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STOCKHOLM, SWEDEN - April 9, 2021. Karolinska Development AB (Nasdaq Stockholm: KDEV) announces today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Aprea Therapeutics drug candidate eprenetapopt for the treatment of acute myeloid leukemia (AML). KDev Investments, a company jointly owned by Karolinska Development and Rosetta Capital, holds 8 percent of the shares in Aprea Therapeutics, which is listed on Nasdaq Global Select Market in the USA.
Eprenetapopt is a small molecule targeting the tumor suppressor protein p53. Mutations of the p53 gene occur in around 50% of all human tumors and are associated with poor overall survival.
Press release content from Globe Newswire. The AP news staff was not involved in its creation.
Aprea Therapeutics Receives FDA Orphan Drug Designation for Eprenetapopt for the Treatment of .
Aprea TherapeuticsApril 8, 2021 GMT
BOSTON, April 08, 2021 (GLOBE NEWSWIRE) Aprea Therapeutics, Inc. (Nasdaq: APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate the mutant tumor suppressor protein, p53, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to eprenetapopt for treatment of AML.
“We are pleased to have been granted Orphan Drug designation by FDA for eprenetapopt in AML, building on the Fast Track designation in AML that was granted in November 2020,” said Christian S. Schade, Chairman and Chief Executive Officer of Aprea. “We look forward to continued productive dialogue with FDA and bringing eprenetapopt to patients as soon as possible.”
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The FDA granted orphan drug designation to CLBS12, an investigational nongene-edited cell therapy for the treatment of Buerger’s disease, according to the agent’s manufacturer.
Buerger’s disease, also known as thromboangiitis obliterans, is a condition related to critical limb ischemia and has no approved treatments in the United States.
Source: Adobe Stock.
CLBS12 (Honedra, Caladrius Biosciences) is an autologous cell therapy derived from CD34+ cells. Patients who receive the therapy undergo apheresis that includes drug-induced mobilization of CD34+ cells from bone marrow. The cells are subsequently isolated, concentrated and administered as an IV infusion.
Thursday, February 4, 2021
Market research shows that more than half of US households keep pets, and this number is likely to increase as people continue to be isolated, stay at home, or seek the mental and physical benefits associated with pet ownership during the COVID-19 outbreak. With ownership comes responsibility for the welfare of pets; however, healthcare can be only as good as the available diagnostic tools and treatments. Beyond routine checkups, preventative medicine, and the diagnosis and treatment of common diseases in animals, veterinary medicine often uses drugs and devices to diagnose and treat rare diseases.
Through the Minor Use/Major Species (MUMS) pathway, the U.S. Food and Drug Administration (FDA), recently granted conditional approval to Anivive Lifesciences Inc. for verdinexor (Laverdia-CA1) tablets as a treatment for canine lymphoma, a disease that affects fewer than 70,000 dogs in the U.S. each year. Similar to the FDA’s Orphan Products
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NEW YORK, Jan. 27, 2021 /PRNewswire/
Q BioMed Inc. (OTCQB: QBIO), announced today that the U.S. Food and Drug Administration s Office of Orphan Products Development has granted Orphan Drug Designation to
Uttroside-B, a small molecule chemotherapeutic for the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer. In preclinical studies, Uttroside-B was up to 10-times more potent against HCC cells than Sorafinib, the standard of care drug at the time.
As an Orphan Drug, Uttroside-B may benefit from a seven-year market exclusively following marketing approval, grant funding for clinical trials that contribute to marketing approval, protocol assistance, and tax credits. Preclinical testing is now underway to support an FDA Investigational New Drug (IND) application expected this year.