Industry News

Baxter’s Response to FDA Warning Letter

June 25, 2013

Baxter Healthcare Corporation received a Warning Letter from FDA dated May 31, 2013 regarding operations and processes at its Marion (North Cove), North Carolina and Jayuya, Puerto Rico facilities. The Baxter facilities that received the FDA Warning Letter are not involved in the production of any treatments processed by Baxter鈥檚 BioScience Division including hemophilia clotting […]

CSL Behring Doses First Hemophilia A Patient in Part 3 of Global Phase

June 4, 2013

King of Prussia, — CSL Behring has dosed the first patient in Part 3 of its AFFINITY clinical trial program, which is now in phase III. AFFINITY is an open-label, non-randomized, multi-center study evaluating the efficacy, safety and pharmacokinetics of its novel investigational recombinant coagulation single-chain factor VIII (rVIII-SingleChain) for the treatment of hemophilia A. […]

CSL Behring Receives FDA Approval of Kcentra™

April 30, 2013

King of Prussia, PA 鈥 CSL Behring announced today that the U.S. Food and Drug Administration (FDA) approved Kcentra™ (Prothrombin Complex Concentrate [Human]), the first non-activated 4-factor prothrombin complex concentrate (PCC) for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (e.g., warfarin) therapy in adult patients with acute major bleeding. […]

Baxter Reinforces Commitment To Disparities In Care And Shares A New Vision

April 18, 2013

Baxter Healthcare Corporation announced its continued commitment to the hemophilia community to close the gap in hemophilia care and the company鈥檚 vision to pursue a bleed-free world for people living with this disorder on World Hemophilia Day. For more than 60 years, Baxter has been a dedicated partner to the hemophilia community and is committed […]

Life Sciences Firm Entegrion Lands Global Partner

April 1, 2013

Research Triangle Park, N.C. 鈥 Blood technologies company Entegrion is partnering with an Italian company to develop and commercialize Resusix, Entegrion鈥檚 freeze-dried human plasma. Under the deal, Kedrion Melville gains exclusive worldwide rights to commercialize Resusix. Entegrion, based in Research Triangle Park, will collaborate with Kedrion on clinical development of the product. Clinical trials are […]

FDA Accepts Biogen Idec鈥檚 License Application for First Long-Lasting Factor Therapy for Hemophilia B

March 4, 2013

WESTON, Mass.-Biogen Idec announced today that the U.S. Food and Drug Administration (FDA) has accepted the company`s Biologics License Application (BLA) for the marketing approval of recombinant factor IX Fc fusion protein (rFIXFc) for the treatment of hemophilia B and granted the company a standard review timeline. Recombinant FIXFc is the first product candidate in […]

BioRx Introduces National Physical Therapy Program

February 19, 2013

CINCINNATI, Ohio 聽– BioRx announced today the launch of a new physical therapy program to help patients, physicians, physical therapists, and health insurers manage the complications and costs of hemophilia-related joint damage. The program, called REBUILD, supports a patient’s physical therapy program at the local level. Under the direction of an experienced physical therapist for […]

ATHN and The Hemophilia Alliance Announce Memorandum of Understanding

February 6, 2013

February 6, 2013 聽— The Hemophilia Alliance and the American Thrombosis and Hemostasis Network (ATHN) are pleased to announce they have entered into a Memorandum of Understanding to provide financial assistance to ATHN in support of the ATHN Data Quality Counts program for Hemophilia Treatment Centers (HTCs) across the country. Funding from the Hemophilia Alliance […]

PSI and Bayer Healthcare Introduce Co-Pay/Co-Insurance Pilot Program

January 24, 2013

Midlothian, VA and Wayne, NJ 鈥揓anuary 24, 2013 – Patient Services, Inc. (PSI) and Bayer HealthCare are pleased to announce the Kogenate庐 FS Co-pay/Co-Insurance Assistance Pilot Program. The pilot program is funded by Bayer to help qualified Kogenate庐 FS patients with their out-of-pocket payments. What is offered through the pilot program? PSI will administer and […]

Biogen Idec Submits Application to FDA for First Long-Lasting Factor IX Therapy For Hemophilia B

January 4, 2013

WESTON, Mass.– Today,聽Biogen Idec聽announced the company recently submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the marketing approval of recombinant factor IX Fc fusion protein (rFIXFc) for the treatment of hemophilia B. rFIXFc is the first product candidate in a new class of long-lasting clotting factor therapies that […]

Incivek (telaprevir) In Combination with Drugs Peginterferon Alfa and Ribavirin (Incivek Combination Treatment): Drug Safety Communication – Serious Skin Reactions

