Pharma News

New drug formulary will help expedite use of agents in clinical trials

  • Posted on: 13 January 2017
  • By: PharmaTutor News

The National Cancer Institute (NCI) launched a new drug formulary (the "NCI Formulary") that will enable investigators at NCI-designated Cancer Centers to have quicker access to approved and investigational agents for use in preclinical studies and cancer clinical trials. The NCI Formulary could ultimately translate into speeding the availability of more-effective treatment options to patients with cancer.


Study unveils how stress may increase risk of cardiac disease and stroke

  • Posted on: 13 January 2017
  • By: PharmaTutor News

Heightened activity in the amygdala - a region of the brain involved in stress - is associated with a greater risk of heart disease and stroke, according to a study published in The Lancet that provides new insights into the possible mechanism by which stress can lead to cardiovascular disease in humans.


OmniActive acquire Indfrag Ltd

  • Posted on: 12 January 2017
  • By: Shalini.Sharma

OmniActive Health Technologies Ltd. announced that it has acquired 85 per cent stake, and has entered into definitive agreements to acquire the balance stake, in Bangalore-based leading health and nutrition active natural ingredients player Indfrag Ltd (Indfrag). The acquisition includes all products related to Indfrag’s Food and Nutrition business. 

This is in line with OmniActive’s programme to create global partnerships which help expand the portfolio of high quality authenticated ingredients for the dietary supplement and functional food industries.


Enanta declare results from phase 3 CERTAIN-1 study of genotype 1 chronic HCV infected Japanese patients

  • Posted on: 12 January 2017
  • By: Shalini.Sharma

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 Enters Into Licensing Agreement with Assembly Biosciences

  • Posted on: 12 January 2017
  • By: Shalini.Sharma

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 acquire Lysosomal Therapeutics

  • Posted on: 12 January 2017
  • By: Shalini.Sharma

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's RHB-105 Results Presented at the Innovations in Gastroenterology 2017 Symposium

  • Posted on: 12 January 2017
  • By: Shalini.Sharma

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’s Phase III Study of PLX-PAD Cells approved by U.S. FDA

  • Posted on: 12 January 2017
  • By: Shalini.Sharma

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.


Lee's Pharma sign exclusive license of monoclonal antibody drug, TAB014 from Tot Biopharm

  • Posted on: 12 January 2017
  • By: Shalini.Sharma

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.


FDA grants Roche’s TECENTRIQ (atezolizumab) Priority Review

  • Posted on: 12 January 2017
  • By: Shalini.Sharma

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.


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