PharmaShots Weekly Snapshots (September 30

This week PharmaShots’ news was all about the updates on Clinical Trials, Pharma, Biotech, COVID-19, Regulatory & MedTech. Check out our full report below:

BMS Reports Data from P-IIIb/IV (PSORIATYK SCALP) and Real-World (RePhlect) Studies of Sotyktu for Moderate-to-Severe Scalp Psoriasis

Read More: BMS

Merus Reports the First Patient Dosing in P-III (LiGeR-HN1) Study of Petosemtamab Plus Keytruda for 1L Treatment of R/M Head and Neck Squamous Cell Carcinoma (HNSCC)

Read More: Merus

UroGen Reports the First Patient Dosing with UGN-103 in P-III (UTOPIA) Study to Treat Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer

Read More: UroGen

Johnson & Johnson Highlights the Real-World Study of Erleada (Apalutamide) for Treating Metastatic Castration-Sensitive Prostate Cancer at ECOP 2024

Read More: Johnson & Johnson

AbbVie Seeks the US FDA’s Accelerated Approval of Telisotuzumab Vedotin (Teliso-V) for Treating Non-Squamous NSCLC

Read More: AbbVie

Sanofi and Regeneron’s Dupixent Receives the US FDA’s and NMPA’s Approval to Treat Chronic Obstructive Pulmonary Disease (COPD)

Read More: Sanofi & Regeneron

Astria Therapeutics’ Navenibart Gains the US FDA’s Orphan Drug Designation to Treat Hereditary Angioedema

Read More: Astria Therapeutics

Johnson & Johnson Submits sBLA of Darzalex Faspro Regimen to the US FDA for Newly Diagnosed Multiple Myeloma Patients

Read More: Johnson & Johnson

AstraZeneca and Daiichi Sankyo Report the US FDA’s sBLA Acceptance of Enhertu with Priority Review to Treat HR+/HER2-low Metastatic Breast Cancer

Read More: AstraZeneca & Daiichi Sankyo

AstraZeneca Reports the US FDA’s sNDA Acceptance of Calquence with Priority Review for Mantle Cell Lymphoma

Read More: AstraZeneca

Sagimet’s Denifanstat Gains the US FDA’s Breakthrough Therapy Designation to Treat Noncirrhotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Read More: Sagimet

BMS Reports the US FDA’s Approval of Opdivo Plus CT as a Neoadjuvant Treatment of Resectable Non-Small Cell Lung Cancer (NSCLC)

Read More: BMS

Daiichi Sankyo Reports the sNDA Submission of Enhertu to Treat HER2 Low or Ultralow Metastatic Breast Cancer in Japan

Read More: Daiichi Sankyo

Genentech Reports the Acquisition of Regor's CDK Inhibitors Portfolio Targeting Breast Cancer

Read More: Genentech & Regor

Recordati to Acquire Sanofi’s Enjaymo, Enhancing its Rare Diseases Portfolio

Read More: Recordati & Sanofi

Prime Medicine and BMS Join Forces to Develop and Commercialize Various Prime Edited Ex Vivo T-Cell Therapies

Read More: Prime Medicine & BMS

ABL Bio Collaborates with Merck to Develop ABL103 Plus Keytruda for Treating Solid Tumors

Read More: ABL Bio & Merck

Organon and Shanghai Henlius Biotech Provides Update on P-III Trial of HLX11 (Biosimilar, Perjeta)

Read More: Organon & Shanghai Henlius Biotech

Fresenius Kabi and Formycon Report the US FDA’s Approval of Otulfi (Biosimilar, Stelara)

Read More: Fresenius Kabi & Formycon

Teva and mAbxience Join Forces on Second Biosimilar Candidate in Oncology

Read More: Teva & mAbxience

Elucid Reports the US FDA’s Approval of PlaqueIQ Image Analysis Software for Cardiovascular Disease Evaluation

Read More: Elucid

SetPoint Medical Reports the US FDA’s IDE Approval to Initiate Neuroimmune Modulation Platform’s Evaluation for Relapsing-Remitting Multiple Sclerosis

Read More: SetPiont Medical

OrthAlign Reports the US FDA’s Approval of Lantern Hip Technology for Hip Arthroplasty

Read More: OrthAlign