Category: Industry News

Shire Files Preliminary Injunction Against Genentech/Roche

Note: 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 ongoing U.S. patent infringement lawsuit surrounding Genentech/Roche’s emicizumab, currently being marketed as […]

Genentech Announces Interim Result from Phase III HAVEN 4 Study

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 positive interim results from the Phase III HAVEN 4 study evaluating HEMLIBRA® (emicizumab-kxwh) prophylaxis dosed once every four weeks in adults and adolescents […]

Genentech Releases Phase III HAVEN 3 Results

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 (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

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®Â (emicizumab-kxwh) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes […]

Alnylam Announces Successful Outcome Following FDA Meeting to Discuss Fitusiran Program

The following is an edited version of a press release from Alnylam Pharmaceuticals. To read the press in full, click here. Alnylam completed a successful meeting with the U.S. Food and Drug Administration (FDA), reaching alignment on safety measures and a risk mitigation strategy for clinical studies with fitusiran.  These measures include protocol-specified guidelines along […]

uniQure Announces Hemophilia B Gene Therapy Program To Enter Pivotal Study

Note: The followed is excerpted from a press release from uniQure. Read uniQure’s full press release HERE.  uniQure announced today plans to advance their development program for hemophilia B gene therapy into a pivotal study using an enhanced version of their product candidate called AMT-061. AMT-061 is identical to AMT-060 in every way apart from a change from […]

Bayer Issues Voluntary Recall of Kogenate FS

Note: The following is the full text of an email communication received by HFA from Bayer HealthCare Pharmaceuticals: Bayer in consultation with the FDA has voluntarily recalled approximately 300 vials (part of one lot) of Kogenate® FS, Antihemophilic Factor (Recombinant) in the U.S. as an excipient, used to stabilize the product during manufacturing, may not conform […]

Bioverativ Enters Joint Project With UK-Based Bicycle Therapeutics

 Bioverativ and a UK-based biotech company called Bicycle Therapeutics will work together to try to identify new therapies for hemophilia and also sickle cell disease.  The research will focus on using a new approach – called Bicycles – which the companies hope will lead to a new way to treat the blood disorders.Read the full […]

Alnylam Suspends Fitusiran Dosing due to Thrombotic Event

The following is an edited version of a press release from Alnylam Pharmaceuticals. To read the press in full, click here. Alnylam recently became aware of a fatal serious adverse event (SAE) that occurred in a patient with hemophilia A who was receiving fitusiran in the Phase 2 OLE study. As a result, the Company […]

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

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