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

AstraZeneca Reports the Data from P-IIIb (BATURA) Study of Airsupra (Albuterol/Budesonide) for Intermittent or Mild Persistent Asthma  

Read More: AstraZeneca                                                                                                            

GE HealthCare Reports the P-I Study Data of its Macrocyclic Manganese-Based MRI Contrast Agent 

Read More: GE HealthCare                                                                                                          

Hansa Biopharma Reports the Results from the NICE-01 Clinical Evaluation of HNSA-5487  

Read More: Hansa Biopharma                                                                                                          

BerGenBio Reports the Data from P-Ib/IIa (BGBC016) Clinical Evaluation of Bemcentinib as 1L Treatment of NSCLC  

Read More: BerGenBio                                                                                                                 

Cybrexa Therapeutics Doses the First Patient with CBX-12 Under P-II Study for Treating Ovarian Cancer 

Read More: Cybrexa Therapeutics                                                                                               

Sage Therapeutics Provides Data from the P-II (LIGHTWAVE) Trial of Dalzanemdor to Treat Mild Cognitive Impairment and Dementia in Alzheimer’s Disease 

Read More: Sage Therapeutics 

Merck Provides Update on P-III (KEYNOTE-689) Study of Keytruda as a Perioperative Treatment of Head and Neck Squamous Cell Carcinoma 

Read More: Merck 

Aurigene Oncology Reports Results from the P-I (SWASTH) Trial of Ribrecabtagene Autoleucel for Multiple Myeloma in India 

Read More: Aurigene Oncology 

Oncoinvent Reports the First Patient Dosing with Radspherin in its P-II Clinical Evaluation for Ovarian Cancer 

Read More: Oncoinvent 

Pfizer Reports the Data from P-III (TALAPRO-2) Study of Talzenna Plus Xtandi for Treating mCRPC 

Read More: Pfizer 

Johnson & Johnson Reports Tremfya Pooled Analysis from GALAXI-2, 3 and QUASAR Trials 

Read More: Johnson & Johnson 

Zealand Pharma and Boehringer Ingelheim Report the US FDA’s Breakthrough Therapy Designation of Survodutide for MASH  

Read More: Zealand Pharma and Boehringer Ingelheim       

Biogen’s Felzartamab Gains the US FDA’s Breakthrough Therapy Designation to Treat AMR in Kidney Transplant Recipients 

Read More:  Biogen 

Roche’s Reports the US FDA’s Approval of Itovebi as a Treatment for HR+ and HER2- breast cancer with a PIK3CA mutation 

Read More:  Roche 

Burning Rock and Dizal Reports China's NMPA Approval of Co-Developed Companion Diagnostic (CDx) for Lung Cancer

Read More: Burning Rock and Dizal

Astellas Join Forces with AviadoBio for AVB-101 Gene Therapy Targeting Frontotemporal Dementia and Other Indications 

Read More: Astellas and AviadoBio 

Boehringer Ingelheim Join Forces with Circle Pharma to Develop a Novel Precision Cancer Treatment 

Read More: Boehringer Ingelheim and Circle Pharma 

Exact Sciences Reports the US FDA’s Approval of Cologuard Plus Test for Non-Invasive Colorectal Cancer Screening 

Read More: Exact Sciences                                                                                                          

The US FDA Grants Approval to ALK’s Series of AccuTest Devices for Allergy Testing and Diagnosis 

Read More: ALK        

Roche’s Ventana CLDN18 (43-14A) RxDx Assay Receives CE Mark Approval to Diagnose G/GEJ Cancer Patients with CLDN18 Protein Expression 

Read More: Roche         

RIVANNA launches a Global FIH Trial for its Accuro XV Musculoskeletal Imaging System 

Read More: RIVANNA 

Caldera Medical Reports the Acquisition of UVision360, Strengthening its Minimally Invasive Hysteroscopy Portfolio 

Read More: Caldera Medical       

Johnson & Johnson Completes the Acquisition of V-Wave 

Read More: Johnson & Johnson and V-Wave 

Teva Reports the Acceptance of Regulatory Submissions for TVB-009P (Biosimilar, Prolia) by the US FDA and EMA 

Read More: Teva Pharmaceuticals            

Bio-Thera Collaborates with Gedeon Richter for BAT2206 (Biosimilar, Stelara) 

Read More: Bio-Thera and Gedeon Richter       

Alvotech Reports the EMA’s Acceptance of MAA for AVT03 (Biosimilar, Prolia and Xgeva) 

Read More: Alvotech 

Elanco Animal Health Reports the US FDA’s Approval of Credelio Quattro for Protection Against Parasites in Dogs 

Read More: Elanco Animal Health     

AstraZeneca Inks a Pact with CSPC Pharmaceutical Group to Advance a Lipid-Lowering Pre-Clinical Candidate 

Read More: AstraZeneca and CSPC Pharmaceutical 

Bayer Collaborates with MOMA Therapeutics for the Development of a Small Molecule Oncology Program 

Read More: Bayer and MOMA Therapeutics 

Revalesio Reports Results from its Non-Clinical Study of RNS60 for Amyotrophic Lateral Sclerosis (ALS) 

Read More: Revalesio                                                                     

Related Post: PharmaShots Weekly Snapshots (September 30 – October 04, 2024)