Labcorp launches first FDA-cleared blood test for Alzheimer’s

Labcorp (NYSE:LH) announced Monday the nationwide availability of the Lumipulse pTau-217/Beta Amyloid 42 Ratio, the first blood-based test cleared by the U.S. Food and Drug Administration to aid in diagnosing Alzheimer’s disease.

The test, developed by Fujirebio Diagnostics, Inc., detects amyloid plaques associated with Alzheimer’s through a simple blood draw, offering a less invasive alternative to traditional diagnostic methods such as cerebrospinal fluid testing and PET scans.

According to clinical studies cited in the press release, the test demonstrated a positive predictive value of 92% and a negative predictive value of 97%.

"The path to an Alzheimer’s diagnosis has long meant a diagnostic journey requiring years of invasive procedures and expensive imaging," said Dr. Brian Caveney, chief medical and scientific officer at Labcorp.

The test is intended for adults aged 50 and older who show signs of cognitive decline in specialized care settings. It is not designed as a standalone diagnostic tool and must be interpreted alongside other clinical information.

This launch follows the recent release of new clinical guidelines from the Alzheimer’s Association supporting the use of blood-based biomarkers for evaluating patients suspected of having Alzheimer’s disease in specialty care settings.

Patients can access the test through a healthcare provider’s order and complete the blood draw at any of Labcorp’s more than 2,200 Patient Service Centers nationwide.

https://www.investing.com/news/company-news/labcorp-launches-first-fdacleared-blood-test-for-alzheimers-disease-93CH-4197375

Vanda touts 'landmark' win over FDA in years-long dispute over Hetlioz's jet lag disorder bid

 With a win in a D.C. appeals court, Vanda Pharmaceuticals has earned a point over the FDA in the years-long face-off between the drugmaker and the drug regulator.

Vanda has been fighting to market its sleep disorder med Hetlioz for jet lag disorder since 2019, when the FDA first rebuffed the bid with a complete response letter (CRL). The company unsuccessfully attempted to dispute the rejection and eventually took the FDA to court after the agency delayed requests for a hearing on the matter.

Under the Food, Drug and Cosmetic Act, the FDA must allow drug manufacturers an opportunity for a hearing within 180 days of a new drug application. In 2024, a D.C. court sided with Vanda, ruling that the FDA must resolve the drug application or hold a hearing, considering that the application had been pending for “almost 2,000 days” at the time with over 500 days since the company’s most recent hearing request.

Instead of a hearing, the FDA issued an order refusing to approve the jet lag indication. Vanda then brought the matter to the U.S. Court of Appeals for the D.C. Circuit., arguing that the FDA had disregarded the “voluminous factual evidence” Vanda had provided.

Now, the appeals court has agreed with Vanda in a “sweeping win” setting aside the FDA’s action, Vanda announced in a Monday release. The court determined that the FDA’s “treatment of Vanda's evidence is cursory” and that each of its trials of Hetlioz in jet lag disorder “showed statistically significant improvement on the primary endpoint measured."

The court decision throws the ball back in the FDA’s court, where Vanda expects the agency to approve the application or allow a hearing. The company “looks forward to further demonstrating that Hetlioz should be approved to treat jet lag disorder,” it said.

Vanda is no stranger to taking the FDA to court and has done so several times regarding both Hetlioz and other matters. With the latest win against the agency under its belt, the company suggests that other drug manufacturers can do the same.

“For too long, drug manufacturers failed to exercise their rights to lawful treatment by the FDA,” the company said in its release. “Vanda has demonstrated how courts can set aside illegal government actions that harm innovation and deprive Americans of important new therapeutics.”

To hear Vanda tell it, the decision “significantly alters the relationship between the FDA and the parties it regulates,” requiring the agency to “meaningfully engage” with evidence presented by drugmakers and not “shield its decisions via a plea for deference.”

Vanda is consistently outspoken about its gripes with the FDA, with the most recent feud outside of Hetlioz surrounding another CRL and subsequent hearing delay for its stomach disorder candidate tradipitant. The company slammed “FDA bureaucrats,” who, according to Vanda, have blamed the hearing delay on staffing cuts in the Center for Drug Evaluation and Research and presented “a new scapegoat” in new FDA Commissioner Marty Makary, M.D. The company sued the agency for the “unlawful delay” in April.

