This author has yet to write their bio.Meanwhile lets just say that we are proud clickgiant contributed a whooping 60 entries.
HIGH IMPACT – Madrigal reported positive topline data from the double-blind portion of the its phase 3 MAESTRO-NAFLD study of resmetirom in NASH. Patients in the study were identified based on non-invasive imaging and biomarkers, and were treated with either 80mg, 100mg resmetirom once daily or placebo for 52 wks. Safety (969 patients) Safe and well-tolerated […]
HIGH IMPACT – During Roche’s HDSA presentation, the company discussed GENERATION-HD1 trial data and post-hoc analysis in subgroups of patients. The call was led by Peter McColgan (Roche) and Lauren Boak (Roche). The speaker mentioned that there were over 700 participants listening in to the talk. The GENERATION HD-1 study is a randomized, multi-center double-blind […]
HIGH IMPACT – Poseida announced in its Q3 press release that it will end its P-BCMA-101 autologous CAR-T program and prioritize its allogeneic CAR-T P-BCMA-ALLO1. “While we believe the P-BCMA-101 autologous program has competitive advantages and would be approvable, one long-term strategic benefit of that program has been to inform our highly-differentiated allogeneic approach. With […]
November 2, 2021 at 10:00 AM ET (sign up here) Please join us to review recent and upcoming clinical and regulatory developments in skin and auto-immune disease. Bloomberg Intelligence analyst Michael Shah, and Senior Principal of inThought Research Amanda Weyerbacher, PhD, will be joined by dermatologist Steven R. Feldman, MD, PhD and rheumatologist Christopher Ritchlin […]
June 9 at 11am – 12:30pm ET (sign up here) Please join us for a review of key data presented at the American Society of Clinical Oncology (ASCO) Annual Meeting. Bloomberg Intelligence analysts Marc Engelsgjerd, MD, and Sam Fazeli, PhD, and inThought Research analyst Matt Presby, PhD, will be joined by expert speakers Patrick Forde, MBBCh, […]
HIGH IMPACT – Reata has submitted an NDA to the FDA for bardoxolone methyl for the treatment of chronic kidney disease caused by Alport Syndrome. Reata has requested priority review for the application. The submission was based on the results of the phase 2/3 CARDINAL study which demonstrated statistically significant improvement in kidney function as […]
HIGH IMPACT – During its Q4 2020 earnings call, Prothena gave an update on its prasinezumab clinical program for Parkinson’s disease. During the clinical overview, Prothena highlighted that prasinezumab specifically targets the C-terminus of alpha-synuclein and is the “first antibody to show significant slowing of motor progression and improvements in imaging biomarkers.” The company stated […]
HIGH IMPACT – Both Pfizer and Amgen provided updates on its BCMA bispecific programs in Q4/FY 2020 earnings calls on February 2. Pfizer’s BCMAxCD3 bispecific, elranatamab (PF-06863135), received FDA Fast Track designation in late January for the treatment of multiple myeloma patients who are refractory to at least one proteasome inhibitor, one immunomodulatory drug and one […]
MODERATE IMPACT Ipsen will present 26 abstracts at TOXINS 2021. A key presentation titled AbobotulinumtoxinA: Evidence for Long Duration of Response from 5 Patient Populations demonstrates long-duration of Dysport. Data from the long-term open-label extension study indicated that repeat cycles of Dysport resulted in at least 12 weeks duration for a large proportion of study patients for […]
November 19, 2020 Impact: High Results for Affimed’s AFM13 (CD30/CD16A ICE; Innate Cell Engager) in combination with Keytruda (pembrolizumab) in a phase 1b study for r/r Hodgkin Lymphoma patients have been published in the journal Blood. Key efficacy data included (n=30): ORR (Objective Response Rate): 88% (CR rate: 46%) at the recommended dose level Investigators deemed […]
