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NEWS

ViiV Healthcare Reports the EC’s Approval of Vocabria + Rekambys to Treat HIV
Shots: ViiV Healthcare (owned by GSK with Pfizer & Shionogi as shareholders) has received EC’s approval for Vocabria (cabotegravir) combined with J&J’s Rekambys (rilpivirine) to treat HIV-1 in virologically suppressed adolescents (≥12yrs. & ≥35kg), following CHMP opinion in Dec 2024 MAA was based on 24wks. data from ongoing P-I/II (MOCHA) trial evaluating the safety,…
January 31, 2025
Axsome
Axsome Therapeutics Receives the US FDA Approval for Symbravo (meloxicam and rizatriptan) to Treat Migraine
Shots: The US FDA has approved Symbravo for acute treatment of migraine with/without aura in adults based on P-III (MOMENTUM), P-III (INTERCEPT) & P-III (MOVEMENT) trial; commercially available in ~4mons. MOMENTUM trial assessed Symbravo (single dose) vs PBO/meloxicam/rizatriptan, showing greater pain & symptoms freedom (photophobia, phonophobia & nausea) at 2hrs., sustained through 24-48hrs., 77%…
January 31, 2025
Bayer
Bayer Introduces CanesMeno Digital Educational Hub and Products in the UK to Provide Menstrual Support
Shots: Bayer launched CanesMeno in the UK to provide menopause support that incl. digital informative resources (CanesMeno Hub) & scientifically-backed products (Hydration & Comfort Gel, Multi-Support, & Night Support). Wider availability in major supermarkets & grocery stores will start from early spring 2025 The hub offers a 3-min. guide, a tracker for personalized insights…
January 31, 2025
Daiichi Sankyo & Astrazeneca
Daiichi Sankyo and AstraZeneca Dose the First Patient with Adjuvant Datroway in P-III (TROPION-Lung12) Trial for Adenocarcinoma NSCLC
Shots: Daiichi & AstraZeneca have dosed first patient with adj. Datroway (6 mg/kg) + rilvegostomig/ rilvegostomig monotx. (750mg) in P-III (TROPION-Lung12) trial to treat stage 1a/1b adenocarcinoma NSCLC (tumors <4 cm) after complete tumor resection who are ctDNA+ or exhibit high-risk of relapse Study will evaluate DFS as the 1EP, while OS, safety, patient-reported…
January 31, 2025
Ethris Reports Topline Data from P-I trial of ETH47 for Uncontrollable Asthma
Shots: Ethris presented full topline data from P-I trial of ETH47 (nasal) in 40 healthy subjects as a potential treatment for uncontrollable asthma Study showed dose-dependent IFNλ production in nasal lining fluid above therapeutic levels & activated antiviral ISG mRNA expression in nasal brush samples, confirming ETH47’s pharmacodynamic activity & MoA. Based on this,…
January 30, 2025
Siolta Therapeutics Enters into a Joint Research Agreement with Cowellnex
Shots: Siolta Therapeutics has entered into a preclinical research partnership with Cowellnex, a joint investment of Kirin and Kyowa Kirin, to develop an LBP focused on preventing necrotizing enterocolitis (NEC) The collaboration will utilize Siolta’s Precision Symbiotics Platform, enabling Cowellnex to expedite the discovery and development of innovative product aimed at preventing the occurrence…
January 30, 2025
Amgen
Amgen Receives EC’s Approval for Blincyto to Treat Philadelphia Chromosome-Negative CD19-Positive B-Cell Precursor Acute Lymphoblastic Leukemia (B-ALL)
Shots: The EC has approved Blincyto monotherapy as a part of consolidation therapy to treat 1L philadelphia chromosome-negative CD19+ B-ALL adults based on P-III (E1910) trial Blincyto + CT showed improved OS with 4.5yrs. median follow up vs CT alone, whereas 5-yrs. mFU demonstrated 82.4% vs 62.5% OS in 112 pts The trial was led by…
January 30, 2025
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