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WFH & NHF Issue Joint Statement Regarding Two Deaths Reported in Orphan Disease Gene Therapy Clinical Trial

June 30, 2020

  The following is information from the World Federation of Hemophilia. A joint World Federation of Hemophilia (WFH) and National Hemophilia Foundation (NHF) statement* is issued on two deaths reported in orphan disease gene therapy clinical trial (*on behalf of the WFH Coagulation Product Safety, Supply, and Access Committee): We have become aware of two […]

Racing Against Time, Medical Researchers, Life Science Companies and COVID-19 Survivors Launch National Campaign to Drive Blood Plasma Donation

June 18, 2020

The following is an excerpt from a press release from CSL Behring. Read the press release in its entirety here. 鈥淭he Fight Is In Us鈥 Campaign Seeks to Mobilize COVID-19 Survivors to Accelerate the Development of Potentially Lifesaving Therapies A coalition of world-leading medical and research institutions, blood centers, life science companies, technology companies, philanthropic […]

Coronavirus (COVID-19) 鈥 What HFA is Doing

April 30, 2020

Click Below to Translate Page to Spanish. STATEMENTS AND UPDATES During this time of rapidly-changing news surrounding the COVID-19 outbreak, HFA聽will continue to publish updates and information about COVID-19 and its effects on the bleeding disorders community. MEDICAL NEWS INDUSTRY NEWS & PRODUCT AVAILABILITY NATIONAL, GOVERNMENT AND LOCAL NEWS RESOURCES FAQ: BLEEDING DISORDERS AND COVID-19 […]

Voluntary Recall Notice: Saline Flush Syringes Recalled

April 21, 2020

The following is information from BD. BD is conducting a voluntary medical device recall for multiple lots of the BD PosiFlush™ SF (Sterile Field) Saline Flush Syringe 10mL identified in the Table above and Attachment A. This product has been confirmed to exhibit holes in the packaging, which impacts package integrity and potentially compromises a […]

NVHR Applauds Latest Guidance from CDC Recommending Hepatitis C Screening for U.S. Adults

April 10, 2020

The following is a press release from the National Viral Hepatitis Roundtable. The latest guidance from the CDC is an important step in the fight for hepatitis C elimination, but increased federal funding for viral hepatitis still needed. The National Viral Hepatitis Roundtable, a national coalition working to eliminate viral hepatitis, today applauded the U.S. […]

Global Plasma Leaders Collaborate to Accelerate Development of Potential COVID-19 Hyperimmune Therapy

April 6, 2020

The following is from a press release featuring various industry partners. See the press release here. Partnership brings together world-leading plasma companies to focus on developing and delivering a hyperimmune immunoglobulin in the global fight against COVID-19 Biotest, BPL, LFB, and Octapharma have joined an alliance formed by CSL Behring and Takeda Pharmaceutical Company Limited […]

APLUS Statement on FDA Policy Changes Related to Blood and Plasma Donation

April 2, 2020

Today the FDA released several new guidance documents with permanent and temporary (during the COVID-19 emergency) changes to several policies related to blood and plasma donation.聽 HFA has signed on to a statement with coalition partners from the American Plasma Users Coalition reiterating APLUS鈥檚 longstanding position that complex blood safety policies such as those related […]

Supplemental MASAC Statement Regarding Home Delivery and Refill Under State of Emergency Declaration

March 30, 2020

The following is a statement provided by MASAC,聽the National Hemophilia Foundation’s Medical and Scientific Advisory Council. Patients on home therapy receive regular shipments of clotting factor concentrate (CFC) or non-factor replacement therapy (e.g., emicizumab-kxwh) from their pharmacy providers, often on a monthly basis or as home supplies are depleted. Having an adequate supply of these […]

Diplomat Statement on COVID-19

March 27, 2020

The following is a statement provided by Diplomat Specialty Infusion Group. “Living and working through a global pandemic 鈥 the coronavirus (COVID-19) 鈥 is an event none of us has experienced in our lifetime. As the situation continues to evolve, we want you to know that your Diplomat Specialty Infusion Group team will be here […]

