Neurotech Pharmaceuticals Reports the US FDA Approval for Encelto to treat Macular Telangiectasia Type 2

Shots: The US FDA has approved Encelto (revakinagene taroretcel-lwey) to treat macular telangiectasia type 2 (MacTel); commercially available in the US by Jun 2025 Approval was based on P-III trial data demonstrating reduced macular photoreceptor loss for ~24mos. post-implantation Encelto (intravitreal implant) utilizes an encapsulated cell therapy tech to continuously deliver ciliary neurotrophic…

ByRidhi RastogiMarch 7, 2025

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Tris Pharma Reports P-III Clinical Data of Cebranopadol to Treat Moderate-to-Severe Acute Pain

Shots: Tris has reported topline data from P-III (ALLEVIATE-2) trial in post-bunionectomy pts, plus additional data from P-III (ALLEVIATE-1) trial in post-abdominoplasty pts. Data from both trials, plus HAP studies will support the US FDA’s NDA filing in 2025 ALLEVIATE-2 evaluated cebranopadol (400µg QD, PO) vs oxycodone (10mg QID, PO) vs PBO, meeting its…

ByRidhi RastogiMarch 7, 2025

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HUTCHMED Reports Enrollment Completion in P-II Trial of Fanregratinib for Intrahepatic Cholangiocarcinoma in China

Shots: HUTCHMED has reported enrollment completion in P-II trial of fanregratinib to treat intrahepatic cholangiocarcinoma (IHCC) in pts with FGFR2 fusion or rearrangement; favorable trial results will support NMPA’s NDA submission The P-II trial of fanregratinib will assess ORR as 1EP whereas PFS, DCR, DoR, & OS as 2EPs in pts (n=87). Topline data…

ByRidhi RastogiMarch 7, 2025

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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…

ByRidhi RastogiMarch 6, 2025

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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…

ByRidhi RastogiMarch 6, 2025

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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…

ByRidhi RastogiMarch 6, 2025

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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…

ByRidhi RastogiMarch 6, 2025

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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…

ByRidhi RastogiMarch 6, 2025

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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…

ByRidhi RastogiMarch 6, 2025

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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…

ByRidhi RastogiMarch 5, 2025

Ridhi Rastogi

Neurotech Pharmaceuticals Reports the US FDA Approval for Encelto to treat Macular Telangiectasia Type 2

Tris Pharma Reports P-III Clinical Data of Cebranopadol to Treat Moderate-to-Severe Acute Pain

HUTCHMED Reports Enrollment Completion in P-II Trial of Fanregratinib for Intrahepatic Cholangiocarcinoma in China

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

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