Pharma News

Daiichi Sankyo Company, Limited  announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its investigational HER2-targeting antibody drug conjugate DS-8201 for the treatment of HER2-positive unresectable and/or metastatic breast cancer in patients who have progressed after prior treatment with HER2-targeted therapies including ado-trastuzumab emtansine (T-DM1).

Pfizer Inc. announced new data from a randomized Phase 2 study of glasdegib (PF-04449913), an oral, smoothened (SMO) inhibitor, showing the addition of glasdegib to low-dose cytarabine (LDAC) significantly increased overall survival (OS) when compared to LDAC alone in patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS) who were ineligible for intensive chemotherapy (HR: 0.501, 80% CI: 0.384, 0.654, one-sided log rank p-value 0.0003). Glasdegib is the first SMO inhibitor to show clinical benefit in this patient population. These data were presented today at the 58th American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego, CA.

Helsinn Integrative Care, Helsinn’s business unit focused on evidence-based, non-pharmaceutical cancer supportive care products, announces that Xonrid® Gel, a topical gel for radiotherapy-induced dermatitis, already classified as a medical device in the EU, has received 510(K) FDA clearance in the US.

Dr Reddy’s Laboratories has launched nystatin and triamcinolone acetonide cream, USP, in the United States market, approved by the US Food & Drug Administration (FDA).

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Lundbeck announced the US Food and Drug Administration (FDA) has determined that the supplemental New Drug Application (sNDA) for the expanded labeling of Abilify Maintena for the maintenance treatment of bipolar I disorder in adult patients is sufficiently complete to permit a substantive review and is considered filed. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target date of July 28, 2017, to complete its review.

MonoSol Rx, a specialty pharmaceutical company leveraging its PharmFilm® drug delivery technology to improve patient outcomes and to address unmet needs, announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to Diazepam Buccal Soluble Film (Diazepam BSF) for the treatment of Acute Repetitive Seizures (ARS). The Company plans to initiate a pivotal study of Diazepam BSF in adults in early 2017. 

Biostage, Inc. a biotechnology company developing bioengineered organ implants to treat cancers and other life-threatening conditions of the esophagus, bronchus and trachea, announced that its Cellspan™ Esophageal Implant was granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) to restore the structure and function of the esophagus subsequent to esophageal damage due to cancer, injury or congenital abnormalities.

AbbVie , a global biopharmaceutical company,  announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to risankizumab (ABBV-066; formerly BI 655066) for the investigational treatment of Crohn's disease in pediatric patients. Risankizumab is being evaluated in immunological disorders, including Crohn's disease, psoriasis, psoriatic arthritis and asthma.

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Vtesse, Inc., a company committed to developing medicines to benefit patients with ultra rare, life-threatening diseases, announced that the US Food and Drug Administration (FDA) granted Rare Pediatric Disease designation to VTS-270, the company’s investigational drug for children with Niemann-Pick Type C1 disease (NPC). NPC is a progressive, irreversible, chronically debilitating – and ultimately lethal – genetic disease.