Hetlioz has been marketed for over a decade for non-24 hour sleep-wake disorder and won an expansion into nighttime sleep disorders associated with Smith-Magenis syndrome in 2020. 

https://www.fiercepharma.com/pharma/vanda-scores-landmark-win-over-fda-years-long-dispute-over-hetlioz-jet-lag-disorder-bid

Ultragenyx initiates rolling BLA submission for GSDIa gene therapy

 Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE), a $2.86 billion market cap biotech company whose shares have surged 8.4% in the past week, has begun a rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration for its DTX401 AAV gene therapy, the company announced Monday.

The therapy is being developed as a treatment for Glycogen Storage Disease Type Ia (GSDIa), a rare inherited condition that affects approximately 6,000 people in commercially accessible regions. Ultragenyx, which has demonstrated strong revenue growth of 26.77% over the last twelve months and maintains a healthy current ratio of 2.45, has submitted the non-clinical and clinical modules to the FDA and plans to complete the full BLA with the chemistry, manufacturing and controls module in the fourth quarter of 2025. 

"Initiating the BLA for DTX401 is an important milestone for this much needed treatment option for individuals and families affected by this disorder," said Eric Crombez, chief medical officer at Ultragenyx, in a press release statement. Wall Street appears optimistic about the company’s prospects, with analysts maintaining a bullish consensus recommendation of 1.38 out of 5 (where 1 is Strong Buy).

The BLA includes 96-week data from a randomized, placebo-controlled Phase 3 study showing patients had reductions in total daily cornstarch at their last visit compared to baseline in both the ongoing DTX401 group (-60%) and the Crossover Placebo to DTX401 group (-64%).

https://www.investing.com/news/company-news/ultragenyx-initiates-rolling-bla-submission-for-gsdia-gene-therapy-93CH-4197613

MSNBC to MS NOW: The official line

 Later this year, MSNBC will take on a new name: My Source News Opinion World (MS NOW).

This name further underscores our mission: to serve as your destination for breaking news and thoughtful analysis and remain the home for the perspectives that you’ve relied on for nearly 30 years.

For our viewers who have watched us for decades, it may be hard to imagine this network by any other name. We understand. But our promise to you remains as it always has. You know who we are, and what we do.

The same familiar and trusted hosts and journalists who make sense of what is happening in Washington, across the country, and around the world will still be here — whether that’s as you’re having a cup of coffee getting ready for the day ahead, seeking answers during breaking news moments, going deeper on the day’s headlines in the evenings, or discussing the week’s biggest stories on the weekends.

You might be wondering, why is this change happening? As part of our move to a new media company, VERSANT — which also includes CNBC, Golf Channel, GolfNow, and SportsEngine — we’ll no longer be part of NBCUniversal and NBC News. This gives us the freedom to chart our own path forward, and we’re excited about where it’s headed.

In fact, we’ve been growing. In the past few months, we’ve welcomed Pulitzer, Emmy, Murrow, and Peabody award-winning journalists into our newsroom, and have been recruiting for nearly 100 new roles. At a time when so many newsrooms are shrinking, we’re investing in more reporting, more coverage, and more ways to serve you.

Regardless of our name, our commitment to this community remains as strong as it’s ever been and in the months ahead we will unveil new ways to connect with you directly.

We will continue to cover the day’s news, ask the questions that matter most, and share how it impacts you, without fear or favor.

As Rachel often reminds us all … watch this space.

https://www.msnbc.com/news/msnbc-changing-name-ms-now-rcna225560

Chinese equities bought by hedge funds at the fastest pace in 7 weeks

 Hedge funds bought Chinese stocks (NYSEARCA:FXI), (NYSEARCA:KWEB), (NASDAQ:MCHI), (NYSEARCA:GXC) at the fastest pace since the end of June, according to Goldman Sachs’ Prime Brokerage.

The equity buys were driven long buys, and to a lesser extent short covers, at a ratio of 1.9 to 1, Goldman Sachs’ Prime analysts said.

