Specialty Oncology Drugs One of the Top Markets Generating Most Growth - Seite 2

In other pharma and biotech developments in the markets of note this week: 

Opko Health Inc. (NASDAQ:OPK) recently announced its partner Vifor Fresenius Medical Care Renal Pharma (VFMCRP) has received approval from Health Canada to market RAYALDEE® in Canada for the treatment of secondary hyperparathyroidism (SHPT) in adults with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency. "We established a global development and commercialization plan for RAYALDEE as this therapy addresses an important medical need in CKD patients worldwide, and we want to ensure that as many people as possible have access to its benefits," stated Phillip Frost, M.D., Chairman and Chief Executive Officer of OPKO Health. "We congratulate our partner Vifor Fresenius on their achievement and thank them for the dedication and hard work they put into reaching this milestone event."

Celgene Corporation (NASDAQ:CELG) recently announced results from a phase III, randomized, double-blind, international clinical study (AUGMENT). REVLIMID® (lenalidomide) plus rituximab (R2) achieved a highly statistically significant improvement in the primary endpoint of progression-free survival (PFS), compared to rituximab plus placebo, in the final PFS analysis. AUGMENT evaluated the efficacy and safety of the investigational combination of R2 versus rituximab plus placebo in patients (N=358) with relapsed/refractory follicular and marginal zone lymphoma. In addition to achieving the primary endpoint of the study, a favorable trend was observed for overall survival (OS) during this analysis and follow-up will continue for the mature OS results. The safety profile of R2 was consistent with the known safety profiles of the individual medicines, and no new safety signals were identified with the combination.

Nektar Therapeutics (NASDAQ:NKTR) recently announced that the U.S. Food and Drug Administration (FDA) has filed and accepted for review the company's New Drug Application (NDA) for NKTR-181 for the treatment of chronic low back pain in adult patients new to opioid therapy. NKTR-181 is a new molecular entity (NME) and the first analgesic opioid molecule to exhibit a low incidence of specific CNS-mediated side effects, such as euphoria, through the targeted alteration of brain-entry kinetics. The NDA is expected to be assigned a PDUFA (Prescription Drug User Fee Act) target action date of May 28, 2019 by the FDA. Nektar's NDA submission is supported by an extensive clinical and nonclinical data package. The clinical data submitted in the NDA comprised 15 studies in 2,234 subjects and includes a 600-patient efficacy study in patients with chronic low back pain who are new to opioid therapy; a 630-patient long-term 52-week safety study in patients with noncancer pain, who are new to opioid therapy, as well as those who are experienced with opioid therapy; pharmacokinetic/ pharmacodynamic studies in over 450 subjects; and two human abuse potential studies evaluating both therapeutic and supratherapeutic doses of NKTR-181 versus an oxycodone control in recreational drug users.