Business

FDA panel urges rejection of experimental Alzheimer’s drug

Published

6 years ago

November 9, 2020

WASHINGTON (AP) — Government health advisers sharply criticized a closely watched Alzheimer’s drug on Friday, concluding there wasn’t enough evidence that the experimental drug slowed the brain-destroying disease.

The panel of outside experts for the Food and Drug Administration agreed that a pivotal study in patients failed to show “strong evidence” that the drug worked. The experts warned of multiple “red flags” with the data, which did not initially show any benefit until another analysis with later results.

Friday’s meeting follows months of skepticism about the drug, developed by Cambridge, Massachusetts-based Biogen Inc. and Japan’s Eisai Co.

“Alzheimer’s treatment is a huge, urgent, unmet need,” said panelist Dr. Joel Perlmutter, of Washington University School of Medicine. “But if we approve something with data that is not strong we have the risk of delaying good, effective treatments.”

He was one of eight panelists who voted against the drug’s evidence; one voted that the drug showed “strong evidence” and two members said they were undecided. The panel also rejected the merits of a second study of the drug.

The FDA is not required to follow the group’s guidance but their negative opinion could weigh heavily on the agency’s decision on whether to greenlight the drug. The FDA is expected to make a decision by March.

The Biogen drug, known as aducanumab, does not cure or reverse Alzheimer’s; the claim is that it modestly slows the rate of decline. Current drugs only temporarily ease symptoms and no new options have emerged since 2003.

Much of panel’s commentary was a rejection of the FDA’s viewpoint. Earlier in the day, the FDA’s chief staff reviewer gave a glowing review of the drug, calling study data submitted by Biogen “exceptionally persuasive,” “strongly positive” and “robust.” But an FDA statistician noted flaws and inconsistencies in the results and potential safety issues.

″“It feels like the audio and video on TV are out of sync,” said panel member Dr. Caleb Alexander of Johns Hopkins University.

The drugmakers halted two studies of their drug last year after disappointing results. But several months later the companies reversed course, announcing that a new analysis showed the drug was effective at a higher dose and that the FDA advised that it might warrant approval.

More than 5 million people in the United States and many more worldwide have Alzheimer’s, the most common form of dementia.

The drug is expected to be very expensive and “could bankrupt our health care system” while giving patients false hope, the consumer group Public Citizen warned in comments ahead of the meeting.

The FDA evaluation focuses on safety and effectiveness. But advocates for approval, including the Alzheimer’s Association, are pushing to make need part of the decision.

ABOUT THE DRUG

Aducanumab (pronounced “add-yoo-CAN-yoo-mab”) aims to help clear harmful clumps of a protein called beta-amyloid from the brain. Other experimental drugs have done that but it made no difference in patients’ ability to think, care for themselves or live independently.

It’s a biotech medicine made from living cells, and such drugs are very expensive. No price estimate has been announced for the drug, which is given through an IV once a month.

If aducanumab is approved, it’s expected to be covered by Medicare, the government plan for seniors. The FDA and Medicare are barred from considering cost when reviewing a new drug or treatment.

Even qualifying for the drug could be expensive. It’s only been tested in people with mild dementia from Alzheimer’s or a less severe condition called mild cognitive impairment. To verify a diagnosis has required brain scans that cost $5,000 or more. Insurers including Medicare don’t cover the scans because their benefits are unclear, but that could change if a scan becomes a gateway to treatment.

THE EVIDENCE

Historically, the FDA often required two studies showing safety and effectiveness, but in recent years has relaxed that standard.

Each of the two aducanumab studies enrolled about 1,650 people and were stopped roughly halfway through when it seemed the drug wasn’t working. Biogen says that later results show one study was positive at the highest dose; the second study was clearly negative. The company says an analysis from both studies on people who got the highest dose for the longest time shows benefit.

But there are many questions about the validity of such analyses. Another complication: the studies were changed after they were underway to let some people get a higher dose. And the placebo group in the positive study worsened more than the one in the negative study did, which could help explain why aducanumab appeared better by comparison in that one.

The FDA review largely dismissed safety concerns, including swelling in the brain that occurred in as many as one-third of patients, often leading to discontinuation of the drug.

The FDA should require a third study to test the drug in ideal conditions and get a clear answer, said the Mayo Clinic’s Dr. David Knopman, in an interview ahead of the meeting. He’s on the FDA advisory panel but didn’t participate in Friday’s meeting because he helped lead one study. He and other doctors published a journal report earlier this week arguing against approval.

