AstraZenecas Farxiga pads its case for new heart-helping approval

FiercePharma | August 20, 2019

AstraZenecas Farxiga pads its case for new heart-helping approval
AstraZeneca is still stinging after its SGLT2 diabetes drug Farxiga was waved off by the FDA in Type 1 disease. But heres something that could ease the pain- New outcomes data showing Farxiga cut cardiovascular risks in heart failure patients with or without diabetes. In a phase 3 trial, Farxiga cut the risk of cardiovascular death or hospitalization in patients with reduced ejection fraction HFrEF, when added to standard treatments for heart failure. The data could help Farxiga score a CV risk-reduction approval, a distinction its rivals in the SGLT2 class already have. The trial, dubbed Dapa-HF, was the first to test an SGLT2 drug against heart failure in patients with or without Type 2 diabetes, the company said. It pitted Farxiga plus standard therapy against standard therapy alone. AstraZeneca plans to take the data to regulators "as soon as possible," Mene Pangalos, EVP of BioPharmaceuticals R&D, said in a statement.

Spotlight

Advanced medical devices and diagnostics improve health and quality of life, relieving pain and suffering, and helping people return to work and saving billions in healthcare costs.

Related News

Fixx Pharmaceuticals Wants to Dominate Hemophilia Market With Gene Editing

Prnewswire | August 28, 2020

Fixx Pharmaceuticals Inc. is pleased to announce the launch of its biotechnology business operations in Las Vegas, Nevada and San Francisco, California. The company is focused on developing a cure for Hemophilia through the use of CRISPR gene editing. There are currently 20,000 people in the U.S. who suffer from hemophilia and 400,000 globally. "We are looking to commercialize a product as soon as possible," says Jesse John Francis Clark, founder of Fixx. "We are going to develop a product that is more cost-effective for payers. We're looking to keep it under $2 million per patient," he said, saying that the overall cost of care of hemophilia patients will decrease. "If we are successful in developing a commercialized product, we are looking at upwards of $40 billion in sales from the U.S. market alone. I think our investors will be happy with that," says Clark.

Read More

PHARMACY MARKET

Narrativa Raises $1.3M to Help Pharma Companies Accelerate the FDA Drug Approval Process

Narrativa | May 19, 2021

Narrativa, which has developed an artificial intelligence (AI) medical writing platform to assist pharmaceutical firms in speeding up drug approval and lowering overall compliance costs, recently completed a $1.3 million funding round. The Los Angeles-based firm currently uses its SaaS platform to automate the production of Clinical Study Reports (CSRs) and other regulatory reports for several pharmaceutical firms and other clinical research organizations (CROs). The AI-writing assistant platform utilizes advanced Natural Language Generation (NLG) to process millions of data points from clinical trials and generate readable and understandable written medical narratives, improving accuracy and minimizing the time and expense of producing critical (and time-consuming) regulatory documents. "The pharma industry has evolved as a result of the availability and quality of data from clinical trials, with the most significant impact on drug discovery. To detect trends, test hypotheses, and understand the effectiveness of treatments, pharmaceutical firms have often focused on empirical data. It's time to put artificial intelligence to work assisting medical authors in the development of regulatory documents "Narrativa's founder and CEO, David Llorente, says. Pharmaceutical firms spend more than $1.5 billion on regulatory documentation, and it may take up to a year to complete the paperwork for FDA approval of a new drug. The amount of time taken on regulatory documentation significantly lengthens the time it takes for new drugs to reach the market. About Narrativa Narrativa was established in 2015 with the idea that technology should be used to positively transform the world. Narrativa, named one of the most important companies in the field of NLG by Samsung, helps companies expand by anticipating trends and converting data into the human language in real-time. Narrativa creates automated content in a variety of areas, including finance, pharmaceuticals, insurance, media, and gaming, using its artificial intelligence system and machine learning experience.

Read More

PHARMA TECH

Tranquilmoney Releases PharmTracker for Independent Pharmacies, Small and Medium Pharmacy Chains

Tranquilmoney | December 28, 2020

Tranquilmoney, Inc., an organization that oversaw drug store outsider case compromise for Costco Pharmacy for more than 20 years, has delivered an electronic adaptation of its product. Any drug store would now be able to join to PharmTrackerTM and begin utilizing the framework to handle their cases. Tranquilmoney has overseen over $1 billion per year in drug store receivables compromise with 100% compromise and 99.9% assortments. Industry guidelines of assortment are about 92.5%. Dr. Karun Philip, Chairman and CEO, says "Drug store claims are moderately little with a normal of $40 from the protection plans. More than 20 years, we built up a framework that consolidated Artificial Intelligence, enormous information stockrooms, and area specialists, that in blend permit us to coordinate each installment to its relating guarantee. Thusly, all non-installments are recognized, and an underpayment of even one penny is identified and can be rebilled." PharmTrackerTM can be utilized as a self-administration programming on the web or as a reevaluated administration. Utilizing Tranquiilmoney's framework will help a Pharmacy gather as much as 99.9% from protection, more than the business standard of about 92.5%. Tranquilmoney expenses start at 45 pennies for every case for at least 3000 cases for each month going down to 2 pennies a case for bigger volumes. Here is the finished value list.

Read More

Spotlight

Advanced medical devices and diagnostics improve health and quality of life, relieving pain and suffering, and helping people return to work and saving billions in healthcare costs.