June 25, 2023

Publication of phase III FRESCO-2 results evaluating fruquintinib in patients with previously treated colorectal cancer in The Lancet – Takeda and HutchMed

Takeda and HUTCHMED (China) Limited announced that results of the Phase III FRESCO2 study evaluating fruquintinib in patients with previously treated metastatic colorectal cancer (CRC) were published in The Lancet.The publication provides details of the FRESCO-2 study results as of June 24, 2022. Summary results from this cut-off date were presented on September 12, 2022, at the European Society for […]

admin Health 0 1 min read
June 24, 2023

FDA approves Bylvay for patients living with cholestatic pruritus due to Alagille syndrome – Ipsen

Ipsen announced that the FDA has approved Bylvay (odevixibat) for the treatment of cholestatic pruritus in patients from 12 months of age with Alagille syndrome (ALGS). Bylvay is a once-daily, non-systemic ileal bile acid transport inhibitor (IBATi) that acts locally in the small intestine and has minimal systemic exposure. Bylvay was approved as the first drug treatment option for patients […]

admin Health 0 2 min read
June 23, 2023

Additional data from phase IV Tepezza clinical trial presented at the Endocrine Society annual meeting reinforces efficacy in people with thyroid eye disease (TED) regardless of disease activity or duration – Horizon Therapeutics / Amgen

Horizon Therapeutics plc announced the presentation of new data from the randomized, double-masked, placebo-controlled Phase IV clinical trial (NCT04583735) evaluating Tepezza in patients with long disease duration and low Clinical Activity Score (CAS), a measure of disease activity. The oral presentation at the Endocrine Society Annual Meeting (ENDO 2023) supports the efficacy and safety of Tepezza in TED patients regardless […]

admin Health 0 2 min read
June 22, 2023

FDA approves Columvi, the first and only bispecific antibody with a fixed-duration treatment for people with relapsed or refractory diffuse large B-cell lymphoma – Roche

Roche announced that the FDA has approved Columvi (glofitamab-gxbm) for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) not otherwise specified or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate and durability of response […]

admin Health 0 3 min read
June 21, 2023

VBI Vaccines announces PreHevbri is now available in the United Kingdom for the prevention of hepatitis B in adults

VBI Vaccines Inc. announced that PreHevbri [Hepatitis B vaccine (recombinant, adsorbed)] is now available in the United Kingdom for active immunization against infection caused by all known subtypes of the hepatitis B virus (HBV) in adults. It can be expected that hepatitis D will also be prevented by immunization with PreHevbri as hepatitis D (caused by the delta agent) does […]

admin Health 0 28 sec read
June 20, 2023

First-of-its-kind head-to-head clinical trial reaffirms the efficacy of Emgality in episodic migraine prevention – Eli Lilly

Eli Lilly and Company announced results of the CHALLENGE-MIG clinical trial of Emgality (galcanezumab-gnlm) and Nurtec ODT (rimegepant orally disintegrating tablet), the first and only trial of its kind comparing two calcitonin gene-related peptide (CGRP) antagonist therapies. Emgality did not meet the study’s primary endpoint, defined as statistical superiority to Nurtec ODT on the percentage of participants achieving a 50% […]

admin Health 0 1 min read
June 19, 2023

Bayer starts phase II/III study with vericiguat in children with heart failure

Bayer and its development partner MSD (a tradename of Merck & Co., Inc., Rahway, NJ, USA) announced that the first patient has been enrolled in the Phase II/III VALOR trial. VALOR will investigate the efficacy, afety, and pharmacokinetics of vericiguat (Verquvo) in pediatric patients aged greater than 28 days to 18 years with heart failure due to left ventricular systolic […]

admin Health 0 1 min read
June 18, 2023

Soliris approved in China for the treatment of adults with refractory generalised myasthenia gravis – AstraZeneca

Soliris (eculizumab) has been approved in China for the treatment of adult patients with refractory generalised myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive. Soliris is the first and only complement inhibitor approved for the treatment of gMG in China. The approval by the National Medical Products Administration (NMPA) in China was based on comprehensive results from the Phase […]

admin Health 0 1 min read
June 17, 2023

FDA approves Injectafer to treat iron deficiency and heart failure – Daiichi Sankyo + American Regent Inc

Daiichi Sankyo, Inc. and American Regent, Inc., a Daiichi Sankyo Group company, announced that the FDA approved Injectafer (ferric carboxymaltose injection) for the treatment of iron deficiency in adult patients with heart failure categorized as New York Heart Association class II/III to improve exercise capacity. “This new indication for Injectafer marks the first and only FDA approval of an intravenous […]

admin Health 0 54 sec read
June 16, 2023

MHRA (UK) expands approval for Xeomin to treat focal spasticity of the lower limbs affecting the ankle joint – Merz Therapeutics

The MHRA (UK) has granted approval for a new indication for Merz Therapeutics’ Xeomin (incobotulinumtoxinA) to treat focal spasticity of the lower limbs affecting the ankle joint. The therapy was previously approved in the UK to treat upper limb spasticity. The expanded approval allows the company to provide holistic support to those living with spasticity who need comprehensive treatment. The […]

admin Health 0 27 sec read

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