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Sanofi to Acquire Bioverativ for $11.6 Billion

January 22, 2018

Note:聽The following is edited from a press release from Sanofi. Read the full press release in its entirety聽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 […]

New Biopharmaceutical Company, Sigilon Therapeutics, Launches

July 7, 2017

Note: The following is an edited version of a press release from Sigilon聽Therapeutics.聽Read the press release from Sigilon聽Therapeutics聽in it鈥檚 entirety聽here. Flagship Pioneering, a fully-integrated life science innovation聽enterprise, recently聽announced the launch of Sigilon Therapeutics Inc. Sigilon Therapeutics is a聽biopharmaceutical company that discovers and develops category-defining biocompatible encapsulated聽cell therapies. Sigilon Therapeutics鈥 discovery platform combines cell engineering and […]

FDA Accepts Bioverativ’s Application for Investigational Hemophilia A Drug

June 12, 2017

Bioverativ announced on June 12, 2017 that the U.S. Food and Drug Administration (FDA) has accepted the company鈥檚 Investigational New Drug (IND) application for BIVV001 (also known as rFVIIIFc-VWF-XTEN), a novel, investigational factor VIII therapy designed to potentially extend protection from bleeds with prophylaxis dosing of once weekly or longer for people with hemophilia A. […]

FDA Approves New Novo Nordisk Treatment for Patients with Hemophilia B

June 1, 2017

  Novo Nordisk recently announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application for REBINYN庐 (Coagulation Factor IX (Recombinant), GlycoPEGylated) for the treatment of adults and children with hemophilia B.聽Novo Nordisk expects to launch REBINYN庐 in the U.S. in the first half of 2018. For more info on REBINYN, […]

Spark Therapeutics Presents Updated Preliminary Data from Hemophilia B Phase 1/2 Trial

April 14, 2017

Spark Therapeutics issued a press release on updated preliminary data from 10 infused participants in the ongoing Phase 1/2 clinical trial of investigational SPK-9001 for hemophilia B. The data is聽being presented at Hemostastis &聽Thrombosis Research Society (HTRS) this week. The press release can be read in full here.

Sangamo BioSciences Receives Orphan Drug Designation From The FDA For SB-FIX

September 9, 2016

The following is excerpted from a press release from PRNewswire. Read the press release in it’s entirety聽here. Sangamo BioSciences, Inc.聽announced earlier this week that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to SB-FIX, the company’s zinc finger nuclease (ZFN)-mediated genome editing product candidate for the treatment of hemophilia B. Sangamo […]

Spark Therapeutics Announces Updated Data from Hemophilia B Trial

June 14, 2016

Note: The below is an edited version of a press release by Spark Therapeutics.聽The original release can be read in it’s entirety聽here. PHILADELPHIA,聽June 13, 2016 –聽Spark Therapeutics announced today updated results of the first cohort from the ongoing Phase 1/2 clinical trial of聽SPK-9001, the lead investigational candidate in its聽SPK-FIX聽program, which is being studied for the […]

FDA Approves First Single Chain Product for Hemophilia A

May 27, 2016

Note: The below is an edited version of a press release by CSL Behring.聽The original release can be read in it’s entirety聽here. KING OF PRUSSIA, Pa., May 26, 2016 — CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has approved AFSTYLA [Antihemophilic Factor (Recombinant), Single Chain], its novel long-lasting recombinant factor […]

FDA Approves Revised Wilate Product Labeling For Surgery

September 3, 2015

Note: This is an edited form of a press release from Octapharma. To read the original release in its entirety,聽click here. Octapharma USA announced on August 13, 2015 that the U.S. Food and Drug Administration (FDA) has approved revised product labeling for WILATE庐 [von Willebrand Factor/Coagulation Factor VIII Complex (Human)] to include prevention of excessive […]

FDA Approves New Hemophilia B Treatment

April 30, 2015

  Note: This is an edited version of a Emergent BioSolutions Inc.聽press release. To read the full release,聽click here. Emergent BioSolutions Inc. announced on Thursday, April 29 the聽U.S. Food and Drug Administration聽(FDA) has approved IXINITY庐, an intravenous recombinant human coagulation factor IX therapeutic for the control and prevention of bleeding episodes and for perioperative management […]

CSL Behring Renews Pledge to World Federation of Hemophilia

April 15, 2015

  In recognition of World Hemophilia Day April 17, the World Federation of Hemophilia (WFH) and CSL Behring announced today that CSL Behring has once again committed to donating bleeding disorder protein therapy international units (IUs) to the WFH Global Alliance for Progress (GAP) Program and other WFH programs, as well as making significant financial […]

PPTA: Ebola Virus and Plasma Protein Therapies

October 14, 2014

The recent outbreak of Ebola virus has caused great concern among many people. We read stories about isolation, experimental therapies and many deaths. It is understandable that this raises questions for persons who are more vulnerable to infections such as persons with immunedeficencies. We have seen questions and concerns expressed by various persons and would […]

Octapharma鈥檚 Hemophilia A Product Approved in Europe

August 7, 2014

The European Commission has published approval of Octapharma鈥檚 Nuwiq 庐 (simoctocog alfa) for the treatment and prophylaxis of bleeding in all age groups with hemophilia A (congenital factor VIII [FVIII] deficiency). Nuwiq 庐 is the newest generation of FVIII replacement, produced in a human cell line cultured without additives of human or animal origin. Nuwiq […]


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