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FDA suggests ways to curb constraints with rare disease gene therapy trials

Pharmaceutical Technology

In 2020, the FDA released a guidance document for the industry with recommendations for sponsors developing gene therapies for rare diseases. This document delved into aspects related to manufacturing, preclinical, and clinical trial design for all phases of clinical development.

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Sandoz confirms late-stage clinical development plans for proposed biosimilar aflibercept, a key ophthalmology medicine

The Pharma Data

Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept. Sandoz will begin enrolling the first patient in MYLIGHT, a clinical Phase III confirmatory efficacy and safety study, shortly 1. Disclaimer.

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Oncology treatment decisions aren’t just based on clinical data

pharmaphorum

Once widely acknowledged as so special that only scientists and clinical specialists need to apply, oncology has become exponentially more clinically targeted and sophisticated over the last decade. Yet how many other therapy areas have market leaders that don’t even have clinical approved indication in that indication?

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Sandoz confirms late-stage clinical development plans for proposed biosimilar aflibercept, a key ophthalmology medicine | Novartis

The Pharma Data

With eight marketed biosimilar medicines globally and 15+ molecules in pipeline, Sandoz is investing in future of biosimilars for patients and healthcare systems. Holzkirchen, May 3, 2021 – Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept.

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Field Trip becomes latest psychedelic firm to go public

pharmaphorum

COMP360 is a crystalline formulation of psilocybin in phase 2b clinical development in patients who have not responded to standard therapy for depression. Compass has a patented synthetic version of psilocybin, the active ingredient in magic mushrooms, and raised around $127.5 million with its IPO shortly after the announcement.

Medicine 122
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FDA Approves Updated Indication for Merck’s KEYTRUDA® (pembrolizumab) for Treatment.

The Pharma Data

In addition, as part of the label update, this indication has been revised to be for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for any platinum-containing chemotherapy.

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Citius Pharmaceuticals Announces $20.0 Million Private Placement Priced At-the-Market

The Pharma Data

. (“Citius” or the “Company”) (Nasdaq: CTXR), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, today announced that it has entered into securities purchase agreements with certain institutional and accredited investors to raise approximately $20.0