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

The CHMP Grants Positive Opinion to BMS’ Reblozyl for the Treatment of Transfusion-Dependent Anemia Due to Myelodysplastic Syndrome (MDS)

Read More: BMS                                                                 

The CHMP Recommends AstraZeneca’s Voydeya for Approval in the EU to Treat Paroxysmal Nocturnal Haemoglobinuria (PNH) with Residual Haemolytic Anaemia

Read More: AstraZeneca                                                         

CHMP Grants Positive Opinion to BeiGene’s Tevimbra (tislelizumab) as a Treatment for Non-Smal Cell Lung Cancer (NSCLC)

Read More: BeiGene                                                       

The US FDA Grants the Breakthrough Designation to Bayer’s BAY2927088 for the Treatment of Non-Small Cell Lung Cancer (NSCLC)

Read More: Bayer                                                                    

The US FDA Accepts Incyte’s BLA for Axatilimab with Priority Review to Treat Chronic Graft-Versus-Host Disease

Read More: Incyte                                                                 

ARTHEx Biotech Reports the US FDA's IND Clearance to Commence the P-I-IIa (ArthemiR) Study of ATX-01 for Treating Myotonic Dystrophy Type 1 (DM1)

Read More: ARTHEx Biotech                                                            

The US FDA Clears Spero Therapeutics’ IND Application of SPR206 for the Treatment of MDR Gram-Negative Bacterial Infections

Read More: Spero Therapeutics                                                  

The US FDA Accepts and Grants Priority Review to Applied Therapeutics’ NDA for Govorestat as a Treatment for Classic Galactosemia

Read More: Applied Therapeutics                                              

The US FDA Grants ODD to SN BioScience’s SNB-101 for Treating Pancreatic Cancer

Read More: SN BioScience                                                           

Sanofi’s P-II Study of Rilzabrutinib Reveals Reduction in Itch Severity & Improved Efficacy in Adults with Chronic Spontaneous Urticaria (CSU)

Read More: Sanofi                                                 

GSK Reports the P-III (EAGLE-1) Trial Results of Gepotidacin for Treating Urogenital Gonorrhoea (GC)

Read More: GSK                                                           

Boehringer Ingelheim’s Survodutide, Under P-II Development, Shows Improvement in Metabolic Dysfunction-Associated Steatohepatitis (MASH) 

Read More: Boehringer Ingelheim                                                        

BioLineRx Doses First Patient with Motixafortide in P-II Study for Treating Pancreatic Ductal Adenocarcinoma (PDAC)

Read More: BioLineRx                                                                   

Ironwood Pharmaceuticals Highlights P-III Results for Apraglutide to Treat Short Bowel Syndrome with Intestinal Failure (SBS-IF)

Read More: Ironwood Pharmaceuticals                                           

Innovent Reports Updates for IBI3002 Under P-I Clinical Evaluation as a Treatment of Asthma

Read More: Innovent                                                                 

BeiGene Highlights the Results from a Comparative Analysis of Brukinsa with Acalabrutinib to Treat Chronic Lymphocytic Leukaemia (CLL) 

Read More: BeiGene                                                                  

Cardiff Oncology Highlights the P-II Results for Onvansertib to Treat Colorectal Cancer

Read More: Cardiff Oncology                                                      

Virtual Incision’s MIRA Surgical System Gains the US FDA’s Marketing Authorization for Adults Undergoing Colectomy Procedures

Read More: Virtual Incision                                                                

The US FDA Grants 510(k) Clearance to Selux Diagnostics’ PBC Separator with Selux AST System for Antibiotic Susceptibility Testing

Read More: Selux Diagnostics                                                  

Amber Therapeutics Highlights Data from the Study of Amber-UI Pudendal Neuromodulation System for Urinary Incontinence

Read More: Amber Therapeutics                                                

The US FDA Grants Breakthrough Device Designation to ONWARD Medical’s ARC Brain-Computer Interface (BCI) System

Read More: ONWARD Medical                                                                   

The US FDA Grants a 51099(k) Clearance to Embolx’s Soldier High-Flow Microcatheter 

Read More: Embolx                                                                       

The MHLW Approves Chugai’s FoundationOne CDx Cancer Genomic Profile as a Companion Diagnostic for the Detection of Solid Tumor

Read More: Chugai                                                                      

The US FDA Approves Alvotech and Teva Pharmaceutical’s Simlandi, Biosimilar to Humira

Read More: Alvotech & Teva Pharmaceutical                          

Neomorph and Novo Nordisk Join Forces to Discover Molecular Glue Degraders for Cardiometabolic and Rare Diseases

Read More: Neomorph & Novo Nordisk                                

Biotheus and Bitterroot Bio have Signed a Multi-Year Research Collaboration Agreement to Develop Bispecific Proteins in Cardio-Immunology

Read More: Biotheus & Bitterroot Bio                                   

Viatris and Idorsia Partner to Develop and Commercialize Selatogrel and Cenerimod

Read More: Viatris & Idorsia                                                   

AbbVie and OSE Immunotherapeutics Partner to Develop OSE-230 for Treating Chronic Inflammation

Read More: AbbVie & OSE Immunotherapeutics                         

Amneal Signs an Exclusive Licensing Agreement with Zambon Biotech for IPX203 to Treat Parkinson’s Disease (PD)

Read More: Amneal Pharmaceuticals & Zambon Biotech      

Arcutis and Sato Pharmaceutical for the Development and Commercialization of Topical Roflumilast for Dermatological Indications in Japan

Read More: Arcutis & Sato Pharmaceutical               

Related Post:- PharmaShots Weekly Snapshots (February 19 – February 23, 2024)