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

Minghui Pharmaceutical Reports Topline Data from P-III Study of Tofacitinib Etocomil (MH004) Ointment for Atopic Dermatitis

Read More: Minghui Pharmaceutical

InventisBio Reports Results from the P-II Trial of D-2570 to Treat Moderate to Severe Plaque Psoriasis

Read More: InventisBio

Everest Medicines Reports Results from the P-Ib/IIa Study of EVER001 to Treat Primary Membranous Nephropathy

Read More: Everest Medicines

Eli Lilly Reports Results from the P-IIIb (SURMOUNT-5) Trial of Zepbound (Tirzepatide) in Obese Adults

Read More: Eli Lilly

VivaVision Biotech Reports Topline Results from P-II Study of VVN461 for Post-Operative Inflammation Following Cataract Surgery

Read More: VivaVision Biotech

Daiichi Sankyo Reports Pooled Analysis from TROPION-Lung05 & TROPION-Lung01 Trials of Datopotamab Deruxtecan (Dato-DXd) for NSCLC

Read More: Daiichi Sankyo

Duality Biologics and BioNTech Highlight Interim Data from P-I/IIa Trial of BNT324/DB-1311 in Advanced Solid Tumors at ESMO Asia 2024

Read More: Duality Biologics and BioNTech
 

Renalys Pharma’s Sparsentan Secures the MHLW’s Orphan Drug Designation to Treat Primary IgA Nephropathy

Read More: Renalys Pharma

Revelation Biosciences Reports the US FDA’s IND Acceptance of Gemini for Chronic Kidney Disease

Read More: Revelation Biosciences

Cytokinetics Reports the US FDA’s NDA Acceptance of Aficamten to Treat Obstructive Hypertrophic Cardiomyopathy

Read More: Cytokinetics

Rigel’s R289 Secures the US FDA’s Fast Track Designation for Treating Lower-Risk Myelodysplastic Syndrome

Read More: Rigel

HUTCHMED and Innovent Report the NMPA’s Conditional Approval of Elunate Plus Tyvyt to Treat Advanced Endometrial Cancer

Read More: HUTCHMED and Innovent

Merck’s Sacituzumab Tirumotecan (Sac-TMT) Secures the US FDA’s Breakthrough Therapy Designation to Treat Non-Squamous NSCLC

Read More: Merck

Allay Therapeutics’ ATX101 Secures the US FDA’s Breakthrough Therapy Designation to Treat Post-Surgical Pain

Read More: Allay Therapeutics

Merus Reports the US FDA’s Accelerated Approval of Bizengri (Zenocutuzumab-zbco) for NRG1+ Pancreatic Adenocarcinoma and NSCLC

Read More: Merus

Roche Reports the US FDA’s sBLA Acceptance of Columvi (Glofitamab) Combination to Treat R/R Diffuse Large B-Cell Lymphoma (DLBCL)

Read More: Roche

AstraZeneca’s Imfinzi (Durvalumab) Secures the US FDA’s Approval for Treating Limited-Stage Small Cell Lung Cancer

Read More: AstraZeneca

Phanes Therapeutics’ PT217 Secures the US FDA’s Fast Track Designation for Neuroendocrine Prostate Cancer (NEPC)

Read More: Phanes Therapeutics

AstraZeneca Reports the US FDA’s sBLA Acceptance and Priority Review of Imfinzi to Treat Muscle-Invasive Bladder Cancer

Read More: AstraZeneca

Affimed Secures the US FDA’s Regenerative Medicine Advanced Therapy (RMAT) Designation for Acimtamig and AlloNK Combination

Read More: Affimed

Helix Biopharma to Acquire Laevoroc Immunology’s LR 09, Expanding its Immune-Oncology Portfolio

Read More: Helix Biopharma and Laevoroc Immunology

Silo Pharma and Kymanox Join Forces for SP-26 Ketamine Implant Device Targeting Pain Management

Read More: Silo Pharma and Kymanox

Merus Collaborates with Partner Therapeutics to Commercialize Zenocutuzumab for Treating NRG1 Fusion-Positive Cancer

Read More: Merus and Partner Therapeutics

PTC Therapeutics Join Forces with Novartis to Develop PTC518 for Treating Huntington's Disease

Read More: PTC Therapeutics and Novartis

Lisata Therapeutics Collaborates with Kuva Labs to Advance Non-Invasive, High-Precision Cancer Diagnostics

Read More: Lisata Therapeutics and Kuva Labs

Relay Therapeutics and Elevar Therapeutics Collaborate to Develop Lirafugratinib (RLY-4008) for Cholangiocarcinoma and Other Solid Tumors

Read More: Relay Therapeutics and Elevar Therapeutics

Muna Therapeutics Partners with GSK to Develop Novel Treatments for Alzheimer’s Disease

Read More: Muna Therapeutics and GSK

Carlsmed Reports the US FDA’s Approval of aprevo Cervical Breakthrough Fusion Device

Read More: Carlsmed

Biocon Biologics Reports the US FDA’s Approval of Yesintek (Biosimilar, Stelara)

Read More: Biocon Biologics

Merck and Ridgeback Biotherapeutics Begin P-III (MOVe-NOW) Trial of Lagevrio (Molnupiravir) to Treat COVID-19 in High-Risk Adults

Read More: Merck and Ridgeback Biotherapeutics

Related Post: PharmaShots Weekly Snapshots (November 25 – November 29, 2024)