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. atopic AD The FDA has extended the action date, allowing the time to review additional data analyses submitted by Lilly in response to recent information requests from the FDA. The […]Read More
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 The study resulted in a reduction of severe asthma attacks and rapidly improved lung function within 2wks, safety results were generally consistent with the known safety profile of Dupixent. Dupixent […]Read More
Shots: The NDA submission is based on two P-III studies (COUGH-1 & -2) involves assessing gefapixant (45/15mg, bid) vs PBO in 2,044 patients with RCC & UCC In both the studies, gefapixant resulted in the reduction of in 24hrs.-cough frequency @12 & 24wks respectively. Data were presented at ERS 2020 Gefapixant is a selective P2X3 […]Read More
Shots: The US FDA has accepted the BLA under the 351(k) for CHS-1420 with an anticipated BsUFA date as Dec’2021 The company plans to launch the CHS-1420 in the US on or after Jul 01, 2023 as per the terms of an agreement with AbbVie Coherus collaborated with Junshi in Feb’2021 to in-license toripalimab in […]Read More
Shots: The US FDA has accepted for review the BLA of SB11, a proposed biosimilar referencing Lucentis (ranibizumab) The EMA has accepted for review the MAA of SB11 in Oct’2020. If approved, SB11 will add to the biosimilars portfolio developed under the collaboration of Samsung Bioepis and Biogen including Benepali, Imraldi & Flixabi In Nov’2019, […]Read More
Shots: Novartis reported that the US FDA has extended its review of sBLA for ofatumumab (OMB 157) to treat patients with RMS. The company anticipates the regulatory action in Sept’2020 Novartis works with the US FDA to continue the review for ofatumumab (SC) in RMS, for the approval in the US with expected EU approval […]Read More
Shots: Shots: The companies receive the US FDA’s Refusal to File letter regarding the BLA for idecabtagene vicleucel for patients with heavily pre-treated r/r MM, which was submitted in Mar’2020 Upon preliminary review, the US FDA determined that the Chemistry, Manufacturing and Control module of the BLA requires further detail to complete the review Ide-cel […]Read More
Shots: The BLA is based on P-III ICARIA-MM study results assessing Isatuximab in combination with pomalidomide and dexamethasone in patients with RRMM, presented at ASCO2019 and EHA 2019 Isatuximab has received the US FDA and EMA’s ODD designation for RRMM and the EMA has accepted its MAA in Q2’19 with its expected FDA’s PDUFA date […]Read More
PharmaShots Year in Review | Top 10 Pharma News of 2018 1. Celgene to Acquire Juno for its Cellular Immunotherapy & Hematology Portfolio Published: 22 Jan, 2018 | Tags: Celgene, Acquire, Juno, Cellular, Immunotherapy, Hematology Portfolio 2. Sanofi to Acquire Bioverativ for its Hemophilia Products Published: 22 Jan, 2018 | Tags: Sanofi, Acquire, Bioverativ, Treat, […]Read More
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