PharmaShots Weekly Snapshots (February 12 – February 16, 2024)

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PharmaShots Weekly Snapshots (February 12 – February 16, 2024)

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



CSL Highlights Results from the P-III (AEGIS-II) Study of CSL112 for Acute Myocardial Infarction 

Read More: CSL                                                                                                         

Shionogi Reports the Results for Ensitrelvir in P-III Trial for the Treatment of Common COVID-19 Symptoms  

Read More: Shionogi                                                                                               

Larimar Therapeutics Highlights the P-II Results for Nomlabofusp as a Treatment for Friedreich’s Ataxia  

Read More: Larimar Therapeutics                                                                   

KalVista Pharmaceuticals Reports the P-III (KONFIDENT) Study Results of Sebetralstat for Treating Hereditary Angioedema  

Read More: KalVista Pharmaceuticals                                                        

Otsuka Highlights P-III Study Results of AVP-786 for Treating Agitation in Patients with Dementia due to Alzheimer's Disease 

Read More: Otsuka                                                                                   

Replicate Bioscience Reports P-I Trial Results of RBI-4000 for Rabies 

Read More: Replicate Bioscience                                                             

Sanofi Reports P-II Results for Frexalimab as a Treatment for Relapsing Multiple Sclerosis (MS) 

Read More: Sanofi                                                                                       

Applied Therapeutics Highlights the P-III Results for Govorestat (AT-007) to Treat Sorbitol Dehydrogenase (SORD) Deficiency 

Read More: Applied Therapeutics                                                           


The US FDA Accepts Humacyte’s and BLA for Human Aacelluar Vessel and Grants Priority Review for the Treatment of Vascular Trauma 

Read More: Humacyte                                                                                             

The US FDA Granted the Fast Track Designation to GSK’s Bepirovirsen for the Treatment of Hepatitis B  

Read More: GSK                                                                                                   

The US FDA Grants BTD to AlphaMedix Developed Jointly by RadioMedix and Orano Med for Treating GEP-NETs 

Read More: RadioMedix & Orano Med                                                             

Biogen’s Skyclarys (omaveloxolone) Receives the European Commission’s Approval for the Treatment of Friedreich’s Ataxia (FA) 

Read More: Biogen                                                                                             

Takeda’s Eohilia (budesonide oral suspension) Received the US FDA’s Approval for the Treatment of Eosinophilic Esophagitis (EoE) 

Read More: Takeda                                                                                        

The US FDA and the EMA Accepts Galderma’s BLA with Priority Review for Nemolizumab to Treat Nodularis and Atopic Dermatitis  

Read More: Galderma                                                                                   

Ascentage Pharma Receives Clearance from the US FDA to Begin P-III Study of Olverembatinib for Chronic-Phase Chronic Myeloid Leukemia 

Read More: Ascentage Pharma                                                                 

Diamyd Medical’s Diamyd Receives US FDA’s Fast Track Designation for Type 1 Diabetes 

Read More: Diamyd Medical                                                                           

The US FDA Accepts and Grants Priority Review to BMS’ sNDA for Augtyro to Treat Solid Tumors 

Read More: BMS                                                                                         

Merit Medical Receives the US FDA’s 510(k) Clearance for SCOUT MD Surgical Guidance System to Detect and Treat Soft Tissue Cancers  

Read More: Merit Medical                                                                             

The MHLW Granted Priority Review to Astellas’ sNDA for Padcev and Keytruda as Combination Therapy to Treat Bladder Cancer  

Read More: Astellas                                                                                        


For an Aggregate of ~$0.81M, RaySearch Acquires Pharmacolog’s DrugLog 

Read More: RaySearch & Pharmacolog                                                                 

For an Aggregate of ~$4.3B, Gilead Sciences to Acquire CymaBay Therapeutics  

Read More: Gilead Sciences & CymaBay Therapeutics                                  


Tyber Medical’s Proximal Tibia Plating System Receives the US FDA’s 510(k) Clearance 

Read More: Tyber Medical                                                                                  


Roche Signs an Agreement with PathAI to Enhance Digital Pathology Capabilities for Companion Diagnostics 

Read More: Roche & PathAI                                                                           


Ono Pharmaceutical and Shattuck Labs Partner to Develop Bifunctional Fusion Proteins for Treating Autoimmune and Inflammatory Diseases 

Read More: Ono Pharmaceutical & Shattuck Labs                                   

VantAI Joins Forces with BMS to Expedite Molecular Glue Drug Discovery Through Artificial Intelligence 

Read More: VantAI & BMS                                                                          

Erasca Signs two Clinical Trial Collaboration and Supply Agreements with Novartis to Develop Naporafenib Combinations for Treating Solid Tumors 

Read More: Erasca & Novartis                                                                      

Numab Therapeutics and Ono Pharmaceutical Collaborate to Develop Multi-specific Antibody, NM49, for Treating Cancer 

Read More: Numab Therapeutics & Ono Pharmaceutical                    

Intellia Therapeutics Signs a Collaboration Agreement ReCode Therapeutics to Develop Novel Gene Editing Therapies for Cystic Fibrosis (CF) 

Read More: Intellia Therapeutics & ReCode Therapeutics                      


Boehringer Ingelheim and Veeva System Partner to Simplify Clinical and Regulatory Operations in Animal Health 

Read More: Boehringer Ingelheim & Veeva System                           

Jaguar Health Receives the US FDA Approval on the Clinical Trial Protocol for Canalevia-CA1 to Treat Chemotherapy-Induced Diarrhea in Dogs 

Read More: Jaguar Health                                                                             

Bharat Yadav

Bharat is a data whiz who collate and analyzes the data to generate valuable insights, contributing to both our monthly reports and the extraction of key information from press releases. Through his work, Bharat plays a crucial role in ensuring Pharmashots delivers the most relevant and up-to-date information to our readers.

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