Shots: The P-III CheckMate -274 study involves assessing of Opdivo vs PBO in 709 patients in a ratio (1:1) with muscle-invasive urothelial cancer at a high risk of recurrence after radical surgery for up to 1yr. The study met its 1EPs of DFS in both all randomized patients and in patients whose tumor cells express […]Read More
Shots: Novavax has initiated a P-III study assessing the efficacy, safety, and immunogenicity of NVX-CoV2373 vs PBO in Matrix-M in up to 10,000 individuals aged 18-84yrs. with/out relevant comorbidities, over the next 4-6wks. Half the participants will receive two IM injections of a vaccine comprising 5µg of protein antigen with 50µg Matrix‑M adjuvant, administered 21 […]Read More
Shots: The two P-III studies (ENHANCE-1 & ENHANCE-2) will assess the efficacy and safety of nebulized ensifentrine (3mg, bid) as monothx. and added onto a single bronchodilator either a LAMA/ LABA vs PBO in ~800 patients with mod. to sev. COPD at sites primarily in the US and EU for 24wks. & 48wks. respectively The […]Read More
Shots: The P-II TAURIEL study involves assessing of semorinemab vs PBO in 457 patients with early AD across 97 sites Genentech divulges that the P-II TAURIEL study did not meet its co-1EPs of efficacy (reducing decline on CDR-SB) but meets its 1EPs of safety while the two 2EPs (ADAS-Cog13 & ADCS-ADL) was not met, results […]Read More
Shots: The company has enrolled the first patient in P-I/IIa Study assessing XZ.700 in 48 patients with mild to moderate AD in the Netherlands. This marks the world’s 1st evaluation of a pharmaceutical endolysin for topical use in humans The patients will be treated for 14 days with a cream containing XZ.700 at 3 different […]Read More
Shots: Novartis has received the FDA’s feedback following their review of data from the STRONG study of AVXS-101 (IT) in older patients with SMA. The FDA has recognized the potential of therapy and recommends a pivotal confirmatory study to augment the existing STRONG data, further supporting the regulatory submission for IT formulation The new study […]Read More
Shots: Novartis’ Kisqali + endocrine therapy has achieved 5 out of 5 scores on ESMO-MCBS, confirming substantial benefit for premenopausal women with HR+/HER2- aBC, based on OS benefit and improved QoL in the P-III MONALEESA-7 study Kisqali is also the only CDK4/6 inhibitor to receive a score of 4 out of 5 in combination with […]Read More
Shots: Roche divulges results from three P-III studies of Tecentriq (atezolizumab) clinical development program in TNBC at the ESMO Virtual Congress 2020. The P-III IMpassion031 assessing Tecentriq + CT vs PBO + CT demonstrated improvement in pathological complete response (pCR: 57.6% vs 41.1%) in early TNBC patients The P-III IMpassion130 study assessing Tecentriq + nab-paclitaxel […]Read More
Shots: The P-III ADAURA study involves assessing of Tagrisso (80mg, qd, PO) vs PBO for the adjuvant treatment of 682 patients with stage IB, II, IIIA EGFRm NSCLC following complete tumor resection and adjuvant CT as indicated for 3yrs. or until disease recurrence Results: 82% reduction in the risk of CNS recurrence or death; patients […]Read More
Shots: The P-III PACIFIC study involves assessing of Imfinzi vs PBO in patients with unresectable, Stage III, LA NSCLC whose disease had not progressed following concurrent platinum-based CRT. The updated post-hoc analyses demonstrated OS @4yrs. (49.6% vs 36.3%), m-OS (47.5 vs 29.1mos); patients not progressed after 4yrs. (35% vs 19.5%) respectively, presented at ESMO The […]Read More
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