This week PharmaShots' news was brimmed with updates on clinical trials, regulatory, biosimilars, biotech, MedTech, and pharma. Check out our full report below:

• 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 reported the completion of patients enrollment in the 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 the first patient in the 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 granted an 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 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 received the US FDA’s breakthrough therapy designation for NRG1 fusion NSCLC

Read more: Merus 

• The EC granted conditional marketing authorization for Taiho's Lytgobi to treat patients with cholangiocarcinoma, based on the (FOENIX-CCA2) open-label trial

Read more: Taiho

• 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 signed license deal with Pheon Therapeutics for ADC to treat cancer

Read more: Biocytogen and Pheon Therapeutics 

• Hillstream and Applied Biomedical Science Institute collaborated to license the technology for HER2 and HER3 ADC

Read more: Hillstream and Applied Biomedical Science Institute

• 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

• Carrick Therapeutics collaborated with Arvinas and Pfizer for Samuraciclib and Vepdegestrant

Read more: Carrick Therapeutics

• The EC granted full MA to Novavax’s COVID-19 vaccine

Read more: Novavax

Related Post: PharmaShots Weekly Snapshots (June 26 – 30, 2023)