December 19, 2012

AUDIENCE: Internal Medicine, Gastroenterology, Dermatology ISSUE: FDA received reports of serious skin reactions, some fatal, in patients taking the hepatitis C drug Incivek (telaprevir) in combination with the drugs peginterferon alfa and ribavirin (Incivek combination treatment). Some patients died when they continued to receive Incivek combination treatment after developing a worsening, or progressive rash and […]

Pfizer Hemophilia: The Way You Log Is About To Change

December 4, 2012

Pfizer Hemophilia is excited to announce the launch of its first mobile logging tool, HemMobile鈩, a free mobile app designed to help hemophilia patients and caregivers using any factor replacement product log infusions and bleeds and stay aware of general health and wellness. Developed with input from members of the bleeding disorders community, HemMobile鈩 was […]

Novo Nordisk introduces HemaGo, a mobile application to track hemophilia treatment, bleeding episodes and life events

November 27, 2012

Princeton, N.J. (November 27, 2012) — Novo Nordisk announced today the introduction of HemaGo, a mobile application (app) to help individuals with hemophilia and their caregivers monitor the details of treatment, including medications, dosing, bleed information and the impact of hemophilia on life events. The app offers multiple profiles so that more than one family […]

Novo Nordisk files for regulatory approval of turoctocog alfa for haemophilia A in the US and EU

October 16, 2012

Novo Nordisk today announced the submission of the regulatory application for turoctocog alfa (NN7008) to the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). Turoctocog alfa is a third-generation recombinant coagulation factor VIII intended for prevention and treatment of bleeding in people with haemophilia A. “We are very excited about having […]

Biogen’s Hemophilia Drug Meets Late-stage Trial Goal

October 4, 2012

(Reuters) – Biogen Idec Inc said on Wednesday its experimental treatment for patients with hemophilia B, a rare inherited blood disorder that impairs coagulation, met the main goal of controlling bleeding in a late-stage trial. A single injection of the long-lasting clotting factor, being developed in partnership with Swedish Orphan Biovitrum, controlled bleeding in 90.4 […]

Novo Nordisk discontinues development of vatreptacog alfa following analysis of phase 3 results

September 28, 2012

Novo Nordisk today announced the decision to discontinue the development of vatreptacog alfa, a fast-acting recombinant factor VIIa analogue for haemophilia patients with inhibitors. The decision follows analysis of the data from the phase 3a trial adeptTM 2. On 9 August, Novo Nordisk announced that a few patients in the trial had developed anti-drug antibodies […]

Intern trio distinguish themselves in the Bayer Hemophilia Leadership Development Program

August 27, 2012

We’re proud to announce that our three summer interns have recently completed the Bayer Hemophilia Leadership Development Program (BHLDP). All three distinguished themselves as future leaders in the bleeding disorders community through their hard work, enthusiasm and can-do spirit. The interns spent time both at Bayer and at local hemophilia advocacy organizations to round out […]

Patient Services, Inc. and Baxter Introduce the Hemophilia Co-Pay/Co-Insurance Assistance Pilot Program

August 20, 2012

Midlothian, VA — Many members of the hemophilia community are struggling with the high costs of healthcare. At Patient Services, Inc. (PSI), we recognize the importance of assisting patients to afford and access treatment. Therefore, PSI is pleased to announce that Baxter Healthcare Corporation has developed a 12-month Hemophilia Co-pay/Co-insurance Assistance Pilot Program which will […]

Baxter Announces FDA Approval of Advate 4,000 IU Dosage Strength

July 16, 2012

DEERFIELD, Ill., JULY 16, 2012 – Baxter International Inc. (NYSE:BAX) today announced that the U.S. Food and Drug Administration (FDA) has approved a new 4000 IU dosage strength of ADVATE [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method]. 聽ADVATE is a full-length recombinant factor VIII (FVIII) product that is indicated for the control and prevention of bleeding episodes […]

BioRx Receives Limited Distribution Rights to Corifact庐 for the Treatment of Congenital Factor XIII Deficiency

July 11, 2012

Cincinnati, OHIO –聽July 11, 2012聽– BioRx, a national specialty pharmacy and infusion services provider, has been added to the limited distribution network for Corifact® [Factor XIII Concentrate (Human)], manufactured by CSL Behring. Corifact is the only FDA-approved treatment for congenital Factor XIII (FXIII) deficiency, reported to be one of the rarest bleeding disorders in the […]

Inspiration Biopharmaceuticals Announces Clinical Hold of Clinical Trials Evaluating IB1001 for the Treatment and Prevention of Bleeding in Hemophilia B

July 10, 2012

Inspiration releases an important update about their clinical trial program for IB1001, an intravenous recombinant factor IX (rFIX) product that is being investigated for the treatment and prevention of bleeding episodes in people with hemophilia B. Click here for the official聽IBI press release.

