FDA Advises CSL Behring Their Promotional Materials are Misleading
Note: The following is a summary of a letter dated Feb. 27, 2018, from the US Food and Drug Administration (FDA) to CSL Behring. You can read the original letter here. The FDA has advised CSL Behring that the company’s promotional materials make misleading claims about the effectiveness of its Idelvion (Factor IX) product. “Such […]
Novo Nordisk Launches Rebinyn in the United States for People with Hemophilia B
Note: The following is an excerpt from a press release from Novo Nordisk. Read the full press release here. Novo Nordisk, a global healthcare company, today announced that Rebinyn, Coagulation Factor IX (Recombinant), GlycoPEGylated, is now available in the United States for the treatment of hemophilia B.Rebinyn is an extended half-life injectable medicine used to treat […]
Breakthrough in Hemophilia Gene Therapy
The following is an excerpt from an article in Medical News Bulletin. Read the full article here. Researchers at Spark Therapeutics and Pfizer tested the safety and efficacy of a new hemophilia gene therapy vector for the treatment of hemophilia B. The body’s ability to stop bleeding and repair damaged blood vessels depends heavily upon […]
Octapharma Support Enables Bombardier to Climb Mount Vinson, Becoming First Hemophiliac to Ascend the Seven Summits
Note: The following is an excerpt from a press release from Octapharma USA. Read the full press release here. Octapharma Partnership with Mountain Climber will Culminate with Release of Documentary Bombardier Blood Later This YearMountain climber Chris Bombardier of Denver, Co., became the first hemophiliac to climb the Seven Summits of the world on Jan. […]
Sanofi to Acquire Bioverativ for $11.6 Billion
Note: The following is edited from a press release from Sanofi. Read the full press release in its entirety here. Sanofi and Bioverativ Inc., a biopharmaceutical company focused on therapies for hemophilia and other rare blood disorders, have entered into a definitive agreement under which Sanofi will acquire all of the outstanding shares of Bioverativ for $105 […]
Third Circuit Says Health Care Company's Donations Didn't Violate Anti-Kickback Statute
Note: The following information comes from an article published in the New Jersey Law Journal. Read the full article here. The U.S. Court of Appeals for the Third Circuit has cleared Medco Health Solutions of violating the Anti-Kickback Statute, finding in a precedential ruling that a whistleblower failed to show a connection between alleged kickbacks […]
Consolidated Postings Regarding Shire's Lawsuit Against Genentech/Roche
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 ‘choosing […]
Shire Provides Statement Regarding Lawsuit
Shire has published a statement regarding the ongoing lawsuit Shire has filed against Genentech/Roche. Read the full statement in its entirety here.
HFA and NHF Issue Joint Statement Regarding Shire Lawsuit Against Genentech/Roche
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 Shire has requested from the […]
Genentech Provides Statement Regarding Patient Access to Hemlibra
Genentech has published a statement regarding patient access to Hemlibra (Emicizumab-kkwh). Read the full statement in its entirety here.
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