Miss a day, miss a lot. Subscribe to The Defender's Top News of the Day. It's free.

EU Backs Use of Novo Nordisk’s Weight Loss Drug in Adolescents

Reuters reported:

The European Medicines Agency said on Friday its committee has recommended expanding the use of Danish drugmaker Novo Nordisk’s (NOVOb.CO) weight loss drug in adolescents aged 12 years and older.

Novo’s Wegovy, a semaglutide-based drug, activates GLP-1, a hormone that triggers the feeling of fullness in the body after eating. It has been approved in the U.S. and European Union for the treatment of obesity in adults.

The company did not indicate a timeline for its plans to launch the drug, already available in Denmark and Norway, in other EU countries.

Earlier this year, the American Academy of Pediatrics also recommended the use of weight-loss drugs in children aged 12 years or older, following the U.S. Food and Drug Administration‘s approval in December of the drug for that population.

$50 Billion in Opioid Settlement Cash Is on the Way. We’re Tracking How It’s Spent.

Kaiser Health News reported:

More than $50 billion in settlement funds is being delivered to thousands of state and local governments from companies accused of flooding their communities with opioid painkillers that have left millions addicted or dead.

That’s an enormous amount of money — double NASA’s budget and five times the revenue of an NBA season.

But how that massive windfall is being deployed and how future dollars will be spent seem to be shrouded in mystery. Reporting requirements are scant, and documents filed so far are often so vague as to be useless.

Most of the settlements stipulate that states must spend at least 85% of the money they will receive over the next 15 years on addiction treatment and prevention. But defining those concepts depends on stakeholders’ views — and state politics. To some, it might mean opening more treatment sites. To others, buying police cruisers.

Novo Nordisk Says Stopping Obesity Drug May Cause Full Weight Regain in 5 Years

Reuters reported:

Patients discontinuing the use of weight-loss drugs such as Wegovy risk regaining their original body weight in about five years, a Novo Nordisk (NOVOb.CO) official said on Wednesday.

Based on individual profiles, patients could gain back about half of the original body weight in two to three years if they stop the treatment, the Danish drugmaker’s head of global drug discovery, Karin Conde-Knape, told a health conference organized by CNBC.

The data pointed to the chronic nature of obesity and suggested that continuous treatment would be required to maintain weight and health improvement.

Wegovy, a semaglutide-based drug, is approved in the U.S. for the treatment of obesity in adults. The drug activates GLP-1, a hormone that triggers the feeling of fullness in the body after eating.

As Deadly Pathogen Spreads, GSK Throws a Lifeline to Scynexis With $90 Million Deal to Market Antifungal

Fierce Pharma reported:

Just as the CDC warns about the alarming spread of an emerging drug-resistant fungus, GSK has moved to snatch an FDA-approved drug that could tackle the pathogen — and salvage a floundering company along the way.

GSK is shelling out $90 million upfront to obtain the antifungal drug Brexafemme from New Jersey biotech Scynexis, the British pharma said Thursday. The drug is approved in the U.S. to treat a type of vaginal infection called vulvovaginal candidiasis (VVC).

Antimicrobial therapies have long been an area of low interest in the biopharma investment world. But GSK struck the deal just days after the U.S. CDC warned about the alarming spread of a potentially deadly drug-resistant fungus, a type of yeast called Candida auris, or C. auris.

Prescriptions for Stimulants Jumped During the Pandemic — Data Might Signal Improved Adult ADHD Awareness, but Questions Remain About Pandemic Prescribing

MedPage Today reported:

Prescriptions for stimulants have risen in recent years, with the sharpest increases seen during the pandemic, according to the CDC.

In an analysis of claims from employer-sponsored insurance, the percentage of enrollees with one or more prescription stimulant fills rose from 3.6% in 2016 to 4.1% in 2021, Melissa Danielson, MSPH, of the CDC, and colleagues reported in Morbidity & Mortality Weekly Report (MMWR).

“Although improved access to ADHD care through telehealth during the pandemic might have benefitted some persons with ADHD symptoms, it might have also introduced the potential for inadequate ADHD evaluations and inappropriate stimulant prescribing,” the researchers wrote.

CVS Health Expands to the Home With $8 Billion Signify Health Deal

Axios reported:

With its $8 billion acquisition of medical services provider Signify Health in the books, CVS Health is expanding its footprint into home health, CEO Karen Lynch said Wednesday at Axios’ What’s Next Summit.

Why it matters: CVS is among the retail giants in an arms race to add capabilities like primary care or telehealth across the healthcare continuum. It’s vying with Amazon, Walmart, Dollar General and Walgreens, among others.

The pharmacy giant already owns Aetna, pharmacy benefit manager CVS-Caremark and healthcare service brands MinuteClinic and HealthHUB.

Biden Admin Urges Supreme Court to Hear ‘Skinny Labels’ Case Between Teva, GSK

Reuters reported:

The Biden Administration told the U.S. Supreme Court on Wednesday that it should agree to hear a patent appeal over drug labels involving Teva Pharmaceuticals USA Inc (TEVA.TA) and GlaxoSmithKline LLC that could have significant ramifications for the generic-drug industry.

The U.S. Solicitor General said Teva’s generic version of GSK’s heart drug Coreg could not have violated GSK’s patent rights because Teva omitted the infringing use of the drug from its labeling.

Such “skinny labels” typically allow generic drugmakers to launch their products earlier while avoiding liability for infringing brand-name drugmakers’ patents.

A Teva spokesperson said Thursday that the company was pleased with the Solicitor General’s recommendation on an “important issue impacting both the pharmaceutical industry and U.S. patent law.”