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

Novo Nordisk Reports Headline Results from P-IIIb (STEP UP) Study of Semaglutide 7.2mg in Obese Adults without Diabetes 

Read More: Novo Nordisk 

Yoltech Initiates a Dose-Escalation Study for YOLT-204 to Treat β -Thalassemia 

Read More: Yoltech 

Antennova to Highlight P-I/II (CLINCH) Trial Data of ATN-022 to Treat Advanced/Metastatic Gastric Cancer at ASCO GI 2025 

Read More: Antennova 

Coherus to Highlight Final P-II Study Data of Casdozokitug Regimen to Treat Metastatic Hepatocellular Carcinoma at ASCO-GI 2025 

Read More: Coherus 

Tris Pharma Reports the P-III (ALLEVIATE-1) Study Results of Cebranopadol to Treat Moderate-to-Severe Acute Pain 

Read More: Tris Pharma 

Agenus Highlights Data from Five Studies of Botensilimab/Balstilimab (BOT/BAL) Regimen as Multiple lines of Therapy in Colorectal Cancer at ASCO GI 2025 

Read More: Agenus 

Rakuten Medical Commences Global P-III (ECLIPSE) Study of ASP-1929 Plus Keytruda as a 1L Treatment of Recurrent Head and Neck Cancer 

Read More: Rakuten Medical 

Lisata Therapeutics and WARPNINE Reports Initial Results from P-Ib/IIa (iLSTA) trial of Certepetide Regimen in Pancreatic Ductal Adenocarcinoma (PDAC) 

Read More: Lisata Therapeutics and WARPNINE 

Amgen Receives the US FDA Approval for Lumakras + Vectibix to Treat Chemorefractory KRAS G12C-Mutated Metastatic Colorectal Cancer (mCRC) 

Read More: Amgen 

Daiichi Sankyo and AstraZeneca Receives the US FDA Approval for Datroway (Datopotamab Deruxtecan-dlnk) to Treat HR+/HER2- Metastatic Breast Cancer 

Read More: Daiichi Sankyo and AstraZeneca 

AstraZeneca’s Calquence (Acalabrutinib) Plus Chemoimmunotherapy Secures the US FDA’s Approval for Mantle Cell Lymphoma (MCL) 

Read More: AstraZeneca 

GSK’s Jemperli Plus Chemotherapy Receives the EC’s Approval as a 1L Treatment of Primary Advanced or Recurrent Endometrial Cancer 

Read More: GSK 

Takeda Receives Health Canada’s Approval for Fruzaqla (fruquintinib) to Treat Metastatic Colorectal Cancer (mCRC) 

Read More: Takeda 

The US FDA Approves sNDA for J&J’s Spravato (esketamine) to Treat Major Depressive Disorder (MDD) 

Read More: J&J 

The EC Approves Sanofi’s Sarclisa + standard-of-care VRd to Treat Newly Diagnosed Multiple Myeloma (NDMM) 

Read More: Sanofi 

Solid Biosciences’ SGT-212 Secures the US FDA’s Fast Track Designation for Treating Friedreich’s Ataxia 

Read More: Solid Biosciences 

Zai Lab’s ZL-1310 Secures the US FDA’s Orphan Drug Designation to Treat Small Cell Lung Cancer (SCLC) 

Read More: Zai Lab 

Fermion Technology and Simcere Pharma Join Hands to Develop FZ002-037 for Pain Management 

Read More: Fermion Technology and Simcere Pharma 

InnoCare and KeyMed Together Partner with Prolium Bioscience to Develop ICP-B02 

Read More: InnoCare and KeyMed 

Junshi Biosciences & LEO Pharma Collaborate to Commercialize Toripalimab in Europe 

Read More: Junshi Biosciences and LEO Pharma 

ArriVent Biopharma Collaborates with Lepu BioPharma to Develop and Commercialize MRG007 for the Treatment of Gastrointestinal Cancers 

Read More: ArriVent Biopharma and Lepu BioPharma 

Abbvie Partners with Neomorph to Develop Novel Molecular Glue Degraders for Oncology and Immunology 

Read More: Abbvie and Neomorph 

IMMvention Therapeutix Partners with Novo Nordisk to Develop Oral BACH1 inhibitors for Chronic Conditions 

Read More: IMMvention Therapeutix and Novo Nordisk 

Holon Health Reports Development of Holon Vibe App for the People with Substance Use Disorders (SUD) 

Read More: Holon Health 

The US FDA Approves Innovate’s MediBeacon Transdermal GFR System to Evaluate Renal Function 

Read More: Innovate 

Roche Receives 510(k) Clearance & CLIA Waiver for Cobas Liat Multiplex Assay Panels to Diagnose Sexually Transmitted Infections 

Read More: Roche 

Medidata (Dassault Systèmes brand) and Tigermed Expand their Strategic Collaboration to Expedite Clinical Trials Globally 

Read More: Medidata and Tigermed 

Formycon Reports the EC’s Approval of FYB203 (Biosimilar, Eylea) Under the Brand Names Ahzantive and Baiama 

Read More: Formycon 

Virbac Launches Zenifel Pheromone Product to Address Stress-Related Behaviors in Cats 

Read More: Virbac

Tiziana Life Sciences Identifies New Immune Biomarkers in Multiple Sclerosis Patients Treated with Foralumab 

Read More: Tiziana Life Sciences 

Related Post: PharmaShots Weekly Snapshots (January 13, 2025 – January 17, 2025)