Health News Roundup: U.S. FDA approves Acer Therapeutics' genetic disorder drug; BioNTech starts human trial to test malaria vaccine and more

"We can now happily confirm that the vaccines have arrived at the embassy and they will be stored here until we can officially start the vaccination drive which will be as soon as possible," the spokesperson said. U.S. FDA approves Acer Therapeutics' genetic disorder drug The U.S. Food and Drug Administration (FDA) has approved Acer Therapeutics Inc's drug for treating patients with a type of genetic disorder called urea cycle disorders (UCDs), according to the health regulator's website.

Following is a summary of current health news briefs.

BioNTech vaccines for German expatriates in China have arrived at German embassy

A shipment of BioNTech COVID-19 vaccines for German nationals in China have arrived at the German embassy in Beijing, an embassy spokesperson told Reuters on Friday. "We can now happily confirm that the vaccines have arrived at the embassy and they will be stored here until we can officially start the vaccination drive which will be as soon as possible," the spokesperson said.

U.S. FDA approves Acer Therapeutics' genetic disorder drug

The U.S. Food and Drug Administration (FDA) has approved Acer Therapeutics Inc's drug for treating patients with a type of genetic disorder called urea cycle disorders (UCDs), according to the health regulator's website. The approval letter, issued on Thursday, said the drug, sodium phenylbutyrate, could be used as an adjunctive therapy to the standard of care for patients with UCDs with certain deficiencies.

China lacked a 'zero COVID' exit plan. Its people are paying the price

At the public hospital in Shanghai where Nora, a 30-year-old doctor, works, tension has spiraled since China relaxed its stringent zero-COVID policy on Dec. 7. Patients quarrel with doctors to access drugs that are in short supply, like cough medicines and pain killers. Medics are overloaded; infected staff continue to work because of a scarcity of personnel.

Valneva makes U.S. regulatory submission for one-shot chikungunya vaccine

Vaccines company Valneva said on Friday that it had completed a regulatory submission step with the United States Food & Drug Administration (FDA) for its single-shot chikungunya vaccine candidate, VLA1553. Chikungunya is a mosquito-borne viral disease. Valneva plans to make regulatory submissions for its VLA1553 vaccine in Europe in the second half of 2023.

U.S. FDA approves Roche's lymphoma therapy

The U.S. health regulator has approved Roche Holding AG's therapy for treating a type of rare cancer called follicular lymphoma. The U.S. Food and Drug Administration's approval for Lunsumio was based on an early-to mid-stage study that showed the drug cleared signs of cancer in patients, with most patients responding to the treatment for at least 18 months, the company said late Thursday.

Omicron subvariant XBB jumps to 18% of U.S. COVID cases - CDC

The highly-contagious Omicron subvariant XBB has surged to more than 50% of COVID-19 cases in the northeastern United States and risks spreading fast as millions of Americans begin holiday travel on Friday. In the week ended Dec. 24, XBB was estimated to account for 18.3% of the COVID-19 cases in the United States, up from 11.2% in the previous week, according to the U.S. Centers for Disease Control and Prevention on Friday (CDC).

Eisai, Biogen's new Alzheimer's drug should be priced below Aduhelm - report

An influential drug pricing research group said Eisai Co Ltd and Biogen Inc's new Alzheimer's disease treatment lecanemab should be priced lower than the drug Aduhelm that was developed by the companies. In a draft report released on Thursday, the Institute for Clinical and Economic Review (ICER) said a price range of between $8,500 and $20,600 annually for lecanemab would meet some commonly used thresholds for cost effectiveness.

India plans to make COVID-19 negative test mandatory for passengers from high caseload countries

India is planning to make a COVID-19 negative test report mandatory for passengers arriving from countries with a high number of cases, the country's health minister said during an interview with broadcaster NewsX on Friday. "In the next one week, selected countries will be identified where the caseload is higher today," minister Mansukh Mandaviya said. "People from there who come to India will have to upload their (COVID-19) RT-PCR reports and only then come."

China's stretched health system braces for peak in COVID infections

China is expecting a peak in COVID-19 infections within a week, a health official said, with authorities predicting extra strain on the country's health system even as they downplay the disease's severity and continue to report no new deaths. In the face of a surging outbreak and widespread protests against its "zero-COVID" regime of lockdowns and testing, China began dismantling it this month, becoming the last major country to move towards living with the virus.

BioNTech starts human trial to test malaria vaccine

BioNTech on Friday initiated an early-stage study to evaluate its experimental malaria vaccine in humans, the German drugmaker said. The Phase 1 trial is expected to enrol 60 volunteers in the United States with no history of malaria to assess the vaccine candidate at three-dose levels.