Pharming’s MAA Application for Leniolisib Receives Approval by the EMA to Treat Activated Phosphoinositide 3-Kinase Delta Syndrome

Published: Oct 28, 2022| Tags: Pharming, Leniolisib, Activated Phosphoinositide 3-Kinase Delta Syndrome, Regulatory, P-II, P-III, EMA

Puma Biotechnology Presents P-II (SUMMIT) Basket Trial Results of Neratinib for EGFR Exon 18-Mutant NSCLC at EORTC/NCI/AACR 2022

Published: Oct 28, 2022| Tags: Puma Biotechnology, Neratinib, EGFR Exon 18-Mutant NSCLC, Clinical Trial, P-II (SUMMIT) Basket Trial, EORTC, NCI, AACR, 2022

Sciwind Biosciences Reports P-IIb Trial Interim Results of XW003 (ecnoglutide) for the Treatment of Obesity

Published: Oct 28, 2022| Tags: Sciwind Biosciences, XW003, ecnoglutide, Obesity, Clinical Trial, P-IIb Trial

Mustang Bio Presented P-I/II Clinical Trial of MB-106 for Waldenstrom's Macroglobulinemia at 11th International Workshop

Published: Oct 28, 2022| Tags: Mustang Bio, MB-106, Waldenstrom's Macroglobulinemia, Clinical Trial, P-I/II Clinical Trial, 11th International Workshop

AstraZeneca Presents P-III (CHAMPION-NMOSD) Trial Results of Ultomiris (ravulizumab) for Neuromyelitis Optica Spectrum Disorder at ECTRIMS 2022

Published: Oct 28, 2022| Tags: AstraZeneca, Ultomiris, ravulizumab, Neuromyelitis Optica Spectrum Disorder, Clinical Trial, P-III, CHAMPION-NMOSD Trial, ECTRIMS, 2022

ITM’s ITM-11 Receives the FTD by the US FDA for the Treatment of Neuroendocrine Tumors

Published: Oct 27, 2022| Tags: ITM, ITM-11, Neuroendocrine Tumors, Gastroenteropancreatic Neuroendocrine Tumors, Regulatory, P-III, COMPOSE, COMPETE

Janssen’s Tecvayli (teclistamab-cqyv) Receives the US FDA’s Approval for the Treatment of Relapsed or Refractory Multiple Myeloma

Published: Oct 27, 2022| Tags: Janssen, Tecvayli, teclistamab-cqyv, Multiple Myeloma, Regulatory, US, FDA, Approval

BIOCORP and Novo Nordisk Expands its 2021 Agreement to Commercialize Mallya Smart Sensor in Japan

Published: Oct 27, 2022| Tags: BIOCORP, Novo Nordisk, Mallya Smart Sensor, FlexTouch insulin pens, NovoPen 6, NovoPen Echo Plus, Pharma, Japan

Genentech Reports P-III (BALATON) and (COMINO) Studies Results of Vabysmo (faricimab-svoa) for the Treatment of Retinal Vein Occlusion

Published: Oct 27, 2022| Tags: Genentech, Vabysmo, faricimab-svoa, Retinal Vein Occlusion, Clinical Trial, P-III, BALATON, COMINO

AstraZeneca Reports Results of Capivasertib in P-III Trial for the Treatment of Advanced HR-positive Breast Cancer

Published: Oct 27, 2022| Tags: AstraZeneca, Capivasertib, Advanced HR-positive Breast Cancer, Clinical Trial, P-III, CAPItello-291

Bayer’s Kerendia (finerenone) Receives Health Canada’s Approval for the Treatment of Chronic Kidney Disease and Type 2 Diabetes

Published: Oct 27, 2022| Tags: Bayer, Kerendia, Chronic Kidney Disease, Type 2 Diabetes, Regulatory, P-III, FIDELIO-DKD, FIGARO-DKD

Merck Reports P-III Trial Results of Prevymis for the Prevention of Cytomegalovirus Disease in Adults After Kidney Transplantation

Published: Oct 25, 2022| Tags: Merck, Prevymis, Cytomegalovirus Disease, Kidney Transplantation, Clinical Trials, P-III Trial

Janssen Presents P-IIb (QUASAR) Induction Study Results of Tremfya (guselkumab) for Active Ulcerative Colitis at ACG 2022

Published: Oct 25, 2022| Tags: Janssen, Tremfya, guselkumab, Active Ulcerative Colitis, P-IIb (QUASAR) Induction Study at ACG 2022

Syncona to Acquire AGTC for ~$73.5M

Published: Oct 25, 2022| Tags: Syncona, AGTC, AGTC-501, X-linked retinitis pigmentosa, ~$73.5M, M&A

Sumitovant and Sumitomo to Acquire Myovant Sciences for ~$1.7B

Published: Oct 25, 2022| Tags: Sumitovant, Sumitomo, Myovant Sciences, prostate cancer, ~$1.7B, M&A

Novartis Reports P-III (APPLY-PNH) Trial Results of Iptacopan for Paroxysmal Nocturnal Hemoglobinuria

Published: Oct 25, 2022| Tags: Novartis, Iptacopan, Paroxysmal Nocturnal Hemoglobinuria, Clinical Trial, P-III APPLY-PNH Trial

AstraZeneca’s Imjudo (tremelimumab) + Imfinzi (durvalumab) Receive the US FDA’s Approval for Unresectable Liver Cancer

Published: Oct 25, 2022| Tags: AstraZeneca, Imjudo, tremelimumab, Imfinzi, durvalumab, Unresectable Liver Cancer, Regulatory, US, FDA, Approval

Related Post: PharmaShots Weekly Snapshots (October 17- 21, 2022)