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

AstraZeneca Presents Post-Hoc Data from P-III (NIAGARA) Trial of Imfinzi in Muscle-Invasive Bladder Cancer Patients regardless of Complete Pathology Response at ASCO GU 2025 

Read More: AstraZeneca 

Exelixis Presents 5-year Follow-Up Data from P-III (CheckMate -9ER) of Cabometyx + Opdivo in Renal Cell Carcinoma Patients at ASCO GU 2025 

Read More: Exelixis 

BMS Reports P-III (CheckMate-816) Trial Data of Opdivo as a Neoadjuvant Treatment of Resectable NSCLC 

Read More: BMS 

Akeso Reports First Patient Enrollment in P-III Study of Ivonescimab + CT to Treat Triple-Negative Breast Cancer (TNBC) in China 

Read More: Akeso 

Ono Pharmaceutical Reports the US FDA Approval of Romvimza to Treat Symptomatic Tenosynovial Giant Cell Tumor (TGCT) in Adults 

Read More: Ono Pharmaceutical 

GSK Reports the US FDA Approval of Penmenvy (MenABCWY Vaccine) for Protection Against Invasive Meningococcal Disease (IMD) 

Read More: GSK 

Galderma’ Nemluvio Receives UK’s MHRA & Swissmedic Approval for Atopic Dermatitis and Prurigo Nodularis 

Read More: Galderma 

Regeneron and Sanofi Report the US FDA’s sBLA Acceptance for Dupixent to Treat Bullous Pemphigoid (BP) 

Read More: Regeneron and Sanofi 

The US FDA Grants Breakthrough Therapy Designation to Innate Pharma’s Lacutamab for R/R Sézary Syndrome 

Read More: Innate Pharma 

Merus Receives the US FDA’s Breakthrough Therapy Designation for Petosemtamab to Treat 1L PD-L1+ Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) 

Read More: Merus 

Merck Receives the EC’s Approval for Welireg (Belzutifan) for Von Hippel-Lindau (VHL) Disease-Associated Tumors and Previously Treated Renal Cell Carcinoma 

Read More: Merck 

Gilead Reports US FDA’s NDA Acceptance of Lenacapavir for Pre-Exposure Prophylaxis (PreP) to Prevent HIV in Individuals at Risk 

Read More: Gilead 

The US FDA Accepts NDA of Boehringer Ingelheim’s Zongertinib for HER2 (ERBB2)-Mutant NSCLC 

Read More: Boehringer Ingelheim 

GSK Reports the China’s NMPA Acceptance of Nucala (Mepolizumab) as an Add-on Treatment for COPD 

Read More: GSK 

Gilead Receives EC’s Conditional Marketing for Seladelpar to Treat Primary Biliary Cholangitis (PBC) 

Read More: Gilead 

Biogen Collaborates with Stoke Therapeutics to Develop and Commercialize Zorevunersen for Dravet Syndrome 

Read More: Biogen and Stoke Therapeutics 

Epitopea Partners with Merck to Discover Cryptigen Tumor-Specific Antigens Using Epitopea’s CryptoMap platform 

Read More: Epitopea and Merck 

CSPC Pharmaceutical Collaborates with Radiance Biopharma to Develop and Commercialize RB-164 (SYS6005) as an Anti-Cancer Therapy 

Read More: CSPC Pharmaceutical and Radiance Biopharma 

Harbour BioMed Enters into a Collaboration with Insilico Medicine to Advance AI-Driven Antibody Discovery and Development 

Read More: Harbour BioMed and Insilico Medicine 

Incyte Partners with Genesis to Develop and Commercialize Novel Small Molecules Using Genesis’ GEMS AI Platform 

Read More: Incyte and Genesis 

Navi Medical Technologies Receives the US FDA’s 510(k) Clearance for Neonav ECG Tip Location System 

Read More: Navi Medical Technologies 

The US FDA Approves MED-EL’s Sonnet 3 Audio Processor for Optimal Hearing 

Read More: MED-EL 

Cosette Pharmaceuticals to Acquire Mayne Pharma for ~$430M 

Read More: Cosette Pharmaceuticals and Mayne Pharma 

AstraZeneca Purchases FibroGen China for ~$160M 

Read More: AstraZeneca and FibroGen China 

Anivive Lifesciences Completes Pivotal Field Study of Laverdia-CA1 (Verdinexor Tablets) for Canine Lymphoma 

Read More: Anivive Lifesciences 

Elanco Launches Pet Protect Supplement Line for Dogs and Cats 

Read More: Elanco 

Samsung Bioepis Reports the EC’s approval of Obodence & Xbryk (Biosimilar, Denosumab) 

Read More: Samsung Bioepis 

Celltrion Secures the EC’s Approval for Eydenzelt (Biosimilar, Eylea), Stoboclo & Osenvelt (Biosimilars, Prolia & Xgeva) 

Read More: Celltrion 

Alvotech and Teva Report the Regulatory Filing Acceptance for AVT06 (Biosimilar, Eylea) Across the US 

Read More: Alvotech and Teva 

CSL and Arcturus Therapeutics Report the EC’s Approval of Kostaive Against COVID-19 

Read More: CSL and Arcturus Therapeutics 

Related Post: PharmaShots Weekly Snapshots (February 10th, 2025 – February 14th, 2025)