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The US FDA has approved Qfitlia to treat routine prophylaxis and prevent or reduce the frequency of bleeding episodes in pts. (age≥ 12yrs.) with hemophilia A or B, with or without factor VIII or IX inhibitors. Regulatory submissions have been completed in China & Brazil
Qfitlia published clinical data in the NEJM in 2017, showing…
NEWS
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Ono Pharmaceutical entered into an option agreement to obtain exclusive rights for identified small-molecule compounds developed by leveraging Reborna’s proprietary RNA-targeting drug discovery platform
Furthermore, the companies will collaborate to discover small molecule drug candidates for mutually selected rare neurological disorders
Upon exercising the option, Ono will gain exclusive worldwide rights to develop, manufacture, and…
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The EC has approved Tivdak an ADC, as a monotx. for adults (n=502) with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy
Approval was backed by P-III (innovaTV 301) global trial evaluating Tivdak vs CT alone (topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed)
The trial met its 1EP of OS,…
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AstraZeneca presented data at the ACC'25 and simultaneously published data in JACC from the PURSUIT P-IIb study (n=480) evaluating the efficacy, safety, and tolerability of AZD0780 (1mg, 3mg, 10mg & 30mg QD) added to SoC statin therapy vs PBO in dyslipidemic patients with LDL-C levels ≥70 and <190 mg/dL on moderate or high intensity…
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The US FDA has granted De Novo authorization to Visby Medical Women's Sexual Health Test for OTC use
Clinical studies with 2,000+ users showed that the test offers comparable accuracy to laboratory-based PCR machines, whereas its companion app guides users through testing, interpretation of results, & provides further care options
Visby Medical Women's Sexual…
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Spirited Paw (Standard Process' Brand) has launched Calm supplement to manage stress-related behaviors like occasional anxiety in cats & dogs
Calm consists of scientifically-backed ingredients along with plant-based nutrients like Kalette, ginger & chamomile extracts, grown on Standard Process’ 868-acre USDA-certified organic farm
Calm contains L-Theanine, L-Tryptophan, & marine-derived Magnesium, with L-Theanine tested in…
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The CHMP has recommended Calquence + bendamustine & rituximab for the treatment of 1L MCL adults, who are ineligible for autologous HSCT; regulatory review is ongoing in Japan & other regions
Opinion was based on P-III (ECHO) trial assessing the combination vs SoC (bendamustine & rituximab) in 1L MCL pts (≥65yrs.; n=635), which showed…
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The P-II (ALPACA) trial assessed lepodisiran (16, 96, or 400mg) vs PBO for ~18mos. in 320 pts, who were dosed at baseline & day 180, with an additional arm receiving 400mg at baseline & PBO at day 180; P-III [ACCLAIM-Lp(a)] trial enrollment is ongoing
Trial met its 1EP, with 400mg reducing Lp(a) by 93.9%…
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The CHMP has recommended Opdivo + Pt-based CT as neoadj. followed by Opdivo alone as adj. treatment of adults with resectable NSCLC at high risk of recurrence & PD-L1 expression ≥1%. If approved, EC’s decision would be valid in all 30 EEA states
The P-III (CheckMate-77T) study assessed neoadj. Opdivo + CT, followed by surgery…
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The EMA has validated MAA of HLX11, a biosimilar version of Perjeta (pertuzumab) for all indications of the reference product
Submission was supported by P-III trial evaluating HLX11 vs Perjeta as neoadj. therapy in HER2+/HR-, early stage or locally advanced breast cancer as part of complete treatment regimen. Study met its 1EP of total…

