This week PharmaShots’ news was all about the updates on Regulatory, Clinical Trials, Pharma, Animal Health & MedTech.

Check out our full report below: 

Health Canada Accepts Filling and Priority Review of Acadia’s TROFINETIDE for Rett Syndrome

Read More: Health Canada                                                                                            

US FDA Granted Fast Track Designation to Medicure’s MC-1 for PNPO deficiency

Read More: US FDA                                                                                                        

EMA Granted Extended Approval to Astellas’ XTANDI (Enzalutamide) for Recurrent Early Prostate Cancer Treatment

Read More: EMA                                                                                                             

CSL Vifor and Travere Therapeutics’ FILSPARI (sparsentan) Received European Commission Approval Against IgA Nephropathy

Read More: CSL

Ascendis Pharma Receives MHRA Approval for YORVIPATH (Palopegteriparatide) Against Chronic Hypoparathyroidism in Great Britain

Read More: Ascendis

Blue Arbor’s RESTORE Neuromuscular Interface System Receives FDA Breakthrough Device Designation & TAP Enrolment

Read More: Blue Arbor 

Medivir’s MIV-711 Receives FDA ODD and RPDD for Legg-Calvé-Perthes Disease

Read More: Medivir 

US FDA Grants Fast Track Designation to Compass Therapeutics’ CTX-009 with Paclitaxel for Previously Treated Metastatic or Locally Advanced Biliary Tract Tumors.

Read More: US FDA   

Aurigene and Vipergen Enter into a Strategic Collaboration to Offer DEL Screening and Integrated Drug Discovery Services

Read More: Aurigene and Vipergen 

Ipsen Enters into an Option Agreement with Skyhawk Therapeutics for Two RNA Targeting Small Molecules in Rare Neurological Diseases

Read More: Ipsen  

Ochre Bio and Boehringer Ingelheim Enter into a Collaboration to Develop and Commercialize Novel Regenerative Treatments for Advanced Liver Disease

Read More: Ochre Bio and Boehringer    

Vertex and Treefrog Therapeutics Sign a Licensing Agreement & Collaborate to Enhance Production of Vertex’s Cell Therapies for Type-I Diabetes

Read More: Vertex and Treefrog  

Angle Enters into a Supply Agreement with AstraZeneca to use DDR Assay in Pharmaceutical R&D

Read More: Angle  

MFDS Korea Approves Onconic Therapeutics’ JAQBO (Zastaprazan citrate) for Treatment of Gastroesophageal Reflux Disease (GERD) in adults

Read More: MFDS Korea  

Regeneron and Mammoth Collaborate for CRISPR Gene Editing Therapies Against Multiple Diseases

Read More: Regeneron    

 Incyte to Acquire Escient Pharmaceuticals and its MRGPR Antagonist Assets

Read More: Incyte  

Labcorp to Acquire Invitae Under US Bankruptcy Code Section 363

Read More: Labcorp 

Cochlear's Osia System Gets FDA Clearance for Children Aged 5 Years and Above

Read More: Cochlear's

Immunovia Reports Positive Results of Next Generation Test from Model Development Study for Pancreatic Cancer Detection.

Read More: Immunovia

Hepion Pharmaceuticals Begins Wind-Down Activities in ASCEND-NASH P-IIb Study

Read More: Hepion 

GENETIKA+ and NeuroSense Commence Precision Medicine Collaboration with the Ongoing P-II Trial in Alzheimer’s Disease 

Read More: GENETIKA+  

Krystal Biotech doses First Patient with Inhaled KB707 in the P-I study for treating Locally Advanced or Metastatic Solid Tumors of the Lung

Read More: Krystal Biotech 

Sanofi’s Rilzabrutinib Meets Primary Endpoint of the LUNA-3 (P-III) Study for the Treatment of Immune Thrombocytopenia (ITP)

Read More: Sanofi

Neurocrine Biosciences Reports Positive Results from P-II study of NBI-1065845 in MDD

Read More: Neurocrine

CureVac collaborates with GSK to Initiate P-I/II study of Avian Influenza (H5N1)

Read More: CureVac

Atom Bioscience Initiates Enrolment in Global P-IIb/III Study of ABP-671 to Treat Chronic Gout in US

Read More:  Atom Bioscience

Vistagen Reports Positive Results from P-IIa Study of PH15 for Improvement of Psychomotor Impairment

Read More: Vistagen

Cresilon Teams Up with Covetrus, MWI Animal Health, and Patterson Veterinary Supply for VETIGEL (Haemostatic Gel)

Read More: Cresilon