All The Most Important Pharmaceutical News Stories Of The Week – July 2018 – Week #4
Catalyst Biosciences Announces Positive Interim Data from a Phase 2/3 Study of Marzeptacog Alfa (Activated) in Individuals with Hemophilia A or B with Inhibitors
July 18, 2018
Catalyst Biosciences, Inc., a clinical-stage biopharmaceutical company focused on developing novel medicines to address hematology indications, has announced interim data from its Phase 2/3 study of subcutaneous (SQ) prophylactic Factor VIIa (FVIIa) variant marzeptacog alfa (activated) (MarzAA) being developed for the treatment of hemophilia A or B with inhibitors in a poster presentation at the 64TH Annual Scientific and Standardization Committee (SSC) Meeting of the International Society on Thrombosis and Haemostasis (ISTH) in Dublin. The Company also presented the most current data from the Phase 1/2 trial of SQ prophylactic Factor IX (FIX) candidate CB 2679d/ISU304 being developed for the treatment of hemophilia B.
FDA grants Breakthrough Therapy Designation for Roche’s Tecentriq in combination with Avastin as first-line treatment for advanced or metastatic hepatocellular carcinoma (HCC)
July 18, 2018
Roche has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab) as an initial (first-line) treatment for people with advanced or metastatic hepatocellular carcinoma (HCC), the most common form of liver cancer. The designation is based on data from a Phase Ib study assessing the safety and clinical activity of the combination of Tecentriq and Avastin.
Novartis Kisqali® now first and only CDK4/6 inhibitor indicated in US as first-line therapy specifically for premenopausal women; and as initial therapy with fulvestrant in postmenopausal women
July 18, 2018
Novartis has announced a new approval for Kisqali® (ribociclib) from the US Food and Drug Administration (FDA) for women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer. Kisqali is now the only CDK4/6 inhibitor indicated for use with an aromatase inhibitor for the treatment of pre-, peri- or postmenopausal women in the US, and also is indicated for use in combination with fulvestrant as both first- or second-line therapy in postmenopausal women. FDA reviewed this supplemental New Drug Application (sNDA) under its Real-Time Oncology Review and Assessment Aid pilot programs and approved the application in less than one month after submission.
Pfizer And Lilly Announce Positive Top-Line Results from Phase 3 Trial of Tanezumab For the Treatment of Osteoarthritis (OA) Pain
July 18, 2018
Pfizer Inc. and Eli Lilly and Company have announced that a 16-week Phase 3 study in patients with osteoarthritis (OA) pain evaluating subcutaneous administration of tanezumab, an investigational humanized monoclonal antibody, met all three co-primary endpoints. The study demonstrated that patients who received two doses of tanezumab separated by eight weeks experienced a statistically significant improvement in pain, physical function and the patients’ overall assessment of their OA, compared to those receiving placebo. Tanezumab is part of an investigational class of pain medications known as nerve growth factor (NGF) inhibitors and in addition to OA pain, is being evaluated for chronic low back pain (CLBP) and cancer pain (due to bone metastases).
Roche’s Tecentriq in combination with pemetrexed and platinum-based chemotherapy reduced the risk of disease worsening or death in the initial treatment of people with advanced lung cancer
July 19, 2018
Roche has announced that the Phase III IMpower132 study met its co-primary endpoint of progression-free survival (PFS) and demonstrated that the combination of Tecentriq® (atezolizumab) plus chemotherapy (cisplatin or carboplatin plus pemetrexed) reduced the risk of disease worsening or death (PFS) compared to chemotherapy alone in the initial (first-line) treatment of advanced non-squamous non-small cell lung cancer (NSCLC). While a numerical improvement for the co-primary endpoint of overall survival (OS) was observed, statistical significance was not met at this interim analysis, and the study will continue as planned with final OS results expected next year. Safety for the Tecentriq and chemotherapy combination appeared consistent with the known safety profile of the individual medicines, and no new safety signals were identified with the combination.
Allergan and Molecular Partners Announce Two Positive Phase 3 Clinical Trials for Abicipar pegol 8 and 12-week Regimens for the Treatment in Patients with Neovascular Age-Related Macular Degeneration
July 19, 2018
Allergan plc and Molecular Partners, a clinical-stage biopharmaceutical company developing a new class of drugs known as DARPin® therapies, have announced the release of two positive clinical trials, SEQUOIA and CEDAR for abicipar, demonstrating that both the 8-week and 12-week treatment regimens met the pre-specified primary endpoint of non-inferiority to ranibizumab. SEQUOIA and CEDAR are identical global phase 3 studies designed to assess the efficacy and safety of abicipar compared with ranibizumab in treatment-naïve patients with neovascular age-related macular degeneration (AMD). The primary endpoint measured the proportion of treated patients with stable vision at week 52.
July 20, 2018
Pfizer Inc. has announced that the United States (U.S.) Food and Drug Administration (FDA) has approved NIVESTYM™ (filgrastim-aafi), a biosimilar to Neupogen1 (filgrastim), for all eligible indications of the reference product. The FDA approval was based on a review of a comprehensive data package and totality of evidence demonstrating a high degree of similarity of NIVESTYM compared to its reference product.
FDA Grants Approval of TIBSOVO®, the First Oral, Targeted Therapy for Adult Patients with Relapsed/Refractory Acute Myeloid Leukemia and an IDH1 Mutation
July 20, 2018
Agios Pharmaceuticals, Inc. has announced that TIBSOVO® (ivosidenib) was granted approval from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (R/R AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA approved test. TIBSOVO®, an oral, targeted inhibitor of the IDH1 enzyme, is the first and only FDA-approved therapy for patients with R/R AML and an IDH1 mutation.
BeiGene Announces Preliminary Topline Results of Pivotal Trial in China for Anti-PD-1 Antibody Tislelizumab in Hodgkin’s Lymphoma
July 22, 2018
BeiGene, Ltd., a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, announced preliminary topline results from the independent review of response data from the pivotal Phase 2 trial of tislelizumab, an investigational anti-PD-1 antibody, in Chinese patients with relapsed/refractory classical Hodgkin’s lymphoma (R/R cHL). There was a demonstration of robust activity, with high overall and complete response rates in addition to a safety profile that is consistent with other PD-1 inhibitors.
Top Pharma News of the Week – July 23rd last edit: 2018-07-23T17:53:11+00:00 da