All The Most Important Pharmaceutical News Stories Of The Week – April 2018 – Week #1
Data from TOPACIO Trial Reported at SGO Demonstrates Compelling Clinical Activity of ZEJULA in Combination with an Anti-PD-1 Antibody in Patients with Platinum Resistant/Refractory Ovarian Cancer
March 26, 2018
TESARO, Inc., an oncology-focused biopharmaceutical company, announced the presentation of maturing data from the TOPACIO trial of niraparib in combination with an anti-PD-1 monoclonal antibody, KEYTRUDA® during a plenary session today at the 2018 Society for Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer in New Orleans, Louisiana. It has been identified that the Efficacy of niraparib in combination with an anti-PD-1 mAb surpasses historical efficacy benchmarks for PD-1 or PARP monotherapies in difficult-to-treat types of ovarian cancer, regardless of biomarker status.
March 27, 2018
Merck KGaA, a leading science and technology company, has announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted SAKIGAKE ’fast-track’ designation for its investigational molecule tepotinib for patients with advanced non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping mutations. SAKIGAKE designation promotes research and development in Japan, aiming at early practical application for innovative pharmaceutical products, medical devices, and regenerative medicines, and can reduce a drug’s review period down from 12 months to a target of 6 months. This is the first regulatory designation granted to tepotinib.
March 27, 2018
GlaxoSmithKline plc announces that it has reached an agreement with Novartis for the buyout of Novartis’ 36.5% stake in their Consumer Healthcare Joint Venture for $13 billion (£9.2 billion). The Consumer Healthcare Joint Venture was formed as part of the three-part transaction between GSK and Novartis which was approved by shareholders in 2014. Last year, GSK’s Consumer Healthcare business reported sales of £7.8 billion and since 2015 sales have grown 4% on a 3 year CAGR basis (2015-2017 at 2014 CER) with an overall improvement in operating margins from 11.3% in 2015 to 17.7% in 2017.
March 28, 2018
Takeda Pharmaceutical Company Limited confirms that it is considering making an approach to Shire regarding a possible offer for the company. Takeda’s consideration of such an offer is at a preliminary and exploratory stage and no approach has been made to the Board of Shire. There can be no certainty that an approach, if made, will lead to any transaction. Takeda believes that a potential transaction with Shire presents an opportunity to advance Takeda’s stated Vision 2025, build on its current strong momentum, and create a truly global, value-based Japanese biopharmaceutical leader.
Bluebird bio and Celgene Corporation Enter into Agreement to Co-Develop and Co-Promote Anti-BCMA CAR T Cell Therapy bb2121 in the United States
March 28, 2018
Bluebird bio, Inc. and Celgene Corporation have announced that the companies have entered into an agreement to co-develop and co-promote bb2121, an investigational anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cell therapy for the potential treatment of patients with relapsed/refractory multiple myeloma in the United States.
Pfizer Announces Positive Topline Results from Phase 3 Attr-Act Study of Tafamidis In Patients with Transthyretin Cardiomyopathy
March 29, 2018
Pfizer Inc. has announced that the Tafamidis Phase 3 Transthyretin Cardiomyopathy (ATTR-ACT) study evaluating tafamidis for the treatment of transthyretin cardiomyopathy met its primary endpoint, demonstrating a statistically significant reduction in the combination of all-cause mortality and frequency of cardiovascular-related hospitalizations compared to placebo at 30 months. The preliminary safety data showed that tafamidis was generally well tolerated in this population and no new safety signals were identified.
FDA Approves BLINCYTO® (blinatumomab) to Treat Minimal Residual Disease-Positive B-Cell Precursor Acute Lymphoblastic Leukemia in Adults and Children
March 29, 2018
Amgen has announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for BLINCYTO® (blinatumomab) for the treatment of adults and children with B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1 percent. This indication is approved under accelerated approval based on MRD response rate and hematological relapse-free survival (RFS). Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. BLINCYTO, the first-and-only approved bispecific CD19-directed CD3 T cell engager (BiTE®) immunotherapy, is now also the first-and-only therapy to be FDA-approved for MRD.Top Pharma News of the Week – April 2nd last edit: 2018-04-02T21:12:12+00:00 da