World Federation of Hemophilia Recommendations for Hemophilia Patients

March 23, 2020

The following is information from the World Federation of Hemophilia. From the World Federation of Hemophilia Medical Advisory Board (MAB)* and the WFH Committee on Product Availability, Safety, and Supply (CPSSA)**:聽 For hemophilia patients currently treated with standard or extended recombinant half-life FVIII or FIX concentrates, FEIBA, FVIIa, or emicizumab: No reason to change the […]

BioMatrix Specialty Pharmacy Statement on Specialty Drug Availability

March 19, 2020

The following is a statement provided by BioMatrix. “BioMatrix Specialty Pharmacy is closely monitoring the COVID-19 pandemic. Our organization has initiated proper聽response measures to ensure bleeding disorder patients maintain access to the specialty drugs required to effectively聽manage their condition throughout this emergent situation. BioMatrix is leveraging its national footprint, detailed聽business continuity plans, and extensive assets […]

Pfizer and BioNTech to Co-Develop Potential COVID-19 Vaccine

March 17, 2020

The following is information provided by Pfizer and BioNTech. On March 13, 2020, Pfizer issued a five-point plan calling on the biopharmaceutical industry to join the company in committing to collaboration to combat COVID-19. 聽Pfizer Inc. and BioNTech announced that the companies have agreed to a letter of intent regarding the co-development and distribution (excluding […]

Plasma Protein Therapeutics Association Updated Statement Regarding Coronavirus

March 17, 2020

The following is a statement provided by PPTA.聽 “Hello Stakeholders,聽 As previously noted, I am writing to inform you of an update to PPTA鈥檚 statement regarding coronavirus and the safety of plasma protein therapies. This update provides clarity regarding the safety margins of plasma protein therapies manufactured by PPTA member companies and maintains the main […]

Coronavirus (2019-nCoV) Update #3

March 12, 2020

On March 11, 2020, the World Health Organization announced that it is classing COVID-19 as a pandemic, and repeated its call for countries to take urgent and aggressive action to control the spread of the virus. Also on March 11, 2020, PPTA updated its statement on coronavirus and the safety of plasma protein therapies, noting […]

HFA Temporarily Halts All Staff Travel

March 11, 2020

UPDATE: As of March 27, 2020, HFA will halt travel for HFA staff until April 30, 2020. As the nation continues to respond to an outbreak of coronavirus (COVID-19), Hemophilia Federation of America has made the difficult decision to temporarily halt all travel plans of our staff throughout the month of March.聽 While we had […]

Bayer Statement on Availability of Factor VIII Products Amid 2019-nCoV (Novel Coronavirus)

March 5, 2020

Bayer has issued the following statement regarding the supply and availability of Bayer’s Factor VIII/Hemophilia A products in the wake of the聽2019-nCoV (novel coronavirus) outbreak:

Coronavirus (2019-nCoV) Update #2: MASAC Statement

March 5, 2020

On March 3, 2020, NHF鈥檚 Medical and Scientific Advisory Committee (MASAC) published a letter to the community regarding the evolving coronavirus outbreak. MASAC鈥檚 letter seeks to 鈥減rovide some interim guidance for the bleeding disorders community,鈥 directs people to the CDC website as a reliable source of information, and highlights some information regarding product supply and […]

Genentech Statement on Hemlibra Supply Amid 2019-nCoV (Novel Coronavirus)

February 28, 2020

Genentech has issued the following statement regarding the supply and availability of Hemlibra in the wake of the聽2019-nCoV (novel coronavirus) outbreak: Please note that HFA does not recommend, endorse or make any representation about the efficacy, appropriateness or suitability of any specific products, treatments, or opinions. If you have any questions or concerns about your […]

Takeda Issues Pharmacy Level Recall of VONVENDI

February 26, 2020

Late yesterday (February 25, 2020), Takeda announced a pharmacy-level recall of two lots of VONVENDI von Willebrand factor (recombinant) 1,300 IU vials. Takeda鈥檚 announcement stated that 鈥淎lthough both lots met all acceptance criteria, Takeda is issuing a voluntary recall out of an abundance of caution. Takeda believes that despite this voluntary recall that [sic] there […]

How FDA is Putting the Patient Voice at the Forefront of Gene Therapy Clinical Trials for Hemophilia

February 12, 2020

By Najat Bouchkouj, M.D., Bindu George, M.D., and Karen Jackler, MPH A person with hemophilia can experience aspects of their disease that even the most qualified doctors and scientists can鈥檛 fully appreciate. This is why the Center for Biologics Evaluation and Research at the Food and Drug Administration is working to hear and understand the […]

