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)