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