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:
Estrella Immunopharma Reports the Approval to Start a Higher Dose Cohort After the Completion of First Dose Cohort in STARLIGHT-1 Study
Read More: Estrella Immunopharma
Regeneron Presents P-I/II (CHORD) Trial Data of DB-OTO for Profound Genetic Hearing Loss at Association for Research in Otolaryngology 2025
Read More: Regeneron
AstraZeneca Reports Interim Data from P-III (SERENA-6) Trial of Camizestrant to Treat Advanced Breast Cancer
Read More: AstraZeneca
Bayer Presents P-III (QUANTI CNS) Trial Data of Gadoquatrane at European Congress of Radiology 2025
Read More: Bayer
Belite Bio Reveals Interim P-III (DRAGON) Trial Data of Tinlarebant for Adolescent Stargardt Disease
Read More: Belite Bio
Mirum Pharmaceuticals Receives the US FDA Approval for Ctexli to Treat Cerebrotendinous Xanthomatosis
Read More: Mirum Pharmaceuticals
Innovent Reports the NMPA’s NDA Acceptance & Priority Review of Neoadjuvant Ipilimumab + Sintilimab for Colon Cancer
Read More: Innovent
Takeda Reports EMA Approval for Additional SC Administration Option of Takhzyro (lanadelumab) for Patients aged ≥12 with Recurrent HAE
Read More: Takeda
Gilead Reports the EMA’s MAA and EU-M4all Acceptance of Lenacapavir for Pre-Exposure Prophylaxis (PreP) to Prevent HIV in Individuals at Risk
Read More: Gilead
Merck Reports the US FDA’s sBLA Acceptance of Neoadjuvant Keytruda with Priority Review for Locally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC)
Read More: Merck
Telix Pharmaceuticals Reports the US FDA’s BLA Acceptance with Priority Review of Zircaix (89Zr-DFO-girentuximab) for Kidney Cancer Imaging
Read More: Telix Pharmaceuticals
Ardelyx Reports China’s NMPA Approval of Tenapanor for Hyperphosphatemia in Patients
Read More: Ardelyx
GRIN Therapeutics Reports the US FDA’s Breakthrough Therapy Designation for Radiprodil to Treat Seizures in GRIN-Related Neurodevelopmental Disorder
Read More: GRIN Therapeutics
The CHMP Adopts Positive Opinion for AbbVie’s Rinvoq (Upadacitinib) to Treat Giant Cell Arteritis in Adults
Read More: AbbVie
ALK Reports US FDA Approval of Odactra to Treat Children with House Dust Mite Allergy
Read More: ALK
Fapon Biopharma Reports the US FDA Approval of IND Application for FP008 to Treat Solid Tumors
Read More: Fapon Biopharma
Summit Therapeutics Partners with Pfizer to Assess Ivonescimab in Combination with Pfizer’s ADCs for Various Solid Tumor Settings
Read More: Summit Therapeutics and Pfizer
Takeda Partners with BridGene Biosciences to Identify Novel Small Molecules in Immunology and Neurology
Read More: Takeda and BridGene Biosciences
Foresight Diagnostic & Allogene Therapeutics Extend Collaboration to Develop Minimal Residual Disease (MRD) Assay
Read More: Foresight Diagnostic & Allogene Therapeutics
ABANZA Reports the US FDA 510(k) Clearance of WasherCap Mini for Orthopedic Surgeries
Read More: ABANZA
Visby Medical Reports the US FDA Clearance and CLIA Waiver for Point-of-Care Respiratory Health Test
Read More: Visby Medical
Carlyle & SK Capital to Acquire Bluebird Bio
Read More: Carlyle, SK Capital & Bluebird Bio
Thermo Fisher Scientific to Acquire Solventum’s Purification & Filtration Business for ~$4.1B
Read More: Thermo Fisher Scientific and Solventum
Teleflex Enters a Definitive Agreement to Acquire BIOTRONIK’s Vascular Intervention Business for ~$797.7M (€760M)
Read More: Teleflex and BIOTRONIK
Alvotech and Teva Launch Selarsdi (Biosimilar, Stelara) in the US
Read More: Alvotech and Teva
Celltrion Secures the EC’s Approval for Avtozma (Biosimilar, RoActemra)
Read More: Celltrion
Sandoz Launches Pyzchiva (Biosimilar, Ustekinumab-ttwe) in the US for Chronic Inflammatory Diseases
Read More: Sandoz
Boehringer Ingelheim Introduces Vaxxitek HVT+IBD+H5 Vaccine Against Marek’s Disease, Infectious Bursal Disease and H5 Avian Influenza
Read More: Boehringer Ingelheim
Medgene collaborates with Elanco for H5N1 Cattle Vaccine
Read More: Medgene and Elanco
VeroSource Solutions Launches Digital Twin on its VS Platform
Read More: VeroSource Solutions
Related Post: PharmaShots Weekly Snapshots (February 17th, 2025 – February 21th, 2025)
