Gilead Reports NDA Submission of Filgotinib to PMDA for Ulcerative Colitis in Japan
Shots: The submission is based on P-IIb/III SELECTION study evaluating the efficacy and safety of filgotinib (200mg, qd) vs PBO in patients with mod. to […]
Shots: The submission is based on P-IIb/III SELECTION study evaluating the efficacy and safety of filgotinib (200mg, qd) vs PBO in patients with mod. to […]
Shots: The company has completed the enrollment in the P-IIB HOPE4MCI trial evaluating the efficacy of AGB101 vs PBO in 164 patients to treat amnestic […]
Shots: The company has initiated patient enrolment in P-III ULTRA-V trial evaluating Ukoniq + ublituximab + venetoclax, vs Ukoniq + ublituximab (U2) in patients with […]
Shots: Bio-Thera to receive $30M up front following the achievement of P-III satisfactory results and is eligible for commercial milestones along with royalties. The transaction […]
Shots: MD Anderson will sponsor and lead P-I/II study to assess DS-1594 as monothx. and in combination regimens for patients with r/r AML and ALL […]
Shots: The submission is based on two P-III studies KEEPsAKE-1 & -2 studies involves assessing Skyrizi (150mg) vs PBO in adult patients with active PsA […]
Shots: The EC’s approval is based on data from DELIVER and REFINE studies evaluating the efficacy, PK, and PD of Tysabri (300mg, SC, q4w) vs […]
Shots: Lilly and Incyte reported that the US FDA has extended the review period of sNDA for baricitinib to treat adults with mod. to sev. […]
Shots: The company has completed the enrollment in the first cohort of P- I/II trial involves assessing AMT-130 in 10 patients, out of which six […]
Shots: The first patient has been dosed in P-Ib trial evaluating SpringWorks’ Nirogacestat (GSI) + Janssen’s Teclistamab (Ab targeting BCMA and CD3) in patients with […]
Shots: The MAA is based on the P-III EV-301 trial which involves assessing Enfortumab Vedotin vs CT in ~ 600 patients with LA/m-UC, prior treated […]
Shots: The P-IIIa STEP 4 trial involves assessing the safety and efficacy of Semaglutide (2.4 mg, SC, qw) vs PBO in adults with obesity for […]
Shots: The US FDA has issued refusal to file a letter covering the label expansion application for semaglutide (2.0mg/qw) for T2D, which was submitted on […]
Shots: The NDA is based on P-II study-004 trial involves assessing Belzutifan (120 mg, PO, qd) in 61 patients with VHL disease who had at […]
Shots: The companies will co-develop & co-commercialize the combination of Gilead’s Lenacapavir and Merck’s Islatravir in long-acting oral & injectable formulations for HIV. Gilead & […]
Shots: The sBLA is based on P-III study assessing Dupixent + SOC maintenance therapy in children aged 6-11yrs. with moderate-to-severe asthma with type 2 inflammation […]
Shots: The sNDA submission is based on the P-III REACH3 study assessing ruxolitinib vs best available therapy in adult and pediatric patients ≥12yrs. with steroid-refractory […]
Shots: Imcyse to receive up front, ~$180M as milestones along with royalties. Pfizer to purchase an equity stake in Imcyse Initially, the companies will collaborate […]
Shots: The MAA submission is based on a P-Ib/II CARTITUDE-1 study assessing the safety and efficacy of cilta-cel in adults with r/r MM. The company […]
Shots: Shionogi to receive an up front, milestones as well as royalties on sales of the therapy. BioAge to get exclusive US and EU rights […]
Shots: The BLA submission is based on P-II POD1UM-202 trial involves assessing of retifanlimab (500 mg, q4w) in 94 patients with locally advanced or metastatic […]
Shots: The approval is based on the pivotal AURORA P-III study and AURA-LV P-II study involves assessing of Lupkynis + SoC in 533 patients to […]
Shots: Aquestive will receive upfront, milestones, royalties on net sales for Exservan (oral film formulation) in the US and will earn revenue pursuant to the […]
Shots: The approval is based on pivotal phase III ATLAS and FLAIR study assessing Cabenuva in 1,100+ HIV-1 adults to replace the current ARV regimen […]
Shots: MiNA to receive $267.6M in up front, exclusivity fee on first neurological target and will be eligible to receive research, development, regulatory and commercial […]
Shots: The approval is based on pivotal P-III VICTORIA trial involves assessing of Verquvo (2.5mg, 5mg & 10mg) vs PBO in 5,050 adult patients with […]
Shots: Regenxbio has reported that the ATMOSPHERE trial evaluating RGX-314 is active and patient screening is ongoing. The study will enroll 300 patients across two […]
Shots: The BLA submission is based on P-lll study assessing the safety and efficacy of Somatrogon (0.66 mg/kg, qw) vs Somatropin (0.034 mg/kg, qd) in […]
