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Clinical Trials

Novartis Reports Results of Kesimpta (ofatumumab) in P- III ASCLEPIOS Trials for Newly Diagnosed Patients with RMS

Shots: The company reported new post hoc data from the P- III ASCLEPIOS trials assessing Kesimpta (ofatumumab) vs teriflunomide in a subgroup of newly diagnosed, treatment-naïve patients with RMS The results showed a 60% reduction

Clinical Trials

Janssen Presents Results of Nipocalimab (M281) in P-II Vivacity-MG Study for Adults with Generalized Myasthenia Gravis at AAN2021

Shots: The P-II Vivacity-MG study involves assessing the safety, tolerability, efficacy, PK, PD, and immunogenicity of nipocalimab in addition to SoC vs PBO in a ratio (1:1:1:1:1) in 68 patients with gMG The 1EPs of

Pharma

Evotec Signs a License Agreement with Kazia Therapeutics for Clinical Development of EVT801

Shots: Evotec to receive a up front as well as research funding for biomarker development and CMC and is eligible to receive $361.21M as clinical & commercial milestones along with royalties on the net sales

Regulatory

Sanofi’s Sarclisa (isatuximab) Receives EC’s Approval for Adults with Relapsed and Refractory Multiple Myeloma

Shots: The approval is based on data from the P-III IKEMA study evaluating Sarclisa + carfilzomib and dexamethasone (Kd) vs Kd alone in 302 patients with relapsed MM across 69 centers spanning 16 countries Results:

Clinical Trials

Lilly and Incyte Report Results of Baricitinib in P-III COV-BARRIER Study for Hospitalized Patients with COVID-19

Shots: The P-III COV-BARRIER study involves assessing Baricitinib (4mg, qd) + SoC (which included 79% receiving corticosteroids and 19% receiving remdesivir, with some receiving both) vs PBO + SoC in 1525 patients in a ratio

Clinical Trials

Zogenix Presents Results of Fintepla’s (fenfluramine) Study Highlighting the Impact of Treatment on Dravet Syndrome Patients, Caregivers, and Families at AAN 2021

Shots: The P-III study is designed to assess caregivers’ perspectives on the long-term seizure & non-seizure-related benefits of Fintepla on patients with Dravet syndrome and on their caregivers and families Results: seizure-related benefits noted by

M&A MedTech

ThermoFisher to Acquire PPD for ~$17.4B

Shots: ThermoFisher to acquire PPD for $47.50/share making a total purchase price of $17.4B along with ~$3.5B of net debt with a premium of ~24% to the closing price of PPD’s common stock as of

Regulatory

Roche’s Evrysdi (risdiplam) Receives Health Canada’s Approval for Spinal Muscular Atrophy in Adults and Children

Shots: The approval is based on two studies i.e. FIREFISH & SUNFISH. The FIREFISH study involves assessing Evrysdi in infants aged 2-7mos. with symptomatic Type 1 SMA, and the SUNFISH study assesses Evrysdi in children

Clinical Trials

GSK Discontinues the P-II Trials of Feladilimab for Advanced or Metastatic Head and Neck Squamous Cell Carcinoma

Shots: GSK has stopped the enrollment in its P-II INDUCE-3 trial, including discontinuing treatment with feladilimab, following the recommendation by IDMC The P-II INDUCE-3 study involves assessing feladilimab + Merck’s pembrolizumab vs PBO+ pembrolizumab in