All The Most Important Pharmaceutical News Stories Of The Week – May 2018 – Week #1
New Analyses from Pivotal Phase III Trials of Oral Ozanimod in Relapsing Multiple Sclerosis to Be Presented at the 2018 American Academy of Neurology Annual Meeting
April 24, 2018
Celgene Corporation has announced additional phase III data analyses evaluating the efficacy and safety of ozanimod, a novel, oral, selective sphingosine 1-phosphate 1 (S1P1) and 5 (S1P5) receptor modulator, versus interferon beta-1a (Avonex®) in patients with relapsing multiple sclerosis (RMS). The phase III SUNBEAM and RADIANCE Part B studies evaluated two doses of oral ozanimod (1 mg and 0.5 mg ozanimod HCl) compared with IFN beta-1a in patients with RMS.
European Commission Approves Bristol-Myers Squibb’s Opdivo (nivolumab) Four-Week Dosing Schedule for Advanced Melanoma and Previously Treated Renal Cell Carcinoma
April 25, 2018
Bristol-Myers Squibb Company has announced that the European Commission (EC) has approved an every four-week (Q4W) Opdivo(nivolumab) monotherapy dosing schedule of 480 mg infused over 60 minutes as an option for patients with advanced melanoma and previously treated renal cell carcinoma. The EC also approved a two-week (Q2W) Opdivo dosing option of 240 mg infused over 30 minutes to replace weight-based dosing for all six approved monotherapy indications in the EU.
Vertex Initiates Phase 3 Studies of VX-445, Tezacaftor and Ivacaftor as a Triple Combination Regimen for People with Cystic Fibrosis
Apr. 26, 2018
Vertex Pharmaceuticals Incorporated has announced that it is initiating two Phase 3 studies of VX-445, tezacaftor and ivacaftor as an investigational triple combination regimen for people with cystic fibrosis (CF). The first Phase 3 study will evaluate approximately 360 people with CF who have one copy of the F508del mutation and one minimal function mutation and is designed to support the submission of a New Drug Application (NDA) in the U.S. using data from the study’s 4-week primary efficacy endpoint together with safety data through 12 weeks of treatment. The second Phase 3 study will evaluate approximately 100 people with CF who have two copies of the F508del mutation, the most common genetic form of the disease, and is designed to support the submission of an application for approval in patients with two copies of the F508del mutation in the U.S. using data from the study’s 4-week primary efficacy endpoint together with 24-week safety data generated from the Phase 3 study in patients with one F508del mutation and one minimal function mutation.
Allergan Announces Second Positive Phase 3 Clinical Trial for Ubrogepant — an Oral CGRP Receptor Antagonist for the Acute Treatment of Migraine
April 27, 2018
Allergan plc, has announced positive results from ACHIEVE II (UBR-MD-02), the second of two pivotal Phase 3 clinical trials evaluating the efficacy, safety and tolerability of orally administered ubrogepant 25 mg and ubrogepant 50 mg compared to placebo in a single migraine attack in adults. Allergan anticipates filing of a New Drug Application (NDA) to the FDA in 2019.
CHMP recommends EU approval of Roche’s Perjeta for post-surgery treatment of HER2-positive early breast cancer at high risk of recurrence
April 27, 2018
Roche has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Perjeta® (pertuzumab) in combination with Herceptin® (trastuzumab) and chemotherapy (the Perjeta-based regimen) for post-surgery (adjuvant) treatment of adult patients with HER2-positive early breast cancer (eBC) at high risk of recurrence. A final decision regarding the approval of the Perjeta-based regimen, along with the full details of the approved indication, is expected from the European Commission in the near future.
FDA to Conduct Priority Review of Cemiplimab as a Potential Treatment for Advanced Cutaneous Squamous Cell Carcinoma
April 30, 2018
The U.S. Food and Drug Administration (FDA) has accepted priority review the Biologics License Application (BLA) for cemiplimab for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or patients with locally advanced CSCC who are not candidates for surgery. Advanced CSCC is the deadliest non-melanoma skin cancer. Cemiplimab is an investigational human monoclonal antibody targeting the checkpoint inhibitor PD-1 and was granted Breakthrough Therapy designation status by the FDA in September 2017. The target action date for the FDA decision is October 28, 2018.
Novartis receives FDA approval of Tafinlar® + Mekinist® for adjuvant treatment of BRAF V600-mutant melanoma
April 30, 2018
Novartis has announced that the US Food and Drug Administration (FDA) has approved Tafinlar® (dabrafenib) in combination with Mekinist® (trametinib) for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection. The FDA granted the combination Breakthrough Therapy Designation for this indication in October 2017 and Priority Review in December 2017.
April 30, 2018
United Therapeutics Corporation and SteadyMed Ltd. have announced the signing of a definitive merger agreement under which United Therapeutics will acquire SteadyMed for $4.46 per share in cash at closing and an additional $2.63 per share in cash upon the achievement of a milestone related to the commercialization of Trevyent®. The transaction, including the $75 million in contingent consideration, is valued at $216 million.
Gilead and Verily Announce Scientific Collaboration to Identify and Understand Immunological and Molecular Drivers of Inflammatory Diseases
April 30, 2018
Gilead Sciences, Inc. and Verily Life Sciences LLC, an Alphabet company, have announced a scientific collaboration using Verily’s Immunoscape platform to identify and better understand the immunological basis of three common and serious inflammatory diseases: rheumatoid arthritis, inflammatory bowel disease and lupus-related diseases. In this first large-scale deployment of Immunoscape, a unique platform for generating immunological data and insights, Verily will analyze biological samples and clinical disease and treatment response data from patients participating in current and future Gilead clinical trials. This three-year collaboration represents the broadest effort to date to interrogate the activity of specific subtypes of immune cells to better understand disease signatures and treatment response and has the potential to guide future drug discovery and development with the goal of improving outcomes for people living with these diseases.
April 30, 2018
Novartis has announced new positive brolucizumab (RTH258) data in neovascular age-related macular degeneration (nAMD) from a pre-specified secondary analysis of the Phase III HAWK and HARRIER trials. The findings showed that patients assessed as appropriate for a 12-week treatment frequency during the first 12-week cycle after loading could reliably stay on that quarterly interval through week 48. This is the first time a high level of reliability has been prospectively demonstrated for a pre-specified secondary endpoint of a 12-week dosing interval with an anti-vascular endothelial growth factor (VEGF) therapy in Phase III trials.Top Pharma News of the Week – May 1st last edit: 2018-05-01T17:36:24+00:00 da