Liu Shi, a China native, is eager to find a better treatment for his HIV. The medication currently available to him has to be taken every day and can cause serious side effects, such as drowsiness and kidney and liver failure. He hopes that the newly approved, Albuvirtide will change that. Albuvirtide, developed by Frontier…
FDA Approves First Biosimilar To Neulasta
Fulphia, a biosimilar product of the Mylan-Biocon collaboration, has been approved by the FDA to reduce the duration of febrile neutropenia in patients treated with chemotherapy. Febrile neutropenia refers to the signs of infection resulting from a low count of neutrophils, a type of white blood cell. This marks the second biosimilar approval granted to…
Johnson & Johnson Halts Study Due To Liver Safety Concerns
Several years ago, Janssen, part of Johnson & Johnson, began the study of their investigational drug, a BACE inhibitor, for late-onset preclinical stage Alzheimer’s disease. However, earlier today, the company released a statement announcing the end of the study due to the observation of serious liver enzymes in some of the study participants who received…
FDA Names Drugmakers Accused Of Blocking Generics
Last week, Trump and Health & Human Secretary, Alex Azar, stated they were going to crack down on the drug manufacturers that “play” the system by blocking competitors from developing cheaper, generic versions of their products. The idea is that this would increase competition in the pharmaceutical industry, which would help lower the cost of drugs.…
FDA Approves First Non-Opioid For Management Of Opioid Withdrawal Symptoms
On Wednesday, U.S. WorldMed’s Lucemyra became the first non-opioid therapy for the management of opioid withdrawal symptoms approved by the FDA. FDA Commissioner Scott Gottlieb commented on the approval, saying, “as part of our commitment to support patients struggling with addiction, we’re dedicated to encouraging innovative approaches to help mitigate the physiological challenges presented when patients discontinue…
FDA Approves First Biosimilar Of 2018
The approval of Pfizer’s Retacrit marks the FDA’s first biosimilar approval of 2018. Retacrit (epoetin alfa-epbx) is a biosimilar to Epogen/Procrit (epoetin alfa) for the treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection. Retacrit is also approved for use before and after surgery to reduce…
Novartis Receives FDA Rejection
The FDA issued Sandoz, a Novartis division, a complete response letter (CRL) regarding the Biologics Licensing Application (BLA) for its proposed biosimilar Rituxan (rituximab). The FDA issues CRLs when they are not ready to approve a product. Deutsche Bank analyst, Tim Race states he anticipated Rituxan sales to drop by about $150 million this year as a…