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Genentech Response to HFA-NHF Letter Regarding Particulate Matter in Hemlibra

October 17, 2019

On October 16, 2019, Genentech sent the following letter to HFA and NHF. Genentech鈥檚 letter responds to questions posed in the joint HFA-NHF letter of October 11, regarding reports of particulate matter in vials of Hemlibra. HFA and NHF will keep the bleeding disorders community informed as further information develops. Please note that HFA and […]

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 […]

Genentech Patient Foundation Responds to HFA-NHF Letter

September 27, 2019

On September 24, 2019, HFA and NHF sent a聽letter聽to Genentech and MedVantx regarding the shipment of incorrect length injection needles to patients who receive Hemlibra through the Genentech Patient Foundation. The Genentech Patient Foundation responded to our inquiries by letter dated September 25, 2019. You can read their response聽here. HFA and NHF will update the […]

Joint Statement #1 on Genentech Patient Foundation/Medvantx Needle Error

September 24, 2019

Late in the day on Friday, September 20, 2019, Genentech informed HFA and NHF that a contracted specialty pharmacy, Medvantx, had shipped incorrect length injection needles to patients who receive Hemlibra through the Genentech Patient Foundation. HFA and NHF posted that notice on September 21st. Today we followed up with a letter to Genentech and […]

Genentech Patient Foundation/Medvantx Announce Ancillary Safety Issue

September 21, 2019

HFA has received the聽following notice from Genentech regarding the shipment of incorrect length injection needles to patients who receive Hemlibra through the Genentech Patient Foundation: “We were recently informed that ancillary supplies shipped by a specialty pharmacy, Medvantx, to a specific group of patients receiving Hemlibra through the Genentech Patient Foundation contained incorrect length injection […]

Genentech Presents Data for Hemlibra at the ISTH 2019 Congress

July 10, 2019

The following is an excerpt from a press release from Genentech. Read the press release in its entirety here. Genentech, a member of the Roche Group, announced today new data for Hemlibra庐 (emicizumab-kxwh) across multiple pivotal studies in people with hemophilia A with and without factor VIII inhibitors at the International Society on Thrombosis and […]

Spark Therapeutics Enters into Merger Agreement with Roche

February 25, 2019

The following is an excerpt from a press release from Spark Therapeutics. Read the press release in its entirety here. Spark Therapeutics , a fully integrated, commercial gene therapy company dedicated to challenging the inevitability of genetic disease, announced today that it has entered into a definitive merger agreement for Roche to fully acquire Spark […]

Genentech joins the World Federation of Hemophilia Humanitarian Aid Program

February 21, 2019

The following is a press release from Roche. Read the press release in its entirety here. Roche announced it has joined the World Federation of Hemophilia Humanitarian Aid Program, a landmark initiative leading the effort to change the lack of access to care and treatment for people with inherited bleeding disorders in developing countries. Together […]

Roche joins the World Federation of Hemophilia Humanitarian Aid Program

February 7, 2019

The following is an excerpt from a press release from Roche. Read it in its entirety here. Roche today announced that it has joined the World Federation of Hemophilia Humanitarian Aid Program, a landmark initiative leading the effort to change the lack of access to care and treatment for people with inherited bleeding disorders in […]

Genentech’s Hemlibra Provided Sustained Bleed Control in a Study of Children with Hemophilia A with Factor VIII Inhibitors

December 20, 2018

The following is an excerpt from a press release from Genentech. Read the press release in its entirety here. Genentech, a member of the Roche Group announced data from the primary analysis of the Phase III HAVEN 2 study evaluating Hemlibra庐 prophylaxis in children younger than 12 years of age with hemophilia A with factor […]

Genentech’s Hemlibra Provided Sustained Bleed Control in the Largest Pivotal Study in Children with Hemophilia A with Inhibitors

December 5, 2018

The following is an excerpt from a press release from Genentech. Read the press release in its entirety here. Genentech, a member of the Roche Group, announced data from the primary analysis of the Phase III HAVEN 2 study evaluating Hemlibra庐聽prophylaxis in children younger than 12 years of age with hemophilia A with factor VIII […]

