The EC Approves BMS’ Opdivo + Yervoy as 1L Treatment for Hepatocellular Carcinoma

Shots: The EC has approved Opdivo + Yervoy as 1L therapy to treat inoperable or advanced HCC adult pts in 30 EEA states; sBLA under the US FDA’s priority review (PDUFA: Apr 21, 2025) Approval was based on P-III (CheckMate-9DW) trial assessing Opdivo (1mg/kg, Q3W) + Yervoy (3mg/kg, Q3W), followed by Opdivo alone (480mg,…

ByRidhi RastogiMarch 10, 2025

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GumPaws Launches Gummy Supplements to Promote Dental Health in Dogs

Shots: GumPaws has launched gummy supplements to support dental health in dogs GumPaws gummies are designed with specific density & chewiness to improve friction, helping clean plaque & support dental care in dogs, offering dual-benefit compared to conventional supplements Gummies are formulated with scientifically-backed natural ingredients that start absorbing through the gums &…

ByRidhi RastogiMarch 7, 2025

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Biocon Biologics Partners with Civica to extend access of Insulin Aspart in the US

Shots: Biocon Biologics has entered into strategic collaboration agreement with Civica to extend access & affordability of Insulin Aspart in the US As per the deal, Biocon will supply Insulin Aspart drug substance to Civica, which will manufacture prefilled pens & vials of insulin at its Petersburg, Virginia facility. Civica will commercialize it in the US…

ByRidhi RastogiMarch 7, 2025

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AstraZeneca Reports P-III (MATTERHORN) Trial Data of Imfinzi as Perioperative Therapy for Stage II-IVA G/GEJ Cancers

Shots: AstraZeneca has reported P-III (MATTERHORN) trial data assessing perioperative Imfinzi + FLOT (fluorouracil, leucovorin, oxaliplatin, & docetaxel) vs PBO + FLOT in 948 pts with stage II-IVA G/GEJ cancers Pts received Imfinzi (1500mg) + FLOT or PBO + FLOT for Q4W × 2 cycles before surgery followed by Imfinzi or PBO for Q4W × 12…

ByRidhi RastogiMarch 7, 2025

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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

Ridhi Rastogi

The EC Approves BMS’ Opdivo + Yervoy as 1L Treatment for Hepatocellular Carcinoma

GumPaws Launches Gummy Supplements to Promote Dental Health in Dogs

Biocon Biologics Partners with Civica to extend access of Insulin Aspart in the US

AstraZeneca Reports P-III (MATTERHORN) Trial Data of Imfinzi as Perioperative Therapy for Stage II-IVA G/GEJ Cancers

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

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