Hemophilia Federation of America is a national nonprofit organization that assists, educates and advocates for the bleeding disorders community.
In Genentech鈥檚 ongoing efforts to transparently communicate with the hemophilia community, they have shared two updates to the Hemlibra label that were requested by the U.S. Food and Drug Administration. These changes, which were accepted and implemented on March 10, 2021, impact the Warnings and Precautions (sections 5.1 and 5.2) and Clinical Pharmacology (section 12.3) […]
The following is a press release from Genentech. “The World Health Organization has declared the COVID-19 (coronavirus) outbreak a global pandemic. We extend our heartfelt sympathies to everyone who has lost loved ones, to patients and healthcare professionals battling this devastating outbreak. With multiple countries implementing measures to slow the spread of the virus, based […]
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 that the U.S. Food and Drug Administration has approved Hemlibra庐(emicizumab-kxwh) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children, ages newborn and older, […]
On Aug. 7, 2018, the U.S. District Court in Delaware ruled against Shire in its request for a preliminary injunction against Roche AG from creating, transporting and marketing its recently-approved drug Hemlibra in the U.S., which received FDA approval to treat people with hemophilia A with inhibitors in 2017. This ruling means there are no […]
The following is an excerpt from the press release from Genentech. Read the full press release here. Genentech, a member of the Roche Group, announced the full results from the Phase III HAVEN 3 study evaluating HEMLIBRA庐 (emicizumab-kxwh) prophylaxis administered every week or every two weeks in people with hemophilia A without factor VIII inhibitors […]
[Reposted from January 16, 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. 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 […]
In an effort to provide the hemophilia community a centralized location to find the most up-to-date statements and press releases regarding a recent injunction Shire is seeking in its lawsuit against Genentech/Roche, HFA will publish links on this page. As a reminder,聽HFA will NOT engage in the dialogue around patent ownership and will not be […]
Note: This is an edited form of a press release from Genentech. To read the original release in its entirety,聽click here. Genentech announced on Friday, September 4, 2015, that the U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to ACE910 (RG6013, RO5534262) for the prophylactic treatment of people who are 12 years […]
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