Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Mylan with its partners Lupin and Biocon received MAA for Nepexto (biosimilar, etanercept) in EU and the US FDA’s Approval for Semglee (biosimilar, insulin glargine) respectively Our team at PharmaShots has summarized 15 key events of the […]Read More
Shots: FKB327 (biosimilar, adalimumab) is an injectable medication that involves inhibition of Tumor Necrosis Factor (TNF) blocks the inhibition of activity, thereby reducing inflammation and other disease symptoms including RA, plaque psoriasis, Crohn’s disease, and ulcerative colitis In 2018, Fujifilm signed an agreement with Mylan to commercialize biosimilar adalimumab in EU and will expand it […]Read More
1. Ultragenyx and Kyowa Kirin’s Crysvita (burosumab) Receive the US FDA’s Approval for the Treatment of Tumor-Induced Osteomalacia Published: Jun 19, 2020 | Tags: Ultragenyx, Kyowa Kirin, Crysvita, burosumab, Receives, US, FDA, Approval, Treatment, Tumor-Induced Osteomalacia 2. Pfizer and Sangamo’s Giroctocogene Fitelparvovec (SB-525) Demonstrate Positive Effect in P-I/II Alta Study for Hemophilia A Published: Jun 18, 2020 […]Read More
Shots: The US FDA’s approval is based on two P-II studies (144wks. & 88wks. study) assessing Crysvita in 14 & 13 patients conducted by Ultragenyx & Kyowa Kirin in the US & Japan and South Korea respectively Results: increment in serum phosphorus and serum 1,25-dihydroxyvitamin D levels, thus improving osteomalacia. Additionally, whole-body bone scans demonstrated […]Read More
WHO to Accelerate Global Research and Innovation Against Corona Virus Published: Feb 06, 2020 | Tags: WHO, Accelerate, Global, Research, Innovation, Against, Corona Virus 2. Curis Amends its Existing Collaboration with Aurigene for the Development and Commercialization of CA-170 Published: Feb 07, 2020 | Tags: Curis, Amends, Existing Collaboration, Aurigene, Development, Commercialization, CA-170 3. Novo […]Read More
Shots: Kyowa will terminate its sales and marketing activities for ASACOL on Mar 31, 2020. Zeria to get exclusive full rights for sales and marketing for ASACOL from Apr 01, 2020 In Jan 2007, Kyowa and Zeria signed an exclusive co-development and co-marketing agreement for ASACOL in Japan ASACOL (mesalazine) is an anti-inflammatory enteric-coated tablet […]Read More
Shots: The approval is based on trials assessing KW-6002 vs PBO across EU, the US and Japan in patients with PD taking a stable dose of levodopa-based regimens with/out other PD medications The candidate will serve as an adjunctive treatment to the PD patients which is validated by the EMA and is now under review […]Read More
Shots: As per the first agreement, Ardelyx to receive $10M for research and is eligible to receive ~10.5M upfront and up to $500M as development & commercialization milestone and will execute research in collaboration with Kyowa Kirin for only two targets Following the end of the research period, Kyowa Kirin to get an option to […]Read More
1. Johnson & Johnson Initiates Voluntarily Recall of a Single Lot of its Baby Powder in the US Published: Oct 18, 2019 | Tags: JnJ, Initiates, Voluntarily, Recall, Baby Powder, US 2. AbbVie’s Rinvoq (Upadacitinib) Receives CHMP Positive Opinion to Treat Moderate to Severe Active Rheumatoid Arthritis Published: Oct 18, 2019 | Tags: AbbVie, Rinvoq, Upadacitinib, Receives, […]Read More
Shots: The Nourianz is now available in the US as adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson’s disease experiencing motor fluctuations, re-emerge between treatment dose known as “off” episodes The FDA’s approval of Nourianz is based clinical study assessing Nourianz vs PBO as adjunctive treatment to levodopa/carbidopa in adult patients with PD experiencing […]Read More
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