Health News Roundup: US FDA declines to approve Ascendis' hormone disorder therapy; Gilead, US square off in billion-dollar HIV drug patent trial and more

But sales of both its vaccine and oral antiviral treatment came in above Wall Street estimates. US FDA halts India's Sun Pharma trials on dermatological drug The U.S. Food and Drug Administration (FDA) has asked India's Sun Pharmaceutical Industries Ltd to halt tests on one dose of an experimental dermatological drug due to the potential of blood clots, the company said on Tuesday.

Following is a summary of current health news briefs.

WHO says risk 'moderate' after laboratory in Sudan seized by fighters

The World Health Organization said on Tuesday it had found after a risk assessment that there was a "moderate risk" related to the seizure of a public health laboratory in Sudan's capital Khartoum by one of the warring parties. "The situation and the risk are being seen as moderate," WHO spokesperson Tarik Jasarevic told reporters at a briefing in Geneva.

US FDA declines to approve Ascendis' hormone disorder therapy

Ascendis Pharma A/S said on Monday the U.S. Food & Drug Administration had declined to approve the Danish drugmaker's experimental therapy to treat adult patients with a hormone disorder called hypoparathyroidism, citing concerns linked to manufacturing control of the drug and device combination. The company's U.S.-listed shares surged 19% in premarket trade as the agency did not express concerns about the clinical data submitted and did not seek fresh pre-clinical or late-stage trials in a so-called complete response letter.

Amgen sues Novartis to block generic osteoporosis, bone cancer drugs

Amgen Inc sued Novartis AG's Sandoz in New Jersey federal court Monday, accusing Sandoz's proposed versions of its multibillion-dollar bone-strengthening drugs Prolia and Xgeva of infringing several patents. Amgen asked the court to block Sandoz's biosimilars of the drugs until its patents expire. One of the patents named in the complaint does not expire until 2037.

Gilead, US square off in billion-dollar HIV drug patent trial

Gilead Sciences Inc is headed to trial in Delaware federal court this week to fight claims that it owes the U.S. government a share of multibillion-dollar profits from its HIV-prevention drug regimen. The government is seeking more than $1 billion from Gilead for allegedly failing to compensate the Centers for Disease Control and Prevention (CDC) for discovering that Gilead's HIV-treatment drug Truvada could help prevent the disease.

Incyte misses quarterly estimates on weak sales of key drugs

Incyte Corp on Tuesday reported first-quarter profit and revenue below Wall Street estimates as sales of two of its key drugs were hit by lower medical insurance coverage. The Delaware-based pharmaceutical company reported revenue of $808.7 million for the quarter through March, missing estimates of $859.2 million, according to Refinitiv estimates.

Pfizer leans on COVID products to top estimates

Pfizer Inc on Tuesday reported higher-than-expected first-quarter revenue and profit, buoyed by demand for its COVID-19 products, and reaffirmed its 2023 earnings forecast as it banks on newer drugs to contribute to growth later this year.

The company has said it expects 2023 to be a low point for COVID product sales, before potentially returning to growth in 2024. But sales of both its vaccine and oral antiviral treatment came in above Wall Street estimates.

US FDA halts India's Sun Pharma trials on dermatological drug

The U.S. Food and Drug Administration (FDA) has asked India's Sun Pharmaceutical Industries Ltd to halt tests on one dose of an experimental dermatological drug due to the potential of blood clots, the company said on Tuesday. The FDA has also said that patients with alopecia areata - an autoimmune condition that results in patchy hair loss - on the 12 mg dose of the drug deuruxolitinib should discontinue its use, Sun Pharma said.

Australia to ban recreational vaping in e-cigarette crackdown

Australia said on Tuesday it will ban recreational vaping and tighten other aspects of e-cigarette laws in the biggest crackdown on the tobacco industry in more than a decade to try to stop an alarming rise in teenage vaping. The government aims to ban all disposable vapes, which often comes in fruity flavours, ban the import of non-prescription vapes and limit nicotine levels, aiming for the sale of vapes to be confined to helping smokers quit.

Group of EU states seeks to reduce dependency on China for pharmaceuticals

A group of 19 European Union member states are pushing for measures to reduce the bloc's dependency on Chinese imports of pharmaceutical ingredients, a paper dated May 2 showed. The move comes a week after the European Commission proposed an overhaul of the legislation governing its 136 billion euro ($148 billion) pharmaceuticals industry.

Elanco's therapy for canine parvovirus gets first nod

Elanco Animal Health Inc said on Tuesday the U.S. Department of Agriculture (USDA) has provided a conditional license for its antibody to treat canine parvovirus, making it the first approved therapy. Parvovirus, a highly contagious disease, spreads by direct dog-to-dog contact as well as contact with contaminated feces. While unvaccinated dogs and puppies are most at risk, the virus can affect all dogs, causing acute gastrointestinal illnesses such as diarrhea and vomiting.