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Syncromune and Eucure enter antibody licence deal

Pharmaceutical Technology

According to the deal, the worldwide rights for developing and marketing intratumoral combination treatment containing Eucure’s YH002 and two additional active ingredients of the Syncrovax therapy will be acquired by Syncromune.

Antibody 130
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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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Polyrizon IPO Strengthens Momentum in Non-Invasive Drug Delivery Solutions

XTalks

per unit, included 958,903 units, each containing one ordinary share and three warrants to purchase additional shares at an exercise price of $4.38 Trading began on the Nasdaq Capital Market under the ticker “PLRZ” on October 29, 2024. The IPO, priced at $4.38 Polyrizon Ltd.

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Novartis Provides Update on AVXS-101 Intrathecal Clinical Development Program

The Pharma Data

Trial design and other details are being evaluated and a comprehensive update on the overall Novartis SMA clinical development program will be provided at a future time following further discussions with health authorities. This guidance provides clarity on the path to registration for AVXS-101 IT.

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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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Pfizer and BioNTech Receive Positive CHMP Opinion for Conversion of COMIRNATY® Conditional Marketing Authorization to Full Marketing Authorization in the European Union

Pfizer

Pfizer and BioNTech Receive Positive CHMP Opinion for Conversion of COMIRNATY® Conditional Marketing Authorization to Full Marketing Authorization in the European Union. Standard marketing authorization recommendation applies to all indications and formulations in the European Union, including COMIRNATY® Original/Omicron BA.4-5

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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?