Shots: Chi-Med initiated the filing of NDA to the US FDA for surufatinib to treat pancreatic & non-pancreatic NET & plans to complete the NDA […]
Shots: The US FDA’s CRDAC voted 12 to 1 supporting the use of Entresto (sacubitril/valsartan) in the treatment of patients with HFpEF The decision was […]
Shots: Richter signed an asset purchase agreement with Janssen for Evra transdermal contraceptive patch assets outside the US. The total deal value is $263.5M The […]
Shots: The approval is based on P-III BLOCKSTONE study assessing Xofluza (baloxavir marboxil, 10/20mg) vs PBO in patients in household members aged ≥12yrs. who was […]
Shots: The MAA is based on a P-II VISION study assessing Tepotinib as monothx. in patients with advanced NSCLC of METex14 skipping alterations, prospectively assessed […]
Shots: The NMPA has accepted HLX15’s IND to be used in the treatment of multiple myeloma. HLX15 is Henlius’ second self-developed product around blood tumor […]
Shots: The US FDA has granted FT designation to NVX-CoV2373 which is currently in late-phase clinical development. Novavax expects to initiate pivotal P-III study in […]
Shots: The approval is based on ABRE clinical study assessing the Abre stent in 200 patients with iliofemoral venous outflow obstruction across the spectrum of […]
Shots: Henlius to receive upfront, regulatory, and commercial milestone payments of ~$43M, eligible to receive $30M for every $1B above the first $600M of the […]
Shots: The CHMP’s positive opinion is based on ORION program including P-III studies assessing Leqvio in 3,600+ patients on a maximally tolerated statin dose. Inclisiran […]
Shots: The NDA submission is based on P-III UPTRAVI IV study he safety and tolerability of 20 patients with PAH temporarily switching from oral UPTRAVI […]
The approval is based on P-III trial assessing Wynzora Cream vs Taclonex Topical Suspension in 794 patients for the treatment of plaque psoriasis in adults […]
Shots: SK bioscience signs a development and supply agreement for Novavax’ NVX-CoV2373 to supply it globally including the COVAX facility. SK bioscience will manufacture the […]
Shots: The NDA filing is based on P-III studies evaluating Veklury vs PBO, conducted by NIAID. The studies demonstrated that Veklury led to faster time […]
Shots: Lupin has launched favipiravir in India under the brand name ‘Covihalt’ for the treatment of mild to moderate COVID-19 Covihalt will be available as […]
Shots: The US FDA has granted FT designation to LEO’s delgocitinib cream as the potential treatment for adults with moderate-to-severe CHE. There are currently no […]
Shots: Redx to receive $17M in early payment by the time of successful commencement of a P-I study, $360M as development, a regulatory and commercial […]
Shots: The approval is based on the principle of extrapolation of its efficacy data in adults also supported by pharmacokinetic and safety data in children. […]
Shots: The designation is based on P-II study evaluating MK-6482 in patients with VHL-associated RCC with nonmetastatic RCC tumors >3cms in size, unless immediate surgery […]
Shots: The MAA is based on P-III study assessing the efficacy and safety of vosoritide, further supported by the long-term safety and efficacy from the […]
Shots: Gustave Roussy to receive funding and support from Daiichi Sankyo for integrative research program including clinical, translational, and preclinical studies for DS-1062 and patritumab […]
Shots: Jnana to receive $40M upfront payment in cash and is eligible to get ~$1B as research funding, preclinical, development, and commercialization milestone along with […]
Shots: The P-III OASIS-2 study involves assessing mirikizumab vs PBO & Cosentyx (secukinumab) in 1,465 patients with mod. to sev. PsO. The patients were randomized […]
Shots: The US FDA has granted ODD for Kiniksa’s Rilonacept to treat pericarditis, which includes recurrent pericarditis. The company plans to submit sBLA in recurrent […]
Shots: The BLA submission is based on L-MIND P-II trial data results assessing Tafasitamab + lenalidomide in patients with r/r DLBCL and retrospective observational matched […]
Shots: Fulcrum to receive $10M upfront, reimbursement for R&D costs, research, development and commercial milestone of up to $295M for first product commercialized and additional […]
Shots: The second P-III LIBRETTO-531 involves assessing of selpercatinib vs physician’s choice of cabozantinib or vandetanib in 400 patients in ratio (2:1) with advanced or […]
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