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Results For "biomarker"

200 News Found

Eisai initiates rolling submission for Biological Licence Application of Lecanemab
Biotech | September 28, 2021

Eisai initiates rolling submission for Biological Licence Application of Lecanemab

The BLA is being submitted under the accelerated approval pathway and is primarily based on clinical, biomarker and safety data from the Phase 2b clinical trial in people with early AD and confirmed amyloid pathology


Positive results from Lynparza with abiraterone delays Metastatic prostrate cancer
Drug Approval | September 28, 2021

Positive results from Lynparza with abiraterone delays Metastatic prostrate cancer

Prostate cancer is the second-most common cancer in men and despite an increase in the number of available treatments for men with mCRPC, five-year survival remains low


Roche receives positive CHMP opinion for Gavreto
Drug Approval | September 18, 2021

Roche receives positive CHMP opinion for Gavreto

If approved, Gavreto will be the first and only targeted treatment approved by the EMA that includes first-line treatment of people with RET fusion-positive advanced NSCLC


U.S. FDA approves Thermo Fisher Scientific’s Oncomine Dx target test
Medical Device | September 16, 2021

U.S. FDA approves Thermo Fisher Scientific’s Oncomine Dx target test

It approves tissue-based NGS companion diagnostic for Takeda's targeted therapy for NSCLC patients with EGFR Exon20 insertion mutations


US FDA grants Lantern Pharma additional Orphan Drug tag for LP-184
Biotech | August 31, 2021

US FDA grants Lantern Pharma additional Orphan Drug tag for LP-184

The drug is also intended for the treatment of glioblastoma multiforme


European Commission grants market authorisation for BioMarin’s Voxzogo
Biotech | August 28, 2021

European Commission grants market authorisation for BioMarin’s Voxzogo

It is estimated that over 11,000 children across Europe, Middle East, and Africa are affected by achondroplasia and could be eligible for treatment with Voxzogo


Merck donates Rs 1.7 crore to IIT Bombay for Covid-19 research
News | August 26, 2021

Merck donates Rs 1.7 crore to IIT Bombay for Covid-19 research

The two-year donation supports the development of clinical tests for Covid-19 severity assessment and the focus on the development of simple immunoassays using single molecule counting technology


Tesis Labs and Personal Genome Diagnostics tie-up to advance cancer treatment
Digitisation | August 11, 2021

Tesis Labs and Personal Genome Diagnostics tie-up to advance cancer treatment

The aim is to create new genomics solutions that could combat cancer and advance market access


QIAGEN and OncXerna Therapeutics sign licensing and master companion diagnostic agreements
Drug Approval | August 10, 2021

QIAGEN and OncXerna Therapeutics sign licensing and master companion diagnostic agreements

QIAGEN and OncXerna enter into a global master agreement to advance the development of the Xerna TME panel as a potential Next Generation Sequencing (NGS) companion diagnostic for OncXerna’s Navicixizumab


Merck invests €270 million in a new research center at Darmstadt
News | July 19, 2021

Merck invests €270 million in a new research center at Darmstadt

As of 2025, the new Translational Science Center will offer room for more than 500 scientists, who will conduct research in a wide variety of fields ranging from the identification of disease biomarkers to the development of targeted therapies