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…

Continue Reading
Decline of Telehealth During the Pandemic and After

Decline of Telehealth During the Pandemic and After

The pandemic has forced healthcare organizations to rely heavily on telehealth services. In 2020, virtual visits accounted for more than a quarter of all outpatient visits in the U.S., and they’ve been steadily increasing since then. But there is a flip side to this trend. Recent data shows that telehealth is declining in healthcare, which could create a burden for both healthcare systems and patients. Let’s take a look at why this is happening and what can be done about it.
Reasons behind the decline  There are several factors driving the decline in telehealth utilization in healthcare settings. One reason is cost…

Continue Reading
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,…

Continue Reading
Community Health Systems reports GoAnywhere hacked

Community Health Systems reports GoAnywhere hacked

Community Health Systems filed with the Securities and Exchange Commission that it was notified by a third-party vendor for secure file transfer of an incident that resulted in unauthorized disclosure of its patient data.WHY IT MATTERS
The GoAnywhere managed file transfer platform first warned about a zero-day remote code injection exploit on February 1, according to the technical bulletin posted by noted security researcher Brian Krebs on Infosec.exchange. 
“The attack vector of this exploit requires access to the administrative console of the application, which in most cases is accessible only from within a private company network, through [virtual private network] or by allow-listed IP…

Continue Reading
DrFirst Acquires Diagnotes Secure Messaging and Care Coordination Platform

DrFirst Acquires Diagnotes Secure Messaging and Care Coordination Platform

Expands Backline by DrFirst’s Capabilities for Clinical Communications in Health Systems and Beyond
Healthcare technology pioneer DrFirst today announced it has acquired select assets of Indianapolis-based Diagnotes. The acquisition will allow Backline by DrFirst to expand its capabilities to break through communication silos in healthcare at each stage of the patient care journey, promote positive patient outcomes, and enhance satisfaction for staff and patients.
Diagnotes provides a suite of team-based, patient-centered collaboration tools built specifically for the healthcare sector. The app increases clinicians’ productivity and the quality of patient care by allowing healthcare providers to communicate with colleagues in their system and affiliates in other systems. The…

Continue Reading
Roundup: First insomnia DTx in South Korea gets regulatory nod and more briefs

Roundup: First insomnia DTx in South Korea gets regulatory nod and more briefs

South Korea clears first local insomnia DTx The South Korean Ministry of Food and Drug Safety has given its first market approval for a digital therapeutic device for treating insomnia, according to a news report.
The mobile-based medical device-as-a-software called Somzz by Aimmed delivers a CBT programme that helps increase sleep duration.
India OKs health monitoring smartwatch CardiacSense
Xplore Health, a medical tech company in India, has received approval from the Indian Regulatory Authority for a wearable health monitoring device it carries.
The company is the distributor of the medical smartwatch product of Israeli medical device developer CardiacSense.
Based on a news report, the smartwatch enables continuous monitoring of vital…

Continue Reading
How to Rein in Unpredictability During High-Traffic Respiratory Illness Season

How to Rein in Unpredictability During High-Traffic Respiratory Illness Season

‘Tripledemic’ concerns have been on the rise with the collision of flu, Covid-19, and respiratory syncytial virus (RSV) wreaking havoc in clinics and hospitals. Yet staff are expected to provide smooth, fast, and effective care journeys for all, no matter the volume of patients. We know, however, that everything doesn’t always go as planned when patient traffic explodes. Bottlenecks like long wait times and limited appointment options inevitably skyrocket, and staff bear the brunt of patients who (understandably) want to be seen immediately, in conjunction with staff members intermittently being out sick themselves.
Living in an environment of extreme health unpredictability affects…

Continue Reading
Retail disruptors face big strategy questions in 2023, says AHA

Retail disruptors face big strategy questions in 2023, says AHA

A new report from the American Hospital Association Center for Health Innovation explores how retail companies and tech giants like Apple and Google will drive transformational change in healthcare delivery in 2023 and beyond.WHY IT MATTERS
With billions of dollars invested this past year, such as CVS Health’s purchase of Signify Health, the AHA report highlights retail healthcare companies having grabbed significant market share in primary care, concierge medicine, virtual care and in-home medical services. 
They’ve also broadened their reach into pharmacy benefits management, behavioral health and other areas, said AHA researchers in the report.
One example is Amazon. While the company is in the process of buying…

Continue Reading
Blood Biotech Grifols Cuts Deep in the U.S. to Find €400M in Savings

Blood Biotech Grifols Cuts Deep in the U.S. to Find €400M in Savings

Grifols, a company that turns blood plasma into therapies for immunological disorders and other conditions, is laying off about 2,000 U.S. workers as part of a corporate restructuring projected to yield up to €400 million in annual cost savings, the biotech announced Wednesday.
The layoffs represent about 8% of the Barcelona-based company’s global workforce, but they will happen mainly in its U.S. plasma operations. That’s notable because as a company that relies on plasma, the U.S. is vital to its business. The starting point for Grifols’s therapies is blood plasma. Key to its drug-making process is fractionation, in which the protein components…

Continue Reading