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Eolas Therapeutics has secured full development rights from AstraZeneca for AZD4041 to treat opioid use disorder (OUD) and other substance use disorders; terms remain confidential
As per the agreement, Eolas will take full responsibility for AZD4041 under the existing IND and advance it to P-II trials with NIDA UG3 support, focusing on a patient-centered…
NEWS
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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…
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The US FDA has approved Bravecto Quantum (Fluralaner for Extended-Release Injectable Suspension), a once-yearly injectable for flea and tick protection in dogs, will be available in U.S. veterinary clinics by Aug, 2025
Bravecto Quantum kills adult fleas and controls flea and tick infestations (Ixodes scapularis, Dermacentor variabilis, Rhipicephalus sanguineus) for 12 mos., and Amblyomma…
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The US FDA accepted Merck’s NDA for once-daily oral doravirine/islatravir (DOR/ISL) for virologically suppressed HIV-1 adults; PDUFA target action date: Apr 28, 2026
DOR/ISL showed non-inferiority to bART in open-label P-III MK-8591A-051 and to BIC/FTC/TAF (50mg/200mg/25mg) in P-III MK-8591A-052 at Week 48; the safety profile was generally comparable in the P-III MK-8591A-051 study
The…
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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…
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AbbVie and IGI Therapeutics, a subsidiary of Ichnos Glenmark Innovation, have entered into an exclusive licensing deal for ISB 2001, a drug targeting oncology & autoimmune diseases developed using IGI's proprietary BEAT protein platform
As per the deal, AbbVie will obtain exclusive rights to develop, manufacture, and commercialize ISB 2001 across North America, Europe,…
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The EC has approved Tevimbra (tislelizumab) + gemcitabine & cisplatin for 1L treatment of adults with metastatic or recurrent nasopharyngeal carcinoma (NPC), not amenable to curative surgery or radiotherapy
Approval was based on P-III (RATIONALE-309) trial assessing Tevimbra + gemcitabine & cisplatin vs PBO + gemcitabine & cisplatin in 263 treatment-naïve NPC pts
Trial…
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LEO Pharma has reported 16wk. interim data from P-IIIb (ADHAND) trial assessing Adbry monotx. (tralokinumab; 300mg, Q2W) vs PBO for 16wks. in adults with mod. to sev. atopic dermatitis on hands eligible for systemic therapy, followed by a 16wk. open-label phase, where all pts received Adbry
Trial met its 1EP, with higher proportion of…
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Biocytogen & BeOne have entered into a global licensing agreement for multiple fully human antibodies discovered using Biocytogen’s RenMicefully human antibody platform
As per the deal, Biocytogen will receive an upfront payment, development, regulatory, & commercial milestones, with net sales-based tiered royalties on licensed products. Although, financial terms remain undisclosed
Collaboration builds on BeOne Medicines…
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Exactech has received the US FDA 510(k) clearance for the Equinoxe Scapula Reconstruction System to treat acromial & scapular spine fractures; limited US pilot launch is expected later this year
Equinoxe Scapula Reconstruction System allows orthopedic surgeons to treat scapular fractures using single & dual plating techniques, which is compatible with any rTSA implant…

