Category: MedCity News

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

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

MedCity News

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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PBMs Come Under Fire During Senate Hearing

PBMs Come Under Fire During Senate Hearing

MedCity News

Pharmacy Benefit Managers (PBMs) took a hit from lawmakers during a Thursday hearing held by the Senate Commerce Committee, with some questioning why the drug middlemen are even necessary.
“The way I see the situation on PBMs, I don’t know why the hell they even exist,” said Sen. Jon Tester, D-Montana. “They were set up with all the right reasons … But what I see them doing in my state, I don’t think the consumer gets much benefit and they’re shutting down small businesses on main street right and left and those are called our local neighborhood pharmacies.” The hearing discussed how…

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Decline of Telehealth During the Pandemic and After

Decline of Telehealth During the Pandemic and After

MedCity News

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…

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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

MedCity News

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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The Adderall Shortage

The Adderall Shortage

MedCity News

The current Adderall shortage is of serious concern to both patients who have attention deficit hyperactivity disorder (ADHD) and clinicians. This shortage cannot be quickly alleviated by a simple increase in the amount of medication manufactured, unless the upper limit to the amount of Adderall’s active ingredient that can be manufactured in a given year is raised by the Drug Enforcement Agency (DEA). The limit has been imposed because the active ingredient can be abused as a recreational drug. It is necessary to control the supply of any medication with abuse liability, but this must be achieved without compromising the legitimate…

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Is Interoperability Tech Worth the Investment? Experts Say Yes for 3 Reasons

Is Interoperability Tech Worth the Investment? Experts Say Yes for 3 Reasons

MedCity News

Editor’s note: This story is based on discussions at Abarca Forward, a conference in San Juan, Puerto Rico, hosted by Abarca, a pharmacy benefit manager. MedCity News’ Editor-in-Chief Arundhati Parmar and Senior Reporter Katie Adams were invited to attend and speak at the conference. All travel and related expenses for the team were covered by Abarca. However, company officials had no input in editorial coverage. 
In order for the U.S. healthcare system to operate smoothly, various stakeholders must cooperate with one another and share data seamlessly. But this notion is far from being achieved — the industry is still seriously plagued by…

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

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

MedCity News

‘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…

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Moderna Flu Vax Prompts Response to More Common Strains, But Misses in Influenza B

Moderna Flu Vax Prompts Response to More Common Strains, But Misses in Influenza B

MedCity News

A Moderna messenger RNA vaccine for influenza now has preliminary data from a pivotal study showing the shot prompted a strong immune response to the more common strains of the virus but fell short against less common strains.
The results reported Thursday are from one of two pivotal studies for the Moderna vaccine, mRNA-1010, which is assessing the shot for safety and immune response. A separate Phase 3 study is evaluating the shot for efficacy. Results from that study could come as early as next month. Moderna’s vaccine encodes hemagglutinin, a protein on the surface of the influenza virus that is also…

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Talkspace Launches New Mental Health Portal for Employers

Talkspace Launches New Mental Health Portal for Employers

MedCity News

Virtual behavioral health provider Talkspace unveiled a new product Thursday that provides employers with access to a library of mental health resources that they can share with employees.
New York City-based Talkspace serves employers, payers and consumers, and provides self-guided mental health programs, therapy and psychiatry. Its new product, Talkspace Engage, aims to help employers promote their mental health benefits to their employees, a challenge that many companies struggle with, said Erin Boyd, chief growth officer of enterprise at Talkspace. “One resounding common theme that we heard among [employers] was that, ‘I don’t know how to get people to use these benefits…

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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

MedCity News

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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