WHAT IT WOULD MEAN FOR PATIENTS

Nearly a dozen Alzheimer’s patients, family members and doctors urged approval of the drug during a public comment period of the online meeting, saying the move would provide hope to patients and spur development of additional therapies.

But any benefit from the drug “is relatively small,” said Dr. Eliezer Masliah, neuroscience chief at the U.S. National Institute on Aging, commenting before the meeting.

In the positive study, the drug modestly slowed the rate of mental decline — a difference of only 0.39 on an 18-point score of thinking skills. How much that means in terms of being able to live independently, recognize family members or remember things is unclear.

Drugs that remove amyloid may have to be combined with medicines that do other things in the brain, and used early enough before damage occurs, to do much good, Masliah said.

If the drug is approved, the American Academy of Neurology urged the FDA to not make it a broad authorization, which could expose many patients to a medicine that might harm rather than help, and could “overwhelm the health care system.”

Business

GOAA Highlights Airport Improvements, Approves New Small Business Policies

Published

4 days ago

October 22, 2026

FNN NEWS

Gate Link train on an elevated guideway at Orlando International Airport, with palm trees, airport buildings and a control tower behind it.

A Gate Link train travels along an elevated guideway at Orlando International Airport, with the airport’s control tower in the background. Photo courtesy of the Greater Orlando Aviation Authority.

Terminal upgrades, parking projects and international connections mark the authority’s fiscal year review.

ORLANDO, Fla. (FNN) — The Greater Orlando Aviation Authority highlighted terminal improvements, expanded international connections and parking projects during its fiscal 2026 review, while its board adopted changes to a local business program and announced a new statewide small business initiative.

The updates affect Orlando International Airport and Orlando Executive Airport, which GOAA operates.

“We are undertaking an ambitious effort to redefine what it means to deliver a world-class airport experience,” GOAA CEO Lance Lyttle said in the authority’s announcement.
“As we welcome more visitors, more airlines, more routes, and new programs, our responsibility is to elevate every part of the journey — making it more welcoming, intuitive, and connected.”

A Gate Link train travels along an elevated guideway at Orlando International Airport, with the airport’s control tower in the background. Photo courtesy of the Greater Orlando Aviation Authority.

Terminal Improvements Focus on Connections and Families

Among the completed projects was an enclosed pedestrian bridge with moving walkways connecting Orlando International Airport’s train station and Terminal C.

Terminal C also opened a new wing serving gates 250–254, providing additional capacity and becoming the new home for Virgin Atlantic’s airport operations.

Three new Family Zones — one in each terminal — offer spaces for children and families to play, read and recharge. GOAA also highlighted improvements to directional signs along airport roads, in parking areas and throughout the terminals.

Parking Expansion and $40 Million Improvement Program

GOAA reported progress on a parking guidance system at Terminal C, with phased activation across all garages planned through mid-2027.

Dedicated employee parking areas are intended to free additional spaces for travelers. Planning is also underway for two new garages expected to add 8,000 public parking spaces over the next few years.

Separately, the authority’s $40 million Beautiful Airports Program targets safety, functionality and appearance across garages, terminals and other airport areas.

Aviation Investments and International Service

The fiscal year review highlighted a $50 million investment by dnata, a $26 million redevelopment by Signature Aviation at Orlando International Airport and groundbreaking for Sky Harbour’s $40 million campus at Orlando Executive Airport.

International service developments included ZIPAIR’s nonstop passenger charter flights between Orlando and Tokyo and Iberia’s launch of nonstop service to Madrid.

GOAA described ZIPAIR’s service as the first passenger charter connection between Florida and the Asia-Pacific region.

Business Policy Changes Broaden Eligibility

The board adopted revisions to GOAA’s Local Developing Business program following research, town halls and discussions with internal experts.

The changes increase the allowable personal net worth threshold and clarify how assets are excluded from that calculation, including primary residence equity, business equity, retirement assets and certain nonliquid holdings.

Business size standards were also revised to account for inflation and increased operating costs. The announcement did not specify the updated financial thresholds.

A new Small Business program will complement the local program and extend eligibility to qualifying businesses throughout Florida. Under the announced framework, participating businesses must fall within 50% of the applicable U.S. Small Business Administration size standard.

GOAA said detailed guidelines for both programs would be posted on its website. Those guidelines will provide businesses with the information needed to assess eligibility.

