NEWS

Vektor Medical Secures the European CE Mark Approval for AI-Powered vMap System to Advance Arrhythmia Care

Shots: Vektor Medical has received the European CE Mark approval for vMap System for non-invasive arrhythmia mapping vMap System converts 12-lead ECG data into 3D arrhythmia source maps within a minute to help identify arrhythmia drivers & guide treatment for atrial fibrillation & ventricular tachycardia The system also integrates with lab workflows to deliver rapid, non-invasive,…

October 8, 2025

Bavarian Nordic Announces Topline P-II Trial Data of MVA-BN Mpox/Smallpox Vaccine in Younger Population

Shots: Bavarian Nordic has reported topline P-II trial results evaluating two standard doses of the MVA-BN mpox/smallpox vaccine in 460 participants, incl. children (2–11 yrs) & adults (18–50 yrs) across 2 cohorts in the DRC & Uganda In the trial, 227 children among 451 evaluable subjects showed a non-inferior immune response to adults (n=224) 2wks.…

October 8, 2025

Hikma and Celltrion Partner to Commercialize Biosimilars Across the MENA Region

Shots: Hikma Pharmaceuticals & Celltrion have entered into exclusive licensing agreements for various biosimilar candidates across the Middle East & North Africa (MENA) region, expanding their previous partnerships The agreement will include the commercialization of 6 biosimilars to expand access across multiple therapeutic areas, incl. allergic diseases, ophthalmology, skeletal-related disorders, immune diseases & oncology As…

October 8, 2025

Sanofi Reports P-II (ALPHAMEDIX-02) Trial Data of AlphaMedix for Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET)

Shots: Sanofi has reported data from the ongoing P-II (ALPHAMEDIX-02) trial assessing AlphaMedix (67.6μCi/kg, Q8W, ~4 cycles) in pts, incl. PRRT-naïve (n=35) & exposed (n=26) pts with histologically confirmed unresectable or metastatic SSTR+ GEP-NETs & ≥1 site of measurable disease Trial met all 1EPs with improved ORR & prolonged benefit, plus showed improvement across 2EPs…

October 8, 2025

Arcutis Biotherapeutics Receives the US FDA’s Approval for Zoryve Topical Cream to Treat Atopic Dermatitis

Shots: FDA approved Zoryve (0.05% roflumilast; QD) for pts (2-5yrs.) based on P-III (INTEGUMENT-PED), INTEGUMENT-OLE study & a P-I PK trial; commercially available by end of Oct 2025 INTEGUMENT-PED (n=652) showed rapid disease clearance with benefits from Wk. 1, as 25.4% vs 10.7% achieved vIGA-AD Success & a 2-grade improvement at Wk. 4; trial also met all…

October 7, 2025

AbbVie Reports Topline P-II (ELATE) Trial Data on Botox (OnabotulinumtoxinA) for Upper Limb Essential Tremor

Shots: AbbVie has reported topline P-II (ELATE) trial data assessing Botox (onabotulinumtoxinA) vs PBO in pts with upper limb essential tremor Trial met its 1EP with improved Tremor Disability Scale-Revised scores at 18wks. & showed a greater TREDS-R total unilateral score reduction (-2.61 vs -1.61), plus it also achieved all six 2EPs; data to be…

October 7, 2025

AstraZeneca Reports P-III (Bax24) Trial Data on Baxdrostat for Treatment-Resistant Hypertension

Shots: AstraZeneca has reported P-III (Bax24) trial data assessing baxdrostat (2mg; QD) + SoC vs PBO + SoC in 218 pts with treatment-resistant hypertension for 12wks. Trial achieved its 1EP, showing reduced 24hr. ambulatory systolic blood pressure at 12wks., with consistent efficacy across the day, incl. early morning; data to be presented at AHA’25 &…

October 7, 2025

Daiichi Sankyo Reports the MHLW’s sNDA Submission of Enhertu + Perjeta to Treat HER2+ Breast Cancer

Shots: Japan’s MHLW has received the sNDA of Enhertu + pertuzumab for the treatment of pts with HER2+ unresectable or recurrent breast cancer sNDA was supported by P-III (DESTINY-Breast09) trial data on Enhertu (5.4mg/kg) ± Perjeta vs taxane, trastuzumab & Perjeta (THP) in HER2+ metastatic breast cancer pts (n=1157), which showed improved PFS by 44%,…

October 7, 2025

Algen Biotechnologies Collaborates with AstraZeneca to Advance Drug Discovery in Immunology

Shots: Algen has entered into a multi-target collaboration with AstraZeneca to accelerate novel immunology target discovery, leveraging the AlgenBrain platform As per the deal, AstraZeneca will receive exclusive rights to develop and commercialize therapies for selected targets identified through the partnership in exchange for ~555M incl. upfront, development, regulatory & commercial milestone payments AlgenBrain models disease…

October 7, 2025

Chiesi Group Enters a ~$2.1B Deal with Arbor Biotechnologies to Develop Novel Rare Disease Gene Editing Programs

Shots: Chiesi Group has entered into an exclusive global collaboration & license deal with Arbor for ABO-101 in primary hyperoxaluria type 1 (PH1) & a multitarget option to use Arbor’s gene editing platform for developing liver-targeted therapies for rare diseases As per the deal, Chiesi will obtain exclusive rights to develop & commercialize ABO-101 for PH1…

October 7, 2025

NEWS

Vektor Medical Secures the European CE Mark Approval for AI-Powered vMap System to Advance Arrhythmia Care

Bavarian Nordic Announces Topline P-II Trial Data of MVA-BN Mpox/Smallpox Vaccine in Younger Population

Sanofi Reports P-II (ALPHAMEDIX-02) Trial Data of AlphaMedix for Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET)

Arcutis Biotherapeutics Receives the US FDA’s Approval for Zoryve Topical Cream to Treat Atopic Dermatitis

AbbVie Reports Topline P-II (ELATE) Trial Data on Botox (OnabotulinumtoxinA) for Upper Limb Essential Tremor

AstraZeneca Reports P-III (Bax24) Trial Data on Baxdrostat for Treatment-Resistant Hypertension

Daiichi Sankyo Reports the MHLW’s sNDA Submission of Enhertu + Perjeta to Treat HER2+ Breast Cancer

Algen Biotechnologies Collaborates with AstraZeneca to Advance Drug Discovery in Immunology

Chiesi Group Enters a ~$2.1B Deal with Arbor Biotechnologies to Develop Novel Rare Disease Gene Editing Programs

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