Global Plasma Leaders Collaborate to Accelerate Development of Potential COVID-19 Hyperimmune Therapy
The following is from a press release featuring various industry partners. See the press release here. Partnership brings together world-leading plasma companies to focus on developing and delivering a hyperimmune immunoglobulin in the global fight against COVID-19Biotest, BPL, LFB, and Octapharma have joined an alliance formed by CSL Behring and Takeda Pharmaceutical Company Limited to […]
HEMA Biologics Announces FDA Approval of SEVENFACT
The following is a press release from HEMA Biologics. HEMA BiologicsTM Announces FDA Approval of SEVENFACT® [coagulation factor VIIa (recombinant)-jncw] for Treatment and Control of Bleeding Episodes Occurring in Adult and Adolescent Hemophilia A and B Patients with Inhibitors Louisville, KY – April 6, 2020 HEMA Biologics, LLC, (“HEMA Biologics”) today announced that the U.S. […]
Takeda Announces Program Updates During COVID-19
The following is information shared with the bleeding disorders community by Takeda. “Takeda has been closely monitoring the news surrounding COVID-19. Our highest priority is the health and safety of our community during this uncertain time.We are taking steps to help ensure the community’s safety including postponing upcoming educational events such as our HELLO TALK® […]
Pfizer Pauses Recruitment to Clinical Studies
The following is information shared by Pfizer Inc. “To avoid adding to the demands on the healthcare system during this unprecedented crisis with COVID-19, we are pausing for three weeks the recruitment portion of our new and ongoing global interventional clinical studies. We are taking this action in the interests of public health, so that […]
uniQure Announces Achievement of Target Patient Dosing in HOPE-B Pivotal Trial
The following is a press release from uniQure. uniQure N.V., a leading gene therapy company advancing transformative therapies for patients with severe unmet medical needs, announced it has achieved the targeted dosing of patients in the HOPE-B pivotal trial of etranacogene dezaparvovec (AMT-061), an investigational AAV5-based gene therapy incorporating the patent-protected FIX-Padua variant for the […]
Spark Temporarily Suspends New Enrollment in Study
The following is a letter provided by Spark Therapeutics. “In the unprecedented time of the COVID-19 (novel coronavirus) pandemic, Spark Therapeutics has closely monitored this evolving situation and taken steps to protect the well-being and safety of both our workforce and the patients and families we serve.In reference to our ongoing gene therapy clinical program […]
Octapharma Letter on Inventory During COVID-19
The following is a letter provided by Octapharma. “As we all manage the challenges presented by the Coronavirus pandemic, Octapharma USA would like to remind you of our commitment to providing our customers life-saving therapies, manufactured to the highest standards of viral clearance and safety. Our staff continues to focus on maintaining production of all of […]
Hemlibra Supply and Coronavirus Update
The following is a press release from Genentech. “The World Health Organization has declared the COVID-19 (coronavirus) outbreak a global pandemic. We extend our heartfelt sympathies to everyone who has lost loved ones, to patients and healthcare professionals battling this devastating outbreak.With multiple countries implementing measures to slow the spread of the virus, based on […]
Pfizer Hemophilia Product Availability Status During COVID-19
The following is a press release from Pfizer. Pfizer Confirms BeneFIX® and XYNTHA® Remain Available Pfizer recognizes the public concern in relation to the COVID-19 pandemic, which continues to evolve. We are actively monitoring the situation across the globe, assessing the implications to our patients, colleagues and company, and taking actions to support continued health […]
Takeda Guidance on Novel Coronavirus and Product Supply
The following is a letter from Takeda.  “To the bleeding disorders community, As a global pharmaceutical leader, our top priority during the ongoing COVID-19 outbreak is to do all we can to make sure our medicines and services continue to reach the individuals who rely on them, while we protect the health of our employees, those […]