Business

Dallas Mayor Eric Johnson Listed as Speaker for Global AI, Supply Chain Summit

Published

2 weeks ago

October 9, 2026

FNN NEWS

Organizers say the Oct. 26–27 conference will bring together business leaders, policymakers and technology professionals for discussions on global commerce, digital transformation and industry innovation.

DALLAS, TX (FNN) — Dallas Mayor Eric L. Johnson is listed as an invited speaker for the Global Procurement, Supply Chain, AI & Logistics Summit and Global Recognition Awards 2026, scheduled for Oct. 26–27 in Dallas, according to an announcement from the event’s organizer.

The American Association of Procurement, Supply Chain and Tourism Management, known as AAPSCM, said the two-day summit will take place at the AC Hotel & Residence Inn Dallas by the Galleria, 5460 James Temple Drive.

The conference will focus on artificial intelligence, supply chain resilience, innovation and the future of global commerce.

Mayor listed among international speakers

Organizers identified Johnson among the invited speakers joining executives, policymakers, academics, consultants and professionals in procurement, supply chain management, technology and logistics.

The announcement describes participants as coming “from the United States and around the world.”

According to the release, Johnson is listed among speakers participating in the Oct. 27 program. The announcement does not specify the subject or time of his remarks.

AI, forecasting and digital transformation

The second day’s agenda includes a session on artificial intelligence and machine learning in inventory management, forecasting, and sales and operations planning.

An executive leadership session titled “Driving Innovation & Digital Transformation” is scheduled to follow.

The program will examine technology’s role in procurement, logistics and supply chain operations, with an emphasis on how leaders respond to changing business conditions.

Awards to recognize industry achievement

The summit will also include procurement and supply chain awards, followed by Global Excellence Awards recognizing individuals, organizations and industry leaders.

Organizers said the awards program includes more than 35 categories spanning procurement, supply chain management, artificial intelligence and logistics.

The announcement describes the awards as recognizing “achievement, innovation and leadership.”

Executives and decision-makers expected

AAPSCM said it expects attendees to include chief executives, chief procurement officers, chief supply chain officers, chief operating officers and technology leaders.

The anticipated audience also includes procurement directors, logistics professionals, government representatives and specialists in AI and digital transformation.

About the organizer

AAPSCM describes itself as a U.S.-based nonprofit professional organization that supports professional development through certification, education, training, membership, conferences and international collaboration.

Event and registration information

Event: 2nd Global Procurement, Supply Chain, AI & Logistics Summit & Global Recognition Awards 2026
Dates: Oct. 26–27, 2026
Venue: AC Hotel & Residence Inn Dallas by the Galleria
Address: 5460 James Temple Drive, Dallas, Texas 75240
Organizer: American Association of Procurement, Supply Chain and Tourism Management
Registration: aapscm-conferences.org
Organization: aapscm.org

Business

Hola at the Park Set for Oct. 3 in Altamonte Springs; Admission Free

Published

4 weeks ago

October 1, 2026

FNN NEWS

Florida National News and FNN News en Español will provide on-site coverage of the Hispanic Heritage Month celebration at Cranes Roost Park.

ALTAMONTE SPRINGS, Fla. (FNN) — Hola at the Park will bring Hispanic culture, local businesses and live entertainment to Cranes Roost Park on Saturday, Oct. 3, from 2 to 6 p.m.

Hosted by the Hispanic Chamber of Metro Orlando and presented by AdventHealth, the event celebrates National Hispanic Heritage Month through food, entertainment, entrepreneurship and community connections.

According to the chamber’s event announcement, admission is free, the celebration is open to the community and no registration is required.

FNN to Spotlight Businesses and Community Voices

Florida National News and FNN News en Español, official media sponsors, will be on location covering the festivities.

The FNN team will spotlight chamber representatives, sponsors, participating businesses and community leaders, while sharing attendees’ perspectives throughout the afternoon.

Coverage will highlight the people, businesses and cultural traditions contributing to the celebration.

Photo: Florida National News

Food, Entertainment and Family Activities

The chamber’s announcement lists authentic cuisine, live entertainment, local businesses, wellness experiences, community resources, networking and family-friendly activities among the event’s offerings.

Attendees will have opportunities to explore Hispanic traditions, connect with entrepreneurs and learn about organizations serving Central Florida.

Photo: Florida National News

A Waterfront Setting in Uptown Altamonte

Cranes Roost Park, located in Uptown Altamonte, features a waterfront setting with scenic walkways around Cranes Roost Lake and the Eddie Rose Amphitheater and floating stage.

The park will serve as the gathering place for an afternoon celebrating Hispanic heritage and the connections between culture, business and community.