Health News Roundup: U.S. FDA declines to approve Cytokinetics' heart drug; FDA neurosciences chief Billy Dunn to leave immediately, analysts raise concern and more

Wall Street analysts said Dunn's departure could impact the regulator's stance on neurological drug decisions in the near term, sending down shares of Reata Pharmaceuticals Inc 30% on Monday when media reports on the exit surfaced. Pfizer gets FDA panel's backing in RSV vaccine race A panel of outside advisers to the U.S. health regulator on Tuesday recommended Pfizer Inc's respiratory syncytial virus (RSV) vaccine, bringing it closer to becoming one of the first approved RSV shots for older adults in the United States.


Devdiscourse News Desk | Updated: 01-03-2023 10:33 IST | Created: 01-03-2023 10:29 IST
Health News Roundup: U.S. FDA declines to approve Cytokinetics' heart drug; FDA neurosciences chief Billy Dunn to leave immediately, analysts raise concern and more
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Following is a summary of current health news briefs.

U.S. FDA declines to approve Cytokinetics' heart drug

Cytokinetics Inc said on Tuesday the U.S health regulator declined to approve its oral drug for a type of heart failure, citing lack of sufficient data to show the drug was effective, and sending shares down 3% after the market trade. The U.S. Food and Drug Administration's decision comes after a panel of outside experts in December recommended against allowing the use of the drug due to safety concerns. The health regulator in its so-called "complete response letter" said the company needs to have an additional trial of the drug, omecamtiv mecarbil, to establish its effectiveness for the treatment of heart failure due to reduced ejection fraction, the company said.

FDA neurosciences chief Billy Dunn to leave immediately, analysts raise concern

The U.S. Food and Drug Administration neurosciences head Billy Dunn will retire from his role effective immediately, the health regulator told Reuters on Tuesday. Wall Street analysts said Dunn's departure could impact the regulator's stance on neurological drug decisions in the near term, sending down shares of Reata Pharmaceuticals Inc 30% on Monday when media reports on the exit surfaced.

Pfizer gets FDA panel's backing in RSV vaccine race

A panel of outside advisers to the U.S. health regulator on Tuesday recommended Pfizer Inc's respiratory syncytial virus (RSV) vaccine, bringing it closer to becoming one of the first approved RSV shots for older adults in the United States. The Food and Drug Administration's (FDA) advisory committee voted 7-4 in favor of the vaccine, saying data from the company's study established that the shot was effective and safe in preventing lower respiratory tract disease caused by RSV in people aged 60 years and older. One member abstained during voting.

U.S. FDA to restrict unlawful import of veterinary tranquilizer Xylazine

U.S. health regulators on Tuesday issued an import alert for drug ingredients and products related to Xylazine, used largely as a veterinary tranquilizer but has been a drug of abuse, to restrict its unlawful entry into the United States. The Food and Drug Administration (FDA) said its move aims to prevent the drug from entering the U.S. market for illicit purposes, while maintaining availability for its legitimate uses in animals.

As China's birth rate slumps, political advisor urges egg freezing for single women

A member of China's top political advisory body said she would propose allowing unmarried women to access egg freezing as a measure to preserve their fertility after the country's population fell last year for the first time in six decades. Lu Weiying, a member of China's top political advisory body, told the state backed Global Times that she would also propose including infertility treatments in the public health insurance system at the upcoming Chinese People's Political Consultative Conference (CPPCC), which kicks off on March 4.

Argentina suspends poultry exports as first industrial case of bird flu confirmed

Argentina has confirmed its first case of bird flu in industrial poultry, its agriculture secretary said on Tuesday, causing it to suspend avian product exports and raising fears the disease could spread and hurt exports from the South American nation. The case was detected in the southern province of Rio Negro, an area with ​​low poultry density, Secretary Juan Jose Bahillo said on Twitter.

FBI director says China lab leak likely caused COVID pandemic

FBI Director Christopher Wray said on Tuesday the agency has assessed that a leak from a laboratory in Wuhan, China, likely caused the COVID-19 pandemic. "The FBI has for quite some time now assessed that the origins of the pandemic are most likely a potential lab incident in Wuhan," Wray told Fox News.

Merck scraps third prostate cancer study as Keytruda therapy disappoints

Merck & Co on Tuesday scrapped a late-stage trial of a combination therapy with its cancer drug Keytruda as interim data showed it was unlikely to meet the main goals, making it the drugmaker's third trial for the disease to be abandoned. The setbacks were likely to put Merck further behind in its quest to develop a treatment for advanced forms of the most common cancer type in the United States.

Two people died of cholera in northwest Syria post-quake -civil defence

Two people have died of cholera in Syria's opposition-held northwest in the aftermath of a devastating earthquake that hit the area, a source from the rescue force that operates there told Reuters on Tuesday. The earthquake left more than 4,000 people dead in the rebel-controlled zone near the Turkish border and damaged fragile health and water infrastructure, prompting fears of a spike in cases of the disease.

U.S. FDA approves Reata's rare genetic disorder drug

The U.S. Food and Drug Administration on Tuesday approved Reata Pharmaceuticals Inc's drug for the treatment of a rare genetic disorder that causes progressive damage to the nervous system, sending shares up nearly 160% after the bell. The drug, Skyclarys, is Reata's first product to gain approval, and Jefferies analyst Maury Raycroft projected that U.S. sales of the drug could reach $400 million by 2030.

(With inputs from agencies.)

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