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

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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)