Tags : New

Merck KGaA Collaborates with Iktos to Deploy AI in New

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

Abbott’s AdviseDx SARS-CoV-2 IgM Test Receives the US FDA’s EUA

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

Eli Lilly Collaborates with Dexcom for Diabetes Management

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

Roche Presents New P-III Data of Tecentriq in Triple-Negative Breast

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

Insights+: The US FDA New Drug Approvals in March and

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. In 2018, the FDA approved 59 novel products including 42 New Chemical Entity and 17 Biologics while breaking its past year’s records of approval. However, there is a […]Read More

QIAGEN Releases QIAstat-Dx Test Kit as the First Syndromic Test

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 US FDA will Approve a New Pathway for Biosimilars

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 US FDA Draft New Guidelines for Proposed Biosimilars and

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

Conglomerate of Rheumatology and Spondylitis Organizations Released New Updated Guidelines

The new updated guidelines are being built on previous recommendations based on best practices for imaging, managing biologic and biosimilars usage in patients, and providing information on new medication The guidelines included 20 clinical questions based on pharmacological treatment indicated in 2015 guidelines and 26 new question on the pharmacological treatment treat-to-target strategy, and use […]Read More