In addition, single stocks and macro products – investments based on macroeconomic trends and events, such as inflation, GDP, geopolitical issues, and fiscal policy – were both net bought, making up 58% and 42% of the total notional net buying, respectively.

“China (NYSEARCA:FXI), (NYSEARCA:KWEB), (NASDAQ:MCHI), (NYSEARCA:GXC) is now the most net bought market on our Prime book so far in August,” analyst said.

Goldman’s Prime book is now over-weight China vs. the MSCI World Index (ACWI) by +4.9%, ranking in the 41^st percentile vs. last year, and in the 16^th percentile vs. five years ago.

Also, within the Prime Book, Chinese equities (FXI), (KWEB), (MCHI), (GXC) make up 5.8% of its gross exposure and 7.3% of its net exposure, ranking in the 94^th and 45^th percentiles vs. last year and in the 48^th and 21^st percentiles vs. five years ago.

Prime Brokerage services exclusively to hedge funds and other institutional investors.

https://www.msn.com/en-us/money/markets/chinese-equities-bought-by-hedge-funds-at-the-fastest-pace-in-7-weeks/ar-AA1KJPud

'Just Being Ghosted’: Canada’s Youth Face Deepening Job Crisis

 

Sheena Ngigi, age 24, assumed her biochemistry degree from the University of Alberta would mean a relatively easy path to a job. Mathias Ashaba, also 24, wanted to leverage his business degree after immigrating from Uganda last year.

Both have applied to dozens of jobs they should be qualified for. And, at every turn, they say they've been rebuffed — if they even hear anything at all. Ngigi has pivoted to applying for receptionist and restaurant gigs in the meantime, though still without any luck, while after almost a year of trying, Ashaba managed to find work as a janitor at a public school.

https://www.bloomberg.com/news/articles/2025-08-18/canada-s-youth-job-market-hits-lowest-point-in-a-generation

Tonix Wins Approval For First New Fibromyalgia Drug in Over 15 Years

 

In Phase III studies, Tonmya showed significantly superior analgesic effects in patients with fibromyalgia versus placebo. The sublingual pill also led to better clinical outcomes.

After more than a decade of waiting for a new therapy, patients with fibromyalgia will now have access to an oral pill in the form of Tonix Pharmaceuticals’ Tonmya, which the FDA signed off on this past Friday.

Given sublingually—under the tongue—before sleep, Tonmya is a non-opioid analgesic designed to be quickly absorbed into the bloodstream. The New Jersey biotech expects to launch Tonmya in the U.S. in the fourth quarter of this year, addressing a market of approximately 10 million patients, according to its Friday release. Common fibromyalgia symptoms include chronic widespread pain and poor sleep.

Two double-blinded, randomized and placebo-controlled Phase III studies supported Tonmya’s approval, providing evidence of efficacy across nearly 1,000 patients. A readout in April showed that the pill significantly lowered pain and improved clinical outcomes in patients with fibromyalgia versus placebo.

Common side-effects, established from three late-stage studies, included mouth numbness, oral discomfort, drowsiness, fatigue, mouth pain and canker sores.

Tonmya’s approval is a “landmark advancement” for patients with fibromyalgia, Tonix CEO Seth Lederman said in a prepared statement on Friday, noting that these patients often suffer from the “debilitating pain” that comes with the disease. “We are hopeful that effectively treating pain with Tonmya could help improve the lives of people with this chronic condition.”

Tonix’s regulatory win for Tonmya comes as a pain powerhouse stumbles. Earlier this month, Vertex Pharmaceuticals announced that its next-generation pain medicine VX-993, an investigational NaV1.8 blocker, was unable to significantly ease pain after bunionectomy—a surgical procedure involving the big toe. The failure pushed Vertex to abandon its acute pain program for VX-993.

Vertex’s Journavx, also an ion channel blocker, in January became the first acute new pain medicine in more than 20 years—and opened up a new non-opioid analgesic pathway for moderate to severe acute pain. Journavx has already emerged as one of Vertex’s top-performing assets. In the second quarter, it brought in $12 million, which, while a relatively small contribution to the company’s $2.96-billion topline, represents a 79% beat to the analyst consensus.

https://www.biospace.com/fda/tonix-wins-approval-for-first-new-fibromyalgia-drug-in-over-15-years