fear, panic, and lies surrounded me.” —Ryan WhiteRyan White was diagnosed with AIDS at the age of 13 in Indiana in 1984, following a blood transfusion to treat hemophilia A, his inherited blood disease.It was a time when most people knew little about HIV and AIDS. Ryan and his family experienced overwhelming and ignorant stigma and discrimination. Some feared he might transmit HIV through casual contact, or made stereotyped assumptions about...
Source: IntraHealth International - August 24, 2017 Category: International Medicine & Public Health Authors: mnathe Source Type: news

Roche says FDA grants priority review to hemophilia drug emicizumab
ZURICH (Reuters) - Swiss pharma group Roche said the U.S. Food and Drug Administration (FDA) granted priority review to its emicizumab for hemophilia A with inhibitors. (Source: Reuters: Health)
Source: Reuters: Health - August 24, 2017 Category: Consumer Health News Tags: healthNews Source Type: news

FDA grants Priority Review to Roche ’s emicizumab for haemophilia A with inhibitors
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has accepted the company ’s Biologics License Application (BLA) and granted Priority Review for emicizumab prophylaxis (preventative) as a once-weekly subcutaneous treatment for adults, adolescents and children with haemophilia A with factor VIII inhibitors. (Source: Roche Media News)
Source: Roche Media News - August 24, 2017 Category: Pharmaceuticals Source Type: news

FDA grants Priority Review to Roche ’s emicizumab for haemophilia A with inhibitors
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has accepted the company ’s Biologics License Application (BLA) and granted Priority Review for emicizumab prophylaxis (preventative) as a once-weekly subcutaneous treatment for adults, adolescents and children with haemophilia A with factor VIII inhibitors. (Source: Roche Investor Update)
Source: Roche Investor Update - August 24, 2017 Category: Pharmaceuticals Source Type: news

Children's Healthcare of Atlanta's Aflac Cancer and Blood Disorders Center awarded $6 million grant
The Aflac Cancer and Blood Disorders Center at Children's cares for more than 450 newly diagnosed children a year and follows 3,200 patients with sickle cell disease, hemophilia and other blood disorders. (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - August 11, 2017 Category: American Health Authors: Ellie Hensley Source Type: news

Gene Therapy Corrects Factor VIII Levels in Hemophilia A Gene Therapy Corrects Factor VIII Levels in Hemophilia A
Transferring a form of the gene for factor VIII using a viral vector corrected plasma levels of the factor and stopped bleeding episodes for patients with severe hemophilia A, a study shows.Medscape Medical News (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - August 7, 2017 Category: Consumer Health News Tags: Cardiology News Source Type: news

Lawsuit: New TennCare rates endanger hemophilia patients
A Tennessee lawsuit claims the state is breaking federal law and putting people with bleeding disorders like hemophilia in great danger by reimbursing less for prescription blood-clotting drugs through its Medicaid program (Source: ABC News: Health)
Source: ABC News: Health - July 18, 2017 Category: Consumer Health News Tags: Health Source Type: news

Novel Agent Reduces Antithrombin Levels to Treat Hemophilia Novel Agent Reduces Antithrombin Levels to Treat Hemophilia
Fitusiran, an RNA interference agent, safely reduces antithrombin levels to allow clot formation to treat hemophilia A or B in patients with or without inhibitors, a study shows.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - July 14, 2017 Category: Consumer Health News Tags: Cardiology News Source Type: news

Roche and Chugai Pharma report positive Phase III results of haemophilia A drug
Roche and UK-based Chugai Pharmaceutical have reported positive data from the Phase III HAVEN 1 clinical trial of emicizumab in patients suffering from haemophilia A. (Source: Drug Development Technology)
Source: Drug Development Technology - July 11, 2017 Category: Pharmaceuticals Source Type: news

Emicizumab Replaces Factor VIII Function in Hemophilia A Emicizumab Replaces Factor VIII Function in Hemophilia A
The bispecific monoclonal antibody emicizumab replaced the function of factor VIII in people with hemophilia A and overcame neutralizing antibodies against factor VIII, results of the HAVEN 1 trial show.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - July 11, 2017 Category: Consumer Health News Tags: Cardiology News Source Type: news

UK to launch inquiry into tainted blood product that killed 2,400 patients
UK officials will launch an inquiry into why thousands of patients, many of them hemophiliacs, became infected with HIV and hepatitis C from blood products used more than 30 years ago. (Source: CNN.com - Health)
Source: CNN.com - Health - July 11, 2017 Category: Consumer Health News Source Type: news

Roche, Shire Court Fight Underscores High Stakes in Hemophilia Roche, Shire Court Fight Underscores High Stakes in Hemophilia
Roche's bid to muscle in on Shire's share of the $11 billion hemophilia drug market took a new, contentious turn this weekend when the British drugmaker won a court injunction against how the Swiss drugmaker talks about its new medicine.Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - July 11, 2017 Category: Consumer Health News Tags: Internal Medicine News Source Type: news

Celebrating 10 years of success for Infusion
As the business took off, more space was needed, and the company moved in 2009 to “real” office space just up the road in Haddam, CT, across the street from the Connecticut River, eventually employing a staff of 10 that year. A year later, in 2010, Infusion had doubled in size and became part of the UDG/Ashfield family. Infusion continued to grow at a steady pace into new therapeutic areas with more clients and employees, and in October 2016, Infusion left its country setting and moved into larger corporate offices in downtown Middletown, CT. Our staff now comprises 45 people and includes account executives, me...
Source: Ashfield Healthcare News - July 11, 2017 Category: Pharmaceuticals Authors: Sarah Edwards Tags: Ashfield Source Type: news

Alnylam and Sanofi commence Phase III programme for haemophilia drug
Alnylam Pharmaceuticals and Sanofi Genzyme have commenced the Phase III clinical programme (ATLAS) of RNAi therapeutic fitusiran in patients with haemophilia A or B, with or without inhibitors. (Source: Drug Development Technology)
Source: Drug Development Technology - July 10, 2017 Category: Pharmaceuticals Source Type: news

Novel Hemophilia A Treatments Advance
(MedPage Today) -- Monoclonal antibody, RNAi tx show promise in trials (Source: MedPage Today Pediatrics)
Source: MedPage Today Pediatrics - July 10, 2017 Category: Pediatrics Source Type: news

Disruptive technology reduces bleeding in hemophilia by 87 percent
Researchers at Children's Hospital Los Angeles developed a new therapy called emicizumab that decreases bleeding episodes by nearly 90 percent. (Source: Health News - UPI.com)
Source: Health News - UPI.com - July 10, 2017 Category: Consumer Health News Source Type: news

Shire, Roche slug it out in billion-dollar haemophilia drug battle
ZURICH (Reuters) - Swiss drugmaker Roche's bid to take a chunk of the $11 billion haemophilia drug market dominated by Shire took another blow with the Irish company winning a preliminary injunction over its Swiss rival's medication. (Source: Reuters: Health)
Source: Reuters: Health - July 10, 2017 Category: Consumer Health News Tags: healthNews Source Type: news