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

Merck Reports P-III (KEYNOTE-689) Trial Data of Perioperative Keytruda for Locally Advanced Head and Neck Squamous Cell Carcinoma 

Read More: Merck 

Relmada Therapeutics Presents Initial P-II Trial Data of NDV-01 for High-Grade Non-Muscle Invasive Bladder Cancer (HG-NMIBC) at AUA 2025 

Read More: Relmada Therapeutics 

Bayer Reports Post-Hoc Data from P-III (ARANOTE) Trial of Nubeqa to Treat Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) 

Read More: Bayer 

Amylyx Pharmaceuticals Reports the First Participant Dosing in P-III (LUCIDITY) Study Evaluating Avexitide in PBH 

Read More: Amylyx Pharmaceuticals 

AstraZeneca Reports P-III (LOGOS & KALOS) Trial Findings of Breztri Aerosphere for Uncontrolled Asthma 

Read More: AstraZeneca 

Italfarmaco Obtains the CHMP’s Positive Opinion for Conditional Marketing of Duvyzat to Treat Duchenne Muscular Dystrophy (DMD) 

Read More: Italfarmaco 

Jazz Pharmaceuticals’ Zanidatamab Secures the CHMP Positive Opinion to Treat HER2+ Biliary Tract Cancer (BTC) 

Read More: Jazz Pharmaceuticals 

Regeneron’s Lynozyfic (Linvoseltamab) Receives the EC’s Conditional Approval for R/R Multiple Myeloma 

Read More: Regeneron 

The CHMP Adopts Positive Opinion on Alnylam Pharmaceuticals' Vutrisiran to Treat ATTR Amyloidosis with Cardiomyopathy (ATTR-CM) 

Read More: Alnylam Pharmaceuticals 

Krystal Biotech’s Vyjuvek (Beremagene Geperpavec-svdt) Receives the EC’s Approval for Dystrophic Epidermolysis Bullosa (DEB) 

Read More: Krystal Biotech 

Abeona Therapeutics’ Zevaskyn Receives the US FDA Approval for Recessive Dystrophic Epidermolysis Bullosa (RDEB) 

Read More: Abeona Therapeutics 

AbbVie’s Rinvoq (Upadacitinib) Receives the US FDA’s Approval for Giant Cell Arteritis 

Read More: AbbVie 

Johnson & Johnson Reports the US FDA’s Approval of Imaavy (Nipocalimab-aahu) for Generalized Myasthenia Gravis (gMG) 

Read More: J&J 

Satsuma Pharmaceuticals’ Atzumi (Dihydroergotamine) Nasal Powder Receives the US FDA’s Approval for Acute Treatment of Migraine 

Read More: Satsuma Pharmaceuticals  

Vertex Pharmaceuticals’ Alyftrek Receives the CHMP’s Positive Opinion for the Treatment of Cystic Fibrosis 

Read More: Vertex Pharmaceuticals 

Bavarian Nordic Reports the MHRA’s Approval of Vimkunya to Prevent Chikungunya 

Read More: Bavarian Nordic 

Prilenia Therapeutics Collaborates with Ferrer to Co-Develop and Commercialize Pridopidine for Indications Beyond Huntington’s Disease (HD) 

Read More: Prilenia Therapeutics and Ferrer 

Eli Lilly Partners with Creyon Bio for Accelerated Discovery and Development of RNA-Targeted Oligonucleotides for Various Diseases 

Read More: Eli Lilly and Creyon Bio 

Amicus Therapeutics Enters a ~$590M Exclusive License Agreement with Dimerix for DMX-200 

Read More: Amicus Therapeutics and Dimerix 

Brightseed and Haleon Collaborate to Discover Small Molecule for Human Health Innovation by Leveraging AI Platform Forager 

Read More: Brightseed and Haleon 

Repare Therapeutics Out-Licenses its Discovery Platforms to DCx Biotherapeutics 

Read More: Repare Therapeutics and DCx Biotherapeutics 

Kardium Reports Preliminary PULSAR IDE Trial Data of Globe PF System for Paroxysmal Atrial Fibrillation (PAF) 

Read More: Kardium 

Personalis Reports Interim VICTORI Study Data of NeXT Personal Assay for the Detection of Colorectal Cancer (CRC) 

Read More: Personalis 

Teleflex’s QuikClot Control+ Hemostatic Device Receives the US FDA’s 510(k) Clearance to Temporary Control All Bleeding Grades 

Read More: Teleflex 

OcuSciences’ OcuMet Beacon Receives the US FDA Clearance for Retinal Health Assessment 

Read More: OcuSciences 

Merck KGaA to Acquire SpringWorks Therapeutics for ~$3.9B 

Read More: Merck KGaA and SpringWorks Therapeutics  

Novartis to Acquire Regulus Therapeutics for ~$1.7B 

Read More: Novartis and Regulus Therapeutics

Biocon Biologics Receives CHMP’s Positive Opinion for Vevzuo and Denosumab BBL (Biosimilars, Xgeva and Prolia) 

Read More: Biocon Biologics 

Henlius and Sandoz Enter a Global Collaboration Agreement to Commercialize HLX13 (Biosimilar, Yervoy) 

Read More: Henlius and Sandoz 

Merck Animal Health Collaborates with AmacaThera to Develop Long-Acting Injectable Formulations for Veterinary Use 

Read More: Merck Animal Health and AmacaThera 

Related Post: PharmaShots Weekly Snapshots (April 21, 2025 – April 25, 2025)