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MyoKardia has announced the promising results of Phase III clinical trials of its lead drug mavacamten for symptomatic, obstructive hypertrophic cardiomyopathy (HCM).
Following the announcement, shares of the California-based company skyrocketed. The Phase III clinical trial – EXPLORER-HCM – demonstrated the potential of the drug in effectively treating HCM and, and it met all the primary and secondary end-points. The company now plans to file for an early 2021 New Drug Application.
Mavacamten is a first-in-class small molecule drug that reversibly binds to myosin targeting the excess contractility and impaired relaxation underlying hypertrophic cardiomyopathy, or HCM. Hypertrophic cardiomyopathy (HCM) is a disease in which the heart muscle (myocardium) becomes abnormally thick (hypertrophied). During the course of the disease, the heart muscle cells enlarge, and the walls of the ventricles (usually the left ventricle) thicken. However, the size of the ventricle often remains normal, which leads to the blocking of blood flow out of the ventricle. The condition is called Obstructive hypertrophic cardiomyopathy (HOCM).
Moreover, Mavacamten is also under Phase II evaluation, MAVERICK-HCM, for symptomatic non-obstructive HCM patients.
AstraZeneca and Merck’s Lynparza (olaparib) in combination with Roche’s Avastin (bevacizumab) receives FDA approval for advanced epithelial ovarian, fallopian tube or primary peritoneal cancer.
The recommendation was based on the results from Phase III PAOLA-1 clinical trial that showed positive outcomes of the combination of the Lynparza and Avastin in the treatment of HRD-positive advanced ovarian cancer by decreasing the risk of disease progression or death by 67%.
The drug has been approved for adults with an advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer has been tested to have either a deleterious or suspected deleterious BRCA mutation and/or genomic instability.
Dyno Therapeutics has announced the launch of its proprietary CapsidMap platform to design novel adeno-associated virus (AAV) vectors.
The company uses its artificial intelligence to design novel AAV vectors to improve gene therapy techniques. The company is proactively collaborating with other pharma and biotech companies to foster its gene therapy techniques. Dyno is already in collaboration with Novartis and has entered into a strategic deal with Sarepta Therapeutics as well.
Under the terms of the deal with Sarepta, Dyno will manage the designing and discovery of novel AAV vectors to improve gene therapy for muscle diseases whereas Sarepta will be responsible for preclinical, clinical and commercial activities. The deal makes Dyno eligible for more than USD 40 Million upfront and license payments during the research phase of the partnership.
Abbott Laboratories has won EUA for its diagnostic kit – SARS-CoV-2 IgG lab-based serology blood test on the Alinity i system for COVID-19.
Company’s diagnostic kit managed to secure the approval even after the FDA has tightened its regulatory guidelines for approving test kits after many flawed hit the market amid COVID-19 crisis. Recently, the FDA gave the green line to Roche’s Elecsys Anti-SARS-CoV-2 antibody test under EUA.
With the approval, the kit becomes Abbott’s fourth diagnostic kit to enter the market under EUA. The Alinity i system is a next-generation immunoassay instrument that can offer great-level efficiencies while running tests. As per a survey by the company, Abbott’s SARS-CoV-2 IgG assay has shown specificity higher than 99.6%, the ability to exclude the false positives, and 100% sensitivity in patients tested 14 days after symptoms began. Abbott has already started shipping its kit to across the U.S., U.K., Italy, Spain and India.