Health News Roundup: FDA's graphic warning labels for cigarettes are constitutional, US appeals court rules; China's Stemirna halts mRNA cancer vaccine trial, researchers say and more

The European Union's drug regulator has been reviewing wider use of the highly popular weight-loss drug Wegovy to include reducing the risk of strokes and heart attacks, adding to the previously-approved use to tackle obesity. US FDA classifies recall of Vyaire Medical's respiratory devices as most serious The U.S. Food and Drug Administration on Thursday classified the recall of privately held Vyaire Medical's respiratory support devices as most serious and said their use could cause major injuries or death.

Following is a summary of current health news briefs.

US surgeons perform first pig-to-human kidney transplant

A 62-year-man with end-stage renal disease has become the first human to receive a new kidney from a genetically modified pig, doctors from Massachusetts General Hospital in Boston announced on Thursday. The four-hour surgery, performed on March 16, “marks a major milestone in the quest to provide more readily available organs to patients,” the hospital said in a statement.

China's Stemirna halts mRNA cancer vaccine trial, researchers say

China's Stemirna Therapeutics has halted an early-stage trial for a new cancer vaccine, two of its trial researchers said, in a fresh setback to the company, which has been grappling with tight funding. Vinod Ganju, an oncologist at Paso Medical in Australia and one of principal trial investigators of Stemirna's personalized cancer vaccine SW1115C3 for patients with malignant solid tumours, said the study had been "on hold for several months".

Wegovy to be covered by US Medicare for heart disease patients

Heart patients insured under the U.S. Medicare program would be covered for Novo Nordisk's weight-loss drug Wegovy as long as it is prescribed to reduce their risk of heart attacks and strokes, the agency overseeing the program said on Thursday.

Medicare prescription drug plans administered by private insurers, known as Part D, currently cannot cover obesity drugs. Under the new guidance, however, such drugs would be paid for if they receive U.S. approval for a secondary use that Medicare does cover, the U.S. Centers for Medicare and Medicaid Services(CMS) said.

FDA's graphic warning labels for cigarettes are constitutional, US appeals court rules

A federal appeals court on Thursday said a U.S. government requirement that cigarette packs and advertisements contain graphic warnings about the dangers of smoking is constitutional, in a victory for the Biden administration and a defeat for the tobacco industry. Reversing a lower court ruling, the 5th U.S. Circuit Court of Appeals in New Orleans found that the 11 warnings required under a 2020 Food and Drug Administration rule were "factual and uncontroversial," and satisfied the First Amendment.

US FDA approves Italfarmaco's drug for Duchenne muscle-wasting disorder

The U.S. FDA has approved privately held Italfarmaco Group's drug to treat Duchenne muscular dystrophy (DMD), an inherited muscle-wasting disorder, the health regulator said on Thursday. The oral drug, to be sold under the brand name Duvyzat, is the first nonsteroidal drug approved to treat patients with all genetic variants of DMD, according to the FDA.

Novo Nordisk's once-weekly basal insulin icodec recommended for marketing approval in Europe

Danish drugmaker Novo Nordisk on Thursday said its once-weekly basal insulin icodec for treatment of diabetes in adults had received a recommendation for marketing authorisation from the European Medicines Agency's human medicines committee.

Germany's health insurance could cover Wegovy for strokes, heart conditions, agency says

Germany's public health insurance scheme can cover certain patients with a risk of heart disease or strokes to take the weight-loss Wegovy drug, a big boost for Novo Nordisk's efforts to convince governments of its wider medical benefits. The European Union's drug regulator has been reviewing wider use of the highly popular weight-loss drug Wegovy to include reducing the risk of strokes and heart attacks, adding to the previously-approved use to tackle obesity.

US FDA classifies recall of Vyaire Medical's respiratory devices as most serious

The U.S. Food and Drug Administration on Thursday classified the recall of privately held Vyaire Medical's respiratory support devices as most serious and said their use could cause major injuries or death. The medical equipment maker recalled certain models of its AirLife Manual Resuscitators, a single patient-use device intended for respiratory support, due to a manufacturing defect.

EU regulator delays decision on Eisai-Biogen Alzheimer's drug

The European Union's medicines regulator has delayed it decision on Eisai and partner Biogen's Alzheimer's disease drug that was expected this week, the Japanese company said on Friday. On Monday, the European Medicines Agency had said it would hold a oral hearing to discuss the drug, lecanemab, this week.

Exclusive-France picks German, French firms in second bird flu vaccine tender

France has picked German company Boehringer Ingelheim and France's Ceva Animal Health to supply bird flu vaccines as part of an unprecedented vaccination campaign against the disease that has decimated poultry flocks, the companies told Reuters. France has been among the countries worst affected by a global spread of highly pathogenic avian influenza, commonly called bird flu, in previous years, which led to the death of tens of millions of poultry in the country.

(With inputs from agencies.)