FibroGen Announces Positive Topline Results from Phase 2 Study of Pamrevlumab in Idiopathic Pulmonary Fibrosis
Aug. 07, 2017
FibroGen, Inc., a science-based biopharmaceutical company, has announced positive topline results from the company’s Phase 2 randomized, double-blind, placebo-controlled study and two combination safety sub-studies of pamrevlumab in patients with idiopathic pulmonary fibrosis (IPF). Pamrevlumab is a proprietary, first-in-class, anti-connective tissue growth factor (CTGF) antibody being evaluated in fibrotic disease and cancer.
August 08, 2017
Dermira, Inc. has announced that it has entered into a licensing agreement with F. Hoffmann-La Roche Ltd and Genentech, Inc., a member of the Roche Group (together Roche). Pursuant to the agreement, Dermira will obtain exclusive, worldwide rights to develop and commercialize lebrikizumab, a monoclonal antibody targeting interleukin 13 (IL-13), for atopic dermatitis and all other indications, except Roche will retain certain rights, including exclusive rights to develop and promote lebrikizumab for interstitial lung diseases, such as idiopathic pulmonary fibrosis.
NICE Recommends Erbitux® in Combination with Platinum-Based Chemotherapy for the Treatment of Recurrent and/or Metastatic Head and Neck Cancer
8 August, 2017
Merck KGaA, a leading science and technology company, has announced that the National Institute for Health and Care Excellence (NICE) for England has issued a positive Final Appraisal Determination (FAD) recommending the routine National Health Service (NHS) use of Erbitux® (cetuximab) in combination with platinum-based chemotherapy as a first-line therapy for the treatment of patients with recurrent and/or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN) in the oral cavity. NICE’s decision confirms the positive benefit Erbitux can have on the survival of patients in this setting.
August 10, 2017
Biotecnol Limited and Cancer Research UK (CRUK) have announced that an experimental immuno-oncology treatment will move into early phase clinical trials for patients with advanced solid tumors, including lung cancers, under a collaboration agreement between Cancer Research UK and Biotecnol Limited. Cancer Research UK will support the early clinical development of the company’s promising first-in-class drug called Tb535H.
Ophthotech Announces Results from Third Phase 3 Trial of Fovista® in Wet Age-Related Macular Degeneration
August 14, 2017
Ophthotech Corporation has announced that the pre-specified primary endpoint of mean change in visual acuity at 12 months was not achieved in its Phase 3 clinical trial investigating the superiority of Fovista® (pegpleranib) anti-PDGF therapy in combination with Eylea® (aflibercept) or Avastin® (bevacizumab) anti-VEGF therapy compared to Eylea® or Avastin® monotherapy for the treatment of wet age-related macular degeneration (AMD). The addition of 1.5mg of Fovista® to an Eylea® or Avastin® regimen did not result in benefit as measured by the mean change in visual acuity at the 12-month time point.
Lexicon Pharmaceuticals reports additional positive data from pivotal phase 3 intandem2 study of Sotagliflozin
August 15, 2017
Lexicon Pharmaceuticals, Inc. has announced additional positive data from the pivotal Phase 3 inTandem2 study of sotagliflozin, an investigational dual SGLT1 and SGLT2 inhibitor. It was previously announced that both doses of sotagliflozin achieved the primary endpoint of the inTandem2 study, showing statistically significant reductions in A1C at 24 weeks in adult patients with type 1 diabetes on a background of optimized insulin. The new data showed that the A1C benefit was sustained over 52 weeks as well as achievement of all secondary endpoints for both sotagliflozin doses.
Bristol-Myers Squibb Announces Topline Results from CheckMate -214, a Phase 3 Study of Opdivo in Combination with Yervoy in Intermediate and Poor-Risk Patients with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma
August 15, 2017
Bristol-Myers Squibb announced topline results today from the CheckMate -214 trial investigating Opdivo (nivolumab) in combination with Yervoy (ipilimumab) versus sunitinib in intermediate and poor-risk patients previously untreated advanced or metastatic renal cell carcinoma. The combination met the co-primary endpoint of objective response rate (ORR) and achieved a 41.6% ORR versus 26.5% for sunitinib.