NEWS

ITM Reports Topline Data from P-III (COMPETE) Trial of ITM-11 at the ENETS 2025 Conference

Shots: The P-III (COMPETE) trial assessed ITM-11 (n=207) vs everolimus (n=102) in pts (N=309) with inoperable, progressive, SSTR+ Grade 1 or 2 Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs). The US FDA’s NDA filing is expected in 2025 The study met its 1EP of improved PFS with mPFS of 23.9 vs 14.1mos., while dosimetry data, ORR, QoL…

March 6, 2025

Suvoda Launches AI assistant Sofia to Streamline Clinical Trial Management

Shots: Suvoda has launched Sofia to simplify trial data access & review for study teams. Initially optimized for drug supply managers using Suvoda’s interactive response Tech (IRT), the company plans to expand to more users & products across the platform Sofia simplifies trial data retrieval with natural language queries, enhances drug supply management by…

March 6, 2025

ARS Pharmaceuticals’ neffy 1mg Secures the US FDA’s Approval to Treat Type I Allergic Reactions in Children

Shots: The US FDA has approved neffy 1mg (epinephrine nasal spray) to treat type I allergic reactions (incl. anaphylaxis) in children [≥4yrs. & 15-30kg (33-66lbs)]; commercially available in the US by end of May’25 Approval was based on extensive clinical data with PK/PD results comparable to approved epinephrine injections in both pediatric & adult…

March 6, 2025

Astellas to Establish Joint Venture with YASKAWA for Cell Therapy Manufacturing

Shots: Astellas has entered into definitive agreement with YASKAWA to establish a joint venture for the development of a cell therapy product manufacturing platform based on previously signed MoU (May 21, 2024) In joint venture, Astellas will own 60% & YASKAWA 40% with $30.14M (¥4.5B) capital & expected to establish in Sept 2025, subject…

March 6, 2025

Johnson & Johnson MedTech Launches Shockwave Javelin Peripheral IVL Catheter in the US

Shots: Shockwave Medical (J&J MedTech’s company) has launched Shockwave Javelin peripheral IVL catheter in the US to modify calcium & cross extremely narrowed vessels in pts with peripheral artery disease (PAD) Shockwave Javelin was studied in FORWARD PAD IDE trial that demonstrated similar safety & effectiveness compared to balloon-based Shockwave IVL catheters, regardless of…

March 6, 2025

Jazz Pharmaceuticals to Acquire Chimerix for ~$935M

Shots: Jazz Pharmaceuticals to acquire Chimerix for ~$935M at a price of $8.55 per share in cash. Upon completion in Q2’25, Jazz will acquire remaining shares via second-step merger Acquisition will strengthen Jazz’s rare oncology presence through development & launch of Chimerix’s lead asset, dordaviprone, while adding durable revenue potential with patent protection through…

March 6, 2025

Contineum Therapeutics Initiates Patient Dosing in P-Ib Study to Evaluate PIPE-791 in Chronic Pain

Shots: Contineum Therapeutics reported the initiation of patient dosing in exploratory P-Ib study of PIPE-791 for chronic pain associated with two separate indications, osteoarthritis (OA) and low back pain (LBP) The company expects to enroll approx. 40 pts. for a treatment duration of 28 days and anticipates topline data in early 2026 PIPE-791…

March 5, 2025

Bioheng Therapeutics Secures the FDA Clearance of IND Application for CTD402 in T-ALL/LBL

Shots: The US FDA approved Bioheng’s IND application for CTD402 to treat pediatric and adult patients with relapsed/refractory T-cell acute lymphoblastic leukemia/lymphoma (R/R T-ALL/LBL) CTD402 will be evaluated in a P-Ib/II single-arm, open-label, dose-finding study to optimize dosing and accelerate clinical development CTD402 is a CD7-targeted universal CAR-T (UCAR-T) cell therapy that is genetically…

March 5, 2025

Genentech Reports the FDA’s sBLA Acceptance for Gazyva to Treat Lupus Nephritis

Shots: Based on positive results from P-III (REGENCY) study, the US FDA has accepted sBLA of Gazyva in Lupus Nephritis; FDA's approval decision is expected by Oct’25 The P-III (REGENCY) study demonstrated improved CRR with Gazyva + standard therapy vs standard therapy alone, along with improvements in complement levels & reductions in anti-dsDNA, markers…

March 5, 2025

Inspira Technologies Reports Positive Results from Clinical Study of HYLA Blood Sensor

Shots: The clinical study of AI-powered clip-on HYLA blood sensor (n=6) showed 96% accuracy vs. traditional blood test analyzers in open-heart surgery pts. The study was also used to test indicator for identifying oxygen deficiencies with 92.3% accuracy The study was conducted at Sheba Hospital, and Inspira plans to gather more patient data to…

March 5, 2025

NEWS

ITM Reports Topline Data from P-III (COMPETE) Trial of ITM-11 at the ENETS 2025 Conference

Suvoda Launches AI assistant Sofia to Streamline Clinical Trial Management

ARS Pharmaceuticals’ neffy 1mg Secures the US FDA’s Approval to Treat Type I Allergic Reactions in Children

Astellas to Establish Joint Venture with YASKAWA for Cell Therapy Manufacturing

Johnson & Johnson MedTech Launches Shockwave Javelin Peripheral IVL Catheter in the US

Jazz Pharmaceuticals to Acquire Chimerix for ~$935M

Contineum Therapeutics Initiates Patient Dosing in P-Ib Study to Evaluate PIPE-791 in Chronic Pain

Bioheng Therapeutics Secures the FDA Clearance of IND Application for CTD402 in T-ALL/LBL

Genentech Reports the FDA’s sBLA Acceptance for Gazyva to Treat Lupus Nephritis

Inspira Technologies Reports Positive Results from Clinical Study of HYLA Blood Sensor

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