Health News Roundup: WHO says risk 'moderate' after laboratory in Sudan seized by fighters; US FDA declines to approve Ascendis' hormone disorder therapy and more
"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.
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.
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.
Indian cough syrup: mystery middleman may be new clue
An unnamed middleman in Mumbai provided a crucial raw material used in Indian-made cough syrups that have been linked to the deaths of more than 70 children in Gambia, a chemicals trader involved in the supply chain told Reuters. The World Health Organization said last year the syrups, made by Indian manufacturer Maiden Pharmaceuticals Ltd, contained lethal toxins ethylene glycol (EG) and diethylene glycol (DEG) – used in car brake fluid. These ingredients can be used by unscrupulous actors as a substitute for propylene glycol (PG), which is a key base of syrupy medicines – because they can cost less than half the price, as Reuters reported in March.
Pfizer beats profit estimates on steady COVID products demand
Pfizer Inc on Tuesday beat estimates for first-quarter profit, helped by steady demand for its COVID products and said it expects newer drugs to contribute to growth later this year, sending its shares up nearly 3% in premarket trading. The company has said it expects 2023 to be a low point for COVID product sales, before potentially returning to growth in 2024.
US to end COVID vaccination requirements on May 11 for foreign travelers, federal workers
The United States will end its COVID-19 vaccination requirements for international travelers and federal workers on May 11, when the coronavirus public health emergency ends, the White House said on Monday. In February, the U.S. House of Representatives voted to lift the requirement that most foreign air travelers be vaccinated against COVID-19, one of the few remaining pandemic travel restrictions still in place.
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.
US Supreme Court spurns challenge to Indiana abortion cremation or burial law
The U.S. Supreme Court on Monday declined to hear a challenge to the legality of an Indiana requirement that abortion providers bury or cremate embryonic or fetal remains following the procedure, sidestepping another dispute involving a contentious Republican-backed state policy concerning abortion. The justices turned away an appeal by an Indianapolis abortion clinic and two women who underwent abortions at the facility of a decision by the Chicago-based 7th U.S. Circuit Court of Appeals to reinstate Indiana's requirement after a federal judge had invalidated it.
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.
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