Shots: The approval follows P-III ORIENT-11 study assessing Tyvyt (sintilimab) vs PBO + Almita (pemetrexed) and platinum CT in 397 participants in a ratio (2:1) as 1L therapy for advanced […]readmore
Tags : therapy
Shots: The acceptance of sNDA is based on P-III ORIENT-32 study assessing in sintilimab + bevacizumab vs sorafenib in 571 subjects in a ratio (2:1) as 1L treatment for patients […]readmore
Shots: Janssen acquires rights to Hemera’s HMR59, administered as a one-time, outpatient, IVT inj. to help preserve vision in patients with geographic atrophy The acquisition will boost Janssen’s eye disease […]readmore
Shots: This BT designation is based on P-IIb/III HPTN 083 study assessing cabotegravir (q8w) vs. FTC/TDF tablets (qd PO, 200/300 mg) in a study population of 4,566 for HIV prevention. […]readmore
Shots: The P-II trial will assess BI 764198 (qd for ~4wks.) in patients hospitalized for COVID-19 with expected enrollment initiation in Oct’2020. The 1EPs will be the percentage of patients […]readmore
Shots: The P-I dose-escalation study will assess the safety, tolerability, and preliminary efficacy of DS-1055 in adult patients with r/r advanced or metastatic head and neck, gastric and esophageal cancers, […]readmore
Shots: The ongoing P-IIIb VISIBLE OLE study involves assessing of Entyvio (SC) in adult patients with UC or CD, following enrolment and participation in the VISIBLE 1 (UC) or VISIBLE […]readmore
Shots: The approval follows P-III ELARIS UF-I and ELARIS UF-II studies assessing Oriahnn (elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules) vs PBO for the management of heavy menstrual bleeding […]readmore
Shots: Saniona to receive up to $84.6 as milestones along with royalties on sales of the therapies. Boehringer Ingelheim to get an exclusive global right to research, develop, manufacture and […]readmore
Regulatory
Merck’s Keytruda (pembrolizumab) in Combination with Inlyta (axitinib) Receives European
Shots: The approval is based on P-III KEYNOTE-426 study assessing Keytruda (200mg) + Inlyta (5mg) vs Sunitinib (50mg) in 861 patients in a ratio (1:1) with advanced RCC regardless of […]readmore