All The Most Important Pharmaceutical News Stories Of The Week – April 2018 – Week #2
The European Medicines Agency Accepts Regulatory Submission for LYNPARZA® (olaparib) in BRCA-Mutated HER2-Negative Metastatic Breast Cancer
April 3, 2018
AstraZeneca and Merck have announced that the European Medicines Agency has validated for review the Marketing Authorization Application (MAA) for LYNPARZA® (olaparib) for use in patients with deleterious or suspected deleterious BRCA-mutated, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have been previously treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting.
April 3, 2018
AstraZeneca and MedImmune, its global biologics research and development arm, today announced that the US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for moxetumomab pasudotox, an investigational anti-CD22 recombinant immunotoxin and a potential new medicine for the treatment of adult patients with hairy cell leukaemia (HCL) who have received at least two prior lines of therapy. The FDA has granted the moxetumomab pasudotox BLA Priority Review status with a Prescription Drug User Fee Act date set for the third quarter of 2018.
Novartis announces JAMA Cardiology publication of data showing Entresto® improves physical and social activity in HFrEF patients versus enalapril
April 4, 2018
Novartis has announced that JAMA Cardiology has published results from a post-hoc analysis demonstrating that treatment with Entresto® (sacubitril/valsartan) significantly improved seven out of 10 types of physical and social activities at eight months in heart failure patients with reduced ejection fraction (HFrEF) versus previous standard of care. The most significant improvements reported were in the ability to carry out household chores and the ability to conduct intimate/sexual relationships. The findings of the analysis are based on data from the PARADIGM-HF trial, the largest clinical trial ever conducted in heart failure.
Magenta Therapeutics Announces First Patient Transplanted with MGTA-456 in Phase 2 Study in Inherited Metabolic Disorders
April 5, 2018
Magenta Therapeutics, a biotechnology company developing novel medicines to bring the curative power of bone marrow transplant to more patients, today announced treatment of the first patient with an inherited metabolic disorder in a Phase 2 study of MGTA-456, an expanded cord blood stem cell product. MGTA-456 is a first-in-class allogeneic stem cell therapy consisting of a single umbilical cord blood unit expanded with an aryl hydrocarbon receptor (AHR) antagonist then administered to a patient through a bone marrow transplant.
April 5, 2018
Ferring Pharmaceuticals and Rebiotix Inc. have announced that they have agreed to the acquisition of Rebiotix by Ferring. This acquisition brings together two innovative healthcare companies that share a common commitment to exploring and understanding the human microbiome to develop new solutions for patients.
Takeda Pharmaceutical and DNDi Collaborate to Progress a Potential New Drug for Visceral Leishmaniasis through the R&D Pipeline
April 5, 2018
Takeda Pharmaceutical Co., Ltd. and the Drugs for Neglected Diseases initiative (“DNDi”) have announced that they have signed an agreement to collaborate in conducting preclinical and phase I clinical studies on drug candidate compounds that had been discovered among the aminopyrazole compound class, aimed at developing an innovative drug for the treatment of visceral leishmaniasis (VL).
Incyte and Merck Provide Update on Phase 3 Study of Epacadostat in Combination with KEYTRUDA® (pembrolizumab) in Patients with Unresectable or Metastatic Melanoma
April 6, 2018
Incyte Corporation and Merck have announced that an external Data Monitoring Committee (eDMC) review of the pivotal Phase 3 ECHO-301/KEYNOTE-252 study results evaluating Incyte’s epacadostat in combination with Merck’s KEYTRUDA® in patients with unresectable or metastatic melanoma determined that the study did not meet the primary endpoint of improving progression-free survival in the overall population compared to KEYTRUDA monotherapy. The study’s second primary endpoint of overall survival also is not expected to reach statistical significance. Based on these results, and at the recommendation of the eDMC, the study will be stopped. The safety profile observed in ECHO-301/KEYNOTE-252 was consistent with that observed in previously reported studies of epacadostat in combination with KEYTRUDA.
Novartis enters agreement to acquire AveXis Inc. for USD 8.7 bn to transform care in SMA and expand position as a gene therapy and Neuroscience leader
April 9, 2018
Novartis has announced that it has entered into an agreement and plan of merger with AveXis, Inc. to acquire the US-based Nasdaq-listed clinical stage gene therapy company for USD 218 per share or a total of USD 8.7 billion in cash. The transaction was unanimously approved by the Boards of both companies.
KEYTRUDA® (pembrolizumab) Monotherapy Met Primary Endpoint in Phase 3 KEYNOTE-042 Study, Significantly Improving OS as First-Line Therapy in Locally Advanced or Metastatic NSCLC Patients Expressing PD-L1 in at Least 1 Percent of Tumor Cells
April 9, 2018
Merck has announced that the pivotal Phase 3 KEYNOTE-042 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC, including nonsquamous or squamous histologies) met its primary endpoint of overall survival (OS). An interim analysis conducted by the independent Data Monitoring Committee (DMC) demonstrated that treatment with KEYTRUDA resulted in significantly longer OS than platinum-based chemotherapy (carboplatin plus paclitaxel or carboplatin plus pemetrexed) in patients with a PD-L1 tumor proportion score (TPS) of ?1 percent. As part of a pre-specified analysis plan, OS was sequentially tested and was significantly improved in patients with a TPS of ?50 percent, with a TPS of ?20 percent and then in the entire study population with a TPS of ?1 percent. The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported monotherapy studies involving patients with advanced NSCLC.
Upadacitinib Meets All Primary and Ranked Secondary Endpoints Including Superiority Versus Adalimumab in Phase 3 Study in Rheumatoid Arthritis
April 9, 2018
AbbVie, a research-based global biopharmaceutical company, has announced positive top-line results from the Phase 3 SELECT-COMPARE clinical trial showing that after 12 weeks, upadacitinib (15 mg, once-daily) met the primary endpoints of ACR20 and clinical remission versus placebo. All ranked secondary endpoints were also achieved versus either placebo or adalimumab (40 mg every other week). The ongoing study evaluates upadacitinib, an investigational oral JAK1-selective inhibitor, in patients with moderate to severe rheumatoid arthritis who are on a stable background of methotrexate and had an inadequate response. Upadacitinib is not approved by regulatory authorities and its safety and efficacy have not been established.Top Pharma News of the Week – April 9th last edit: 2018-04-09T20:50:50+00:00 da