Genentech to Present New Data at the American Society of Hematology 2018 Annual Meeting

November 7, 2018

  The following is an excerpt from a press release from Genentech. Read the press release in its entirety here. Genentech has announced new data that will be presented at this year’s annual American Society of Hematology meeting held in San Diego from Dec. 1-4. Ten聽Genentech聽medicines will be featured in more than 70 abstracts, including […]

Genentech Announces the Launch of New Safety Website

September 3, 2018

Genentech has announced a new web portal for patients and caregivers intended to provide timely and accurate information on targeted serious adverse events of interest for HEMLIBRA. Visit the safety website:聽http://www.emipatientinfo.com/. Earlier this year, Genentech launched a similar site specifically for health care providers. In announcing the launch, Genentech stated 鈥淭his website is meant to […]

Phase III Results for Genentech’s Hemlibra Published in New England Journal of Medicine

August 31, 2018

The following is an excerpt from a press release from Genentech. Read the press release in its entirety here.聽 Genentech, a member of the Roche Group, announced that pivotal data from the Phase III HAVEN 3 study, which evaluated HEMLIBRA庐聽prophylaxis administered every week or every two weeks in adults and adolescents aged 12 years or […]

FDA GRANTS PRIORITY REVIEW TO GENENTECH鈥橲 HEMLIBRA FOR PEOPLE WITH HEMOPHILIA A WITHOUT FACTOR VIII INHIBITORS

June 5, 2018

The following is an excerpt from a press release from Genentech. Read the entire press release here. Genentech, a member of the Roche Group, announced the U.S. Food and Drug Administration has accepted the company鈥檚 supplemental Biologics License Application and granted Priority Review for HEMLIBRA 聽for adults and children with hemophilia A without factor VIII […]

MASAC Issues Safety Information Update on Emicizumab (HEMLIBRA)

April 24, 2018

The National Hemophilia Foundation’s Medical and Scientific Advisory Council (MASAC) has released a safety information update about Emicizumab (Hemlibra), a new subcutaneous treatment for hemophilia A patients with inhibitors. This update has been released following the first report of an anti-drug antibody to Emicizumab. MASAC鈥檚 update issues recommendations for providers and patients in case of […]

Genentech Releases Statement on Hemlibra Patient

April 24, 2018

The following is an excerpt from a statement from Genentech. Read the entire statement 聽HERE. _________________________________________________________ Genentech has recently learned that a patient in the Phase III HAVEN 2 clinical trial developed a neutralizing anti-drug聽antibody. For聽this patient, the anti-drug antibody resulted in reduced efficacy of HEMLIBRA.

FDA Grants Breakthrough Therapy Designation for Genentech’s Hemlibra

April 17, 2018

The following is an excerpt from a press release from Genentech. Read the full press release here.聽 Genentech, a member of the Roche Group, announced today the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation to HEMLIBRA聽for people with hemophilia A without factor VIII inhibitors. Breakthrough Therapy Designation is designed to accelerate the […]

Genentech Offers Hemlibra Update

March 28, 2018

Note: The following is an excerpt from a press release from Genentech. Read the full press release here. ______________________________________________________________________________________ Given the recent dialogue, we are reaching out to clarify the facts surrounding five people with聽hemophilia A with inhibitors to factor VIII who have passed away while receiving Hemlibra庐聽(emicizumab-kxwh). Since 2016, five adults with hemophilia A […]

Genentech Medical Communications Line Available to Answer Questions About Hemlibra聽

March 27, 2018

HFA was informed by Genentech on March 26, 2018,聽that聽a聽total of five聽patient deaths have聽occurred聽while聽the patients were聽using聽Hemlibra聽(emicizumab-kxwh).聽Genentech has little information that they can presently share聽about the circumstances聽surrounding the聽most recent聽patient聽deaths; however, Genentech could confirm that the patients聽had received聽Hemlibra聽as part of聽compassionate use and聽expanded patient access. Genentech has a聽Medical Communications line聽at聽1(800)-821-8590聽for patients, concerned community members, and healthcare providers聽who聽seek further information. […]

Shire Provides Statement Regarding Lawsuit

January 16, 2018

Shire has published a聽statement regarding the ongoing lawsuit Shire has filed against Genentech/Roche. Read the full statement聽in its entirety聽here.    

