Pharma News

Enanta Pharmaceuticals, Inc., a research and development-focused biotechnology company, announced results from AbbVie’s phase 3 CERTAIN-1 study of 8 weeks of treatment with AbbVie’s investigational, pan-genotypic, ribavirin (RBV)-free regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) in Japanese patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection without cirrhosis. Top-line results from the study demonstrated 99 per cent (n=105/106) of patients without cirrhosis, who represent the majority of HCV patients, and without the Y93H variant, achieved sustained virologic response at 12 weeks after treatment (SVR12). The one patient who did not reach SVR12 in this intent to treat (ITT) population was lost to follow-up. All 23 patients with the Y93H variant were assigned to the G/P arm of this comparator study, and 100% achieved SVR12.

Allergan plc and Assembly Biosciences, Inc. announced that Allergan has entered into a research, development, collaboration and license agreement for the worldwide rights to Assembly's microbiome gastrointestinal (GI) development programs. The agreement provides Allergan with worldwide rights to preclinical compounds ABI-M201 and ABI-M301, targeting ulcerative colitis (UC) and Crohn's disease (CD), as well as two additional compounds to be identified by Assembly for Irritable Bowel Syndromes (IBS); with Diarrhea (IBS-D), with Constipation (IBS-C) or Mixed (IBS-M).

Allergan plc, a leading global pharmaceutical company, and Lysosomal Therapeutics (LTI) announced that Allergan has purchased an exclusive option right to acquire LTI.  LTI is focused on innovative small-molecule research and development in the field of neurodegeneration, yielding new treatment options for patients with severe neurological diseases.

RedHill Biopharma Ltd.  announced that the positive final results, announced in June 2015, of the first Phase III study with RHB-105 for the treatment of H. pylori infection were presented by Ira Kalfus, MD, Medical Director at RedHill, at the Innovations in Gastroenterology 2017 Symposium, held in Israel on Friday, January 6, 2017, and received the Second Place Best Abstract Award. RHB-105 is a proprietary, fixed-dose, oral combination therapy for the eradication of H. pylori infection.

Pluristem Therapeutics Inc. announced that the Company’s Phase III study of its PLX-PAD cells in the treatment of critical limb ischemia (CLI) was cleared by the U.S. Food and Drug Administration (FDA). Pluristem’s strategy is to use this single multinational Phase III study to support the submission of a biologics license application (BLA) to the FDA for marketing approval. Pluristem expects to begin enrolling patients in its Phase III study in both the U.S. and Europe during the first half of 2017.

Tot Biopharm Co., Ltd., a high-tech bio-pharmaceutical company, and Lee's Pharmaceutical Holdings Limited, a Hong Kong-based public biopharmaceutical company, jointly announced that Lee's Pharma, through its wholly-owned subsidiary Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Limited has acquired the exclusive license of TAB014, the monoclonal antibody drug developed and manufactured by Tot Biopharm, within China. TAB014 is a new antibody product that can be used to treat wet age-related macular degeneration (wAMD) and other eye diseases.

Roche announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for TECENTRIQ® (atezolizumab) for the treatment of people with locally advanced or metastatic urothelial carcinoma (mUC) who are ineligible for cisplatin chemotherapy, and are either previously untreated (first-line) or have disease progression at least 12 months after receiving chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant). Urothelial carcinoma accounts for 90 percent of all bladder cancers and can also be found in the renal pelvis, ureter and urethra.

Lipocine Inc.  announced receipt of additional guidance from the U.S. Food and Drug Administration ("FDA") on the LPCN 1107 pivotal Phase 3 clinical study design.  LPCN 1107, a novel oral hydroxyprogesterone caproate ("HPC") product candidate that has been granted orphan drug designation by the FDA, is in development for the proposed indication of reducing the risk of preterm birth ("PTB") in women with singleton pregnancy who have a history of singleton spontaneous PTB. Prevention of PTB is a significant unmet need as ~11.7% of all U.S. pregnancies result in PTB (delivery less than 37 weeks), a leading cause of neonatal mortality and morbidity

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Egalet Corporation announced that the U.S. Food and Drug Administration (FDA) has approved ARYMO™ ER (morphine sulfate) extended-release (ER) tablets C-II for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Ajanta Pharma Limited, a specialty pharmaceutical formulation company, has received US FDA final approval for duloxetine hydrochloride delayed release capsules.