Shots: Vertex’ new drug submission for Trikafta has been accepted for Priority Review by Health Canada for the treatment of CF in people aged ≥12yrs. With PR, the conventional review timeline of 300 days is reduced to 180 days. The expected Health Canada’s approval is in H1’21 Trikafta is a triple combination regimen used to […]Read More
Shots: Iktos will leverage its de novo generative design technology to be used in a structure-enabled context, facilitating the rapid & cost-effective design of Merck KGaA’s drug discovery program The collaboration follows the previous agreement of the companies signed in 2019. Merck KGaA is utilizing Iktos’ de novo design software platform Makya for MPO Iktos’ […]Read More
Shots: Abbott has received the US FDA’s EUA for AdviseDx SARS-CoV-2 IgM lab-based serology test for use on the ARCHITECT and Alinity platforms Till now, Abbott has received EUA for its seven tests, including molecular tests, a rapid antigen test and, an IgG Ab test for COVID-19 The IgM test demonstrated 99.56% specificity and 95.00% […]Read More
Shots: The companies will partner to promote Lyumjev (insulin lispro-aabc injection, 100 & 200 units/mL) with Dexcom G6 CGM to aid HCPs in the US for the management of diabetes, including giving visibility to the benefits of a new mealtime insulin HCPs treating T1D & T2D will be able to assess their patient’s glucose levels […]Read More
Shots: Roche divulges results from three P-III studies of Tecentriq (atezolizumab) clinical development program in TNBC at the ESMO Virtual Congress 2020. The P-III IMpassion031 assessing Tecentriq + CT vs PBO + CT demonstrated improvement in pathological complete response (pCR: 57.6% vs 41.1%) in early TNBC patients The P-III IMpassion130 study assessing Tecentriq + nab-paclitaxel […]Read More
The US FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 48 new products so far in 2019. However, there is a significant increase in multiple diseases while the new approvals are helping and advancing the changes to understand, diagnose, and treat the diseases Our team […]Read More
Shots: QIAGEN has started the shipment of its QIAstat-Dx Respiratory SARS-CoV-2 Panel test to the US for diagnosing the patients infected with COVID-19 under a new FDA’s policy, announced on Mar 16, 2020 The QIAstat-Dx test is a multiplexed nucleic acid test that assesses samples such as nasopharyngeal swabs obtained from individuals suspected of the […]Read More
The EMA’s CHMP has adopted a positive opinion recommending the approval of Nepexto, a biosimilar referencing Enbrel (etanercept), for all indications of the reference product including RA, JIA, PsA, axSpA (including AS and nr-axSpA), PsO and pediatric PsO The positive opinion is based on biosimilarity assessment which included pre/ clinical studies demonstrating bioequivalence to the […]Read More
The development project involves investment of $40M and doubled its production capacity and will export biosimilar in Central America, South America, Africa, Asia and the Middle East The plant will currently have 162 employees with 50 new jobs, and it is expected to generate another 50 positions over the coming years work according to GMP […]Read More
Shots: The objective of this guideline is to provide recommendations on when and whether a comparison clinical immunogenicity study is required for biosimilar and interchangeable insulin products targeted to treat Type 1 or Type 2 diabetes mellitus The US FDA stated that if an analytical study is based on state-of-the-art technology supporting “highly similar” for […]Read More
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