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FDA Approves Genentech’s Hemlibra

October 4, 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 that the U.S. Food and Drug Administration 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, […]

U.S. District Court in Delaware rules against Shire in preliminary injunction

August 8, 2018

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 […]

Genentech Announced Full Results of Phase III Haven 3 Study at WFH’s 2018 World Congress in Scotland

May 21, 2018

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® (emicizumab-kxwh) prophylaxis administered every week or every two weeks in people with hemophilia A without factor VIII inhibitors […]

Reposting: HFA & NHF Issue Joint Statement Regarding Shire Lawsuit Against Genentech/Roche

March 21, 2018

[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 […]

Consolidated Postings Regarding Shire’s Lawsuit Against Genentech/Roche

January 16, 2018

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, HFA will NOT engage in the dialogue around patent ownership and will not be […]

FDA Grants Breakthrough Therapy for Subcutaneous Inhibitor Treatment

September 4, 2015

Note: This is an edited form of a press release from Genentech. To read the original release in its entirety, 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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