New Drug Designations – October 2025

Shots: PharmaShots’ Designation Report provides a concise overview of the latest drug designations granted by major regulatory authorities, including the FDA, EMA, MHLW, Health Canada, and NMPA  The October 2025 report covers designations granted to 56 drugs and 9 medical devices, spanning 23 small molecules, 14 biologics, 10 cell and gene therapies & 9 medical devices, among…

ByRidhi RastogiNovember 25, 2025

NEWS

EirGenix Enters ~$152M Licensing Deal with Sandoz to Commercialize EG1206A (Biosimilar, Perjeta)

Shots: EirGenix has partnered with Sandoz to commercialize EG1206A, a biosimilar to Roche’s Perjeta (Pertuzumab), globally excl. Taiwan, Mainland China, Macau, South Korea, Mongolia, Brunei, Cambodia, Indonesia, Laos, Myanmar, the Philippines, & Japan As per the deal, EirGenix will handle product development, manufacturing, & supply, receiving ~$152M in upfront & milestone payments, profit share post-launch…

ByRidhi RastogiNovember 12, 2025

NEWS

CuraTeQ Biologics Reports Positive P-III study results for Denosumab biosimilar for postmenopausal osteoporosis

Shots: CuraTeQ Biologics, a subsidiary of Aurobindo Pharma, reported positive P-III results for its denosumab biosimilar targeting postmenopausal osteoporosis, as an alternative to Prolia The study involved 446 postmenopausal women across 40 sites in EU met all EPs, showing no significant differences between the biosimilar and Prolia The trial confirmed the biosimilar's efficacy in improving…

ByDipanshu DixitSeptember 19, 2025

NEWS

Zenas BioPharma Enters a ~$300M Funding Agreement with Royalty Pharma to Support Obexelimab Development

Shots: Zenas BioPharma has entered into an agreement with Royalty Pharma granting it royalty rights on the future sales of obexelimab As per the deal, Zenas will receive ~$300M, consisting of a $75M upfront & 3 additional $75M each in milestones tied to P-III (INDIGO) trial achievement & FDA approvals in IgG4-RD & SLE, while Royalty Pharma…

ByRidhi RastogiSeptember 4, 2025

INSIGHTS+

New Drug Designations: July 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 July 2025 edition covers designations awarded to 47 drugs and 3 medical devices, comprising 23 small molecules, 9 biologics, 8 cell and gene therapies, and…

ByRidhi RastogiAugust 26, 2025

NEWS

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

New Drug Designations – October 2025

EirGenix Enters ~$152M Licensing Deal with Sandoz to Commercialize EG1206A (Biosimilar, Perjeta)

CuraTeQ Biologics Reports Positive P-III study results for Denosumab biosimilar for postmenopausal osteoporosis

Zenas BioPharma Enters a ~$300M Funding Agreement with Royalty Pharma to Support Obexelimab Development

New Drug Designations: July 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

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