Health News Roundup: U.S. FDA declines to approve Cytokinetics' heart drug; S.African drugmaker Aspen posts 15% drop in interim profit and more

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.

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.

S.African drugmaker Aspen posts 15% drop in interim profit

South African drugmaker Aspen Pharmacare on Wednesday reported a 15% drop in interim profit, citing inflationary pressures, supply chain issues and a drop in COVID vaccine sales. Its headline earnings per share, a profit measure widely used in South Africa, was at 660 cents for the half year that ended Dec. 31, down from 777.2 cents in the year-ago period.

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.

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.

Novavax shares slump premarket on worries over prospects

Novavax Inc's shares plunged more than 24% in U.S. premarket trading on Wednesday, a day after the COVID-19 vaccine maker raised doubts about its ability to remain in business. The stock had dropped as much as 24.4% to $7.0 by 5:30 a.m. ET (1030 GMT), while its Frankfurt-listed shares fell 24.8%.

China scoffs at FBI claim that Wuhan lab leak likely caused COVID pandemic

The FBI has assessed that a leak from a laboratory in the central Chinese city of Wuhan likely caused the COVID pandemic, director Christopher Wray said on Tuesday, a claim China said had "no credibility whatsoever". "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.

EU silence over Pfizer COVID contract talks is problem that won't go away -watchdog

European Commission President Ursula von der Leyen's silence about her dealings with drugmaker Pfizer leading to the EU's biggest COVID-19 vaccine contract is hurting public trust and is a problem that will not go away, its ombudsman said. "We need to hear what went on, otherwise it's going to drag on," Emily O'Reilly said in an interview, pointing to the EU public prosecutor's investigation of the bloc's acquisition of vaccines and the European parliament's COVID committee's plans to hold more hearings on the issue. "So it just won't go away."

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.