PharmaShots Weekly Snapshots (July 03 – 07, 2023)

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PharmaShots Weekly Snapshots (July 03 – 07, 2023)

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)

Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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