Formycon and Fresenius Kabi Report the MHRA’s Approval of Otulfi (Biosimilar, Stelara)

Shots: The UK’s MHRA has approved Otulfi (SC & IV), biosimilar of J&J’s Stelara (ustekinumab), to treat mod. to sev. active Crohn's disease, ulcerative colitis, plaque psoriasis as well as active psoriatic arthritis & is set to enter UK market as per a confidential settlement b/w the companies and J&J. It is approved across the US,…

BySenior EditorJanuary 16, 2025

NEWS

Amgen’s Imdylltra (Tarlatamab) Secures the MHRA’s Conditional Marketing Authorization as a 3L Treatment of ES-SCLC

Shots: The MHRA has granted conditional marketing authorization to Imdylltra for treating adults with ES-SCLC, whose disease progressed post prior 2 lines of treatment. Further evaluation is underway This authorization was supported by P-II (DeLLphi-301) study assessing Imdylltra (10mg, Q2W) in ES-SCLC patients (N=99). It showed ORR of 41% & mDoR of 9.7mos. …

ByRidhi RastogiJanuary 6, 2025

INSIGHTS+

New Drug Designations – March 2024

Shots: PharmaShots' designation report provides a concise overview of several drugs and their designations by the FDA, MHRA and EC. This month’s report includes designations allotted to 10 small molecules, 6 biologics, 5 cell & gene therapy, 1 recombinant fusion protein, 2 actineoplastics, 1 antidepressant, 1 drug conjugate, 1 analgesic and 6 devices Trellis Bioscience's…

BySenior EditorApril 30, 2024

NEWS

Dr. Reddy’s Laboratories Expects the Launch of Versavo (biosimilar, bevacizumab) for the Treatment of Several Cancer Indications Across the UK

Shots: The company has developed Versavo as a biosimilar of Avastin, approved for the treatment of various cancer indications incl. metastatic colorectal cancer, advanced non-squamous NSCLC, recurrent glioblastoma, mRCC, advanced cervical cancer, ovarian cancer & metastatic breast cancer Based on the clinical evaluation, Versavo is expected to be approved and launched across the UK as…

ByDipanshu DixitMarch 19, 2024

INSIGHTS+

Top Performing Drug – Trikafta/Kaftrio (May Edition)

Shots: In continuation of our previous series on the top-performing drug of the month, based on 2021 revenue, this month we have covered Trikafta/Kaftrio as the top-performing drug of the month Trikafta is a combination of ivacaftor, tezacaftor, and elexacaftor indicated for the treatment of cystic fibrosis in pediatric patients who have at least one…

BySenior EditorMay 24, 2023

THOUGHTSPOT

ILAP and its nuance vs PRIME since BREXIT

Introduction PRIME (PRIority MEdicines) EMA launched PRIME on March 07, 2016, to support the development of medicines targeting unmet medical needs. The scheme is based on enhanced interaction and early dialogue with developers of promising medicines, to optimize development plans and speed up evaluation so these medicines can reach patients faster. PRIME builds on the…

BySenior EditorSeptember 13, 2022

Formycon and Fresenius Kabi Report the MHRA’s Approval of Otulfi (Biosimilar, Stelara)

Amgen’s Imdylltra (Tarlatamab) Secures the MHRA’s Conditional Marketing Authorization as a 3L Treatment of ES-SCLC

New Drug Designations – March 2024

Dr. Reddy’s Laboratories Expects the Launch of Versavo (biosimilar, bevacizumab) for the Treatment of Several Cancer Indications Across the UK

Top Performing Drug – Trikafta/Kaftrio (May Edition)

ILAP and its nuance vs PRIME since BREXIT

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