This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Biosimilars, Animal Health & Biotech. Check out our full report below:
Novartis Reports Data from P-III (STEER) Study of Onasemnogene Abeparvovec to Treat Children and Young Adults with Spinal Muscular Atrophy (SMA)
Read More: Novartis
CARsgen Therapeutics Reports Topline Results from P-II Study of Satricabtagene Autoleucel (Satri-cel) to Treat G/GEJ Cancer in China
Read More: CARsgen Therapeutics
Axsome Therapeutics Reports Data from P-III (ACCORD-2 & ADVANCE-2) Trials of AXS-05 in Alzheimer’s Disease Agitation
Read More: Axsome Therapeutics
ADC Therapeutics Reports Enrollment Completion in P-III (LOTIS-5) Study of Zynlonta Plus Rituximab for 2L+ Diffuse Large B-Cell Lymphoma
Read More: ADC Therapeutics
Xgene Pharmaceutical Reports Results from P-IIb Trial of XG005 for Post-Surgical Pain
Read More: Xgene Pharmaceutical
Hanx Biopharmaceuticals Reports the First Patient Dosing with HX044 in P-I Clinical Evaluation
Read More: Hanx Biopharmaceuticals
BeiGene’s Tevimbra Plus Chemotherapy Secures the US FDA’s Approval as a 1L Treatment of G/GEJ Cancers
Read More: BeiGene
BMS’ Opdivo Qvantig SC Injection Secures the US FDA’s Approval for Solid Tumor Opdivo Indications
Read More: BMS
Johnson & Johnson Reports the EC’s Approval of Rybrevant (Amivantamab) Plus Lazcluze (Lazertinib) as a 1L Treatment of EGFRm NSCLC
Read More: Johnson & Johnson
Verastem Reports the US FDA’s NDA Acceptance of Avutometinib Plus Defactinib to Treat Recurrent KRAS Mutant Low-Grade Serous Ovarian Cancer (LGSOC)
Read More: Verastem
Corcept Therapeutics Reports NDA Submission of Relacorilant to the US FDA for Treating Hypercortisolism
Read More: Corcept Therapeutics
HUTCHMED Reports the NMPA’s NDA Acceptance of Orpathys Plus Tagrisso with Priority Review for EGFR-Mutated NSCLC with MET Amplification
Read More: HUTCHMED
MicuRx Pharmaceutical’s MRX-5 Secures the US FDA’s Orphan Drug Designation for Treating NTM Infections
Read More: MicuRx Pharmaceutical
Chimerix Reports the Dordaviprone’s NDA Submission to the US FDA for Recurrent H3 K27M-Mutant Diffuse Glioma
Read More: Chimerix
Innovent Reports the NMPA’s Approval of Dovbleron (Taletrectinib Adipate Capsule) for Treating ROS1-Positive NSCLC
Read More: Innovent
GSK’s Nucala (Mepolizumab) Secures the NMPA’s Approval for Treating Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)
Read More: GSK
IDEAYA Biosciences Partners with Hengrui Pharma to Develop SHR-4849 for Treating SCLC and NET Solid Tumors
Read More: IDEAYA Biosciences and Hengrui Pharma
Orion Corporation Terminates Agreement of Ganaxolone with Marinus Pharmaceuticals in Europe
Read More: Orion Corporation and Marinus Pharmaceuticals
Brii Bio Signs an Agreement with VBI Vaccines to Acquire BRII-179’s IP Rights
Read More: Brii Bio and VBI Vaccines
Pfizer Teminates the Deal to Develop Giroctocogene Fitelparvovec for Hemophilia A with Sangamo Therapeutics
Read More: Sangamo Therapeutics and Pfizer
Innovent Biologics Collaborates with Roche to Develop IBI3009 for SCLC
Read More: Innovent Biologics and Roche
Pharmanovia Collaborates with Radius Health to Commercialize Abaloparatide for Osteoporosis Treatment
Read More: Pharmanovia and Radius Health
Inogen Secures the US FDA’s Clearance for SIMEOX 200 Airway Clearance Device
Read More: Inogen
The China’s NMPA Grants Approval to Genesis Medtech's Articulation Powered Stapler, iReach Omnia, for Complex Surgeries
Read More: Genesis Medtech
Reliance Industries Reports the Acquisition of Karkinos Healthcare for ~$43.88M
Read More: Reliance Industries and Karkinos Healthcare
Immedica Pharma Reports the Acquisition of Marinus Pharmaceuticals for $151M
Read More: Immedica Pharma and Marinus Pharmaceuticals
Galera Therapeutics Completes Nova Pharmaceuticals’ Acquisition
Read More: Galera Therapeutics and Nova Pharmaceuticals
Xbrane Biopharma Reports Resubmission of BLA to the US FDA for Ranibizumab Biosimilar Candidate
Read More: Xbrane Biopharma
PettureX Reports the Launch of AI Pet Health Scanner App, Addressing Pet Health
Read More: PettureX
Atavistik Bio Partners with Pfizer to Discover Novel Precision Allosteric Therapeutics
Read More: Atavistik Bio and Pfizer
Related Post: PharmaShots Weekly Snapshots (December 23rd – December 27th, 2024)