Biogen Idec and Sobi Initiate Global Clinical Trials of Long-Lasting Hemophilia A and B Product Candidates in Children

July 5, 2012

Weston, Mass and Stockholm, Sweden – July 5, 2012 – Biogen Idec (NASDAQ:BIIB) and Swedish Orphan Biovitrum (STO:SOBI) today announced the initiation of two global pediatric clinical trials of the companies’ long-lasting recombinant Factor VIII and Factor IX Fc fusion proteins (rFVIIIFc and rFIXFc) in hemophilia A and B. rFVIIIFc and rFIXFc are fully-recombinant clotting […]

Baxter, 2 mL Diluent Volume for Advate

March 26, 2012

BAXTER INTRODUCES 2 mL DILUENT VOLUME FOR ADVATE [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method] Providing Less Volume to Infuse   ADVATE is now available with a 2 mL diluent (sterile water for infusion) volume for dosage strengths ranging from 250 IU to 1700 IU. This represents a reduction in diluent volume from 5 mL to 2 […]

Baxter Recall: Gammagard Liquid

March 14, 2012

URGENT: BIOLOGIC RECALL INFORMATION Initiated by :聽聽Baxter Healthcare Event Id :聽聽151 Event Date :聽聽03-14-2012 Therapy Gammagard Liquid [Immune Globulin Intravenous (Human)] 10% NDC Number Lot Number Size Packaging Expiration Date 0944-2700-06 LE12LG70AC 20g vial 11-25-2014 Reason Baxter Healthcare Corporation is voluntarily recalling lot LE12LG70AC of GAMMAGARD LIQUID, [Immune Globulin Intravenous (Human)] 10%, 20g size, product […]

Pfizer’s Delivers New Dosage Strength Hemophilia B

February 16, 2012

Pfizer Hemophilia is pleased to announce that the 3000 IU dose of BeneFIX® is now available for hemophilia B patients. BeneFIX is a recombinant coagulation factor IX product indicated for the control, prevention and perioperative management of bleeding episodes in adult and pediatric patients with hemophilia B. Pfizer Hemophilia is the first to offer this […]

Recall of Crickit庐 Convenience Kits

February 7, 2012

Click here for FDA recall North American Rescue, LLC Announces A Follow-Up to the Recall of Crickit® Convenience Kits Because of Possible Health Risk Related to Nationwide Recall of Triad Povidone Iodine Prep Pads Contact: Consumer 1-888-689-6277, Monday through Friday, 8:00am to 5:00pm (ET) FOR IMMEDIATE RELEASE – February 6, 2012 – Greer, SC, February […]


January 5, 2012

Link to Baxter’s Press Release BAXTER INITIATES PHASE I CLINICAL TRIAL OF LONGER-ACTING RECOMBINANT FVIII TREATMENT FOR HEMOPHILIA A Investigational BAX 855 is based on ADVATE Factor VIII Molecule DEERFIELD, Ill., January 5, 2012 – Baxter International Inc. today announced the dosing of the first patients in a Phase I clinical trial of its lead […]

FDA Approves Baxter’s ADVATE as the Only FVIII for Routine Prophylaxis

December 19, 2011

Direct link to Press Release ADVATE for routine prophylaxis reduced annual bleed events in hemophilia A patients from forty-four to one as compared to an on-demand regimen in a clinical study Once every third day pharmacokinetic dosing option offers some patients the opportunity for fewer infusions annually DEERFIELD, Ill., December 16, 2011 – Baxter International […]

Baxter: Labeling Error on Sterile Water

November 17, 2011

Link to NHF’s Medical Advisory November 16, 2011 Baxter Healthcare Corporation has sent a notice of a labeling error affecting the expiration date of the Sterile Water for Injection that is packaged as a diluent with RECOMBINATE [Antihemophilic Factor (Recombinant)]. The Sterile Water for Injection label indicates that the shelf life is longer than what […]

Baxter: Phase III trial of Von Willebrand Treatment

October 14, 2011

FOR IMMEDIATE RELEASE Media Contacts: Deborah Spak, (847) 948-2349 Marie Kennedy, (805) 372-3543 Investor Contacts: Mary Kay Ladone, (847) 948-3371 Clare Trachtman, (847) 948-3085 BAXTER INITIATES PHASE III TRIAL OF INVESTIGATIONAL BAX 111 FOR THE TREATMENT OF VON WILLEBRAND DISEASE First Recombinant Product in Clinical Development for Most Common Inherited Bleeding Disorder DEERFIELD, Ill., OCTOBER […]

Sign up for E-mails, Dateline Magazine, and other ways to stay connected.