This week, Daiichi Sankyo and AZ revealed positive results from the P-III (TROPION-Lung01) for Dato-DXd in advanced NSCLC patients with improvement in PFS
Read more: Daiichi Sankyo and AstraZeneca
Zealand reported the results from the first part of the weight management therapy trial where patients who received 0.6 &1.2mg doses of ZP8396 showed mean body weight reductions of 5.3% and 5.1%, respectively
Read more: Zealand
Krystal Biotech dosed patients in (CORAL-1/US) P-I clinical trial of KB407 for cystic fibrosis with continued patients’ enrolment in P-I study & results are expected in 2024
Read more: Krystal Biotech
Janssen’s JNJ-2113 (oral) performed well in the FRONTIER 1 (P-IIb) trial for adults with plaque PsO & showed an improvement in skin clearance at the highest dose after 16 wks.
Read more: Janssen
Galderma unveils positive results for prurigo nodularis treatment & reached an itch-free state as early as 4wk.
Read more: Galderma
InnoCare highlighted the first patient dosing of ICP-488 for Psoriasis in China
Read more: InnoCare
Photocure Partner Asieris Report the Completion of Patients Enrollment in P-III Clinical Trial of Hexvix in China
Read more: Photocure Partner Asieris
Horizon highlighted (MIRROR) trial results of Krystexxa (pegloticase) + Methotrexate for Uncontrolled Gout with an improvement in the patient response rate
Read more: Horizon
Eli Lilly unveils safety and efficacy results of pirtobrutinib from the P-I/II trial for CLL or SLL
Read more: Eli Lilly
Ultragenyx dosed patient in P-III Program for Setrusumab (UX143) to treat Osteogenesis Imperfecta
Read more: Ultragenyx
NMPA approved Innovent and IASO Bio’s myeloma therapy, based on the P-I/II trial & demonstrated remarkable efficacy with evidence of deep and durable response for high-quality survival
Read more: Innovent and IASO
The US FDA grants IND clearance for the P-I/IIa trial of Skyline’s SKG0106 to treat nAMD & the trial will begin shortly
Read more: Skyline Therapeutics
The US FDA issued a complete response letter to Amneal for IPX203 & requested for additional pharmacokinetic data
Read more: Amneal Pharmaceuticals
Dipharma’s Sapropterin Dipharma launched in the EU and Switzerland & available in the form of soluble tablets of 100mg, powder for oral solutions of 100 & 500mg
Read more: Dipharma
EC approved Vertex’s Orkambi for cystic fibrosis in children aged 1 to <2 years
Read more: Vertex Pharmaceuticals
Incyte nabs UK nod for Opzelura to treat vitiligo cream
Read more: Incyte
Merus’ Zenocutuzumab Receives the US FDA’s Breakthrough Therapy Designation for NRG1 Fusion Non-Small Cell Lung Cancer
Read more: Merus
Boehringer Ingelheim’s Cyltezo (adalimumab-adbm) available in the US for chronic inflammatory diseases patients
Read more: Boehringer Ingelheim
Organon and Samsung Bioepis have launched Humira Biosimilar Hadlima with a list price that is an 85% discount off the reference product Humira
Read more: Organon and Samsung Bioepis
Fresenius Kabi launched citrate-free biosimilar Idacio (adalimumab-aacf) for chronic autoimmune diseases in the US
Read more: Fresenius Kabi
Celltrion launched Yuflyma, a Humira biosimilar available in auto-injector and prefilled syringe options
Read more: Celltrion
Kashiv completed the P-I trial for Xolair biosimilar ADL018 & further plans to initiate dosing in the P-III study soon in CSU patients
Read more: Kashiv Biosciences
Maruho & Alchemedicine collaborated to Develop and Commercialize an aldehyde dehydrogenase 2 activator & continued to improve patients’ QoL by supplying new therapeutic agents
Read more: Maruho and Alchemedicine
Takeda and F-star signed a ~$1B immuno-oncology agreement for cancer
Read more: Takeda and F-star
Biocytogen signs licensed deal with Pheon Therapeutics for ADC to treat cancer
Read more: Biocytogen and Pheon Therapeutics
Abbott secured the US FDA approval for the dual-chamber leadless pacemaker to treat abnormal or slow heart rhythms, based on the (AVEIR DR i2i) IDE study
Read more: Abbott
Related Post: PharmaShots Weekly Snapshots (June 26 – 30, 2023)