This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Biosimilars, Animal Health & DigiHealth. Check out our full report below:
GSK Presents Pooled Analysis from P-III (ANCHOR-1 & 2) Trial of Depemokimab for CRSwNP at AAAAI/WAO Joint Congress 2025
Read More: GSK
Daiichi Sankyo Reports Interim Data of P-III (DESTINY-Gastric04) Study Evaluating Enhertu in HER2+ Metastatic Gastric Cancer Patients
Read More: Daiichi Sankyo
Contineum Therapeutics Initiates Patient Dosing in P-Ib Study to Evaluate PIPE-791 in Chronic Pain
Read More: Contineum Therapeutics
ITM Reports Topline Data from P-III (COMPETE) Trial of ITM-11 at the ENETS 2025 Conference
Read More: ITM
HUTCHMED Reports Enrollment Completion in P-II Trial of Fanregratinib for Intrahepatic Cholangiocarcinoma in China
Read More: HUTCHMED
Tris Pharma Reports P-III Clinical Data of Cebranopadol to Treat Moderate-to-Severe Acute Pain
Read More: Tris Pharma
AstraZeneca Reports P-III (MATTERHORN) Trial Data of Imfinzi as Perioperative Therapy for Stage II-IVA G/GEJ
Read More: AstraZeneca
Krystal Biotech’s Vyjuvek (beremagene geperpavec) Receives the CHMP’s Positive Opinion for Dystrophic Epidermolysis Bullosa (DEB)
Read More: Krystal Biotech
The CHMP Recommends Conditional Approval of Regeneron’s Linvoseltamab to Treat R/R Multiple Myeloma (MM)
Read More: Regeneron
Bavarian Nordic Reports the EC’s Approval of Vimkunya to Prevent Chikungunya
Read More: Bavarian Nordic
Johnson & Johnson’s Darzalex (daratumumab) Receives the CHMP’s Positive Opinion for Multiple Myeloma
Read More: J&J
The US FDA Accepts GSK’s Depemokimab Review Application for Asthma with Type 2 Inflammation and Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)
Read More: GSK
BeiGene Reports the US FDA approval for Tevimbra + CT as a 1L Treatment of Advanced ESCC
Read More: BeiGene
Genentech Reports the FDA's sBLA Acceptance for Gazyva to Treat Lupus Nephritis
Read More: Genentech
Bioheng Therapeutics Secures the FDA Clearance of IND Application for CTD402 in T-ALL/LBL
Read More: Bioheng Therapeutics
ARS Pharmaceuticals’ neffy 1mg Secures the US FDA’s Approval to Treat Type I Allergic Reactions in Children
Read More: ARS Pharmaceuticals
Neurotech Pharmaceuticals Reports the US FDA Approval for Encelto to treat Macular Telangiectasia Type 2
Read More: Neurotech Pharmaceuticals
Magnet Biomedicine Partners with Eli Lilly to Advance Molecular Glue Therapeutics in Oncology
Read More: Magnet Biomedicine and Eli Lilly
AbbVie Enters into a Global License Agreement with Gubra to Develop & Commercialize GUB014295 to Treat Obesity
Read More: AbbVie and Gubra
KYORIN and Novartis Sign a $832.5M Global License Agreement for KRP-M223
Read More: KYORIN and Novartis
Astellas to Establish Joint Venture with YASKAWA for Cell Therapy Manufacturing
Read More: Astellas and YASKAWA
Biocon Biologics Partners with Civica to extend access of Insulin Aspart in the US
Read More: Biocon Biologics and Civica
Inspira Technologies Reports Positive Results from Clinical Study of HYLA Blood Sensor
Read More: Inspira Technologies
Johnson & Johnson MedTech Launches Shockwave Javelin Peripheral IVL Catheter in the US
Read More: J&J
BridgeBio Oncology Therapeutics (BBOT) Enters into Business Combination Agreement with Helix Acquisition Corp. II to Develop RAS and PI3Kα-Targeting Drugs
Read More: BridgeBio Oncology Therapeutics and Helix Acquisition Corp. II
Boston Scientific Enters into a Definitive Agreement to Acquire SoniVie for $600M
Read More: Boston Scientific and SoniVie
Jazz Pharmaceuticals to Acquire Chimerix for ~$935M
Read More: Jazz Pharmaceuticals and Chimerix
Celltrion Reports the US FDA approval for Stoboclo & Osenvelt (Biosimilars, Prolia & Xgeva)
Read More: Celltrion
GumPaws Launches Gummy Supplements to Promote Dental Health in Dogs
Read More: GumPaws
Suvoda Launches AI assistant Sofia to Streamline Clinical Trial Management
Read More: Suvoda
Related Post: PharmaShots Weekly Snapshots (February 24, 2025 – February 28, 2025)
