PharmaShots Weekly Snapshots (April 22 – April 26, 2024)

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                                                                                           Date: Apr 23, 2024 

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

Read More: US FDA                                                                                                        Date: Apr 24, 2024 

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

Read More: EMA                                                                                                            Date: Apr 24, 2024 

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

Read More: CSL                                                                                                           Date: Apr 24, 2024 

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

Read More: Ascendis                                                                                                     Date: Apr 25, 2024

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

Read More: Blue Arbor                                                                                                  Date: Apr 25, 2024

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

Read More: Medivir                                                                                                     Date: Apr 25, 2024

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                                                                                                      Date : Apr 26,2024

 

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

Read More: Aurigene and Vipergen                           Date: Apr22, 2024 

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

Read More: Ipsen                                                                                                                  Date: Apr22,2024

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                                                                             Date: Apr23,2024 

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                                                                                      Date: Apr 23, 2024

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

Read More: Angle                                                                                                                Date: Apr 24, 2024

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

Read More: MFDS Korea                                                                                                 Date: Apr 26, 2024

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

Read More: Regeneron                                                                                                   Date : Apr 26, 2024 

 

 Incyte to Acquire Escient Pharmaceuticals and its MRGPR Antagonist Assets

Read More: Incyte                                                                                                            Date: Apr 24, 2024

Labcorp to Acquire Invitae Under US Bankruptcy Code Section 363

Read More: Labcorp                                                                                                        Date: Apr 25, 2024

 

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

Read More: Cochlear’s                                                                                                 Date: Apr 22, 2024 

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

Read More: Immunovia                                                                                                              Date: Apr 22, 2024

 

 

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

Read More: Hepion                                                                                                              Date: Apr22, 2024 

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

Read More: GENETIKA+                                                                                                       Date: Apr 23, 2024 

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                                                                                                Date: Apr 23, 2024 

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

Read More: Sanofi                                                                                                              Date: Apr 23, 2024 

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

Read More: Neurocrine                                                                                                      Date: Apr 24, 2024 

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

Read More: CureVac                                                                                                            Date: Apr 25, 2024 

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

Read More:  Atom Bioscience                                                                                           Date: Apr 25, 2024 

Sanofi to Highlight New Data from the P-II Study of Frexalimab for the Treatment of Multiple Sclerosis at AAN 2024

Read More: Sanofi                                                                                                                 Date: Apr 17, 2024 

GSK to Feature Results from the P-III (ZOSTER-049) Study of Shingrix for Protection Against Shingles at ESCMID Global 2024

Read More: GSK                                                                                                                    Date: Apr 17, 2024 

Roche to Highlight the P-III (OCARINA II) Trial Results of Ocrevus for Treating Progressive and Relapsing Multiple Sclerosis at AAN 2024

Read More: Roche                                                                                                                 Date: Apr 17, 2024 

GSK to Highlight Results from the P-III (EAGLE-1) Study of Gepotidacin for Treating Uncomplicated Urogenital Gonorrhoea (GC) at ESCMID 2024

Read More: GSK                                                                                                                     Date: Apr 18, 2024 

Lilly Reports the P-III (SURMOUNT-OSA) Study Data of Tirzepatide in Patients with Obstructive Sleep Apnea (OSA) and Obesity

Read More: Eli Lilly                                                                                                                Date: Apr 18, 2024 

Artiva Biotherapeutics Doses First Patient with AlloNK in the P-I Study for Treating Lupus Nephritis

Read More: Artiva                                                                                                                 Date: Apr 18, 2024 

Cerevel Therapeutics Reports Results from P-III Adjunctive Study Evaluating Tavapadon for the Treatment of Advanced Parkinson’s Disease

Read More: Cerevel                                                                                                             Date: Apr 19, 2024 

Oncternal Therapeutics Reports First Patient Dosing in Fourth Cohort of P-I/II Study of ONCT-534 for the Treatment of R/R mCRPC

Read more: Oncternal Therapeutics                                                                                 Date: Apr19,2024

Ventus Therapeutics Reports Results from the P-I Study of VENT-02 in Healthy Volunteers

Read more: Ventus Therapeutics                                                                               Date: Apr19,2024

 

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

Read More: Cresilon                                                                                                          Date: Apr 22, 2024