Ascentage Pharma Reports the NMPA’s Conditional Approval of Lisaftoclax for the Treatment of CLL/SLL

Shots: China’s NMPA has granted conditional approval to lisaftoclax for treating adults with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have previously received ≥1 systemic therapy incl. BTK inhibitors Approval was based on pivotal P-II (APG2575CC201) trial assessing lisaftoclax monotx. in r/r CLL/SLL pts previously treated with BTK inhibitors &/or immunochemotherapy, which met its 1EP of improved…

ByRidhi RastogiJuly 14, 2025

WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Jul 07, 2025 – Jul 11, 2025)   

This week, PharmaShots’ news was all about the updates on clinical trials, Regulatory, Pharma, MedTech, M&A, and Biosimilars. Check out our full report below:  PulseSight Therapeutics Reports First Patient Dosing with PST-611 in P-I (PST-611-CT1) Trial for Dry AMD/Geographic Atrophy  Read More: PulseSight Therapeutics BioAtla Presents Preliminary P-I Trial Data of BA3182 in Patients with…

ByRidhi RastogiJuly 11, 2025

NEWS

Dymicron Secures US FDA IDE Approval for Triadyme-C Cervical Disc Study

Shots: Dymicron received the US FDA’s IDE approval to initiate a pivotal trial of Triadyme-C, a cervical artificial disc, to treat symptomatic cervical disc disease (SCDD) across leading US spine centers starting Q4’25 The study will compare the safety and effectiveness of Triadyme-C vs. anterior cervical discectomy and fusion (ACDF). The 1EP of the study…

ByRidhi RastogiJuly 11, 2025

NEWS

BeOne Medicines’ Tevimbra Receives the EC Approval for Nasopharyngeal Carcinoma

Shots: The EC has approved Tevimbra (tislelizumab) + gemcitabine & cisplatin for 1L treatment of adults with metastatic or recurrent nasopharyngeal carcinoma (NPC), not amenable to curative surgery or radiotherapy Approval was based on P-III (RATIONALE-309) trial assessing Tevimbra + gemcitabine & cisplatin vs PBO + gemcitabine & cisplatin in 263 treatment-naïve NPC pts Trial…

ByRidhi RastogiJuly 10, 2025

NEWS

LEO Pharma Reports Interim P-IIIb (ADHAND) Trial Data on Adbry for Atopic Dermatitis

Shots: LEO Pharma has reported 16wk. interim data from P-IIIb (ADHAND) trial assessing Adbry monotx. (tralokinumab; 300mg, Q2W) vs PBO for 16wks. in adults with mod. to sev. atopic dermatitis on hands eligible for systemic therapy, followed by a 16wk. open-label phase, where all pts received Adbry Trial met its 1EP, with higher proportion of…

ByRidhi RastogiJuly 10, 2025

NEWS

Biocytogen Pharmaceuticals Enters a Licensing Agreement with BeOne Medicines for Multiple Antibody Candidates

Shots: Biocytogen & BeOne have entered into a global licensing agreement for multiple fully human antibodies discovered using Biocytogen’s RenMicefully human antibody platform As per the deal, Biocytogen will receive an upfront payment, development, regulatory, & commercial milestones, with net sales-based tiered royalties on licensed products. Although, financial terms remain undisclosed Collaboration builds on BeOne Medicines…

ByRidhi RastogiJuly 10, 2025

NEWS

Exactech Reports the US FDA 510(k) Clearance of Equinoxe Scapula Reconstruction System for Acromial Stress Fractures

Shots: Exactech has received the US FDA 510(k) clearance for the Equinoxe Scapula Reconstruction System to treat acromial & scapular spine fractures; limited US pilot launch is expected later this year Equinoxe Scapula Reconstruction System allows orthopedic surgeons to treat scapular fractures using single & dual plating techniques, which is compatible with any rTSA implant…

ByRidhi RastogiJuly 10, 2025

NEWS

Taiho Oncology (Part of Taiho Pharmaceutical) Reports the US FDA’s sNDA Acceptance of Inqovi + Venetoclax for Newly Diagnosed AML

Shots: The US FDA has accepted sNDA of Inqovi (decitabine & cedazuridine) + venetoclax for the treatment of newly diagnosed acute myeloid leukemia (AML) pts, ineligible for intensive induction CT (PDUFA: Feb 25, 2026) sNDA was backed by P-IIb (ASCERTAIN-V) trial in 101 adults with newly diagnosed AML ineligible for intensive induction CT, where pts…

ByRidhi RastogiJuly 10, 2025

NEWS

Merck to Acquire Verona Pharma for ~$10B

Shots: Merck has entered into a definitive agreement to acquire Verona Pharma incl. its asset Ohtuvayre (ensifentrine), expanding its cardio-pulmonary pipeline & portfolio As per the deal, Merck will acquire Verona Pharma for $107 per American Depository Share (ADS), each representing 8 ordinary Verona shares, for an aggregate of ~$10B; closing expected in Q4'25 Ohtuvayre…

ByRidhi RastogiJuly 10, 2025

NEWS

Mendaera’s Focalist Robotic System Secures the US FDA 510(k) Clearance for Ultrasound-Guided Procedures

Shots: Mendaera has received the US FDA’s 510(k) clearance for Focalist robotic system for ultrasound-guided procedures Mendaera will begin a limited launch of its Focalist system in 2025 to initially support urology procedures like PCNL, expanding to other specialties, with full commercialization expected in 2026 Focalist is designed to support precise & consistent needle placement…

ByRidhi RastogiJuly 9, 2025

Ridhi Rastogi

Ascentage Pharma Reports the NMPA’s Conditional Approval of Lisaftoclax for the Treatment of CLL/SLL

PharmaShots Weekly Snapshots (Jul 07, 2025 – Jul 11, 2025)

Dymicron Secures US FDA IDE Approval for Triadyme-C Cervical Disc Study

BeOne Medicines’ Tevimbra Receives the EC Approval for Nasopharyngeal Carcinoma

LEO Pharma Reports Interim P-IIIb (ADHAND) Trial Data on Adbry for Atopic Dermatitis

Biocytogen Pharmaceuticals Enters a Licensing Agreement with BeOne Medicines for Multiple Antibody Candidates

Exactech Reports the US FDA 510(k) Clearance of Equinoxe Scapula Reconstruction System for Acromial Stress Fractures

Taiho Oncology (Part of Taiho Pharmaceutical) Reports the US FDA’s sNDA Acceptance of Inqovi + Venetoclax for Newly Diagnosed AML

Merck to Acquire Verona Pharma for ~$10B

Mendaera’s Focalist Robotic System Secures the US FDA 510(k) Clearance for Ultrasound-Guided Procedures

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