Sebela Pharmaceuticals Reports P-III (TRIUMpH) Program Completion and Data on Tegoprazan for Gastroesophageal Reflux Disease (GERD)

Shots: TRIUMpH program consisted of 2 P-III trials assessing tegoprazan in US GERD pts with erosive esophagitis (EE; n=1250 incl. 463 with LA Grade C/D esophagitis) & non-erosive reflux disease (NERD; n=800); FDA’s NDA filing for both EE & NERD is planned in Q4’25 In EE pts, tegoprazan (100 & 50mg) met the 1EP, showing…

ByRidhi RastogiAugust 8, 2025

INSIGHTS+

New Drug Designations: June 2025

Shots:    PharmaShots’ Designation Report offers a concise overview of the latest drug and device designations granted by major regulatory authorities, including the FDA, EMA, MHLW, Health Canada, and NMPA The June 2025 edition covers designations awarded to 43 drugs and 3 medical devices, comprising 17 small molecules, 7 biologics, 8 cell and gene therapies, and…

ByRidhi RastogiJuly 29, 2025

NEWS

Autolus Therapeutics’ Aucatzyl Secures the EC’s Approval for R/R B-Cell Acute Lymphoblastic Leukemia (B-ALL)

Shots: The EC has approved Aucatzyl (Obecabtagene Autoleucel) for treating pts (≥26yrs.) with r/r B-ALL in all 30 EEA states The EC approval was based on the FELIX study (n=100+), which showed that pts in cohort IIA (n=94) receiving ≥1 infusion of obe-cel had a 76.6% CR/CRi rate, with a mDoR of 21.2mos. & mEFS…

ByDipanshu DixitJuly 21, 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

Moleculin Receives RAMPA’s CTA Approval for P-IIb/III (MIRACLE) Study of AnnAraC in R/R AML

Shots: Moleculin received approval from Georgia’s RAMPA to initiate its global P-IIb/III (MIRACLE) study of AnnAraC (Annamycin + cytarabine) in R/R AML, and first pt dosing expected by Aug-end; CTA already approved in EU The study includes adaptive design; Part A will randomize 75-90 pts (1:1:1) to HiDAC + PBO or Annamycin (190 or 230…

ByDipanshu DixitJuly 11, 2025

NEWS

Kashiv BioSciences and Amneal Pharmaceuticals Report Topline Results from the Study of ADL-018 (Biosimilar, Xolair) for CIU/CSU

Shots: Kashiv BioSciences has reported topline results of ADL-018, its proposed biosimilar to Xolair (omalizumab) for Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) unresponsive to H1 antihistamines. The BLA and MAA filings for the product are expected with the FDA and EMA, respectively, in Q4’25 The study met its 1EPs & 2EPs, demonstrating therapeutic equivalence and…

ByDipanshu DixitJune 27, 2025

NEWS

Pfizer Reports the P-III (BASIS) Study Data Evaluating HYMPAVZI to Treat Hemophilia A or B with Inhibitors

Shots: Pfizer reported positive topline results from the P‑III (BASIS) study evaluating HYMPAVZI (marstacimab) in hemophilia A or B pts (N=48) with inhibitors, meeting the 1EP and demonstrating a 93% reduction in annualized bleeding rate (ABR) vs. on‑demand treatment (1.39 vs. 19.78; p < 0.0001) over 12mos. HYMPAVZI, a once‑weekly SC therapy that targets TFPI,…

ByDipanshu DixitJune 27, 2025

NEWS

Royalty Pharma Purchases Revolution Medicines’ Royalty Rights of Daraxonrasib for ~2B

Shots: Royalty Pharma acquiring Revolution Medicines’ royalties for daraxonrasib (P-III RASolute 302), providing up to $1.25B across five $250M milestone tranches, plus an additional $750M debt facility in three tranches Revolution received the $250M upfront, with future payments tied to P-III data (2026), FDA approval (by Jan 2028), and sales milestones, allowing access to further…

ByPrince GiriJune 25, 2025

NEWS

The US FDA Approves Merck’s ENFLONSIA for RSV Prevention in Infants

Shots : Merck’s ENFLONSIA has been approved by the US FDA to prevent RSV lower respiratory tract disease in newborns and infants entering their first RSV season, offering protection for up to 5mos. with a single 105mg dose, regardless of weight The approval was supported by the P-IIb/III (CLEVER) study of ENFLONSIA that demonstrated reduced…

ByDipanshu DixitJune 10, 2025

NEWS

CoreMap Reports the US FDA’s IDE Approval for CoreMap’s EP Map-Guided AF Ablation Study

Shots: CoreMap received the US FDA’s IDE approval of CoreMap EP (Endocardial Electrophysiology) to extend the 3-phase INvENI clinical study into the US in pts with Atrial Fibrillation (AF) and long-standing persistent AF The P-I study assessed acute safety of CoreMap EP in 14 pts while P-II study showed acute safety & effectiveness in 15 pts. The…

ByRidhi RastogiMay 30, 2025

Sebela Pharmaceuticals Reports P-III (TRIUMpH) Program Completion and Data on Tegoprazan for Gastroesophageal Reflux Disease (GERD)

New Drug Designations: June 2025

Autolus Therapeutics’ Aucatzyl Secures the EC’s Approval for R/R B-Cell Acute Lymphoblastic Leukemia (B-ALL)

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

Moleculin Receives RAMPA’s CTA Approval for P-IIb/III (MIRACLE) Study of AnnAraC in R/R AML

Kashiv BioSciences and Amneal Pharmaceuticals Report Topline Results from the Study of ADL-018 (Biosimilar, Xolair) for CIU/CSU

Pfizer Reports the P-III (BASIS) Study Data Evaluating HYMPAVZI to Treat Hemophilia A or B with Inhibitors

Royalty Pharma Purchases Revolution Medicines’ Royalty Rights of Daraxonrasib for ~2B

The US FDA Approves Merck’s ENFLONSIA for RSV Prevention in Infants

CoreMap Reports the US FDA’s IDE Approval for CoreMap’s EP Map-Guided AF Ablation Study

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