This rigorous four-day program is ideal for those who are looking for an in-depth, hands-on introduction to conducting laboratory audits. Participants will come away with a basic understanding of audit [….]
Preparing for a Laboratory Audit
FDA Approves First Gene Therapy to Treat Adults with Hemophilia B
Today, the U.S. Food and Drug Administration approved Hemgenix (etranacogene dezaparvovec), an adeno-associated virus vector-based gene therapy for the treatment of adults with Hemophilia B (congenital Factor IX deficiency) who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.
FDA Approves New Treatment Option for Patients with ALS
The U.S. Food and Drug Administration today approved Relyvrio (sodium phenylbutyrate/taurursodiol) to treat patients with amyotrophic lateral sclerosis (ALS), commonly referred to as Lou Gehrig’s disease.
U.S. FDA Approves CARVYKTI™ (ciltacabtagene autoleucel), Janssen’s First Cell Therapy, a BCMA-Directed CAR-T Immunotherapy for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. Food and Drug Administration (FDA) has approved CARVYKTI™ (ciltacabtagene autoleucel; cilta-cel) for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.1 The approval is based on data from the pivotal CARTITUDE-1 study, which included patients who had received a median of six prior treatment regimens (range, 3-18), and had previously received a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.1 In December 2017, Janssen entered into an exclusive worldwide license and collaboration agreement with Legend Biotech USA, Inc. to develop and commercialize ciltacabtagene autoleucel.
FDA clears wireless, blood pressure-monitoring finger sensor from Caretaker Medical
Published on :The FDA has cleared a next-generation system to continuously monitor patients’ blood pressure while they’re undergoing surgery without the use of inflatable cuffs or invasive arterial catheters.
Maryland Urologist, Founder of Perineologic Develops Safe Approach to Prostate Cancer Biopsy
For the past 30 years, screening for prostate-specific antigen (PSA) levels has been the gold standard for screening of prostate cancer. When high levels are found, physicians typically turn to a diagnostic biopsy using a transrectal route. However, a Maryland urologist has developed a different approach through the perineum, the strip of skin between the rectum and scrotum that is safer and more effective.
How to Partner with the Frederick National Lab and National Cancer Institute
Both the FNL and NCI look for partnerships that can aid their work while providing their partners’ resources and expertise. The lab’s partners often include big pharmaceutical and biotech companies that are more product-driven than NCI and FNL, which are more research-driven.
5 Questions with Sue Carr, RPh, President and Founder, CarrTech, LLC
Sue Carr RPh is President and Founder of CarrTech LLC, a medical device company. CarrTech has developed, patented, and prototyped an all-in-one package one needle filter device to increase safety and compliance while reducing time and waste. CarrTech’s mission is to improve healthcare by making medication preparation safer.
Baltimore’s Personal Genome Diagnostics Secures $103 Million in Financing
Cancer genomics company Personal Genome Diagnostics Inc. (PGDx) secured $103 million in a Series C financing round. Proceeds from the financial infusion will be used to expand the company’s tissue-based and liquid biopsy portfolio and its global commercial footprint to support growth.
Aurinia Wins FDA Approval for First LN Oral Drug
The FDA greenlit Aurinia’s Lupkynis (voclosporin) in combination with a background immunosuppressive therapy regimen for LN, a serious progression of systemic lupus erythematosus (SLE), a chronic, complex and autoimmune disease. The approval not only marks the first medication in the United States specifically approved for active LN, it also marks the first for Aurinia, which is headquartered in Canada and last year opened its 30,000 square-foot commercialization facility in the BioHealth Capital Region.