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CSL Behring Provides Update on Stimate Nasal Spray Availability

October 2, 2020

The following is an excerpt from an update from CSL Behring regarding the availability of Stimate Nasal Spray. Read the update in its entirety here. Ferring Pharmaceuticals Inc. initiated a voluntary, consumer-level recall of all batches of Stimate庐 Nasal Spray (desmopressin acetate) 1.5 mg/mL, which is distributed and sold by CSL Behring LLC.聽 At this […]

CSL Behring Announces Discontinuation of Mononine Coagulation Factor IX

September 15, 2020

CSL Behring issued the following statement to patient advocacy groups: “CSL Behring is focused on delivering breakthrough therapies to improve patients鈥 lives and meet the changing needs of our patients. Since CSL Behring鈥檚 introduction of MONONINE庐 Coagulation Factor IX (Human) in 1992, advancements have been made for the treatment of Hemophilia B.聽 Over time, patients […]

HFA, NHF, Hemophilia Alliance Request Additional Information Regarding Stimate Recall

September 14, 2020

Hemophilia Federation of America and the National Hemophilia Foundation continue to follow up on issues arising from the recent recall of Stimate (desmopressin) nasal spray, which is manufactured by Ferring Pharmaceuticals and distributed in the United States by CSL Behring. On September 3, HFA, NHF and the Hemophilia Alliance sent a new joint letter to […]

Stimate Recall – CSL Behring & Ferring Pharmaceuticals Announces Extension of Stimate Recall to Consumer Level

August 13, 2020

Ferring Pharmaceuticals announced it was extending the recall of Stimate (desmopressin) to the consumer/user level. Stimate is manufactured by Ferring Pharmaceuticals Inc. and is distributed and sold in the United States by CSL Behring. This marks an expansion of Ferring鈥檚 initial July 2020 plans to conduct a narrower pharmacy-level recall. Under a consumer-level recall, people […]

Stimate Recall – CSL Behring & Ferring Pharmaceuticals Response to HFA-NHF Letter

August 7, 2020

  Click Below to Translate Page to Spanish. On July 21, 2020, Ferring Pharmaceuticals issued a voluntary recall of Stimate (desmopressin) nasal spray due to 鈥渟uperpotency鈥 鈥 in other words, amounts of desmopressin being higher than specified. Stimate is used to treat von Willebrand disease (VWD) and mild hemophilia A. It is licensed and distributed […]

Washington Wire: July 2020

July 31, 2020

Click Below to Translate Page to Spanish. Product recall announced On July 21, CSL Behring and Ferring Pharmaceuticals announced a聽recall聽of multiple lots of Stimate (desmopressin),聽in the United States and in other countries around the world. The recall was prompted by the manufacturer鈥檚 discovery of out-of-specification levels of the active ingredient in the marketed product. This聽announcement […]

Joint Statement on Recall of Stimate

July 22, 2020

Click Below to Translate Page to Spanish. On July 21, CSL Behring and Ferring Pharmaceuticals announced the recall of multiple lots of Stimate (desmopressin)聽in the United States, as part of a global recall. This聽troubling聽announcement has raised many questions on the part of national and international patient organizations and community members. Today, HFA and NHF have聽submitted […]

RECALL NOTICE: Voluntary Recall of Stimate (Desmopressin Acetate)

July 21, 2020

Click Below to Translate Page to Spanish. Late today (July 21, 2020), HFA and NHF learned of a聽pharmacy level聽product recall of聽Stimate (desmopressin)聽nasal spray manufactured by Ferring Pharmaceuticals,聽and聽distributed in the U.S. by CSL Behring. Ferring has prepared a Health Hazard Safety Evaluation, warning that 鈥渢here is a reasonable probability that the use of, or exposure to, […]

uniQure Announces License Agreement with CSL Behring to Commercialize Hemophilia B Gene Therapy

June 25, 2020

The following is an excerpt from a press release from uniQure. Read the press release in its entirety here. uniQure N.V., a gene therapy company advancing transformative therapies for patients with severe medical needs, announced that uniQure and CSL Behring have entered into a licensing agreement providing CSL Behring with exclusive global rights to etranacogene […]

Racing Against Time, Medical Researchers, Life Science Companies and COVID-19 Survivors Launch National Campaign to Drive Blood Plasma Donation

June 18, 2020

The following is an excerpt from a press release from CSL Behring. Read the press release in its entirety here. 鈥淭he Fight Is In Us鈥 Campaign Seeks to Mobilize COVID-19 Survivors to Accelerate the Development of Potentially Lifesaving Therapies A coalition of world-leading medical and research institutions, blood centers, life science companies, technology companies, philanthropic […]

CSL Behring Update COVID-19

March 13, 2020

CSL Behring has added a statement to their website regarding the measures the company is taking in the wake of the聽2019-nCoV (novel coronavirus) outbreak.

