NEWS

PharmaEssentia Reports Topline Data from P-III (SURPASS-ET) Trial of Ropeginterferon Alfa-2b-Njft (P1101) in Essential Thrombocythemia (ET)

Shots: PharmaEssentia has reported topline data from a P-III (SURPASS-ET) study assessing P1101 (n=91) vs anagrelide (n=83) in patients (N=174) as a 2L treatment of ET for 12mos. with the US FDA filing for label extension to ET is expected by YE’25 The study achieved its 1EP of durable hematologic response at 9 &…

January 8, 2025

Orna Collaborates with Vertex to Develop Gene Therapies for Sickle Cell Disease (SCD) and Transfusion-Dependent Beta Thalassemia (TDT)

Shots: Orna & Vertex have entered into a 3yrs. strategic research collaboration to utilize the former’s LNP delivery solutions for supporting the development of next-gen. gene editing therapies for SCD & TDT, with Vertex funding the partnership As per the terms, Orna will get $65M upfront (incl. investment in the form of a convertible…

January 8, 2025

GlycoNex Reports Licensing Agreement to Develop SPD8 (Biosimilar, Prolia and Xgeva)

Shots: GlycoNex has reported a licensing agreement to develop SPD8, a biosimilar version of Amgen’s Prolia and Xgeva (denosumab) The licensee will secure rights for the development, regulatory activities & commercialization of SPD8 in the designated regions. The deal includes development and commercial milestones, supporting GlycoNex's global business operations SPD8 is under P-III…

January 7, 2025

GSK’s GSK’227 Secures the US FDA’s Breakthrough Therapy Designation for Treating Late-Line R/R Osteosarcoma

Shots: The US FDA has granted BTD to GSK5764227 (GSK’227) for treating r/r osteosarcoma in patients with disease progression on at least 2 prior lines of therapy Designation was supported by P-II (ARTEMIS-002) trial (carried out by Hansoh Pharma) assessing the safety & efficacy of GSK’227 to treat patients (n=60; 42 had osteosarcoma) with…

January 7, 2025

Hologic Completes the Acquisition of Gynesonics for ~$350M

Shots: Hologic has completed the acquisition of Gynesonics, focused on developing minimally invasive women’s health solutions, for ~$350M The acquisition has strengthened Hologic's portfolio with the addition of Sonata System, a minimally invasive solution for heavy periods & fibroids The Sonata System is developed to capture intrauterine images for diagnosis and transcervical treatment…

January 7, 2025

Absci Corporation Collaborates with Invetx to Develop AI-Based Drug Creation Platform for Animal Health

Shots: Absci Corporation & Invetx have entered into a strategic collaboration to develop an innovative Half-Life Extension platform for animal health The alliance will leverage Absci’s generative AI models to develop modular antibody sequences in animals, while Invetx gains rights to use HLE platform for improving therapeutic effect duration & customer convenience of various…

January 7, 2025

Fortress Biotech and Cyprium Therapeutics Report the US FDA’s NDA Acceptance with Priority Review of CUTX-101 to Treat Menkes Disease

Shots: Fortress and its subsidiary, Cyprium, have reported the US FDA’s NDA acceptance & priority review of CUTX-101 (copper histidinate) to treat Menkes disease, with the decision expected on Jun 30, 2025 Submission was based on a trial of CUTX-101 vs untreated historical control that depicted significantly improved OS & an 80% reduction in…

January 7, 2025

Stryker to Acquire Inari Medical for ~$4.9B

Shots: Stryker has signed a definitive agreement to initiate a tender offer for acquiring all the issued & outstanding shares of Inari Medical for $80 per share in cash, making it a total value of ~$4.9B Upon completion, Stryker will acquire remaining shares in a second-step merger at the same price. The deal is…

January 7, 2025

Oculis Reports Results from P-II (ACUITY) Study of OCS-05 for Treating Acute Optic Neuritis

Shots: The P-II (ACUITY) study assessed safety, tolerability & efficacy of OCS-05 (2 or 3mg/kg/day, IV, QD) vs PBO for 5 days in acute optic neuritis patients (n=36), on steroid in EU. 33/36 received treatment and included in the pre-specified modified ITT analysis. Its IND is approved in the US to begin trial 1EP…

January 6, 2025

Amgen’s Imdylltra (Tarlatamab) Secures the MHRA’s Conditional Marketing Authorization as a 3L Treatment of ES-SCLC

Shots: The MHRA has granted conditional marketing authorization to Imdylltra for treating adults with ES-SCLC, whose disease progressed post prior 2 lines of treatment. Further evaluation is underway This authorization was supported by P-II (DeLLphi-301) study assessing Imdylltra (10mg, Q2W) in ES-SCLC patients (N=99). It showed ORR of 41% & mDoR of 9.7mos. …

January 6, 2025

NEWS

PharmaEssentia Reports Topline Data from P-III (SURPASS-ET) Trial of Ropeginterferon Alfa-2b-Njft (P1101) in Essential Thrombocythemia (ET)

Orna Collaborates with Vertex to Develop Gene Therapies for Sickle Cell Disease (SCD) and Transfusion-Dependent Beta Thalassemia (TDT)

GlycoNex Reports Licensing Agreement to Develop SPD8 (Biosimilar, Prolia and Xgeva)

GSK’s GSK’227 Secures the US FDA’s Breakthrough Therapy Designation for Treating Late-Line R/R Osteosarcoma

Hologic Completes the Acquisition of Gynesonics for ~$350M

Absci Corporation Collaborates with Invetx to Develop AI-Based Drug Creation Platform for Animal Health

Fortress Biotech and Cyprium Therapeutics Report the US FDA’s NDA Acceptance with Priority Review of CUTX-101 to Treat Menkes Disease

Stryker to Acquire Inari Medical for ~$4.9B

Oculis Reports Results from P-II (ACUITY) Study of OCS-05 for Treating Acute Optic Neuritis

Amgen’s Imdylltra (Tarlatamab) Secures the MHRA’s Conditional Marketing Authorization as a 3L Treatment of ES-SCLC

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