EMA Grants Orphan Drug Designation for Annamycin for AML
“We are pleased to receive Orphan Drug Designation from the EMA for Annamycin, which further supports our ongoing efforts to advance this compelling next-generation anthracycline for the treatment of hard-to-treat cancers,” commented Walter Klemp, Chairman and Chief Executive Officer of Moleculin. “Combined with the Orphan Drug Designation we already have in the US and with the new composition of matter patent just awarded by the US Patent and Trademark Office with coverage through 2040, we believe the commercial exclusivity of Annamycin is now very well protected. We continue to be encouraged by the growing body of promising interim clinical data demonstrated by Annamycin. We remain focused on advancing our clinical and regulatory strategies toward our next phase of development, including the planned commencement of a pivotal registration study as a 2nd line therapy in AML before year end.”
Share:
More News
Lamine Mbow, Global Head of Discovery Research, Boehringer Ingelheim, said: “We are building a broad pipeline of ADCs addressing novel tumor target space to develop next-generation cancer treatments. By combining our deep expertise in cancer treatment development with Synaffix’s clinical-stage platform technology, we aim to accelerate the delivery of first-in-class
“The initial therapy of high-risk, non-muscle invasive bladder cancer with BCG has not advanced in decades. Today’s pivotal Phase 3 CREST results are potentially practice-changing, representing the first advance in therapy for BCG-naïve, high-risk, non-muscle invasive cancer in over 30 years,” said Roger Dansey, M.D., Chief Oncology Officer, Pfizer. “These
“Receiving FDA IND clearance is an important milestone in the advancement of TYRA-300 and for patients with NMIBC who urgently need better tolerated therapeutic options,” commented Doug Warner, Chief Medical Officer of TYRA. “We look forward to leveraging Erik’s impressive background to guide our development plans in NMIBC. We expect
“As a leader in hematologic malignancies, AbbVie is committed to advancing innovative treatments for complex cancers like multiple myeloma through our relentless R&D efforts and collaborations,” said Mariana Cota Stirner, M.D., Ph.D., vice president, therapeutic area head for hematology, AbbVie. “We look forward to partnering with Simcere Zaiming, to advance
