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

Roche Highlights 2-Years Data from RAINBOWFISH Trial of Evrysdi for Treating Children with Spinal Muscular Atrophy (SMA) at WMS 2024

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Eli Lilly Highlights 1 Year Analysis from the P-III (VIVID-1) Trial of Mirikizumab for Treating Crohn's Disease at UEG Week 2024

Read More: Eli Lilly

Circle Pharma Reports the First Patient Dosing with CID-078 Under P-I Study for Advanced Solid Tumors

Read More: Circle Pharma

Innovent Biologics Reports the P-II Trial Data of Picankibart (IBI112) in Chinese Patients with Ulcerative Colitis

Read More: Innovent Biologics

Marinus Pharmaceuticals Highlights the P-III (RAISE) Study Data of Ganaxolone to Treat Refractory Status Epilepticus (RSE) at NCS 2024

Read More: Marinus Pharmaceuticals

Latigo Biotherapeutics Reports the First Patient Dosing with LTG-305 in its P-I Study for Non-Opioid Treatment of Pain

Read More: Latigo Biotherapeutics

Merck Highlights the P-IIb/III (MK-1654-004) Study Data of Clesrovimab to Prevent RSV Disease in Healthy Preterm and Full-term Infants at IDWeek 2024

Read More: Merck

Pfizer Reports the US FDA’s Approval of Hympavzi to Treat Hemophilia A/B without Inhibitors in Adults and Adolescents

Read More: Pfizer

AstraZeneca and Daiichi Sankyo Report the NMPA’s Conditional Approval of Enhertu to Treat Metastatic NSCLC with HER2 Mutations

Read More: AstraZeneca and Daiichi Sankyo

Bayer Reports the Regulatory Submission of Nubeqa (Darolutamide) to the EMA for Treating Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Read More: Bayer

Dizal’s Sunvozertinib Receives the NMPA’s Breakthrough Therapy Designation as a 1L Treatment of NSCLC with EGFR Mutations

Read More: Dizal

Novocure’s Optune Lua Receives the US FDA’s Nod for Treating Metastatic Non-Small Cell Lung Cancer

Read More: Novocure

UroGen Reports the US FDA’s NDA Acceptance of Mitomycin (UGN-102) for Treating Non-Muscle Invasive Bladder Cancer

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GSK Reports the US FDA’s NDA Acceptance of Gepotidacin with Priority Review to Treat Uncomplicated Urinary Tract Infections

Read More: GSK

Lantern Pharma’s LP-184 Gains the US FDA’s Fast-Track Designation for Treating Glioblastoma

Read More: Lantern Pharma

Cullinan Therapeutics Reports the US FDA’s IND Approval of CLN-978 to Treat Systemic Lupus Erythematosus

Read More: Cullinan Therapeutics

Alnylam Reports the Submission of Regulatory Application of Amvuttra (Vutrisiran) to the EMA Treating ATTR Amyloidosis with Cardiomyopathy

Read More: Alnylam Pharmaceuticals

AbbVie Reports the US FDA’s Approval of Vyalev (Foscarbidopa and Foslevodopa) for Treating Advanced Parkinson's Disease

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Novartis’ Kisqali (Ribociclib) Gains the CHMP’s Positive Opinion as an Adjuvant Treatment of HR+/HER2- Early Breast Cancer (EBC)

Read More: Novartis

Exelixis and Merck Join Forces to Develop Zanzalintinib for Head and Neck Cancer and Renal Cell Carcinoma

Read More: Exelixis and Merck

Viatris Join Forces with Lexicon Pharmaceuticals to Commercialize Sotagliflozin Across all Markets Outside of the US and EU

Read More: Viatris and Lexicon Pharmaceuticals

Sanofi Collaborates with Orano Med for the Development of Next-Generation Radioligand Therapies

Read More: Sanofi and Orano Med

Factor Bioscience Collaborates with Eterna Therapeutics to Develop Cell Therapy Focusing on Oncology, Autoimmune and Rare Diseases

Read More: Factor Bioscience and Eterna Therapeutics

Poseida Therapeutics Nominates a New CAR-T Development Candidate Under Partnership with Roche

Read More: Poseida Therapeutics and Roche

LaNova Medicines Reports the Commencement of P-I Study Evaluating LM-299 for Solid Tumors and Completes Series C1 Financing Round

Read More: LaNova Medicines

Abbott Reports the Study Advancements in Pulsed Field Ablation, Gets the US FDA’s Nod for Technology Supporting Cardiac Mapping

Read More: Abbott

Bausch + Lomb Reports the US FDA’s Approval of enVista Envy Full Range of Vision Intraocular Lens

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Lundbeck to Acquire Longboard Pharmaceuticals, Strengthening its Neuroscience Portfolio

Read More: Lundbeck and Longboard Pharmaceuticals

Dong-A ST Reports the US FDA’s Approval of Imuldosa (Biosimilar, Stelara)

Read More: Dong-A ST

Merck Animal Health Reports the EMA’s Approval of an Expanded Indication for SC Administration of Bovilis Rotavec Corona

Read More: Merck Animal Health

Related Post: PharmaShots Weekly Snapshots (October 07 – October 11, 2024)