5 Components of a Patient-Centric eCOA Strategy for Oncology Clinical Trials

5 Components of a Patient-Centric eCOA Strategy for Oncology Clinical Trials

Melissa Mooney, Director of eCOA Solutions Engineering at IQVIAIn the US alone, an estimated 1.9 million new cases of cancer were diagnosed in 2022, positioning oncology as a key subject of clinical research. Throughout oncology trial development, it is important that stakeholders acknowledge that only patients can fully understand the impact of treatment on their lives. Regulators are now looking beyond clinical indications such as tumor size and delayed disease progression. When evaluating the risks and benefits of treatment, they want to know whether the side effects are tolerable for patients and how these treatments could be improved from the patient’s…

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Apellis Drug Becomes First Approved Therapy for Vision-Loss Disorder Geographic Atrophy

Apellis Drug Becomes First Approved Therapy for Vision-Loss Disorder Geographic Atrophy

Geographic atrophy, an eye disorder that starts as a loss of central vision and progressively worsens to total blindness, now has its first treatment. The FDA on Friday approved an Apellis Pharmaceuticals drug that slows the progression of this disease, which affects more than 1 million people in the U.S.
Approval of the Apellis drug, pegcetacoplan, covers all patients with geographic atrophy, a broad label that reflects the representative patient population tested in pivotal studies, Chief Medical Officer Caroline Baumal said during a Friday evening conference call. The Waltham, Massachusetts-based company plans to launch the drug in March, marketing the product under…

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Chiesi Wins FDA Approval for First Drug to Treat Ultra-Rare Enzyme Deficiency

Chiesi Wins FDA Approval for First Drug to Treat Ultra-Rare Enzyme Deficiency

A Chiesi Farmaceutici drug for a rare enzyme deficiency is now approved by the FDA, making it the first U.S. treatment for a disorder that leads to a range of cognitive and muscle problems.
The regulatory decision announced late Thursday covers the treatment of children and adults who have alpha-mannosidosis (AM), a disease caused by a genetic mutation that leads to defective or inactive forms of an enzyme called alpha-D-mannosidase. Chiesi’s drug, velmanase alfa, is an engineered version of that enzyme. The privately held Italian company will market its new FDA-approved drug as Lamzede, the same name for the product in Europe,…

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Health Transformation Alliance Teams up With Cognoa for Autism Diagnostic Device

Health Transformation Alliance Teams up With Cognoa for Autism Diagnostic Device

The Health Transformation Alliance (HTA), a group of nearly 60 large employers, announced Thursday it is partnering with pediatric behavioral health company Cognoa for its diagnostic device for autism.
HTA is a cooperative of self-insured employers, including Walgreens, CocaCola, Verizon and American Express. Palo Alto, California-based Cognoa, meanwhile, is a developer of AI-based technologies for early diagnosis of children with developmental and behavioral health conditions. Its Canvas Dx product is authorized by the Food and Drug Administration and assists healthcare providers in diagnosing autism spectrum disorder for children ages 18 months through 72 months. The product is the first of its sort…

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Medication risk analysis company MDI Health raises $20M

Medication risk analysis company MDI Health raises $20M

Healthcare analytics company MDI Health scored $20 million in Series A funding, bringing the company’s total funding to $26 million.Intel Capital led the round, with participation from Maverick Ventures Israel, alongside existing investors Fresh.Fund, Arc Impact, Hanaco Ventures, Jumpspeed Ventures, former Optum senior vice president Richard Montwill, Welltech Ventures and Basad Ventures.
Yoni Greifman, Intel Capital’s investment director, will join MDI’s board of directors.
WHAT IT DOES
Israel-based MDI offers an AI-enabled tool that provides medication risk analysis based on a patient’s medical records with the aim of preventing adverse drug reactions.
The funds will help the company scale its U.S. and Israeli research and…

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HTA to Offer Cognoa’s Canvas Dx Diagnostic Device for Autism to Member Organizations

HTA to Offer Cognoa’s Canvas Dx Diagnostic Device for Autism to Member Organizations

What You Should Know:– Health Transformation Alliance (HTA), a cooperative of nearly 60 of America’s largest employers, has partnered with Cognoa, a pediatric behavioral health company, to offer the company’s Canvas Dx diagnostic device for autism to all HTA Member organizations and their employees.– HTA will offer its member organizations – some of the most influential and significant brands in the U.S. – the opportunity to add Canvas Dx to their benefit design.Expanding Horizons By Increasing Accessibility To Child Health ServicesThis partnership comes at an ideal time when the pandemic has exacerbated long-standing gaps in pediatric behavioral and developmental healthcare. As…

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How to Leverage Diagnostic Development to Guard Against RSV, Flu and Covid-19 [Sponsored]

How to Leverage Diagnostic Development to Guard Against RSV, Flu and Covid-19 [Sponsored]

For the first two years of the Covid-19 pandemic, healthcare professionals focused on understanding the Covid-19 virus, how best to guard against it, and developing tests to detect it. They also tracked, aggregated, and analyzed health data to assess and monitor the public health threat on a regional, state and country-wide level. In the longer term, vaccine development and distribution were used to slow the spread to avoid a collapse of the health system and to reduce the potency of the virus for the majority of people.
More recently, attention has shifted to the long perceived threat of viruses coming together with…

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Heartpoint Global Hopes To Disrupt Congenital Pulmonary Hypertension Treatment With Minimally Invasive Device

Heartpoint Global Hopes To Disrupt Congenital Pulmonary Hypertension Treatment With Minimally Invasive Device

To correct high blood pressure of the pulmonary artery, which can arise from congenital defects of the heart, an artificial heart ucan cost upwards of $190,000. Heart disease accounted for about one in five deaths in 2020 in theUnited States.
Even minimally invasive pulmonary artery banding — a surgical technique that has been in use since Harry Truman was president — requires access to the chest cavity. A new treatment under development by HeartPoint Global seeks to provide a minimally invasive alternative to current treatments for pulmonary arterial hypertension associated with Congenital Heart Disease.A device delivered through the leg would cost only…

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