Health News Roundup: US FDA extends review of Ascendis Pharma's hormone disorder therapy; CDC makes public influenza A wastewater data to assist bird flu probe and more

The group also lowered its full-year earnings outlook, citing negative currency effects, but retained its operating forecast. US relaxes regulations for labs handling bird flu samples to ease virus response U.S. government officials have temporarily relaxed strict guidelines on how public health laboratories and healthcare facilities handle, store and transport H5N1 bird flu samples, which are considered high-risk pathogens, in response to the recent spread of the virus to dairy cattle.

Following is a summary of current health news briefs.

Bayer's first-quarter adjusted profit falls less than expected

Bayer beat first-quarter analyst forecasts as it reported a slight drop in adjusted earnings on Tuesday, providing a respite for the CEO's turnaround efforts. The group also lowered its full-year earnings outlook, citing negative currency effects, but retained its operating forecast.

US relaxes regulations for labs handling bird flu samples to ease virus response

U.S. government officials have temporarily relaxed strict guidelines on how public health laboratories and healthcare facilities handle, store and transport H5N1 bird flu samples, which are considered high-risk pathogens, in response to the recent spread of the virus to dairy cattle. The revised guidance, which has not been previously reported, came at the request of the Association of Public Health Laboratories (APHL), which represents state and local labs that monitor and detect public health threats, according to interviews and correspondence seen by Reuters.

US FDA declines expanded use of Dynavax's hepatitis B vaccine on insufficient data

The U.S. drug regulator has declined to approve expanded use of Dynavax Technologies' hepatitis B vaccine in a section of patients, citing insufficient data over destruction of some trial documents, the company said on Tuesday. The Food and Drug Administration in its so-called "complete response letter" stated that the data it had was insufficient owing to destruction of data source documents by the third-party clinical trial site operator for about half of the subjects enrolled in the trial, according to the company.

Wegovy users keep weight off for four years, Novo Nordisk study says

Patients taking Novo Nordisk's Wegovy obesity treatment maintained an average of 10% weight loss after four years, potentially boosting the drugmaker's case to insurers and governments to cover the cost of the effective but expensive drug. The Danish drugmaker presented the new long-term data on Tuesday at the European Congress on Obesity in Venice, Italy, in a new analysis from a large study for which substantial results had been published last year.

Merck stops testing combo drug for skin cancer as more patients discontinue

Merck said on Monday it had discontinued an experimental combination treatment testing a new type of immunotherapy in patients with a severe form of skin cancer after side effects led to high discontinuation. This is the latest setback for the experimental drug, vibostolimab, and the related promising new class of immunotherapies called anti-TIGIT.

US FDA extends review of Ascendis Pharma's hormone disorder therapy

The U.S. Food & Drug Administration has extended its review of Ascendis Pharma's therapy to treat adult patients with a hormone disorder by three months, the company said on Tuesday.

U.S.-listed shares of the company were down 6.6% in late afternoon trading.

CDC makes public influenza A wastewater data to assist bird flu probe

The U.S. Centers for Disease Control and Prevention (CDC) on Tuesday released data on influenza A found in wastewater in a public dashboard that could assist in tracking the outbreak of H5N1 bird flu that has infected cattle herds. Last week, an agency official told Reuters about U.S plans to make public data collected by its surveillance system.

Japan's Shionogi says COVID treatment did not meet endpoint in late-stage trial

Japan's Shionogi & Co said on Monday its pill-based treatment for COVID-19 did not meet the primary endpoint of showing a statistically significant reduction of 15 common symptoms of the illness in a global, late-stage trial. The company's pivotal Phase 3 study (SCORPIO-HR) of ensitrelvir did however demonstrate a potent antiviral effect compared to placebo, the company said.

Denmark faces Wegovy shortage due to rising demand

Denmark faces a supply shortage for two doses of Novo Nordisk's Wegovy weight-loss drug in the coming months due to rising demand, the Danish Medicines Agency said on Monday. The hugely popular Wegovy is given by weekly injection and belongs to a class of drugs known as GLP-1 agonists originally developed to treat type 2 diabetes.

US reclassification could drive fresh research funding into pot sector

The U.S. pot sector could see an influx of medical research funding from healthcare investors amid renewed interest from pharmaceutical firms, should a proposal to reclassify cannabis as a lower-risk substance be approved, industry experts said. The current classification as a Schedule I substance has limited research into cannabis due to restricted access to cannabis products, regulatory hurdles and funding limitations.

(With inputs from agencies.)