Industry News

NeuroDerm Ltd. , a clinical stage pharmaceutical Company developing drugs for central nervous system (CNS) disorders,  announced the completion of a pilot study (trial 101) in healthy subjects comparing the pharmacokinetics (PK) of ND0701, the Company’s proprietary continuous, subcutaneously delivered apomorphine liquid formulation, and commercial apomorphine (APOGO®). Study results demonstrate that ND0701 produced PK results that were comparable to those produced by the referenced drug.  Based on these results, the Company plans to pursue a PK similarity regulatory development route in the EU for ND0701, will initiate a follow-up comparison PK study in the first half of 2017 and meet with European regulatory authorities in the second half of 2017 to discuss its development strategy.  The Company is evaluating in parallel the development of ND0701 for the U.S. market.

NeuroDerm Ltd. , a clinical stage pharmaceutical company developing drugs for central nervous system (CNS) disorders, announced that following its End-of-Phase 2 meeting with the United States Food and Drug Administration (FDA) in late October, the Company intends to pursue a comparative bioavailability regulatory path for the Company's lead product candidate ND0612 based on comparative pharmacokinetic (PK) data in place of data from Phase 3 clinical efficacy trials.

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Roche announced data from the positive, pivotal phase III GALLIUM study that compared Gazyva/Gazyvaro (obinutuzumab) plus chemotherapy followed by Gazyva/Gazyvaro alone head-to-head against MabThera/Rituxan (rituximab) plus chemotherapy followed by MabThera/Rituxan alone for people with previously untreated follicular lymphoma. At a pre-planned interim analysis in May 2016, an independent data monitoring committee determined that the study met its primary endpoint early. The results showed Gazyva/Gazyvaro-based treatment reduced the risk of disease worsening or death (progression-free survival; PFS, as assessed by investigator) by 34 percent compared to MabThera/Rituxan-based treatment (HR=0.66; 95% CI 0.51-0.85, p=0.0012). Median PFS was not yet reached. Adverse events with either Gazyva/Gazyvaro or MabThera/Rituxan were consistent with those seen in previous studies.

Novelion Therapeutics, Inc.,specialty pharmaceutical company, announced that its subsidiary, Aegerion Pharmaceuticals, Inc., has entered into a licensing agreement with Amryt Pharma (Amryt) for the exclusive rights to Lojuxta (lomitapide) hard capsules in certain European and Middle Eastern territories.

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.