Coronavirus (2019-nCoV) Outbreak Update

February 6, 2020

The U.S. Centers for Disease Control and Prevention (CDC) are closely monitoring an outbreak of respiratory illness caused by a new coronavirus first identified in Wuhan, China. The new coronavirus (scientific identifier: 2019-nCoV) has resulted in thousands of confirmed cases in China; additional cases have been identified in other countries. As of February 3, 2020, […]

FDA Communication: Important Information for Potential Donors of Blood and Blood Products

December 20, 2019

The following is an excerpt from a recent communication from the United States Food and Drug Administration. Read the full communication here: The Food and Drug Administration (FDA) would like to remind the public that individuals who have ever tested positive for HIV (the virus that causes AIDS) should not donate blood, because of the […]

Genentech Issues Statement on Hemlibra Particles; MASAC Responds

October 7, 2019

Today, Genentech provided the following statement regarding reports of particulate matter in vials of Hemlibra. You can read Genentech鈥檚 statement below, and can read comments on the statement from NHF鈥檚 Medical and Scientific Advisory Council (MASAC). The events of the past several months, including today鈥檚 announcement by Genentech, underscore the importance of the joint Safety […]

FDA Identifies Biomarker for Immune Response to FVIII Products Used to Treat Hemophilia A

September 17, 2019

The following is a press release from the FDA. Read the press release on the FDA website聽here. Scientists at the U.S. Food and Drug Administration developed a technique that enables them to determine whether immune system cells called dendritic cells appear primed to trigger the production of antibodies against Factor VIII (FVIII) products used to […]

FDA Issues a MedWatch Safety Alert Regarding Certain Hepatitis C Medications

August 28, 2019

The following is an excerpt from a FDA MedWatch Safety Alert. Read the full safety announcement here. FDA has received reports that the use of Mavyret, Zepatier, or Vosevi to treat chronic Hepatitis C in patients with moderate to severe liver impairment has resulted in rare cases of worsening liver function or liver failure. FDA […]

RECALL NOTICE: Bayer Voluntarily Recalling Factor 8 Product

July 19, 2019

The following is a press release from Bayer regarding a voluntary recall. PATIENTS SHOULD NOT USE THIS PRODUCT! Bayer is voluntarily recalling two lots of Kogenate庐 FS antihemophilic factor (recombinant) 2000 IU vials in the United States to the patient level. Certain vials from these two lots that were labeled as Kogenate FS actually contain […]

SPECIAL PRESIDENT AND CEO ANNOUNCEMENT

July 16, 2019

Dear Bleeding Disorders Community 鈥 I want to let you know that I will be stepping down from HFA as your President and CEO at the end of August. Leaving HFA has been an incredibly difficult decision I have been wrestling with for about a year.聽 I love HFA but ultimately this is just the […]

Recall Notice: Fentanyl Transdermal Pain Patches Recalled Due to Product Mislabeling

April 23, 2019

The following is from the FDA MedWatch. Read the recall notice in its entirety here. Alvogen Inc. is voluntarily recalling two lots of Fentanyl Transdermal System 12 mcg/h transdermal patches to the consumer level. A small number of cartons labeled 12 mcg/h Fentanyl Transdermal System patches contained 50 mcg/h patches. The 50 mcg/h patches that […]

Grifols Voluntarily Recalls Profilnine

June 15, 2018

Grifols Biologicals is initiating a voluntary product recall of one lot of Profilnine. Grifols Biologicals has determined there is low risk to the patient associated with this issue; however, Grifols Biologicals is requesting the lot to be returned out of caution. Therapy Plasma Product NDC Number Lot Number Size Packaging Expiration Date 68516-3208-2 A1PBB00072 1000 […]

FDA, CDC identify potential infection risk prompting voluntary recall of syringes by BD Medical

May 1, 2018

The following is an alert from BD Medical. Read the full consumer letter with detailed product information聽here. 聽 Out of an abundance of caution and in the interest of public health, BD is voluntarily recalling certain lots of BD PosiFlush™ Heparin Lock Flush and BD™ Pre-Filled Normal Saline Flush syringes due to a potential for […]


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