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

Merck Reports Topline Data from P-III Studies of Doravirine/Islatravir (DOR/ISL) Regimen to Treat Virologically Suppressed HIV-1 Infection 

Read More: Merck 

Arrowhead Pharmaceuticals Commences P-I/IIa Trial of ARO-INHBE to Treat Obesity 

Read More: Arrowhead Pharmaceuticals 

Apollomics Reports Top-line Data from P-III Bridging Study of Uproleselan in Chinese Patients with R/R Acute Myeloid Leukemia (AML) 

Read More: Apollomics 

BMS Reports Topline Data from Two Pivotal P-III Studies of Sotyktu (Deucravacitinib) for Treating Psoriatic Arthritis (PsA) 

Read More: BMS 

Ractigen Therapeutics Reports the First Patient Dosing with RAG-17 in P-I Study to Treat Amyotrophic Lateral Sclerosis (ALS) 

Read More: Ractigen Therapeutics 

Galimedix Therapeutics Commences Pivotal P-II Trial of GAL-101 Eye Drops for Treating Dry AMD 

Read More: Galimedix Therapeutics 

Zura Bio Reports Global P-II (TibuSURE) Trial of Tibulizumab to Treat Adults with Systemic Sclerosis 

Read More: Zura Bio 

Immunocore Reports the First Patient Dosing with IMC-P115C in P-I Study to Treat Tumors Expressing PRAME 

Read More: Immunocore 

Assembly Biosciences Reveals Interim Data from P-Ib Study of ABI-4334 to Treat Chronic Hepatitis B 

Read More: Assembly Biosciences 

Sensorion Reports the Completion of Patient Recruitment in P-I/II (Audiogene) Gene Therapy Clinical Trial 

Read More: Sensorion 

Eli Lilly Reports the US FDA’s Approval of Zepbound (Tirzepatide) to Treat Moderate-to-Severe Obstructive Sleep Apnea in Obese Adults 

Read More: Eli Lilly 

Pfizer’s Braftovi (Encorafenib) Secures the US FDA’s Accelerated Approval as a 1L Treatment of BRAF V600E-Mutant Metastatic Colorectal Cancer 

Read More: Pfizer 

AstraZeneca’s Tagrisso (Osimertinib) Secures the EC’s Approval to Treat Unresectable EGFR-Mutated Lung Cancer 

Read More: AstraZeneca 

BMS Reports the EC’s Approval of Opdivo (Nivolumab) Plus Yervoy (Ipilimumab) as a 1L Treatment of MSI-H/dMMR Metastatic Colorectal Cancer (mCRC) 

Read More: BMS 

Rhythm Pharmaceuticals Reports the US FDA’s Approval of Imcivree (Setmelanotide) for Patients as Young as 2 Years Old 

Read More: Rhythm Pharmaceuticals 

Sumitomo Pharma’s Gemtesa (Vibegron) Secures the US FDA’s Approval to Treat Overactive Bladder (OAB) Symptoms in Men 

Read More: Sumitomo Pharma 

Nuvation Bio Reports the US FDA’s NDA Acceptance of Taletrectinib with Priority Review to Treat Advanced ROS1+ NSCLC 

Read More: Nuvation Bio 

Anavex Life Sciences Reports the EMA’s MAA Acceptance of Blarcamesine for Treating Alzheimer’s Disease 

Read More: Anavex Life Sciences 

Tonix Pharmaceuticals Reports the US FDA’s NDA Acceptance of TNX-102 SL for Treating Fibromyalgia 

Read More: Tonix Pharmaceuticals 

Takeda’s Hyqvia 10% SC Injection Receives the Japanese Approval to Treat Agammaglobulinemia or Hypogammaglobulinemia 

Read More: Takeda 

Daiichi Sankyo’s Datroway Receives the MHLW’s Approval for Unresectable or Recurrent HR+/HER2- Breast Cancer 

Read More: Daiichi Sankyo 

Novo Nordisk’s Alhemo Receives the US FDA’s Approval as a Prophylactic Treatment of Hemophilia A or B with Inhibitors 

Read More: Novo Nordisk 

Astellas and Sangamo Therapeutics Partner for Administering Genomic Therapies Targeting Neurological Disorders 

Read More: Astellas and Sangamo Therapeutics 

RAPT Therapeutics and Jemincare Pharmaceutical Sign an Exclusive License Agreement to Develop JYB1904 (RPT904) 

Read More: RAPT Therapeutics and Jemincare Pharmaceutical 

AusperBio Raises $73M in Series B Financing to Develop AHB-137 for Chronic Hepatitis B 

Read More: AusperBio 

Mainz Biomed Partners with Quest Diagnostics to Commercialize its Colorectal Cancer Screening Test 

Read More: Mainz Biomed and Quest Diagnostics 

Signati Medical Reports the IDE Trial Completion of Separo Vessel Sealing System for Vasectomy Procedures 

Read More: Signati Medical 

MedMira’s Multiplo(R) Rapid (TP/HIV) Test Secures the Health Canada’s Approval for Syphilis and HIV 

Read More: MedMira 

Bio-Thera Solutions and Tabuk Pharmaceuticals Join Forces to Commercialize BAT2206 (Biosimilar, Stelara) in Saudi Arabia 

Read More: Bio-Thera Solutions and Tabuk Pharmaceuticals 

Axcelead DDP Collaborates with Astellas to Discover Candidates for Targeted Protein Degraders 

Read More: Axcelead DDP and Astellas 

Related Post: PharmaShots Weekly Snapshots (December 16 – December 20, 2024)