All The Most Important Pharmaceutical News Stories Of The Week – July 2018 – Week # 5
Bristol-Myers Squibb and Tsinghua University Announce Collaboration to Accelerate Early Research into Potential Therapies for Autoimmune Diseases and Cancer
July 24, 2018
Bristol-Myers Squibb Company and Tsinghua University have entered into a collaboration to discover therapeutic agents against novel targets for autoimmune diseases and cancers. The collaboration brings together Bristol-Myers Squibb and Tsinghua University’s respective scientific expertise and capabilities with a focus on validating new targets and generating early drug candidates for clinical development.
KEYTRUDA® (pembrolizumab) Monotherapy Met a Primary Endpoint in the Phase 3 KEYNOTE-048 Trial, Significantly Improving OS as First-Line Therapy in Head and Neck Squamous Cell Carcinoma Patients Whose Tumors Expressed PD-L1 (CPS ?20)
July 25, 2018
Merck, known as MSD outside the United States and Canada, has announced that the pivotal Phase 3 KEYNOTE-048 trial investigating KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, for first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), met a primary endpoint of overall survival (OS) as monotherapy in patients whose tumors expressed PD-L1 (Combined Positive Score (CPS) ?20). Based on an interim analysis conducted by the independent Data Monitoring Committee (DMC), treatment with KEYTRUDA monotherapy in these patients resulted in significantly longer OS compared to cetuximab in combination with platinum chemotherapy (cisplatin or carboplatin) plus 5-Fluorouracil (5-FU), the current standard of care for HNSCC in the first-line treatment setting.
Eisai And Biogen Announce Detailed Results of Phase II Clinical Study of BAN2401 In Early Alzheimer’s Disease at Alzheimers Association International Conference (AAIC) 2018
July 26, 2018
Eisai Co., Ltd. and Biogen Inc. announced detailed results from the Phase II study (Study 201) with BAN2401, an anti-amyloid beta (A?) protofibril antibody, in 856 patients with early Alzheimer’s disease as part of Session DT-01 “Recent Developments in Therapeutics” (Presentation number: DT-01-07) at the Alzheimer’s Association International Conference (AAIC) 2018 being held in Chicago, Illinois, United States on July 25. This abstract was accepted for Late Breaking oral presentation at AAIC. BAN2401 demonstrated a dose-dependent reduction in amyloid plaques as measured by amyloid PET, and this reduction was statistically significant at all doses.
July 27, 2018
Sandoz, a Novartis division and the pioneer and global leader in biosimilars, has announced that the European Commission (EC) granted marketing authorization to biosimilar Hyrimoz® (adalimumab) for use in all indications of the reference medicine, including rheumatoid arthritis, plaque psoriasis, Crohn’s disease, uveitis and ulcerative colitis.
Novartis combination Tafinlar® + Mekinist® receives positive CHMP opinion for adjuvant treatment of BRAF V600 mutation-positive melanoma
July 27, 2018
Novartis has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of Tafinlar® (dabrafenib) in combination with Mekinist® (trametinib) for the adjuvant treatment of adult patients with stage III melanoma with a BRAF V600 mutation, following complete resection. The CHMP recommendation is based on findings from the COMBI-AD study, which was published in The New England Journal of Medicine (NEJM).
Imfinzi receives positive EU CHMP opinion for locally-advanced, unresectable non-small cell lung cancer
July 27, 2018
AstraZeneca and MedImmune, its global biologics research and development arm, have announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion, recommending a marketing authorisation of Imfinzi (durvalumab) for the treatment of locally-advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on ?1% of tumor cells and whose disease has not progressed following platinum-based chemotherapy and radiation therapy (CRT). The recommendation is based on the progression-free survival (PFS) and overall survival (OS) primary endpoints of the Phase III PACIFIC trial, and post-hoc subgroup analyses by PD-L1 expression requested by the CHMP.
FDA Approves PERSERISTM (risperidone) for Extended-Release Injectable Suspension for the Treatment of Schizophrenia in Adults
July 27, 2018
Indivior PLC has announced that the U.S. Food and Drug Administration (FDA) has approved PERSERISTM, the first once-monthly subcutaneous risperidone-containing, long-acting injectable (LAI) for the treatment of schizophrenia in adults. Clinically relevant levels were reached after the first injection of PERSERIS without use of a loading dose or any supplemental oral risperidone.
European Medicines Agency Adopts Positive Opinion for KEYTRUDA® (pembrolizumab) Combination with Pemetrexed and Platinum Chemotherapy for the First-Line Treatment of Metastatic Nonsquamous Non-Small Cell Lung Cancer
July 30, 2018
Merck, known as MSD outside the United States and Canada, has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of KEYTRUDA®, Merck’s anti-PD-1 therapy, in combination with pemetrexed (ALIMTA®) and platinum chemotherapy (cisplatin or carboplatin) for the first-line treatment of metastatic nonsquamous non-small cell lung cancer (NSCLC) in adults whose tumors have no EGFR or ALK genomic tumor aberrations, regardless of PD-L1 expression. If approved, this would mark the first approval in Europe for an anti-PD-1 therapy in combination with chemotherapy and is based on overall survival (OS) and progression-free survival (PFS) data from the Phase 3 KEYNOTE-189 trial.Top Pharma News of the Week – July 30th last edit: 2018-07-30T21:48:15+00:00 da