CSL Behring Announces Printing Misalignment for Humate-P

October 15, 2019

CSL Behring has advised HFA and NHF of a printing misalignment on the label of its Humate P product for von Willebrand disease. You can read CSL Behring鈥檚 statement, and see images of the product box,聽below. While the current Humate P notification is prompted by a printing error on the outside of the box, NHF […]

FDA Advises CSL Behring Their Promotional Materials are Misleading

March 6, 2018

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鈥檚 promotional materials make misleading claims about the effectiveness of its Idelvion (Factor IX) product. 鈥淪uch […]

Update 2: Bioverativ Files Complaints Against CSL Behring’s Idelvion

July 19, 2017

As noted in our July 10, 2017 story, Bioverativ has filed complaints in the U.S. District Court for the District of Delaware and with the U.S. International Trade Commission alleging that Idelvion, a novel factor IX albumin fusion protein developed by CSL Behring, infringes upon three Bioverativ patents. HFA, in collaboration with the National Hemophilia […]

Bioverativ Files Complaints Against CSL Behring’s Idelvion

July 10, 2017

Note: This story has been sourced from the website, www.thepharmaletter.com聽and The Australian Business Review. On Friday, July 7, 2017, Bioverativ filed complaints in the U.S. District Court for the District of Delaware and with the U.S. International Trade Commission alleging that Idelvion, a novel factor IX albumin fusion protein developed by CSL Behring, infringes upon […]

CSL Behring Celebrates World Hemophilia Day

April 19, 2017

Global Drug Manufacturer CSL Behring announced last week it’s recognition of World Hemophilia Day by sharing news of a donation of聽more than 4 million international units (IUs) of its medicines to treat hemophilia A and/or von Willebrand Disease to the WFH Global Alliance for Progress (GAP) Program. To read the full release from CSL Behring, […]

Prescription Benefit Program Changes for Recombinant Clotting Factor Product

October 18, 2016

  It has come to our attention that Helixate FS, a recombinant clotting factor product sold and distributed by CSL Behring, is being removed from prescription benefit programs for a limited number of聽patients using CVS/Caremark effective January 1, 2017. Patients currently using Helixate FS who have the “Advanced Control Formulary” plan with聽CVS/Caremark will have the […]

FDA Approves First 14-Day Hemophilia B Treatment

March 5, 2016

Note: The following is an edited form of a press release from the FDA . The original form of the release can be read聽here. The U.S. Food and Drug Administration approved on Friday, March 4, Idelvion, Coagulation Factor IX (Recombinant), Albumin Fusion Protein, for use in children and adults with Hemophilia B. Idelvion is the […]

New Data Released on Long-Acting Hemophilia B Treatment

December 8, 2015

Note: The following is the edited version of a press release issued by CSL Behring. The original release can be found here. On December 7, 2015, CSL Behring聽presented data from its Phase III PROLONG-9FP clinical program evaluating the efficacy and long-term safety of its investigational long-acting fusion protein linking recombinant coagulation factor IX with recombinant […]

FDA Accepts CSL Behring鈥檚 Application for New Hemophilia Treatment

July 28, 2015

Note: The below is an edited press release from CSL Behring. To read the full release, click here. CSL Behring announced that the U.S. Food and Drug Administration has accepted for review the company鈥檚 Biologics License Application (BLA) for its novel investigational recombinant factor VIII single-chain (rVIII-SingleChain) for the treatment of hemophilia A. In the […]

FDA To Review CSL Behring’s New Long-Lasting Hemophilia B Product

February 4, 2015

CSL Behring聽announced that the U.S. Food and Drug Administration (FDA) has accepted for review its Biologics License Application (BLA) for the marketing authorization of its long-acting fusion protein linking recombinant coagulation factor IX with recombinant albumin (rIX-FP). Upon FDA approval, rIX-FP will provide hemophilia B patients with a long-acting treatment option with dosing intervals up […]

FDA Accepts CSL Behring’s Application for New Long-Acting Hemophilia B Product

February 4, 2015

This is an edited version of a press release from CSL Behring. To read the full release, please聽click here. ____________________ 聽CSL Behring聽announced that the U.S. Food and Drug Administration (FDA) has accepted for review its Biologics License Application (BLA) for the marketing authorization of its long-acting fusion protein linking recombinant coagulation factor IX with recombinant […]

CSL Behring Announces 2014 Gettin’ in the Game Winners

November 2, 2014

CSL Behring’s Gettin’ in the Game program, like our FitFactor program, encourages patients with hemophilia, von Willebrand disease (vWD), and other bleeding disorders to become active and stay active, touting the physical and mental benefits of sports and other activities. Recently, CSL Behring held their 13th Junior National Championship program, an annual golf and baseball […]

CSL Opens World-Class Manufacturing Facility for Hemophilia Therapies

May 9, 2014

CSL Limited (ASX:CSL), parent company of CSL Behring which is based in King of Prussia, PA, today opened the CSL Behring Biotechnology Manufacturing Facility in Melbourne, Australia. The new facility, located adjacent to the site鈥檚 manufacturing plant for plasma products, is the centerpiece of CSL鈥檚 $250 million expansion at its Broadmeadows site and will play […]

Press Release: HFA receives $10,000 CSL Behring LEAD Grant

April 6, 2009

April 6, 2009

Washington, DC: Hemophilia Federation of America (HFA) has received a $10,000 grant from CSL Behring to fund its Legislative Action Center.
HFA is a nonprofit organization serving the bleeding disorders community. Established in 1994, the organization has offered programming and grassroots advocacy on behalf of its individual members and its twenty-nine member organizations.
The CSL Behring Local Empowerment Grant will be used to provide the community the Legislative Action Center tool (Capwiz) on the Hemophilia Federation website.


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