Shots: The two companies collaborated for the development of Foundation Medicine’s tissue & blood-based CDx to be used with marketed and investigational treatments in Takeda’s late-stage lung cancer portfolio If approved, the CDx will be used to identify patients who may be eligible for mobocertinib for EGFR Exon20 insertion + mNSCLC and Alunbrig (brigatinib) for […]Read More
Shots: Roche has launched Elecsys Anti-SARS-CoV-2 S Ab for markets accepting the CE Mark. The company has filed for US FDA’s EUA The test can quantitatively measure the level of Abs against SARS-CoV-2 in patients who have been exposed to the virus and can aid in characterizing a vaccine-induced immune response Using the Elecsys Anti-SARS-COV-2 […]Read More
Shots: Baxter will be the exclusive distributor of bioMérieux’s NEPHROCLEAR CCL14 test in the EU and the US following regulatory approval and launch in both territories. The companies will share in-country commercialization, while bioMérieux will retain control over the regulatory process The collaboration will add the diagnostic test to Baxter’s Acute Therapies portfolio, offering the […]Read More
Shots: The approval is based on IMPACT trial, which enrolled ~ 35,000 women to clinically validate CINtec PLUS Cytology as a triage test in various screening scenarios. Publication of the full study findings is pending The approval gives laboratories access to the complete Roche Cervical Cancer Portfolio in the US, including the cobas HPV Test, […]Read More
Shots: The CE mark is granted under the new MDR European regulation, allowing the wearable therapeutic device to be marketed in selected EU countries, starting in 2021 Nerivio has also received the US FDA’s approval for use in the acute treatment of migraine and is currently under review for chronic migraine. Nerivio is the first […]Read More
Shots: The test provides standardized results to assess the risk of complications caused by the BK virus in transplant patients and identify effective treatment options It has received FDA’s BDD for improved treatment/diagnosis of life-threatening diseases for transplant patients. The approval allows Roche to offer HCPs a transplant testing portfolio that includes Cytomegalovirus, Epstein-Barr virus, […]Read More
Shots: The LIFE-BTK study is the first IDE trial in the US to evaluate a fully resorbable device for treating blocked arteries below the knees, or CLI, in people with advanced stages of PAD. The study will assess Esprit BTK resorbable scaffold in 225 patients across the globe The focus of the study is to […]Read More
Shots: The US FDA has granted EUA for cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas 6800/8800 Systems to qualitatively detects and differentiate SARS-CoV-2, Influenza A and B in patients suspected of having respiratory viral infection consistent with COVID-19 The test is a multiplex RT-PCR assay intended to detect the virus in […]Read More
Shots: The US FDA has granted De Novo authorization to Theranova that delivers expanded hemodialysis (HDx) therapy by filtering the wider range of molecules from the blood, targeting the effective removal of conventional (500-25 kDa) and large middle molecules (25-45 kDa) The Theranova cartridge is designed to be used with existing dialysis machines and offers […]Read More
Shots: BiomX will generate metagenomic data of gut microbiome samples obtained from IBD patients with the focus of identifying biomarkers using the XMarker platform Boehringer Ingelheim gets an option to negotiate an exclusive right to biomarkers discovered under the collaboration. The XMarker platform supports the phage therapy for IBD, BX002, via analysis of real-world metagenomic […]Read More
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