HFA and NHF Issue Joint Statement Regarding Shire Lawsuit Against Genentech/Roche

January 12, 2018

In the past few weeks, we have received many inquiries regarding the scope of the injunction Shire is seeking in its lawsuit against Genentech/Roche.聽 Certain information has become public during this period that enables NHF and HFA to provide some limited guidance as to the scope of the injunction that Shire has requested from the […]

Genentech Provides Statement Regarding Patient Access to Hemlibra

January 11, 2018

Genentech has published a聽statement regarding patient access to Hemlibra (Emicizumab-kkwh). Read the full statement聽in its entirety聽here.  

Genentech Presents New Data on Hemlibra at ASH 2017

December 15, 2017

Note: The following is edited from a press release from Genentech. Read the full press release in its entirety here. Genentech, a member of the Roche Group, announced on Dec. 9, 2017, new data from the ongoing HEMLIBRA庐聽(emicizumab-kxwh) clinical development program were presented at the 59th American Society of Hematology (ASH) Annual Meeting. These data […]

Shire Files Preliminary Injunction Against Genentech/Roche

December 14, 2017

Note:聽The following is edited from a press release from Shire. Read the full press release in its entirety here. On December 14, 2017, Shire filed a motion for preliminary injunction against Roche subsidiaries Genentech Inc. and Chugai Pharmaceutical Co., Ltd., as part of an聽ongoing U.S. patent infringement lawsuit surrounding Genentech/Roche’s emicizumab, currently being marketed as […]

Genentech Releases Phase III HAVEN 3 Results

November 20, 2017

The following is an edited excerpt from a press release from Genentech. To read the press release in full, click here. Genentech, a member of the Roche Group, announced positive results from the Phase III HAVEN 3 study evaluating Hemlibra聽(emicizumab-kxwh) in adults and adolescents (aged 12 years or older) with hemophilia A without inhibitors to […]

FDA Approves Genentech’s HEMLIBRA, (Emicizumab-KXWH) for Hemophilia A with Inhibitors

November 16, 2017

Note: The following is an edited excerpt from a press release from Genentech. To read the press release in it’s entirety, click HERE. Genentech, a member of the Roche Group, announced today that the U.S. Food and Drug Administration (FDA) has approved HEMLIBRA庐聽(emicizumab-kxwh) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes […]

FDA Grants Priority Review to Genentech’s Emicizumab for Hemophilia A with Inhibitors

August 24, 2017

Note: The following is an edited version of a press release from Genentech.聽Read the press release from Genentech聽in it鈥檚 entirety here. Genentech, a member of the Roche Group, announced today that the U.S. Food and Drug Administration (FDA) has accepted the company鈥檚 Biologics License Application (BLA) and granted Priority Review for emicizumab prophylaxis (preventative) as […]

Shire Gets Injunction Against Roche Over Emicizumab

July 10, 2017

Note: The following is an excerpt from a Reuters news article. Read the article in full here. Pharmaceutical group Shire said on Sunday it had obtained a preliminary injunction in a Hamburg court against rival Roche聽over its hemophilia drug emicizumab, alleging incomplete and misleading statements surrounding the treatment. Roche said in an emailed statement it […]

New England Journal of Medicine Publishes Articles in Conjunction with ISTH 2017

July 10, 2017

The New England Journal of Medicine has published two articles and an editioral in conjunction with the International Society of Thrombosis and Haemostasis meeting being held in Berlin, Germany, July 8-13, 2017. The articles include information on novel hemophilia treatment products currently in clinical trial. Click on the links below to read the articles in […]


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