Biotech Stocks

Why Expensive U.S. Drug Trials are Pushing Pharma Research Overseas - Seite 3

Dr. Robert Shepard, Moleculin's Chief Medical Officer for Annamycin added: "With the Polish trial now progressing to 150 mg/m², we expect to see even better results. And, although 150 mg/m² was the maximum tolerable dose established by the prior developer of Annamycin due to the incidence of mucositis in patients above that dose level, now that the cryotherapy protocol is well understood to mitigate the potential for dose-limiting mucositis, there is a good opportunity for dose levels to progress even beyond 150 mg/m², so the potential to help patients is very exciting."   Read this and more news for MBRX at:  https://www.financialnewsmedia.com/news-mbrx/

Other recent developments in the biotech industry include:

Zynerba Pharmaceuticals, Inc. (NASDAQ: ZYNE) the leader in innovative pharmaceutically-produced transdermal cannabinoid therapies for rare and near-rare neuropsychiatric disorders, recently announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for the Company's lead development candidate Zygel (ZYN002 CBD gel) for treatment of behavioral symptoms associated with Fragile X Syndrome (FXS). FDA's Fast Track program is designed to facilitate the development of drugs intended to treat serious conditions and fill unmet medical needs, and can lead to expedited review by FDA in order to get new important drugs to the patient earlier.

"The FDA's decision to grant Fast Track Designation for Zygel underscores the significance and severity of the unmet medical need that exists for patients living with Fragile X Syndrome and their caregivers," said Armando Anido, Chairman and Chief Executive Officer of Zynerba. "We believe that Zygel has the potential to be the first treatment indicated to directly address the core behavioral symptoms of this syndrome, and we look forward to working closely with the FDA to obtain approval to market Zygel as soon as possible."

Esperion Therapeutics, Inc. (NASDAQ: ESPR) recently announced that the U.S. Food and Drug Administration (FDA) has accepted both New Drug Applications for bempedoic acid and the bempedoic acid / ezetimibe combination tablet for filing and regulatory review. Bempedoic acid and the bempedoic acid / ezetimibe combination tablet were developed to be complementary, cost-effective, convenient, once-daily, oral therapies for the treatment of patients with elevated low-density lipoprotein cholesterol (LDL-C) who need additional LDL-C lowering despite the use of currently accessible therapies.