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EC approves Lorviqua® (lorlatinib) as first-line lung cancer treatment
Lorviqua® monotherapy approved as first-line advanced non-small cell lung cancer therapy based on promising Phase III trial results.
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Understanding the new EU Clinical Trial Regulation: seven things sponsors should know
In this article, Sarah Bly and Aman Khera of Worldwide Clinical Trials break down the seven key differences between the EU Clinical Trial Directive and new EU Clinical Trial Regulation, discussing when and how sponsors should begin submitting their trials through the new CTIS portal system.
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CHMP meeting highlights, January 2022
The EMA’s Human Medicines Committee (CHMP) recommended approval of Paxlovid for COVID-19 and a new gene therapy for large B-cell lymphomas.
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Scientists behind mRNA vaccine technologies win Frontiers of Knowledge Award
Katalin Karikó, Robert Langer and Drew Weissman win BBVA Foundation Frontiers of Knowledge Award in Biology and Biomedicine for driving the advance of messenger RNA (mRNA) therapeutics.
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Stabilising protein therapeutics with reversible PEGylation
Researchers demonstrate the efficacy and safety of stabilising protein drugs with a reversible PEGylation material called PEG-PRX.
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Tremfya® ranks highest for skin clearance in psoriatic arthritis patients
Newly published Network Meta-Analysis (NMA) from Janssen indirectly compares all published Phase III data for approved treatments for adults with active Psoriatic Arthritis (PsA).
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Could COVID-19 vaccines be freeze dried?
US researchers have been granted $930,000 to develop a freeze drying technique for mRNA-based COVID-19 vaccines.
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Imfinzi™ reduces risk of death in biliary tract cancer patients
Patients treated with Imfinzi and chemotherapy experienced a 20 percent reduction in the risk of death versus chemotherapy alone.
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Study finds Keytruda® improves overall survival in HCC patients
The data adds to the body of evidence relating to the use of Keytruda® as a monotherapy in second-line HCC post sorafenib.
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Riluzole not beneficial for spinocerebellar ataxia type 2
Study reveals riluzole is of no benefit in spinocerebellar ataxia type 2, emphasising the importance of studying homogeneous groups of patients.
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Imfinzi™ plus tremelimumab: “unprecedented survival” in unresectable liver cancer
Almost a third of unresectable hepatocellular carcinoma patients were alive at three years on tremelimumab and Imfinzi regimen.
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New FDA medical device framework to improve women’s health
The FDA’s Center for Devices and Radiological Health releases its strategic plan to improve medical device research and regulation for women.
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mRNA COVID-19 vaccines safe for pregnant women, finds EMA review
A review of studies involving 65,000 pregnancies suggests mRNA COVID-19 vaccines do not increase the risk of pregnancy complications.
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Rare Disease Clinical Outcome Assessment Consortium launched
The Rare Disease Clinical Outcome Assessment (COA) Consortium aims to advance patient-focused assessment of clinical benefit in treatment trials for rare diseases.
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SAHPRA and USP to increase availability of safe health products in South Africa
SAHPRA and US Pharmacopeia have signed a Memorandum of Understanding to expand access to quality-assured health products in South Africa.
